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1 C A N C E R A D V O C A C Y C O A L I T I O N O F C A N A D A R E P O RT CARD Fighting the System While You Fight Cancer Imagine being diagnosed with breast cancer, making the difficult choice to have a mastectomy and then finding you c a n t get to an oncologist because nobody knows where your test results are. Joanne Spilchuk turned to her longtime friend to help find the answers, push the system and keep her spirits up. PAGE 6 Douglas Emerson had spent much of his career working with government. But even he was not fully prepared to deal with the Ontario health ministry when his father needed treatment for multiple myeloma. PAGE 24 What prompted Suzanne Aucoin, a normally reserved educator, to morph into a onewoman assault on the failures of the cancer system? It all started when she learned her Stage I colon cancer had not been cured, but had advanced to Stage IV. PAGE 39 CACC is proud to count itself as one of the advocacy groups that finally focused the attention of our governments and political parties on the failure to control cancer. Responding to advocacy recommendations, some of the priorities of the Canadian Strategy for Cancer Control have been folded into the plans of the Public Health Agency of Canada. But some have not. Notable among the missing elements are important issues surrounding the treatment of cancer. Cancer Care Waits Time Elapsed and Time Wasted Simple examination of unidimensional care events will be very unlikely to capture the relevant issues hindering timely cancer care and the potential impact on patient satisfaction and, most importantly, outcomes. PAGE 8 International Comparisons of Prevention Programs Canada cannot claim to be a leader in secondary p revention seeking to arrest or re t a rd existing disease and its effects through early detection and appropriate treatment. We could learn much from the experience in other countries. PAGE 13 Cancer Drug Access New drugs are being incorporated into increasingly complex, multi-modality treatments with greater prospects for better outcomes. Accessing them may make the difference between life and death for patients with specific cancers. PAGE 26 VOLUME 8, WINTER

2 CANCER ADVOCACY COALITION OF CANADA REPORT CARD VOLUME 8, WINTER E D I T O R S Colleen Savage, Nadine Saby CACC EDITORIAL ADVISORY COMMITTEE William Hryniuk, Geoff Eaton, Kong Khoo, Robert Pearcy, Colleen Savage, Sandi Yurichuk DESIGN Bob Wilcox Special thanks to many organizations for their help in defining and researching cancer priorities for this publication: Advocacy Solutions, Best Medicines Coalition, Canadian Cancer Society, Canadian Association of Provincial Cancer Agencies, cancer agencies and government contacts across the country, the Colorectal Cancer Association of Canada, Lung Cancer Canada, Canadian Prostate Cancer Network, Canadian Breast Cancer Foundation, Canadian Hospice Palliative Care Association and individuals in many other cancer groups. Your advice and cooperation are greatly appreciated. BOARD OF DIRECTORS Jack Chritchley BA, MD, MSc, FRCPC practiced Internal Medicine and Medical Oncology for 25 years in the Interior of British Columbia before joining the BC Cancer Agency as a Vice President leading the provincial Communities Oncology Network. Geoff Eaton is a cancer survivor and founder of RealTime Cancer. James Gowing BA, MB, BS, FRCPC, founded the community cancer clinic in Cambridge, ON and established the National Conference on Community Cancer Clinics. He has been an advocate for community cancer care and cancer control throughout his 40-year medical career. William Hryniuk (chair) MD, FRCPC, has practiced in Canada and the US as a medical oncologist, taught at medical schools, developed and directed major cancer centres and regional cancer control programs. He remains active in basic and clinical research and is currently Medical Director of CAREpath Inc. Darwin Kealey (vice-chair) BA, MA, is a former executive public servant and international entrepreneur with extensive advocacy experience. Kong Khoo MD, FRCPC, is a medical oncologist based in the southern interior of British Columbia, in Kelowna. Eric MacEwen is a founding director of the East Coast Music Awards and has been a singular voice for the music of Canada s East Coast through his weekly syndicated radio program. Eric is also a recent cancer survivor. Anthony Miller MB, FRCP, is Professor Emeritus in the Department of Public Health Sciences, University of Toronto, Director of the Canadian National Breast Screening Study, a. consultant to the World Health Organization and to the US National Cancer Institute, and member of the Council of the Canadian Strategy of Cancer Control. Previously, Director of the Epidemiology Unit of the NCIC and Chairman of the Department of Preventive Medicine and Biostatistics of the U of T. Special Expert in the Early Detection Branch, Division of Cancer Prevention, US National Cancer Institute, Senior Epidemiologist, International Agency for Research on Cancer, Lyon, France, and Head, Division of Clinical Epidemiology, German Cancer Research Centre, Heidelberg, Germany. Robert Pearcey MA, MBBS, FRCR, FRCPC, is a practicing academic radiation oncologist and Professor of Oncology in Edmonton. He also has 14 years of previous administrative experience in Radiation Oncology and is the current chair of the specialty committee in Radiation Oncology for the Royal College of Physicians of Canada. Joseph Ragaz MD, FRCP, is Director of the Oncology Program, McGill University Health Centre. Previously he spent 27 years as a senior medical oncologist, and nationally and internationally recognized breast cancer researcher at the BC Cancer Agency. Jack Shapiro Order of Canada, is presently the Vice Chair of the Canadian Strategy for Cancer Control, Co-chair of the Canadian Cancer Advocacy Network and Board Member for the Canadian Cancer Research Alliance. Sandi Yurichuk BS, MBA, is a cancer advocate and management consultant in the field of oncology CACC except where otherwise noted. All photos supplied by the individuals and used with their consent. Cancer Advocacy Coalition of Canada Suite St. Clair Avenue East Toronto, Ontario M4T 1N5 c a n c e r a d v o c a c o n. a i b n. c o m Phone toll free DISCLAIMER: Cancer Advocacy Coalition of Canada (CACC) provides the Report Card for general information related to current events and topics relevant to cancer in Canada. While CACC makes best efforts to ensure the accuracy and timeliness of the information contained in the Report Card the information is taken from various public and private sources so that no responsibility can be assumed by CACC for the accuracy or timeliness of this information. The opinions expressed in the Report Card are those of the individual authors of individual articles and material. Their views do not necessarily reflect the views of CACC. WARNING: CACC s Report Card should not be used for the purpose of self diagnosis, self treatment or as an alternative to medical care. If you have any concerns arising out of the information contained in CACC s Report Card, you should consult your own physician or medical advisor. If you suspect you have cancer, seek professional treatment immediately. About the Cancer Advocacy Coalition of Canada The CACC is Canada s only full-time, registered, non-profit cancer group dedicated exclusively to advocacy. The CACC is not a charity and operates on unrestricted grants from sponsors based on guidelines that ensure the organization s autonomy. The CACC publishes Canada s only independent evaluation of cancer system performance, the annual Report Card on Cancer. The Board of Directors is comprised of unpaid volunteer oncologists, health sector executives and patient advocates from across the country. Our Vision for the Cancer System An effective, comprehensive, evidencebased cancer system that offers Canadians the best chances for preventing and treating this disease, and addresses the emotional, physical and financial needs of patients and survivors. Our Goals: to benefit cancer survivors and all Canadians Consistent adherence to best practices in cancer care and prevention, making best use of financial and human resources Accountability to patients, survivors and taxpayers, transparency of decisionmaking, priority-setting and performance measurement Reduction of the emotional, physical and financial distress associated with a cancer diagnosis Access to best practices in disease prevention and timely, effective treatment options Increased awareness of prevention choices

3 IN THIS ISSUE Editorial William Hryniuk So You Have Cancer Hurry Up and Wait Joanne Spilchuk Cancer Care Waits Time Elapsed and Time Wasted Daniel Rayson Provincial Wait Times, 2004 Colleen Savage International Comparisons of Prevention Programs Anthony B. Miller and Nadine Saby Provincial Screening Programs Colleen Savage Your Money or Your Life William Hryniuk Cancer Stage Facilitation Initiative Brent Schacter No. Maybe. Yes. Never Again. Douglas Emerson Cancer Drug Access Kong Khoo, William Hryniuk, Joseph Ragaz, James Gowing and Colleen Savage In 1999 They Told Me I Was Cured Suzanne Aucoin Duty of a Physician to Disclose Cancer Treatment Alternatives Katie Osbourne Playing With the Numbers William Hryniuk News Increased Funding Saves Lives James Gowing CANCER CARE IN CANADA, WINTER

4 E D I T O R I A L This has been an eventful year. First and foremost, the federal government has recognized the importance of cancer as a national problem and, as an initial step, prior to the election committed $60-million to dealing with the problem at the national level. Presumably this means a commitment to implement our long-standing Canadian Strategy for Cancer Control (CSCC). In addition, if we are to believe the promises of political parties vying for power, five to six times this amount would also be earmarked for cancer control. Of special interest is the inclusion of an additional $100-million for the CSCC in one of the announcements. CACC is certainly proud to count itself as one of the advocacy groups that finally focused the attention of our governments and political parties on the failure to control cancer. It is still not clear how this newly promised money will be spent, nor what is the framework for implementing the CSCC. Responding to advocacy recommendations, some of the priorities of the CSCC have been folded into the plans of the Public Health Agency of Canada, and some have not. Of those included, establishment of a national surveillance system would appear to be a necessary first step for cancer control. Notable among the missing elements, however, are important issues surrounding the treatment of cancer. Since advances in systemic therapy have been the main reason for recent improvements in survival, it is hard to understand how any strategy can be successful if it does not take into account this aspect of cancer control. We are still trying to push the heavy rock of the CSCC up the steep hill of the relationships between the Public Health Agency of Canada (responsible in the federal government for parts of the CSCC) and the governments of the provinces and territories responsible under the constitution for actual delivery of health (cancer) care. We must continue to ensure that an effective national cancer control strategy will be adequately funded and properly implemented. We expect prevention to win the day in the long-term, but this is small comfort to the 150,000 Canadians who develop the disease every year, or to the thousands of professionals doing their best to save the lives of their patients and give them comfort. In terms of treatment, the advent of highly effective new cancer drugs for use in systemic therapy guarantees that even better results can be expected in the near future. However, as documented in careful detail in this issue, access to the new drugs continues to be very uneven across Canada, largely because of their cost, but also in part due to the cumbersome and often duplicative processes in place in many provinces to assess their worthiness. There is better access in the western half of the country and we can expect the west-east gradient in cancer mortality to become even more marked in the next few years unless something is done to redress the imbalance. Once more it is clear from this imbalance that, as far as cancer treatment is concerned, universal access to health care in Canada remains a myth. U n f o rt u n a t e l y, most Canadians seem unaware of this fact. In studying how to deal with the imbalance issue, the new US plan for providing every American senior with access to drugs, which came into effect on January 1, 2006, should be visited. Better still, the suggestions put forth by Senator Kirby should be seriously considered. It s not as if we don t have the makings of a plan of our own. Yet it appears that our elected politicians have ignored the extensive study and recommendations put forward in 2002 by our own Senate. The high cost of the new drugs bedevils patients, health professionals and governments alike, but the introduction of a national plan would begin to deal with this problem. The cost is the canary in the mineshaft, since the same problem is common to every other chronic disease on the books, and begs for a solution. Without a rational method for calculating the overall effect of each new agent on the health and productivity of the nation, the Sturm und Drang over cost will continue. A national drug plan, coupled with a robust pharmacoeconomic model for calculating cost of illness and cost-effectiveness, would be an important first step towards finding the solution. It would expedite access, 4 CANCER CARE IN CANADA, WINTER

5 redress imbalances which can reach egregious degrees (see Page 20 in this issue), introduce economies of scale in purchasing, and reduce the redundant efforts of separate provincial guideline committees. It would also present a valuable opportunity for measuring the true value of each agent to the economy through linkages with the records of provincial health service plans. Which brings us to the Doctor s Dilemma, as GB Shaw so aptly put it: the drug cost issue has put our oncologists in a bind. On the one hand they are dutybound to tell their patients of every reasonable and effective therapeutic option that exists, even if the institution in which they are working does not provide the treatment. On the other hand, being acutely aware of the cost of the new drugs, oncologists know they will arouse anguish in patients who are not allowed access. Tell they must, as the article on ethics explains (see Page 40 in this issue), but if they tell, it gets worse. Oncologists spend hours filling out forms just to get the new drugs already on the funded list for their patients. Now they must also help their patients access the new drugs which have received approval from Health Canada but have not yet been funded in their particular province. To do this, they must spend many hours on the paperwork re q u i red by govern m e n t authorities and insurance companies. Again, this problem would be largely solved by a national drug plan. Speaking of new drugs, it is time the CSCC was revisited with a view to addressing the drug cost/benefit problem. The CSCC was crafted before the present era of highly active and expensive biologic agents appeared on the scene. Lessons learned from the approaches of the highly successful BC Cancer Agency could be adapted to each province with little additional expenditure of effort and with great benefit. Much could be done with existing resources while waiting for the politicians to make good on campaign promises. If politicians don t help solve this problem, the courts will. Already a Supreme Court decision has struck down the injustice of the Quebec provincial government s position on private health insurance because it deprived individuals of the security of their persons and interfered with the interests protected by the Charter. As a result, the attitudes and posture of every level of government have dramatically changed. Each is now waiting for the other shoe to drop; and drop it has, as evidenced by the pending suit against the Ontario Health Insurance Plan for failure to approve a life-saving liver transplant in a patient with a localized hepatoma, which was subsequently performed in the UK with lasting success. As far as waiting times are concerned, the Canadian public and their oncology professionals are growing increasingly impatient with incomplete, diverse data that continue to be more system-centred than patientcentred. Perhaps the upcoming workshop to be held by the Canadian Association of Provincial Cancer Agencies will finally make real progress toward comparable waiting times data that mean something to the patient. The first step, as we have described in previous Report Cards, is a common set of definitions. Following that, what patients and providers need to know is when a wait increases risk and when it does not. In the absence of any such answers, a number is merely a number. But it hasn t all been problematic. Of the many advances documented in the News section of this Report Card, several stand out. Two new families of drugs have emerged for the treatment of breast cancer, each capable of immediately improving disease-free survival. Adjuvant chemotherapy of lung cancer after resection for cure will hopefully have the same effect. Some of the pivotal trials proving the effectiveness of these approaches were conducted and led by Canadian oncologists, working through the National Cancer Institute of Canada, and funded by the Canadian Cancer Society. And for the first time we can look to cancer prevention by new vaccines and prevention of cancer recurrence by dietary change. So while we strive for improvements, we must also count our blessings. Dr. William Hryniuk CANCER CARE IN CANADA, WINTER

6 So You Have Cancer Hurry Up and Wait BY JOANNE SPILCHUK My first indication of a problem was finding a lump a few weeks before Christmas of I decided that after the holidays I would get to a doctor immediately and have it checked, not realizing the next ten months would become a whirlwind of tests, procedures and hurry up and wait. My local doctor referred me to a surgeon nearby and on January 20, 2005, I was examined and had a quantity of fluid removed from the lump for testing. The surgeon took time to make sure I understood the results may be cancerous and offered to bring my husband into the consulting room to talk about what might happen next. I decided to talk to my husband and daughter at home, where we would be more comfortable. The test results were back on January 27, 2005 and the next day my husband and I were in the surgeon s office for the news. We had talked and cried and tried to prepare ourselves for this appointment. I made a resolution that for the next year I was going to be happy, pushing all other worries aside. The surgeon made sure I understood the tests and the options for treating the cancer found in the fluid from the lump. I felt a complete mastectomy made sense for me. I was told that that several lymph nodes would be removed and tested to see if any nodes were involved. The next few weeks were a round of tests and a lot of travel but getting the tests done quickly was a priority. My surgery was February 9, 2005, within three weeks of my first visit with the surgeon, and I was able to go home three days after surgery. My first surprise was the two tubes dangling from openings where my breast had been. The surgeon and staff explained why and how I was to look after this step of my recovery although nothing had prepared me for this development: it is not mentioned in the pamphlets or books. All went well and on February 18 a local doctor removed the tubes, which was a little more painful than I expected but it was only a few minutes. I was phoning the cancer clinic about an appointment, only to find they had no re c o rd of me or any test re s u l t s The first results on my tissue were received within a week of my surgery; these results were encouraging and on February 25 the surgeon told me to expect an appointment with an oncologist about two weeks after the second results were done. Those second test results were in at the end of the month but not sent to the cancer clinic until March 15. Meanwhile I was phoning the cancer clinic about an appointment, only to find they had no record of me or any test results. They asked, was I sure I had cancer? By this time I began to feel worried about the time it would take to get treatment. Having my friend Sandi help guide me through the medical and emotional upheaval was a godsend. She is a board member of the CACC and made me understand the need to get an appointment with an oncologist as soon as possible. Trying to get an appointment soon became a roller coaster of referrals, ups and downs, and a lot of frustration. The cancer clinic in my home province of Saskatchewan would not have an appointment until four and a half weeks after receiving my results, so on the advice of friends and family I began to approach other provinces. One province could only take me as a patient if I were covered under a federal 6 CANCER CARE IN CANADA, WINTER

7 plan; another province thought they could help but finally said no, as it would be too complicated to set up follow up treatments. I realized provinces do not want each other s patients and my case was not considered extreme enough to warrant going out of province. With persistent telephone calls to the Saskatoon clinic, and with a friend calling as well, I got an appointment on April 13, 2005, nine weeks after my operation and one week ahead of the date originally offered. My daughter attended the appointment with me, helping me to concentrate on the information and focus on asking the right questions. I started my chemotherapy two weeks later on April 27, After six treatments an appointment with the oncologist was booked to discuss follow-up treatment. In my case the physicians were not even offering me Herceptin, although I had learned it showed a 50 percent reduced risk of relapse for my disease. I had to ask for it and lobby for it. Being worn out from travel and treatments, it was a godsend to have a knowledgeable friend by my side to be my advocate. I think a lot of cancer patients start to get brain fog and having a friend or family member with you is important. At the time of this appointment Herceptin was not covered in Saskatchewan, so the cost was a real shock and concern for my family. Fortunately, my husband had checked with his insurance and was told as long as the drug was prescribed by a doctor and filled by a pharmacy they would cover it. Ironically the drug became available just when I needed it. What if it didn t? What if I didn t have insurance? What happens to you then? Cancer is a disease of many faces and most of us come to realize how fortunate we are to have the support of family, whether they are related or so close in friendship that the word family re a l l y CHRONOLOGY OF A WAIT From first appointment with surgeon to surgery: three weeks From surgery to test results: three weeks From test results to first appointment with oncologist: six weeks From first appointment with oncologist to first chemo: two weeks defines who they are. The diagnosis of cancer can in turn affect the health of those close to you. My husband now has high blood pressure and migraines. The stress on patient and family is enormous: waiting for appointments, test results and discovering things do not move smoothly unless you push. The travel, the frustrating ups and downs of waiting, searching for information and answers, can become unbearable. Having family and friends to keep me focused and positive was and is a treasured gift. Lessons learned from my experience You have to be involved with your disease, the decision-making and treatment outcomes. If at all possible have an advocate who will make your appointments happen, take notes and know what treatment options are available. You need a knowledgeable resource. From my friend and advocate, I learned there is new scientific information showing that a reducedfat diet is also beneficial in helping reduce the risk of recurrence for women with my type of breast cancer. The cancer clinic knew nothing about this and did not volunteer to help me. Again, be your own advocate. Joanne Spilchuk is a 51 year old woman being treated for breast cancer, who lives in a community that is a four hour drive from the Saskatoon cancer centre. She is glad to be alive, happy to be with her family and looking forward to a trip to Hawaii when she is 75, with her advocate friend. 2006, CACC. We gratefully acknowledge Joanne Spilchuk s contribu - tion and assignment of her rights in this article to CACC. CANCER CARE IN CANADA, WINTER

8 WAITI NG TI MES WAIT ING T IMES WAITI NG T IMES Cancer Care Waits Time Elapsed and Time Wasted BY DANIEL RAYSON Prolonged waiting times for medical care continues to be one of the most politically contentious, societally enervating, medically challenging and financially draining issues facing Canadian society. The ideal of timely and equal access to care for all is crashing head-on into the medical realities of the 21 st Century. These are characterized by exponentially expanding therapeutic options across all diseases and disabilities, spiralling costs of systemic therapeutics and a medical infrastructure in constant reaction to burgeoning demands for timely service. These issues become even more acute when focusing on cancer care. Cancer, in general, is not an acute medical emergency comparable to a motor vehicle accident, heart attack or surgical abdomen. But it remains a medical urgency in all cases and is compounded by the emotional, psychosocial and situational crises that a cancer diagnosis brings to the affected and their loved ones. Cancer care is, by definition, a multidisciplinary field of medicine requiring close collaboration and interaction with a variety of medical and paramedical specialists, frequently scattered in diff e rent places within institutions and between different institutions. As such, examining the issue of waiting times for care is fraught with inherent difficulties due to the fragmented and often poorly communicated nature of the medical services provided. A true understanding of the impact, as well as the burden of cancer care wait times, requires an understanding of the entire sequential care timeline involved for a particular patient and/or diagnosis. Simple examination of unidimensional care events will be very unlikely to capture the relevant issues hindering timely cancer care and the potential impact on patient satisfaction and, most importantly, outcomes. The concept of elapsed time to care may provide a more accurate and politically neutral definition that may help clarify this entire field of investigation. The overall elapsed time to care comprises components of medically justified as well as unjustified time segments. Medically justified wait times may include components of surgical recovery, symptom stabilization, staging evaluation and second or multidisciplinary opinions regarding diagnosis and treatment plan, among others. This medically justified time will vary across all disease types, stages and clinical situations and may play a critical role in ensuring appropriate therapies are administered and outcomes are optimal. These times are in contradistinction to medically unjustified elapsed times, which could be related to system infrastructure, multilevel resource issues and poor information sharing processes that may v a ry within institutions, across jurisdictions and between provinces. These medically unjustified elapsed times should become the principle targets of intervention, as these are the intervals that often lead to unnecessary prolongation of care and can truly be classified as a wait time, where treatments could and should begin, yet are held up by system inefficiencies as well as resource and staffing deficiencies. Data from a number of investigations clearly support the perception of a significant deterioration in timely access to cancer care nationwide. In Nova Scotia we have previously published data examining elapsed times for breast cancer care from first breast abnormality to the s t a rt of first post-operative therapy (chemotherapy, hormonal therapy or radiation). Over this timeline, six care intervals were assessed. Overall median time from clinical or mammographic detection of breast cancer to initiation of first adjuvant therapy was 91 days, with 25 per cent of patients experiencing an elapsed time of greater than 123 days 1. We have recently completed an analysis of data from a second cohort/group of patients diagnosed in and compared this timeline to our previously published data. Within the overall elapsed time period, certain care segments were significantly more prolonged in the latter cohort. These include time from pathologic confirmation of disease to definitive surgery, date of last definitive surgery to receipt of a referral at the Cancer Centre, as well as date of oncology consultation to start of first adjuvant therapy. These sub-segment prolongations resulted in a significant prolongation of the overall timeline from a median of 91 days in 2000 to 102 days in 2004 (p=0.002) 2. There has also been evidence of a prolongation of wait times for breast cancer surgery from initial diagnosis in Alberta between the years 1997 and , as well as a prolongation in the wait times for prostatectomy in 8 CANCER CARE IN CANADA, WINTER

9 Ontario between the years 1996 and The analysis of elapsed times is and will remain highly dependent on the quality of the data, the clarity of the care time intervals under investigation and the validity of the statistical tools used to describe the data. It must also be recognized that changes in one segment of cancer care may not lead to changes in overall care timelines. This has recently been demonstrated in the UK, where waiting times from GP referral to first hospital appointment have improved, yet times from first appointment to treatment have increased with resultant little change in total waiting times 5. A full understanding of the sequence of care events across disease sites will be critical to the development of rational interventions and resource allocation aimed at improving timely cancer care access. Ideally, wait times for care should be linked directly to outcomes but this has been very difficult, due to the highly variable clinical situations, even within specific disease sites. There has been conflicting data published on adjuvant chemotherapy timing and outcomes for breast cancer. Recently, however, there has been evidence suggesting a poorer disease-free survival for women with hormone receptor negative breast cancer beginning chemotherapy greater than 20 days following surgery 6. It is highly likely that wait times may influence clinical outcomes amongst some patients and not others. An understanding of the full impact of wait times on outcomes will need to arise from investigation of these times amongst specific groups of patients rather than on a global, undifferentiated population with similar disease processes yet highly varying outcomes due to differences in stage, age and pathology. Regardless of ultimate effect on outcome, all patients need to be supported through the periods of elapsed time to care. The situational chaos that arises from a cancer diagnosis will challenge and stress the personal and family coping skills of all those affected. Timely introduction of high quality information and compassionate emotional, psychologic and situational support will go a long way in minimizing the morbidity associated with elapsed times to cancer care, whether medically justified or not. The Breast Cancer Link Program of the Nova Scotia Breast Cancer Site Team has developed such a program for all patients referred to the Nova Scotia Cancer Centre. Upon receipt of referral, an oncology nurse contacts the patient and discusses a variety of issues associated with the wait to see an oncologist, as well as expectations and questions that may arise during the consultation. Acute emotional or situational issues are identified and appropriate ongoing support or other services are offered. The result of this has been a dramatic improvement in quality of life and in patient preparation prior to consultation for all those referred for an oncologic opinion following resection of a primary breast cancer. The Canadian public and their oncology professionals are growing increasingly impatient with incomplete, arbitrary data that remains entirely system- rather than patient-centred. The study of wait times should in no way impede efforts to minimize unjustified elapsed times at all levels within the cancer care system. Waiting for data is no longer an acceptable substitute for proactive intervention. Many of the initial steps can be taken at local or institutional levels and do not necessarily require high level governmental or health jurisdiction policy decisions. Ideally, a fully integrated, validated, and disease-, as well as patient-specific, elapsed time benchmark across all disease sites would dire c t intervention. There is, however, increasing concern that such data will never be fully available and we will continue as a nation to deal with institutional, local and provincial resource issues impeding timely, wellsupported cancer care. A proactive, honest and full examination of the factors impacting wait times for cancer care may lead to improvements and/or solutions apparent at the local level that may not be appreciated at larger population-based levels. All proposed interventions must be examined and evaluated against patientcentred objectives and well-defined care time intervals. The absence of complete data does not excuse the absence of motivated action to expand resources in order to minimize the physical, emotional and situational chaos that all cancer patients experience prior to, at, and following diagnosis. Daniel Rayson, MD, FRCP(C) is a medical oncologist at the QEII Cancer Care Program, Assistant Professor, Department of Medicine at Dalhousie University in Halifax, and Chair of the Provincial Breast Cancer Site Team of Nova Scotia. 2006, Daniel Rayson; used with the kind permission of the author. REFERENCES 1 Rayson D, Chiasson D, Dewar R. Elapsed time from breast cancer detection to first adjuvant therapy in a Canadian province, CMAJ 2004 Mar 16; 170(6): Rayson D, Saint. Jacques N, Meadows J, Younis T, Dewar R. Comparison of elapsed times from breast cancer detection to first adjuvant therapy in a Canadian province, and (in preparation). 3 Siemens DR, Schulze KM, MacKillop WJ, Brundage MD, Groome PA. A population-based study of the waiting times for prostatectomy in Ontario. Can J Urol 2005 Apr; 12(2): Reed AD, Williams RJ, Wall PA, Hasselback P. Waiting times for breast cancer treatment in Alberta. Can J Public Health 2004 Sep-Oct; 95(5): Robinson D, Bell CM, Moller H, Basnett I. Effect of the UK government s 2-week target on waiting times in women with breast cancer in southeast England. Br J Cancer 2003 Aug 4; 89(3): Colleoni M, Bonetti M, Coates AS, Castiglione-Gertsch M, Gelber RD, Price K et al. Early start of adjuvant chemotherapy may improve treatment outcome for premenopausal breast cancer patients with tumors not expressing estrogen receptors. The International Breast Cancer Study Group. J Clin Oncol 2000 Feb; 18(3): CANCER CARE IN CANADA, WINTER

10 WAIT ING T IMES WAIT ING T IMES The more things change, the more they remain the same Provincial Wait Times BY COLLEEN SAVAGE The federal deadline for mandatory reporting passed, the announcements were made and we still can t see any improvement in the provinces ability to report wait times. Every year we learn a bit more about how the numbers were calculated but the picture looks worse, not better. As three patient advocates write in this edition, it is hard to persuade the cancer system (or health ministry) that waiting for systemic treatment for cancer is really a problem. More precisely, it is not a problem if it does not have to appear in provincial reports on wait times. Joanne Spilchuk and her friend spent six weeks trying to get her into the cancer system, but it will not appear that way in mandatory reporting by her cancer agency (So You Have Cancer Hurry Up and Wait, page 6). Provinces have started to spew out numbers to give the appearance of honouring the federal-pro v i n c i a l agreement but still definitions remain as varied as snowflakes. This year s data collection question was intended to remove as much obfuscation as possible, seeking only the three pieces of information that cancer agencies have to admit they know: the referral date, the date of that patient s first appointment with an oncologist, and the date when the first treatment began. We thought we were making it easier. As the table demonstrates, the ability and the willingness of the agencies to provide this most basic information remains very uneven. Again we see footnotes, exceptions, and explanations. Quebec and New Brunswick are still building their information systems as part of the effort to implement organized cancer control programs for the first time; Newfoundland and Labrador is dealing with reorganization of its cancer agency. Ontario wait times do not fit the Table format on the next page and can be found in the footnotes. We also note with interest that one of the first new benchmarks announced by the Federal/Pro v i n c i a l / Te rritorial health ministers effectively doubles the acceptable waiting time for radiation therapy. For years, the Canadian Association of Radiation Oncologists has recommended that radiation therapy begin within four weeks of referral, but the new benchmark is for four weeks from the ready to treat date. This means the entire block of time required for various tests after referral to a cancer center is no longer being included. The next issue will be trying to untangle each jurisdiction s definition of ready to treat as attempts are made to fit most cases into the designated timeframe. Conclusions We have spent several years without success trying to derive waiting times data that would be meaningful to patients, the public and administrators. In our experience, the issues arising include: An array of definitions is used to describe various types of waiting e.g. referral date may mean the day it was first received at the cancer agency/hospital or the day it was deemed complete enough to be accepted. Wait time is being distinguished from elapsed time but patients object strenuously to this apparent manipulation of terminology. The evidence used to predict a connection between wait time and outcome is being variously interpreted depending on which body of experts does the review. Benchmarks are not crafted to fit each stage of each cancer; we still have one-size-fits-all benchmarks. The standards for determining urgency of care are not transparent to the public. Undocumented claims are made that patient-initiated delays are so frequent as to distort the accuracy of wait time reports. If the patient s travel problems create a delay of two days and the clinic s scheduling problems turn that into two weeks, the onus for this entire delay is placed on the patient. A variety of methods are used to report wait times e.g. rolling three-month medians, percentiles served within a fixed time, or one-day sampling extrapolated to a month and four months of such sampling extrapolated to a year. 1 0 CANCER CARE IN CANADA, WINTER

11 The good news An upcoming consensus conference hosted by the Canadian Association of Provincial Cancer Agencies (CAPCA) will finally start to address the plethora of wait time definitions in use across the country. Consensus would greatly assist cancer agencies in collecting the same data elements and reporting in a fashion that allows comparisons. The CACC has pushed for this conference for more than a year after discovering that in every province, the personnel responsible for gathering data were eager to adopt common definitions. In another example of CAPCA leadership, the Cancer Stage Facilitation Project holds promise of contributing to a better understanding of the relationship between wait times and patient outcomes (see page 22). Colleen Savage is President & CEO of the Cancer Advocacy Coalition of Canada WAIT TIME RESULT S CALENDAR YEAR 2004 BC AB 4,5 SK MB 10 ON QC NB NS 14 PEI NL TIME FROM REFERRAL TO FIRST APPOINTMENT TIME FROM FIRST APPOINTMENT TO START OF FIRST TREATMENT Breast Prostate Colorectal Lung Breast Prostate Colorectal Lung 14 days 14 1 days 13 2 days 12 days 34 days 28 1,3 days 34 2 days 14 days CHEMOTHERAPY 6 CHEMOTHERAPY 6 CHEMOTHERAPY 6 CHEMOTHERAPY 6 32 RADIOTHERAPY 6 16 RADIOTHERAPY 6 32 RADIOTHERAPY 6 21 RADIOTHERAPY CHEMOTHERAPY 16 CHEMOTHERAPY 16,17 CHEMOTHERAPY 16 CHEMOTHERAPY 16 CHEMOTHERAPY RADIOTHERAPY RADIOTHERAPY RADIOTHERAPY RADIOTHERAPY RADIOTHERAPY CHEMOTHERAPY 7 CHEMOTHERAPY 7 CHEMOTHERAPY 7 CHEMOTHERAPY 7 7 RADIOTHERAPY 8 7 RADIOTHERAPY 8 7 RADIOTHERAPY 8,9 7 RADIOTHERAPY CHEMOTHERAPY 12 RADIOTHERAPY 8O CHEMOTHERAPY CHEMOTHERAPY RADIOTHERAPY RADIOTHERAPY Median Time in calendar days from receipt of first referral that occurred in 2004 to a cancer agency/centre for a new diagnosis to time first seen by an oncologist of any type. Median Time in calendar days from first visit with an oncologist to first recorded treatment of any type (this is any treatment for which the cancer agency is responsible: i.e. radiation therapy, chemotherapy, hormone therapy). Median means that an equal number of wait times were longer or shorter than the time shown. REFERENCES 1 Figures shown are for the genito-urinary group of cancers, (69% prostate). 2 Figures shown are for the gastro-intestinal group of cancers (40% colorectal). 3 Patients with localized prostate cancer who proceed to radical irradiation, either external beam or implant brachytherapy, commence neo-adjuvant hormonal therapy prior to irradiation to arrest disease progression and minimize the size of the prostate gland prior to XRT in relation to highdose configuration. 4 All waiting times are based on statistics provided by the Alberta Cancer Board s two tertiary care centres the Tom Baker Cancer Centre in Calgary and the Cross Cancer Institute in Edmonton. Please note, last year s results were based on an average and not a median and therefore cannot be directly compared. 5 The Alberta Cancer Board collects manual wait times at a specific point in time, once each month, on a sample of patients. These wait times then provide an estimate for the wait times, on average, for that month. For the purposes of this study the Alberta Cancer Board selected 4 months to represent 2004 (this was an identical process to the one used for last year s results). This year the median wait time was provided. It was based on the same numbers used in the average calculation i.e., this is the median of the four monthly averages for each centre. The submitted wait times reflect the median wait time for all patients at the point in time when the wait time was calculated. In reality patients are prioritized according to need. 6 Median days to next available appointment with tumour group physician. 7 Median days from treatment decision to start of chemotherapy. 8 Median days from consultation with Radiation Oncologist to start of treatment. 9 These waiting times are based on statistics from the Cross Cancer CANCER CARE IN CANADA, WINTER

12 Institute only. Statistics are currently not available from the Tom Baker Cancer Centre. 10 Patients included in data collection were only those who were residents of the province at the time of diagnosis. 11 These waits may be affected by the stage of disease and other important clinical considerations at diagnosis, as well as whether or not the patient undergoes surgery and which type of cancer specialist they are slated to see. 12 For prostate and breast cancer patients, the provision of hormone therapy plays a significant role in the wait times. Many of these patients received hormone therapy almost immediately after their visit, and this therapy must be completed before initiation of other chemo- or radiation therapy. Recovery from any other treatment (surgery or hormone therapy) must occur before additional treatments are initiated, and this is a matter of clinical assessment. 13 Referral to start of systemic therapy, 2004 median wait in weeks: Breast cancer (6.0), Gastro-intestinal cancer (5.0), Lung cancer (4.1). Referral to start of radiation therapy, 2004 median wait in weeks: Breast cancer (8.7), Gastro-intestinal cancer (4.9), Genito-urinary cancer (8.4), Lung cancer (3.1). 14 Only residents of Nova Scotia; only if the first-ever referral occurred in 2004; only for the first referral in 2004; only patients diagnosed with only one malignancy. When considering the time to start of treatment at a cancer centre, only patients who reside near to a cancer centre were included, as patients who live at some distance are more likely to have their chemotherapy delivered closer to home, and start dates of these treatments are not routinely available in cancer centre data. 15 Prostate cancer patients may require hormonal management before chemotherapy or radiation. 16 The systemic wait times are for those excluded from the radiation wait counts due to systemic therapy delivery first. At this time these are the only cases that the PEI Cancer Treatment Centre can provide systemic treatment wait times on. 17 Systemic treatment wait times cannot be established for prostate, due to the fact that many patients start hormonal therapy through their urologist outside of the Cancer Treatment Centre. BRITISH COLUMBIA Both the BC Ministry of Health and the BC Provincial Health Services Authority (PHSA) monitor the service contractual requirements of the BCCA to provide 1 st consults within 14 days and initiation of first planned therapy within 1 month. This performance is tracked monthly and posted to the Ministry web-site for public access. BCCA meets the required standard in excess of 95% at all its regional centres for both radiation therapy and systemic therapy. ALBERTA Last year s report from Alberta used average not median numbers, so the two years cannot be compared. Alberta is involved in a collaborative wait times project with Saskatchewan and Manitoba. Among the aims of this project are to develop standardized definitions and processes for producing consistent and comparable wait times for cancer patients between provinces. Four months of data were used to represent Wait from first referral to first appointment reflects median days to next available appointment with tumour group physician. Wait from first appointment to first treatment reflects median days from treatment decision to start of chemotherapy, or median days from consult with radiation oncologist to start of radiotherapy. SASKATCHEWAN Data includes both of the Saskatchewan Cancer Agency Centres Regina Centre and Saskatoon Centre (last year s results only included the Regina Centre). MANITOBA Cancer Care Manitoba believes that a better measure of wait time is the time between ready to treat and initiation of treatment; this is the philosophy behind the Canadian Association of Radiation Oncologist (CARO) guidelines on wait times for radiation therapy. A better proxy measure of this would be the last visit to an oncologist before treatment; before the clinician determines that chemotherapy or radiation therapy should go ahead, the patient is not truly waiting they are certainly being managed when undergoing pre-treatment or when they are recovering. In many cases, recovery from any other treatment (surgery or hormone therapy) must occur before additional treatments are initiated. As well, particularly for prostate cancer patients, the time for watchful waiting is included and increases the apparent waiting times shown here. This is an option for many patients in that group and the definitions, as provided, do not allow for exclusion of this time. ONTARIO Excludes all time intervals greater than 20 weeks per period; includes Grand River and Durham Regional Cancer Centres and excludes Princess Margaret Hospital. Radiation therapy wait times exclude cases receiving systemic therapy first; systemic therapy wait times exclude cases receiving radiation therapy first. QUEBEC Unable to provide data due to system limitations. The collection of information by the centres of radiology in regards to waiting times allows the Quebec system to retrieve the number of patients affected by prostate cancer, breast cancer, and other cancers that are outside the waiting time after an 8 week waiting period is calculated from the date the person was diagnosed as medically ready and the date of the start of treatments. These data do not permit Quebec to determine the median time between the date the patient is declared medically prepared to receive treatment and the date the treatments begin. However, it is possible to know the number of people who waited more than eight weeks to receive radiation treatments after a medical decision of ready to treat. These numbers were tracked for April and for December, For breast cancer the number of patients waiting longer than eight weeks in April was 35, in December it was19; for prostate cancer, 76 people in April and 41 in December; for other cancers, five people in April and two in December. NEW BRUNSWICK New Brunswick is in the process of establishing the New Brunswick Cancer Network. Radiotherapy centres are collecting data and will be in a position to report in NOVA SCOTIA Nova Scotia has two primary cancer centres, located in Sydney and Halifax and both centres operate community-based referral clinics. Data for these community clinics have been included in the analysis. Nova Scotia included clinical activity in medical, radiation, surgical and palliative oncology. While all adult medical and radiation oncology in the province occurs under the umbrella of the cancer centres, only a portion of surgical and palliative activity is covered through the cancer centre. This system structure may affect comparability of NS data to other jurisdictions. The only cancer treatment reflected in this table is that which is managed within the cancer centre itself, namely radiotherapy and chemotherapy. Treatments that may have been offered to cancer patients as a result of the consult with an oncologist, but not captured in the cancer centre data systems, include the provision of hormone therapy, which is very commonly offered to both breast and prostate patients, but delivered outside the purview of the cancer centres. Chemotherapy does occur at the cancer centres but not for all patients as it can be delivered in local communities. NEWFOUNDLAND AND LABRADOR Not in a position to report wait time data for the 2004/2005 fiscal year; expects to be in a better position to report information for 2005/ CANCER CARE IN CANADA, WINTER

13 PREV ENTI ON PROG RAMS P REV ENTIO N PROGRAMS International Comparisons of Primary and Secondary Prevention Programs with Australia, Finland, USA and UK BY ANTHONY B. MILLER AND NADINE SABY Introduction In October 2005, Canada hosted the First International Conference on Cancer Control (ICCC). This gave us the opportunity to compare the progress Canada is making on cancer control with other countries that have also embarked on this task, though they inherently differ because of variations in their health care systems, with the US being most atypical. The World Health Organization (WHO) defines cancer control as an integrated strategy to diminish cancer incidence, morbidity and mortality through prevention, early detection, treatment, rehabilitation and palliative care. In Canada, developing an integrated strategy, the Canadian Strategy for Cancer Control, has proven difficult because of the federal/provincial/ territorial divide. It was intriguing to discover that in Australia, where there is also a federal/state system, integration of approaches has proven more feasible than here, though what was introduced has not always been as evidence-based as the protagonists of an action would have wished. However, there is now a commitment of that government to establish a new national agency to take the lead on cancer (Cancer Australia), and a new direction for (Elsewhere in this Report Card we comment on the decisions taken in the UK.) In Finland, the Finnish Cancer Society has provided much of the leadership, while in the UK leadership is vested within their National Health Service (NHS) structure. In the United States, cancer control leadership is vested in the Centers for Disease Control and Prevention, though the National Cancer Institute s Division of Cancer Control and Population Sciences is trying to bring together a partnership of federal, state and non-governmental organizations interested in cancer control. Primary prevention All of the comparison countries have adopted tobacco control as the priority for cancer prevention, and with the exception of the United States, have ratified their involvement in the WHO Framework Convention on Tobacco Control (FCTC). The FCTC is an international t reaty which has provisions that set intern a t i o n a l standards on tobacco price and tax increases, advertising and sponsorship, second-hand smoke and labelling, among other things. The first meeting of the FCTC s Conference of Parties, the governing body made up of all ratifying countries which will oversee implementation of the FCTC, is to be held in Geneva in February, Increasingly, countries are also following the lead of the World Health Organization with regard to the promotion of healthy diets, physical activity and reduction in obesity. Canada appears to be in a leadership role here, with several presentations being made at the ICCC on the provincial programs that are being mounted, notably in BC and Alberta. With the Public Health Agency of Canada promoting the Integrated Pan- Canadian Healthy Living Strategy for all chronic diseases, we can expect continuing activity in this area, which is fundamental if we are eventually going to make a major reduction in the numbers of cancer patients. The Healthy Living Strategy has three pillars: Promoting health by addressing the conditions that lead to unhealthy eating, physical inactivity and unhealthy weights. Preventing chronic disease through focused and integrated action on major chronic diseases and their risk factors. Supporting the early detection and management of chronic diseases. CANCER CARE IN CANADA, WINTER

14 Canada cannot claim to be a leader in secondary prevention seeking to arrest or retard existing disease and its effects through early detection and appropriate treatment. These three pillars, together with the federal and provincial tobacco control strategies, already a model for other countries, will keep Canada in the forefront of cancer prevention as a critical component of the Canadian Strategy for Cancer Control. However, there is much more that can be done, even in the area of tobacco control. An established strategy to promote less smoking is taxation. The federal taxes are uniform across the country, but there is substantial variation in provincial taxation levels on cigarettes, with taxes higher in the West. Ontario has low provincial taxation rates for cigarettes, symptomatic of the tobacco producers lobby in Ontario, and the legacy of the smuggling episode of the early-to-mid 90s. At that time, taxes were reduced to try and prevent smuggling through Indian reserves, an activity that eventually saw several tobacco companies and industry executives charged with fraud and conspiracy to make illegal profits from smuggling. Ontario and all eastern provinces need to review their taxation levels on tobacco, and working with bordering US States, should bring up their taxation levels to those of Saskatchewan. Even BC and Alberta have room to increase taxation levels. Another aspect of tobacco control that has been shown to help reduce smoking rates is to promote bans on smoking in public places. Canada has tended to lead the world on this, with Australia, Finland and the US not far behind. However, opposition to smoking bans, especially in pubs, has recently become very prominent in the UK. The government is now attempting to take the lead on this, quoting a successful ban introduced in Ireland over a year ago. At the time of writing, the outcome is unknown. Secondary prevention Canada cannot claim to be a leader in secondary prevention seeking to arrest or retard existing disease and its effects through early detection and appropriate treatment. As participants in the First Intern a t i o n a l Conference heard from the International Union Against Cancer (UICC), all populations should believe that many cancers are curable if diagnosed early. Although early detection of cancer has been promoted here through national programs of public education, largely by the Canadian Cancer Society, the evidence that this was making a major impact on cancer mortality was difficult to obtain. This was due, in part, to stable mortality rates for breast cancer, and for some time, increasing mortality for lung and some other cancers. The emphasis then shifted to screening. As a tool for early detection, screening has been shown in controlled trials to reduce the number of deaths from breast and colorectal cancers by finding them early, when they are most treatable. Studies of the programs in Canada, and in Finland compared to other Nordic countries, have also shown the effectiveness of screening for cervical cancer using cytology (the Pap smear). Treatment of precancerous conditions identified through screening, as for cancers of the cervix and colon, can prevent cancers from developing in the first place. Unfortunately, this is not yet possible for breast cancer. For breast cancer screening, the UK was first into the field with the introduction of a national program, though Finland now has as good compliance (75 per cent and 76 per cent, respectively, of 50- to 64-year olds invited participated in breast cancer screening in the last year for which data is available see Table 1). In the UK, three-yearly screening with mammography for women age 50 to 69 is the norm; in Finland, Australia and Canada the screening interval is two-yearly for women in the same age range. In the US, screening mammography is recommended every one-to-two years for women beginning at age 40, with the updated recommendation for initial screening age being published in The US Centers for Disease Control and Prevention (CDC) provides free access to breast cancer screening for underserved women only. Various public and private efforts have emerged in recent years to increase mammogram usage in the US, particularly among low income, unders e rved and uninsured women. In Canada, scre e n i n g mammography for women age 50 to 69 is free from the provincial programs. Unfortunately only about half, on average, of the eligible women in Canada avail themselves of this opportunity. The earlier age of breast cancer screening initiation in the US compared to other countries is not, however, supported by evidence. Early results of the UK trial involving women age 40 and 41 has so far not shown an indication 1 4 CANCER CARE IN CANADA, WINTER

15 TABLE 1 BREAST CANCER SCREENING AND COMPLIANCE RATES TABLE 2 CERVICAL SCREENING AND COMPLIANCE Australia: in 2001, 72 per cent of women living in private dwellings aged 50 to 69 have mammograms at least once every two years (source: Australian Bureau of Statistics) Canada: In 2004, the highest rates of screening were reported in Newfoundland and Labrador (30 per cent in one year) followed by the biannual rates for Saskatchewan (57 per cent) and New Brunswick (55 per cent). The lowest rate was reported in Ontario (26.8 per cent). Size of the target population affects these rates, as BC and Ontario target ages and respectively while all other provinces aim for ages Finland: biannual screening program 2002 and 2003 covered 61 per cent of 50- to 69-year olds; 76 per cent of 50- to 64-year olds; for 2003 alone, 87.7 per cent of 45- to 74-year olds invited for breast cancer screening participated (source: 2003 statistics from Finnish Cancer Registry) UK: in 2003/04 three-quarters of women 50 to 64-years old invited for screening in England did so (source: UK Office for National Statistics); as of March 31, 2001: 70.6 per cent of the overall target population (includes beyond age 64) screened for breast cancer in last three years US: between 1999 and 2003, 70 per cent of women 40 and over had a recent mammogram within the past two years (source: Health, United States, 2005 statistics published by the Department of Health and Human Services) Australia: cervical screening for women age 20 to 69 every two years; 53 per cent of women age 18 and over have pap smears at least once every two years. Of women age 30 to 39, 73 per cent have pap smear tests at least every two years, compared to 14 per cent of women age 70-years and over (source: Australian Bureau of Statistics) Canada: In 2004, the highest rates of cervical screening for the target population occurred in Manitoba (52 per cent in a two-year period), Nova Scotia (67 per cent in three years) and BC (either 58 or 71 per cent depending on hysterectomy exclusions, in 30 months). The target age group was age everywhere but BC where screening begins at age 21. Finland: 71.8 per cent of invited targeted age group screened for cervical cancer in 2003 (25 to 65-year olds primarily 248,957 invited and 178,727 screened) (2003 statistics from Finnish Cancer Registry) UK: all women age 25 to 64 invited to be screened every three-tofive years, depending on age; as of 2001, 82.8 per cent of target population had been screened for cervical cancer in last five years (UK Office for National Statistics) US: between 1997 and 2003, 79 per cent of women 18 years of age and over had a pap smear within the last three years (U.S. DHHS publication: Health, United States, 2005) of a significant reduction in breast cancer mortality, similar to the Canadian trial reported several years ago. In the UK, a special trial was performed which showed, using indirect indicators, that there was little advantage in moving from three-yearly to annual screening. Canada can learn from the UK and Finland: both have been far more successful in bringing women in their target group into their breast screening programs. Without the level of compliance that these countries have achieved, the Canadian programs are likely to be far less effective. Unfortunately, too many women in Canada are following the US type of opportunistic approach, with mammograms performed by radiologists outside the provincially-run high quality programs. Many of these radiologists were slow to seek accreditation from the Canadian Association of Radiologists (which requires quality control safeguards). However, The Globe and Mail reported recently that increasing proportions of radiologists practicing mammography are being accredited. Canada, especially British Columbia, took the lead for cervical screening, but when the Finns began their program, they were far more effective in reaching their target group, initially women age 35 to 55, now 30 to 60. This is an older age for initiation of screening than in all other countries, but it means that Finland has the most cost-effective program in the world. In spite of a series of National Expert Groups, beginning with the Walton report of 1976, Canada, like the US, still has largely opportunistic screening. And although major impacts in both Canada and the US have been obtained (similar to, but not greater than the impact in Finland), this has been at an enormous cost, not commensurate with the benefits obtained. In the UK, after many years CANCER CARE IN CANADA, WINTER

16 The UK and Finland have been more successful than Canada in reaching their target group for breast screening; the Finns are also more effective in their cervical screening of opportunistic screening beginning in the 1960s, which had little effect on cervical cancer rates, organized cervical screening was initiated in 1988, with a formalized Cervical Screening Program (call and recall system for women registered with a GP). This had a major impact on cervical cancer, so that the rates in the UK have now declined almost to the level of those in the US (which are a little above Canada and Finland). The only other cancer for which there is a good evidence base for screening is colorectal, but as yet, none of the five countries have a functional organized program for bowel cancer screening. Australia, after a pilot study in three areas, has taken the decision to mount one, but only a fraction of the necessary funding has been procured. The major difficulty is securing new federal funding (the govern m e n t s 2005/06 budget committed $43.4-million Australian over three years). Here again the UK seems to be leading the field. A pilot study has been completed, with 58 per cent compliance in round one and 52 per cent in round two, and beginning in April, 2006 they are initiating their national program. The US, as for other sites, promotes opportunistic screening, but it is unclear how many people in the target group (age 50 years and over) have been screened. In several Canadian provinces planning is underway for pilot studies, but as yet none have followed the recommendations of the National Committee on Colorectal Cancer Screening in The problem is two-fold: first, it is unclear whether sufficient compliance will be achieved by occult blood tests to realize even the efficacy in the trials that provide the evidence for this approach (overall 20 per cent reduction in mortality, substantially less than for either cervix or breast); and second, there are not sufficient trained endoscopists to perform the diagnostic tests that would be required for those who test positive. So creating the screening infrastructure on a mass basis is not yet feasible in Canada. The other issue is that it is not clear it is wise to do so. We could have a far greater effect on colorectal cancer by investing more in primary prevention (colorectal cancer being one of the main cancers reduced by physical activity and weight reduction) than we might achieve by screening. A similar conflict, but this time with treatment, exists for other cancers, of which breast is the prime example. Here an overly optimistic recent model-based analysis of US data suggested a benefit from both impro v e d treatment and from screening. However, the modellers made a basic error: they assumed that both approaches were additive, rather than complementary (if you can cure everyone, you would not need to screen at all). They could only make their models fit by assuming that in the absence of improved treatment and screening, mortality would have risen dramatically in the US, which was clearly very unlikely from previous trends. The same conflict almost certainly applies to screening for prostate cancer, and it was interesting that only in the US have national bodies made recommendations to screen. The UK is placing its research funds allocated for prostate cancer into treatment research, not screening. Australia and Finland have not initiated screening, though Finland is participating in the European Trial of Screening for Prostate Cancer, which like a trial in the US, is the only way to provide the evidence required to decide if screening for prostate cancer is worthwhile. It is unfortunate that the barrage of advocacy for PSA screening has failed to recognize the complications of over-diagnosing prostate cancer (over 50 per cent of men in their 60s and 80 per cent in their 80s have a latent prostate cancer), including unnecessary surgery, impotence, incontinence, and sometimes postoperative deaths. The reduction in mortality in the US seems to be due to prolongation of life from modern hormone therapy, not screening. Neither of the two large trials in the US and in several countries of Europe evaluating screening with PSA has yet reported any benefit from the approach. Conclusions It is very clear that Canada, and our governments, have much to learn from the experience in cancer control in other countries. At this delicate stage in the development of the Canadian Strategy for Cancer Control, we need to keep in mind what has already proven successful in other countries, as they do when they look at us. 1 6 CANCER CARE IN CANADA, WINTER

17 S C R E E N I N G S C R E E N I N G Provincial Screening Programs BY COLLEEN SAVAGE Where effective screening tools exist to diagnose cancer in early stages provincial cancer agencies and health ministries have all taken steps to make screening services available. With advice from the Cancer Care Ontario Quality Council, CACC designed a survey 1 to explore the range of screening programs across the country for breast, cervical, colorectal and prostate cancers. The quest was to determine not only how accessible the programs are, but whether they are effective in reaching their target groups and have well-developed processes for quality control and follow-up. Although our survey was not exhaustive and does not describe every variety of screening 2 we did ask about the design, management and effectiveness of existing programs. Screening programs are aimed at a target population with no symptoms or previous history of cancer. R e c ruitment, recall, follow-up, quality assurance, surveillance and evaluation are central elements of an organized screening program, but these are not the only screening services available. For cervical and prostate cancers the vast majority of screening is conducted in the private offices of physicians, and an unknown amount of mammography that might be screening occurs in radiologists offices not connected to provincial breast screening programs. Even if provincial health plans treat the physician-office test as an insured service, the test is not necessarily recorded as part of the cancer agency s or province s screening program. Screening individuals with a family history of cancer often occurs outside provincial screening pro g r a m s simply because those with a family history of cancer tend to develop cancer at an earlier age than those without such a history. CACC asked each province about recruitment, the characteristics of their target populations as well as their screening goals and success in reaching those individuals for screening. The answers display diff e re n c e s between cancers and between provincial capacity to get the job done. The most consistently well-developed scre e n i n g programs are for breast cancer, which are specially organized and funded. In second place would be cervical cancer screening, which is similarly well established although with less focus on organized re c ru i t m e n t. Cervical screening programs rely heavily on public health, community clinics, family physicians and laboratories to perform certain roles and interact with the screening program. For colorectal and pro s t a t e screening there are no formal screening programs, no organized surveillance of screening targets and results and none of the organizational elements that allow for useful measurements of effectiveness. Quality assurance questions sent to each province were meant to elicit information about three critical measures for quality control. Is there a formal recall system in place for an abnormal result? Nine provinces answered yes for breast screening, four answered yes for cervical screening. Do you have a written guideline that describes a recommended process for moving a patient to the investigative phase after an abnormal result? Eight provinces answered yes to this question for breast screening, six answered yes for cervical screening. Where a cancer developed in the interval between screens, is there a quality assurance flag to determine what happened with the first test? Seven provinces answered yes for breast screening, five for cervical screening. Major impediments and solutions The cancer agencies and provincial health ministries responding to this survey were asked to identify the major impediments to more effective cancer screening and possible solutions. Saskatchewan and Nova Scotia name funding as their problem, but other provinces start elsewhere. Responses described the lack of a cohesive plan and coherent agenda for organized screening (BC); lack of functionality CANCER CARE IN CANADA, WINTER

18 S U RVEY SUMMARY More than 150,000 Canadians will be diagnosed with cancer this year, praying it was found early of the current information system (Alberta); inadequate access to the necessary health professionals (Manitoba); lack of organized screening for most screening programs (Ontario); lack of a formal cancer control program (New Brunswick); capacity issues that limit access to services (Nova Scotia); and lack of systematic recruitment or recall (Newfoundland and Labrador). The solutions were not always about funding either, although human, capital and financial resources are c e rtainly needed to address most of the pro b l e m s identified. The first step seems to be the need for a commitment to the very notion of screening as an integral part of cancer control, supported by the planning, technology and human resource strategies to make such efforts effective. One of the most telling commentaries was received from BC, which enjoys some of the most successful screening activities in the country: provinces do not have sufficient resources to devote to the complex issue of what they should be doing. We need to create a standing committee as recommended by the Canadian Strategy Task Force on S c reening to provide assessment and direction on s c reening policies, to build consensus and apply pressure based on well-reasoned science. Such commentary might seem esoteric to eastern provinces where resources are too limited to organize screening recruitment and recall, or from Manitoba, where staff struggle to get mobile screening into remote communities and face significant problems in staff re c ruitment and retention. Nonetheless, the clear message from all provinces was that screening can be a more powerful tool to reduce cancer mortality if given strategic and infrastructure support. Breast Cancer Highest rates of breast cancer expected in 2004: Quebec at 113 cases per 100,000 population, followed by Manitoba (112), Nova Scotia (109) and PEI (108) Most extensive access to scre e n i n g : BC, Albert a, Manitoba, Nova Scotia. All programs target women in the core age group 50-69, but BC has extended this to age 74 and accepts patients between ages if referred by a physician. Alberta accepts women without referral between ages 40-74, while their target age group for recruitment, like so many other provinces, is Manitoba offers all women access to mammography directly through physician referral for diagnostic or screening mammograms, but the screening program covers asymptomatic women age Nova Scotia accepts women between the age of 40 and 49 (outside the target group) who self-refer. The Ontario breast screening program accepts women up to age 75. Goal for reaching target population every two years: Saskatchewan sets its goal at 100 per cent of the target population, while Manitoba, Quebec, New Brunswick, Nova Scotia and Newfoundland and Labrador aim to reach 70 per cent of their target population. Ontario has set goals for 2010 and 2020, at 70 per cent and 90 per cent respectively. Highest percentage of target population reached: Newfoundland and Labrador (30 per cent in one year), Saskatchewan (57 per cent in two years) and New Brunswick (55 per cent in two years). Lowest percentage of target population reached: Ontario (26.8 per cent every two years). Most accessible locations: New Brunswick, with one specialized screening site for every 5,461 women in the target age group. Least accessible locations: Alberta, with one specialized screening site for every 59,770 women in the target age group, although this is off-set by a large and unreported fee-for-service screening activity. All three elements of quality assurance: BC, Manitoba, New Brunswick, Nova Scotia, Newfoundland and Labrador. Dedicated staff and budget for screening program: All, though New Brunswick shares staff with another program. Measurement of screening rates and public reporting: All but Alberta and PEI. Alberta s information system is still in development. Cervical Highest rate of cervical cancer expected in 2004: Nova Scotia at 11 cases per 100,000 population, followed by New Brunswick (10), PEI (10), and Alberta (10) Most extensive access to screening: Pap tests are readily available. The only access limitations were reported by 1 8 CANCER CARE IN CANADA, WINTER

19 Alberta (no more than twice per year), while BC and Ontario note they do not cover human papilloma virus tests. Target population: Alberta, Saskatchewan, Manitoba and Nova Scotia target women between the age of 18 and 69; Newfoundland and Labrador targets women of all ages who are or ever have been sexually active; the BC program screens women with a uterus from the age of 21. We should not confuse the target group with the availability of screening as an insured service. Pap tests are conducted as part of a routine physical exam by the family physician, making the test readily accessible and fully covered by the provincial health plans. That setting affords a great deal of flexibility about the age when screening begins, though the International recommendation 3 is to start screening from the age of 25. Goal for reaching target population: Only thre e provinces stated a goal for cervical screening; BC at 70 per cent every 30 months; Alberta at 80 per cent every three years; and Nova Scotia at 85 per cent every three years. Highest percentage of target population reached: Manitoba (52 per cent in a two-year period), Nova Scotia (67 percent in three years), and BC (either 58 per cent or 71 per cent depending on hystere c t o m y exclusions, in 30 months). Lowest percentage of target population reached: Alberta, Saskatchewan, Ontario, Quebec and PEI could not report, which we take to be more discouraging than the 43 per cent rate in Newfoundland and Labrador. All three elements of quality assurance: Saskatchewan, Manitoba and Nova Scotia. Dedicated staff and budget for screening program: BC, Saskatchewan, Manitoba, Ontario, Nova Scotia and Newfoundland and Labrador Measurement of screening rates and public reporting: BC, Manitoba, Ontario, Nova Scotia and Newfoundland and Labrador. Saskatchewan s new program will be reporting when systems are complete. Expansion plans: BC, Alberta, Manitoba, Ontario, Quebec, Newfoundland and Labrador as an insured service: Alberta screening is linked to family history, Saskatchewan only asks for a referral to a specialist, and Quebec pays for screening colonoscopy and sigmoidoscopy when medically justified. Alberta and Ontario also reported they cover fecal occult blood testing, without the age and family history restrictions of BC. Target population: Only BC and Alberta have identified targets. BC physicians are encouraged to target age 50-74, or age for higher risk individuals. Alberta will provide screening colonoscopy to any patient over the age of 50 and anyone who is no more than ten years younger than a first-degree relative with colorectal cancer. Goal for reaching target population: Not one province identified a goal for colorectal screening. Ta rget population re a c h e d : Unknown. Not one province answered this question. All three elements of quality assurance: None Dedicated staff and budget for screening program: None Measurement of screening rates and public reporting: Ontario Expansion plans: BC, Alberta and Ontario Prostate The most contentious question is prostate cancer screening with the prostate specific antigen (PSA) test as the evidence base to justify screening is not available. Some patients demand it, some physicians want to do at least this much for men in a high risk group, and others are convinced the test is so unreliable as to be almost irresponsible. PSA testing is widely used as a tool to monitor the progress of disease. We asked only one question about the PSA test: what is your province s policy about PSA testing for prostate cancer? Where policies exist in BC, Alberta, Ontario and Nova Scotia the cancer agencies are uniformly against use of the PSA test for screening purposes, and PSA screening is not c o v e red by the provincial health plan. In BC, Albert a, Saskatchewan, Manitoba, Ontario, Quebec, New Brunswick and Nova Scotia, PSA testing is covered for men with symptoms suggesting prostate cancer. Colorectal Highest rates of colorectal cancer expected in 2004: Newfoundland and Labrador at 127 cases per 100,000 population, followed by Nova Scotia (122), PEI (116) and New Brunswick (111) Most extensive access to screening: BC, Alberta, Saskatchewan, Quebec, but there are no form a l screening programs in the country. In BC, eligibility for endoscopy screening or self-administered fecal occult blood testing requires a family history of colorectal cancer. Alberta, Saskatchewan and Quebec are the only other provinces that will pay for a screening colonoscopy REFERENCES 1 The original survey and detailed summary tables of the results will be available on the CACC website In provinces without cancer agencies, the provincial health ministry was asked to respond. Where cancer agencies also supplied copies of their guidelines and processes, these documents will be appended to the summary tables online. 2 For each of the cancers there are screening tools not described in this paper, which should not imply an opinion at CACC on the worthiness of one screening tool vs. another. Talk to your own physician and cancer agency/health department for more detailed information about screening choices. 3 International Agency for Research on Cancer, CANCER CARE IN CANADA, WINTER

20 CANCER COST TSS Whether or not one survives cancer depends on whether one gets the right drug treatment or not Your Money or Your life PA R T III BY WILLIAM HRYNIUK In the last two Cancer Advocacy Coalition Report Cards we have shared the results of our investigations into the phenomenon of the west-east gradient in provincial cancer mortality. The further west you go, the lower the cancer mortality, and this is not solely due to differences in the number of cancer cases in each province. The phenomenon has long been recognized but has been attributed largely to differences in lifestyle, socioeconomic status, and smoking. The CACC thinks there is more to the story. 1,2 Evidence uncovered to date indicates cancer mortality bears an inverse correlation with the level of government funding. The more dollars spent on cancer control in each province, the lower is the mortality from cancer in that province. "And the correlation is very strong and highly statistically significant, with an "R" value equal to This means that the overwhelming majority of factors responsible for differences in mortality rates among provinces (over 96 per cent) are related to differences among provinces in regards to their provincial government funding for cancer control. The correlation supercedes the number of cancer cases and is so strong that it is hard to ignore. We believe this relationship is not just a correlation. Rather we think the level of provincial government funding for cancer control actually determines to some extent what will be the cancer survival in each province. Since treatment with drugs is a major determinant of cancer survival rates, this year we wanted to see if access to newer agents also correlated with these improvements. As documented by Khoo et al 4 elsewhere in this issue, the funding for new cancer drugs does correspond to some extent with the west-east gradient: t h e provinces guaranteeing the widest access to new cancer drugs also have the lowest cancer mortality, and those that do not, have the highest levels of compassionate use or dependence on third-party payers. The aphorism your money or your life certainly seems to hold true as regards cancer treatment. Whether or not you survive your cancer depends at least in part on whether or not you get the right drug treatment. And that depends on the willingness of your provincial government to fund your treatment. Failing that, it depends on your willingness and ability to fend for yourself. We are not the only ones who have come to that conclusion. For example, Cremieux et al 5 have recently re p o rted a strong statistical relationship between Canadian per capita drug spending and life expectancy for infants, and for men and women starting at age 65. Their analysis further shows that substantially better health outcomes are observed in provinces where higher drug spending occurs. In addition, Ragaz et al 6 have recently reported that the reduction in mortality from breast cancer varies among provinces, and is correlated with the ability of each province to organize effective community cancer c o n t rol programs. The results indicated the most substantial breast cancer mortality reduction occurred in BC and Saskatchewan, two provinces with the longest tradition of advanced community programs. We have also not been the only ones to call it Your Money or Your Life. 7 An example of the west-to-east variation in access to effective cancer drugs that translates into survival is the rituximab story. The rituximab story Rituximab is an artificially-produced antibody against lymphoma cells. In early studies it was shown to produce a marked improvement when given to patients with a particular form of lymphoma whose disease had relapsed or had become refractory to conventional chemotherapy. In November 1997, it was approved in the US for use in patients with refractory or relapsed 2 0 CANCER CARE IN CANADA, WINTER

21 TABLE 1 OVERALL SURV I VAL BY TREATMENT ERA 1.0 Elderly patients (n=170) 1.0 Younger patients (n=122) P o s t - r i t u x i m a b P o s t - r i t u x i m a b P re - r i t u x i m a b P re - r i t u x i m a b Y E A R S Y E A R S lymphoma and subsequently has been used off label for other stages of lymphoma in all age groups, as well as other diseases. The chronology of its subsequent approval for various indications in Canada makes interesting reading: In December 2000, the results of a large randomized trial (GELA) in previously untreated lymphoma patients were reported at an international meeting. When rituximab was included as initial t reatment along with conventional c h e m o t h e r a p y, patient outcomes were also markedly improved. The trial was conducted only in patients 60-to- 80 years of age. In March 2001, three months after the report of the GELA trial, the BC Cancer Agency approved and funded use of rituximab as initial treatment for lymphoma patients of all ages in the province of BC. A similar position was taken by the hospitals in New Brunswick, based on the advice of their oncologists. Thus the experts in BC and New Brunswick reached the same conclusion as did the British Haematology Task Force in the UK two years later that based on the way rituximab works and the fact that there is no difference in disease biology based on age, there is no scientific reason why a similar benefit should not be expected in younger patients. The outcomes for young patients included in earlier trials were as good as those of the elderly. 8 Part of the impetus for approving the drug for all ages of patients in BC was that younger patients with lymphoma who had relapsed on other treatments were being offered much more expensive (and toxic) treatment with bone marrow transplantation. Rituximab was a cost-effective means of avoiding this option. In January 2002, Manitoba approved the use of the drug for all ages of patients with lymphoma. In November 2002, 11 months after final publication of the GELA trial, Health Canada approved rituximab for refractory lymphoma. That was five years after approval in the US. At approximately the same time as Health Canada s approval of rituximab for refractory lymphoma, several other Canadian provinces approved it as initial treatment, but only for patients over the age of 60. Evidently the expert groups in these other provinces, viewing the same body of medical evidence as the groups in BC, New Brunswick and the UK, preferred to believe that rituximab had not yet been proven effective in younger patients. By 2003 it was clear that the mortality in BC from the lymphoma type treated by rituximab was dro p p i n g markedly in all age groups. 9 BC investigators presented this data at a large international meeting that same year. By March 2004 lymphoma mortality in BC had been reduced by 50 per cent, as shown above. In January 2004, Saskatchewan approved the use of the drug in all age groups. As 2004 began, the health ministries in Alberta and Ontario still did not fund rituximab for first line therapy in younger patients, even though cancer experts in the two provinces were now convinced of the necessity for treating CANCER CARE IN CANADA, WINTER

22 patients of all ages and were appealing to their ministries for such drug coverage. F i n a l l y, in the spring and summer of 2004, the ministries in these two provinces extended coverage for rituximab but only when a patient activist and an advocacy coalition publicly engaged the respective governments through the media. 10 The early introduction in BC and New Brunswick of rituximab for patients under the age of 60 probably saved at least 20 lives in the period March 2001 to April It can be estimated that during that time upwards of one hundred patients under the age of 60 died of lymphoma in the several Canadian provinces where funding was delayed compared to BC and New Brunswick. The human tragedies accompanying these untimely deaths of relatively young people can only be imagined. But the resulting economic loss can be calculated. Had they been allowed to remain alive as productive and tax-paying citizens, they probably would have paid-off the cost of their treatment in their ensuing working years. Surely the time is at hand for a fundamental change in how new cancer drugs are judged and funded throughout Canada. The BC system, since it is province-wide, connected to rigorous follow-up, and based on deliberations of an arm s - l e n g t h committee, should serve as the model. REFERENCES 1 Your Money or Your Life? CACC Cancer Care in Canada 2003, 6:6-7 2 Your Money or Your Life, Part II. CACC Report Card 2004, 7: C o rrelation coefficients indicate the extent to which two variables are related to one another in a linear (straightforward) way. A correlation coefficient of 1.0 (positive or negative) indicates perfect correlation. A positive r-value indicates, for example, that both variables increase together; a negative r-value means that as one increases, the other decreases. 4 K. Khoo et al. Cancer Drug Access. CACC Report Card 2005, 8: Cremieux PY, Meilleur MC, Ouellette P, Petit P, Zelder M, Potvin K. Public and private pharmaceutical spending as determinants of health outcomes in Canada. Health Econ.14 :107-16, J.Ragaz, JJ Spinelli, G.Villeneuve, L. Ellison, A. Coldman.:Mortality reduction of breast cancer in Canada: Impact of cancer care infra - structure. Amer Soc Clin Onc 2005; Vol. 23; (No. 16S): Abstract #649; p40 7 David M. Cutler. Your Money or Your Life - Strong Medicine for America s Health Care System. Oxford University Press Pettengell R, Linch D. Position paper on the therapeutic use of rituximab in CD20-positive diffuse large B-cell non-hodgkin s l y m p h o m a. Haemato-Oncology Task Force of the British Committee for Standards in Haematology. British J. of Hematology 121:44-48, Laurie H. Sehn, Jane Donaldson, Mukesh Chhanabhai, Catherine Fitzgerald, Karamjit Gill, Richard Klasa, Nicol MacPherson, Susan O Reilly, John J. Spinelli, Judy Sutherland, Kenneth S. Wilson, Randy D. Gascoyne, Joseph M. Connors. I n t roduction of Combined CHOP Plus Rituximab Therapy Dramatically Improved Outcome of Diffuse Large B-Cell Lymphoma in British Columbia. J of Clinical Oncology 23: , Why, Premier? Toronto Sun, June 23, 2004 Cancer Stage Facilitation Initiative BY BRENT SCHACTER In 2005, the Canadian Association of Provincial Cancer Agencies (CAPCA), in association with the members of the Canadian Cancer Surveillance Alliance (CCSA), completed a comprehensive survey of the status of cancer staging activities in Canada, with the intent of identifying best practices and barriers and to make recommendations to further the national staging agenda. The importance of developing and supporting standardized systems for staging patients with cancer, suitable for cancer surveillance at the provincial and national levels and for ensuring appropriate individual patient care, has long been recognized. The practice of classifying cancer cases into groups according to extent of disease arose from observations that patients with localized disease appeared to have a better outcome than patients with more extensive disease. Staging is essential 1. For clinical care in individual patients it is re q u i red for the overall evaluation of newly diagnosed cancer patients so that appro p r i a t e treatment can be planned and an estimate of prognosis can be made. 2. For surveillance purposes, information derived from studying large populations of patients with cancer at a national, provincial or local level is used to more critically evaluate interventions and to assess treatment outcomes against guidelines, standards and quality indicators. The purpose of these population-based surveillance activities is to improve the quality of patient care in the cancer care systems. Following an extensive pro v i n c e - b y - p rovince re v i e w conducted within the past 18 months, a series of recommendations, compiled in The Cancer Stage Facilitation Initiative Report, have been made that are built around achieving a vision for a national cancer surveillance system, including the collection of cancer stage, that will allow for population-based outcome analysis, comparative studies between regions and planning initiatives that are not possible without standardized staging i n f o rmation. (The full re p o rt is available thro u g h 2 2 CANCER CARE IN CANADA, WINTER

23 CAPCA at < In order to achieve these goals, recommendations were made to create a reshaped and unified national leadership body to provide advice and lead the staging initiative, to ensure that appropriate and harmonious provincial and federal legislation is in place to mandate the submission and collection of relevant cancer data, and to provide enhanced provincial and federal funding to support the provincial and territorial registries; in particular to facilitate the development and implementation of new technology, with national standards, and an education program for health care personnel involved in the cancer staging process. In addition, the report recommends country-wide implementation of collaborative staging for populationbased surveillance with maintenance and further development of physician-based (TNM) staging for individual patient care. It was recommended that the development and implementation of new methods of data collection and new information technology should be given a high priority to enhance data collection in the most effective and efficient manner. It was also recommended that there needs to be good collaboration and exchange of information between cancer registry staff and clinical s t a ff in order to enhance effective cancer staging activities. Hospital accreditation surveys should review cancer staging activity in all hospitals that care for patients with cancer. These recommendations for action are comprehensive and realistic towards the goal of achieving enhanced cancer staging in Canada to help achieve better care for cancer patients. Efforts are now underway to ensure that these recommendations are carefully reviewed by the provincial cancer agencies and programs, by the membership of the Canadian Cancer Surveillance Alliance and by the Public Health Agency of Canada. Implementation plans will then be developed in consultation with the provincial, territorial and federal governments and the health care facilities and organizations that will be involved in making these recommendations a re a l i t y. The announcement of funding for the Integrated Chronic Disease Strategy through the Public Health Agency of Canada provides more resources to develop enhanced cancer surveillance in Canada, including more effective cancer staging programs in clinical practice. Brent Schacter, MD, FRCP(C), is chief executive officer of the Canadian Association of Provincial Cancer Agencies. He is also a professor in the Department of Internal Medicine of the University of Manitoba, and continues to practice medical oncology and hematology at CancerCare Manitoba. 2006, Brent Schacter, MD, FRCP(C); used with the kind permission of the author. COLLABORATIVE STAGING Excerpts from the Report of the Cancer Stage Facilitation Initiative Almost coincidental with the initiation of the CAPCA facilitation process, Collaborative Staging (CS) was being introduced into Canada. It had been endorsed by the Canadian Council of Cancer Registries as the preferred method of collecting stage elements for population surveillance purposes. CS is not a new stage classification, but rather a system for collecting the elements of stage that can be translated by a computer algorithm into the commonly used staging classification systems, e.g. TNM (primary Tumour, regional lymph Nodes, distant Metastasis), EOD (Extent of Disease) and summary stage. It has the advantage of allowing the easy addition of important nonanatomic risk factors to the collected information and will also allow comparison over time of cancer cases regardless of the stage classification used. Parallel with the introduction of CS there were several other important developments and innovations: The development of e-path software which allows the automatic, electronic transmission of pathology data on all patients with cancer to a cancer registry. Coupled with this development is the introduction of synoptic pathology reporting. One province is in the process of piloting synoptic electronic surgical reporting of operative procedures that also includes the results of pre-operative investigations. This electronic report is to be completed at the end of a surgical procedure and then transmitted to the pathologist, the registry, the referring physician, etc. Other provinces are at the point of introducing pilots of their own. This technique has the potential to p rovide much of the clinical information that could be combined with the pathology information to result in the final stage. There are other requirements that need development: Electronic transmission of imaging and laboratory data to registries. Developments are required countrywide to solve this problem. The registry in one small province already has electronic access to all the imaging data in that province; More widespread linkages of electronic patient records with registries is another method of collecting staging elements that could be expanded; In addition to the technical developments, the formation of the Staging Implementation Working Group of the Canadian Council of Cancer Registries has provided provincial and territorial registries with data standards, training programs and an implementation plan for CS. The continued support of this committee is important. One can see that with the above systems and technologies staging information/elements could originate from different sites, be transmitted to registries and result in real time staging. This should be the vision for the future. With appropriate resources and leadership, this could be achieved within a reasonable time CANCER CARE IN CANADA, WINTER period. A high priority should be put to achieving this goal.

24 A determined son drags answers from the ministry of health No. Maybe. Yes. Never Again. BY DOUGLAS EMERSON In the fall of 2001, my father was diagnosed with multiple myeloma. A strong and vital man, he had been healthy his entire life. And yet cancer. The whole family was thrown as we faced what too many families must face once cancer has entered their lives: learning about the disease and exploring the treatment options available for their loved one. Multiple myeloma is a cancer of the blood: there is no tumour to be excised or irradiated. There is no known cure, and it is usually fatal within five years of diagnosis. Nevertheless, there have been significant advances in treatment, and Dad still filled with a love of life tried everything: rounds of chemotherapy, stem-cell replacement, steroids and every other option available to myeloma patients in Ontario. By the spring of 2005, however, the cancer was winning. There was one possibility left: our oncologist told us about a drug called Velcade that had recently been approved for use by Health Canada in the treatment of late-stage multiple myeloma. One hitch: we couldn t get it. Already dealing with the stress of Dad s illness, we had to become advocates for his right to access treatment. And we had to hurry. The drug was approved for use in Canada, but the Province had not yet decided whether to reimburse hospitals for using it. The hospital had the option to pay for it themselves, we were told, but our oncologist had already applied and been refused: the hospital could not afford to pay for the drug for all its patients, so it could not justify making it available to some. Even if the family could afford to purchase the drug privately, as an intravenous chemotherapy it had to be administered in a hospital or authorized clinic, but because it was not available to all patients, we were told that no public hospital in the province could legally administer it: Catch-22. Already dealing with the stress of Dad s illness, we had to become advocates for his right to access treatment. And we had to hurry. We went back to the hospital, to our insurance, to the manufacturer: all dead ends. Then we caught a break. The Cancer Advocacy Coalition of Canada got me pointed in the right direction at the Ministry, and I contacted Drug Programs Branch the office responsible for recommending which drugs to list. After two days of desperate inquiries with a half dozen senior staff, they admitted to having the drug under review, but would not confirm when or if it might be listed. Even if it were recommended immediately, the treatment would not be available in hospitals for months time Dad didn t have. They knew of no mechanism by which Dad could obtain emergency access: their own Section 8 program for special access did not apply to intravenous medications, which were handled by Hospitals Branch. Off to Hospitals Branch, where after a similar round of contacts I eventually spoke to the Director. He recognized the urgency of the situation, and was troubled by the apparent absence of an emergency access policy. He agreed to look into addressing that gap, and in the meantime made arrangements to 2 4 CANCER CARE IN CANADA, WINTER

25 It s hard enough having to fight the disease you shouldn t have to fight your government too ensure Dad would be treated. I suspect my stated intention to escalate the issue to the Minister s office, the Premier s office and the media helped expedite the process. Within a week, Dad was receiving the new treatment, and we were fortunate: he was among the 35 per cent of patients for whom the drug proved to be very effective. By that point, however, significant damage had already been done to Dad s kidneys by the proteins the cancer produced, and as a result he would need dialysis for the rest of his life. At the same time, we received distressing news: as swiftly as the Ministry had opened the door for Dad s treatment, it slammed it shut again. The Ministry disavowed any gap in access, any inequity or inconsistency in the system, and no other applications for access would be considered until after a decision was made whether to list the drug (a decision that today, some seven months later, is still outstanding). Dad s opportunity to access this treatment was to be denied to all other myeloma patients in Ontario. We were left with a number of indelible lessons Dad s health suffered greatly due to the delay in receiving treatment: had the drug been available when first requested by our oncologist, it would have prevented his kidney damage and spared Dad considerable deterioration to his quality of life. What s more, its benefits would have been more impactful, and more lasting. Access to drug treatments in Ontario remains gravely flawed, with inconsistencies from drug to drug, hospital to hospital, patient to patient. Most alarming is the lack of a mechanism to obtain special access in cases of urgent human need, but the overall process itself remains cruelly slow another meaning to the term wait time in health care. I had several advantages in my advocacy: I knew people who knew the government, I had an employer willing to give me the time off to investigate, and I had professional experience dealing with government policy and bureaucratic red tape. Few patients and families have those sorts of advantages, and yet without them, Dad would not have lived to see the summer. The patient and their family are ultimately responsible for ensuring they receive the care they need only they see the whole picture of their care, and only they can challenge the system when it breaks down. But it s hard enough having to fight the disease you shouldn t have to fight your government too. As it was, the treatment gave Dad several more months of life irreplaceable time to spend with his wife, his children and his granddaughter. We are very thankful for the support we received, but we feel terrible knowing that so many other families have not had that luxury, and that many more do not have the resources to act as advocates for themselves. It is time to fix the system. Douglas Emerson is a public relations professional in the financial services sector. He continues to be involved in cancer advocacy. Douglas and his wife Natasha live in Burlington, ON. 2006, Douglas Emerson. Used with the kind permission of the author." CANCER CARE IN CANADA, WINTER

26 CANCER DRUGS CANCE R DRUGS Are the guiding principles of the Canada Health Act respected in cancer drug therapy? Cancer Drug Access in Canada BY KONG KHOO, JOSEPH RAGAZ, WILLIAM HRYNIUK, JAMES GOWING, AND COLLEEN SAVAGE In this year s Report Card, we ask two questions. First, Does cancer drug treatment in Canada comply with the principles of the Canada Health Act? Second, Does variable drug access correlate with the west-east gradient in cancer mortality? In last year s Report Card we outlined issues around provincial drug guidelines, explored the phenomenon of the west-east gradient in cancer mortality across the country, and hypothesized that better cancer outcomes correlate with provincial cancer agency budgets. This year we made a more detailed study of drug access and availability in each province, concentrating on newer treatments that may make the difference between life and death for patients with specific cancers. Until the past decade, most cancer drug treatment consisted primarily of cytotoxic chemotherapy and hormone treatments. While some of the new drugs are also cytotoxics or hormones, an increasing number have novel mechanisms of action, interfering with cancer signalling pathways or tumour blood vessel supply (angiogenesis), or are antibodies aimed at antigens specific to certain tumours. Collectively, these new agents are referred to as targeted therapies having a more selective action on specific cancers and reflect our better understanding of molecular biology and the pathophysiology of cancer. At least in the short term, they appear to be somewhat less toxic than previous treatments, although we have yet to discover the longer-term side effects associated with them. These new cancer drugs are now being incorporated into increasingly complex, multi-modality treatments using conventional cytotoxic chemotherapy, surgery and/or radiation with greater prospects for better outcomes. However, with these advances has come the challenge of acquiring and paying for the new drugs, all of which a re substantially more expensive than the pre v i o u s generation of drug treatments. In Canada, spending on drugs is second only to hospital expenditures, and expected to grow even faster. Oncology, in particular, is faced with incorporating many new novel drugs. Cancer drugs and the Canada Health Act Canadians are proud of our national Medicare system and social programs. This is part of how we define our national identity and continue to shape our politics. The Canada Health Act (CHA) of 1985 assured citizens of a national health care system based on five guiding principles 1,39 : Universality: universal coverage for all Canadian citizens on uniform terms and conditions Comprehensiveness: all medically necessary services provided by medical practitioners or hospitals are to be covered by public health care insurance Portability: coverage of services outside the province of residence Accessibility: reasonable access to insured services on uniform terms and conditions, unimpeded by financial or other barriers Public administration: provincial/territorial health care insurance is to be managed by a public agency on a not-for-profit basis 26 CANCER CARE IN CANADA, WINTER

27 We have come to expect universal health care, including cancer care and cancer drug therapy, to be made available through our publicly funded health system almost as a birthright. Cancer surgery and radiation therapy are fully insured services under the CHA. However, the CHA only stipulates coverage for hospital and physician services and does not address drug coverage. In the 1960s and 1970s, when cancer drug treatment consisted mainly of in-patient chemotherapy, it was covered under hospital services. As a result, chemotherapy costs were often sequestered in hospital global budgets or cancer agency budgets. Through the 1980s and 1990s, b e t t e r-tolerated regimens and improved support i v e therapies permitted cancer drug treatment to become p redominantly an out-patient activity, delivere d through cancer centres or hospital ambulatory clinics. With no clear articulation of responsibility or priority for drug therapy, provinces developed their own, disparate and often uncoordinated processes for drug p rovision. Intravenous/parenteral cancer drugs are provided through a patchwork of hospital or cancer agency budgets, and oral and take-home medications often through various outpatient prescription dru g subsidy plans, both public such as provincial pharmac a re plans or private, such as third - p a rt y - i n s u re d health benefits. Or they are not funded at all. Cancer drug funding approval processes While the provision of medical services is the responsibility of the provinces, and is supported in part by transfer payments of federal tax revenues, the federal government is responsible for approval of drugs for commercial sale in Canada. The first step in making a drug available for sale is t h rough application to the Therapeutic Pro d u c t s Directorate (TPD) at Health Canada. Here it is evaluated for safety, quality and evidence of efficacy in treating a specified condition, a review process which averaged 639 days in 2003 (the TPD target was 345 days). Drugs approved for sale are granted a Notice of Compliance (NOC) or Notice of Compliance with conditions (NOC/c) from Health Canada, which allows the manufacturer to sell the product in Canada and market it for a specified indication(s) (condition). After NOC the drug is also available for off label use at the discretion of physicians as scientific evidence emerges of its usefulness in other indications. A pharmaceutical company can apply to Health Canada for an expanded indication to allow them to promote the product for other uses. A process called the Common Drug Review (CDR), conducted under the auspices of the Canadian C o o rdinating Office for Health Te c h n o l o g y Assessment (CCOHTA), evaluates the cost-benefit of new drugs and makes funding recommendations to The cancer drugs selected for scrutiny were those representing key advances in their respective areas over the past few years. the provinces. CDR to this point has not addressed intravenous cancer drugs. Once a drug is approved by Health Canada each province separately has the right to determine whether to pay for it. This results in another lag period. Funding approval of cancer drugs undergoes different evaluation processes in each province. This is summarized in Table 1. Evaluation processes for new cancer drug treatments usually involve multidisciplinary expert groups, including specialty/oncology physician, oncology pharm a c y, pharmacoeconomic, and other health professional input. Larger provinces have more elaborate, formalized systems. There is variable access to new drugs across the provinces, depending on the jurisdiction s prioritization of the treatment, timeliness of the often multi-tier vetting process, and availability of resources to support each new treatment. This results in treatments being available in some provinces but not others at any point in time. Sometimes this disparity persists for years. (See Your Money or Your Life, Part III in this issue, and Here a Guideline, There a Guideline, in Report Card 2004.) The way cancer drugs are funded varies significantly across the country. Quebec, Prince Edward Island, New B runswick and Nova Scotia fund IV cancer dru g s t h rough hospital global budgets. British Columbia, Newfoundland, and Saskatchewan have separate provincial cancer agency drug budgets, which fund IV cancer drugs along with many oral and take-home drugs. Provincial pharmacare programs provide varying CANCER CARE IN CANADA, WINTER

28 TABLE 1 CANCER DRUG APPROVAL STRUCTURES AND PROCESSES BY PROVINCE Prov. Cancer drug approval processes and structures Formal practice guidelines Funding BC BC Cancer Agency (BCCA) Priority and Evaluation Committee (PEC); Provincial Systemic Therapy Program (PSTP), expert provincial tumour groups; annual evaluation of new programs for funding and ranking in terms of strength of evidence, impact, and pharmacoeconomic analysis; Undesignated Request application for case-by-case requests* Web-based Cancer Management Manual, protocols, drug information and preprinted chemotherapy orders BCCA provincial cancer drug budget separate from BCCA operating budget (includes chemo, hormones and new drugs, both oral and IV); BC PharmaCare mainly for support drugs (e.g. G-CSF, neupogen, anti-emetics) AB Provincial tumour groups, Alberta Cancer Board (ACB) Pharmacy and Therapeutics (P&T) Committee; Director s Privileges for case-by-case requests* Web-based protocols and standards ACB global budget or hospital global budget (includes chemo, hormones, and new d rugs); no separate budget for cancer dru g s SK Saskatchewan Cancer Agency (SCA) Provincial Oncology Drug Approval Committee (PODAC) (consists of two pharmacists and four oncologists from Regina and Saskatoon cancer centres); process for case-by-case request* Local consensus guidelines SCA cancer drug budget (includes chemo, hormones, new drugs and anti-emetics; many support drugs) MB Cancer Care Manitoba (CCMB) provincial tumour groups; Winnipeg Regional Health Authority P&T committee evaluates all new oncology drugs; non-formulary process for case-by-case requests* Local consensus guidelines CCMB and hospital global budgets within each Regional Health Authority; Manitoba Pharmacare for oral and take-home cancer drugs ON Cancer Care Ontario (CCO) New Drug Funding Program (NDFP) for IV drugs through a joint CCO-Ministry review as a subcommittee of the Drug Quality and Therapeutics Committee (DQTC); ODB Section 8 Individual Clinical Review mechanism for unapproved oral and takehome drugs, but no exception mechanism for new IV drugs* Web-based clinical practice guidelines (CPGs) and systematic reviews from CCO Program for Evidencebased Care (PEBC) 41 by expert provincial tumour groups; webbased cancer drug information Hospital and CCO global budgets (NDFP, ODB and Trillium); Ontario Drug Benefit Program (ODB) and Trillium Drug Program for oral and take-home drugs QC Hospital or institutions determine use individually once NOC obtained. Two newly formed bodies for oncology also address new cancer drugs: Programme du gestion therapeutique des médicaments (PGTM) and Comité de l évolution des pratiques en oncologie (CEPO) Evolving CEPO guidelines; Group d Étude en Oncologie du Québec (GEOQ) guidelines Cancer drug budget resides within each hospital s global budget; Régie de l assurance maladie du Quebec (RAMQ) is responsible for provincial pharmacare program for take-home drugs (Quebec Public Prescription Drug Insurance Plan) NB Individual oncologist request and evaluation within each hospital/regional health authority. None Hospital global budgets; most new oral and take-home drugs through third-party, self-pay and compassionate release NS Cancer Care Nova Scotia (CCNS) expert provincial tumour groups; newly formed Cancer Systemic Therapy Policy Committee, Oncology Therapy Subcommittee, Capital Health Authority Some local consensus guidelines published on website Hospital global budgets; evolving new process for funding expensive new cancer drugs; Nova Scotia Pharmacare covers oral cancer drugs PEI Individual oncologist request and evaluation for each hospital; Provincial Drug and Therapeutics (PDT) committee None Hospital global budgets for IV therapies only; most oral and take-home drugs through third-party, self-pay and compassionate release NL Newfoundland Cancer Treatment and Research Foundation Provincial Oncology P&T Committee; Newfoundland and Labrador Prescription Drug Program Some local consensus guidelines published on website Hospital and Cancer Agency global budgets; separate Provincial Systemic Therapy Oncology Drug Budget; provincial pharm a c a re p rogram for oral and take-home drugs; larg e component of compassionate use dru g s NOTE: Exceptional arrangements for access * 2 8 CANCER CARE IN CANADA, WINTER

29 levels of coverage for oral or take-home new cancer d rugs. Pharm a c a re programs in Manitoba, Ontario, Quebec and Nova Scotia cover modest proportions of the new oral cancer drugs studied, but those in Alberta, PEI, and New Brunswick did not. Many pharmacare programs only provide for those over age 65 or on social assistance, so drug coverage is frequently supplemented by third-party insurers. Only a few pharmacare programs, such as the Trillium Drug Program in Ontario, provide additional coverage for those under age 65. Effect of access to new cancer agents In the last two Report Cards we hypothesized that cancer mortality is inversely related to the level of funding for cancer agencies in each province. We were interested in finding out whether access to these new agents, which represent the evolving standard of care or newest therapy in their respective areas, coincided with the west-east gradient in provincial cancer mortality. We identified 20 drugs, levels of evidence to support their use, timelines for licensing the agents in Canada as compared with the US, and costs of standard courses of therapy. Then we surveyed the availability of the new cancer drugs in each province. Key issues and barriers not addressed by existing provincial cancer agencies, hospitals, and Federal/Pro v i n c i a l / Te rritorial health ministries were identified, and we summarized whether the availability of treatment respects the guiding principles of the Canada Health Act. Methodology The cancer drugs selected for scrutiny were those representing key advances in their respective areas over the past few years. Twenty drugs or classes of drugs for 20 different cancer indications (representing 24 individual agents) were chosen, among them a broad spectrum of drug classes or types. They included new cytotoxic agents, immunotherapies such as monoclonal antibody treatments and radio-immunoconjugates, novel targeted agents such as signal transduction or protein kinase inhibitors, new hormone treatments, and supportive care drugs. Health Canada, the US Food and Dru g Administration (FDA) and pharmaceutical industry sources were surveyed for approved cancer drug indications. Dates when these drugs were approved in both Canada and the US were determined. Medical oncology and oncology pharmacy experts in each province were surveyed and interviewed to document the dates of approval, funding, and availability of the drugs as of December 25, The pivotal clinical trials giving rise to drug approval were identified and the level of evidence for efficacy graded as re p o rted by the McMaster group 2. Drug costs for a typical course of treatment were calculated based on current Canadian commercial drug pricing. Costs were based on BSA (body surface area) of 1.7 m 2 for cancers with female patients, and 1.8 m 2 for those based on male or mixed populations. Drug costing included the range of costs to accommodate wastage from standard vial sizes for parenteral drugs, and varying durations of standard treatment. It did not include indirect costs, costs of administration (such as nursing or pharmacy resources), associated laboratory or imaging tests, or patient out-of-pocket expenses. If the newer drug was used in combination with another treatment, such as chemotherapy, only the new agent acquisition cost or incremental cost was calculated. Availability of each of the 20 drugs or classes was determined and summarized for each province. See Table 4, page 36. In the process of classifying the numerous alternate methods for drug access we also identified some drugs that were made accessible through other mechanisms for significant numbers of cases. These alternate forms of access or reimbursement are identified in Table 3, column 2 under Access. The special designation (L) was used to describe a range of limited access and initially intended to reflect restricted case-by-case funding. However, for this re p o rt we expanded the designation to situations where we could not document reliable or consistent drug access across a province. For example, in some cases a drug may be available through a provincial pharmacare plan to individuals over 65 years of age or on social assistance, but had no or only partial coverage for other groups. In some provinces, access reflected variable uptake of new drugs by individual oncologists or hospitals, often in the setting of no formal provincewide process for evaluating or recommending new cancer drugs. Results Thirteen of the 20 drugs or classes reviewed had level 1 evidence (efficacy based on at least one positive, large randomized study). Seven had lower levels of evidence, usually based on multi-centre phase II studies or several phase II studies in advanced, incurable relapsed cancers after failure of other drug treatments. Most of these new treatments, certainly those with level 1 evidence for efficacy, had provincial expert guidelines written or in process recommending the treatment. The timeliness of drug approval in Canada lags behind that of the US FDA (Table 2, column 6). In some cases the lag time is impacted by a delay in drug company filing of a new drug submission or supplemental new drug submission for the agent, or a decision not to file for approval in Canada at all. CANCER CARE IN CANADA, WINTER

30 TABLE 2 NEW CANCER DRUGS Indications, levels of evidence, Canadian approval timelines, and incremental drug costs for standard course of treatment CANCER DRUG OR CLASS (TRADE NAME) CANCER INDICATION LEVEL OF EVIDENCE 2 APPROVAL DATE IN US (FDA) APPROVAL DATE IN CANADA (HEALTH CANADA) DELAY FOR APPROVAL IN CANADA (VS US) DRUG COST FOR STANDARD COURSE ($CDN) REFERENCE FOR KEY STUDIES capecitabine (Xeloda) Adjuvant treatment of Duke C colon cancer 1 Jun 15, 2005 Dec 7, years $ 6,000 3 oxaliplatin (Eloxatin) Adjuvant FOLFOX chemotherapy for Duke C colon cancer 1 NOV 4, 2004 Not approved but available through SAP 1.2+ years $ 20 25,000 4 oxaliplatin (Eloxatin) Metastatic colorectal cancer 1 AUG 9, 2002 Not approved but available through SAP 3.4+ years $ 20 25,000 5, 6 pemetrexed (Alimta) Mesothelioma (First line) 1 FEB 4, 2004 May 21, years $ 20 25,000 7 temozolomide (Temodal) Glioblastoma multiforme of brain with XRT and maintenance 1 Approved Aug 11, 1999 for relapsed astrocytoma; Additional approved indication for GBM with XRT & maintenance Mar 15, 2005 Approved Oct 25,1999 for relapsed astrocytoma; no approval yet for GBM indication with XRT and maintenance but drug available 0.8 years $ 20,000 8 trastuzumab (Herceptin) Adjuvant treatment of her2/neu positive breast cancer 1 Submission in process but previously approved Sept 25, 1998 for metastatic breast cancer Submission in process but previously approved Aug 13, 1998 for metastatic breast cancer $ 45 50,000 9, 10 rituximab (Rituxan) Diffuse large cell, B-cell non- Hodgkins lymphoma with CHOP chemo 1 Nov 26, 1997 for relapsed NHL; no approval with CHOP-R for DLC NHL but submitted Aug 2005 to FDA for sbla Mar 17, 2000 for relapsed NHL; approval NOC for additional indication with CHOP-R for DLC B-cell NHL received Nov 6, 2002 (2.3 years for initial NOC) 3.1 years $ 20 34,000 11, 12 bevacizumab (Avastin) Metastatic colorectal cancer with chemo 1 Feb 26, 2004 Sept 9, years $ 30,000 13, 14 cetuximab (Erbitux) Relapsed metastatic colorectal cancer with chemo 3 Feb 12, 2004 Sept 9, years $ 56,000 15, 16 alemtuzumab (Campath) Relapsed chronic lymphocytic leukemia 3 May 7, 2001 Nov 30, years $ 22,000 17, 18 I-131 tositumomab (Bexxar) Relapsed low grade non- Hodgkins lymphoma 3 June 27, 2003 Aug 18, years $ 20,000 19, 20 yttrium-90 ibritumomab (Zevalin) Relapsed low grade non- Hodgkins lymphoma 3 Feb 19, 2002 May 10, years $ 20,000 21, CANCER CARE IN CANADA, WINTER

31 CANCER DRUG OR CLASS (TRADE NAME) CANCER INDICATION LEVEL OF EVIDENCE 2 APPROVAL DATE IN US (FDA) APPROVAL DATE IN CANADA (HEALTH CANADA) DELAY FOR APPROVAL IN CANADA (VS US) DRUG COST FOR STANDARD COURSE ($CDN) REFERENCE FOR KEY STUDIES Aromatase inhibitors - 1. anastrazole (Arimidex) 2. letrozole (Femara) 3. exemestane (Aromasin) Adjuvant treatment of ER positive breast cancer Sept 5, 2002 Oct 29, 2004 Not approved but available Jun 30, 2004 Apr 1, 2005 Not approved but available 1.8 years 0.4 years $1,800 per year $1,800 per year $1,800 per year 23, Bisphophonates 1. clodronate (generic) 2. pamidronate (generic) 3. zoledronic acid (Zometa) Supportive treatment to reduce risk of bone complications of metastatic breast cancer to bone Sept 22, 1998 Feb 22, 2002 Aug 1, 2002 Aug 13, 1999 July 30, years 1.4 years $ per year $1,600 per year $6 6,500 per year thalidomide (Thalomid) Relapsed multiple myeloma 3 Not approved for this indication but available since July 1, 1998 for leprosy Not approved but available through SAP $44, bortezomib (Velcade) Relapsed multiple myeloma 1 May 13, 2003 Jan 27, years $43 57,000 29, 30 erlotinib (Tarceva) Relapsed nonsmall cell lung cancer 1 Nov 18, 2004 July 17, years $14, gefitinib (Iressa) Relapsed nonsmall cell lung cancer 2 May 5, 2003 Dec 17, years $13,000 32, 33, 34 imatinib (Gleevec) Chronic myelogenous leukemia 1 May 10, 2001 Sept 20, years $35 70,000 per year 35, 36 imatinib (Gleevec) Gastro-intestinal stromal tumour 3 Feb 1, 2002 Aug 7, years $35,000 per year 37 For the 20 drugs studied, 14 were approved in both countries with delays in approval times ranging from four months to four-and-a-half years. All 14 drugs were approved first in the US, although Canadian cancer physicians were often involved in the pivotal studies on which approval was based. Of the six dru g s approved only in one country, five were approved only in the US. Three drugs, oxaliplatin (Eloxatin) for two indications and thalidomide (Thalomid) for one indication, were available in Canada only through Special Access P rograms and still have not had Health Canada approval. In at least one case (oxaliplatin), the pharmaceutical company has stopped pursuing approval. Only one drug, rituximab (Rituxan), re c e i v e d approval in Canada for expanded indication before the US. This was CHOP-rituximab therapy for first line treatment of aggressive non-hodgkins lymphoma, but the drug had already received US FDA approval in 1997 and NOC in Canada in 2000, and was being used in the US for a wide variety of off-label indications. Fifteen of the 20 new drugs cost in excess of $20,000 CANCER CARE IN CANADA, WINTER

32 BC has the best funded and most timely access to cancer drugs. (range $20,000 to $70,000) for a standard course of treatment, which ranges from 12 weeks to one year. (Iodine-131 tositumomab/bexxar and yttrium-90 ibritumomab/zevalin were the only two drugs where the duration of treatment was brief.) Of those that are less expensive, such as the bisphosphonates and aromatase inhibitors (AIs), many are oral drugs which are widely available and affordable. However, they have to be taken for prolonged periods of time (e.g. two to five years for AIs taken for adjuvant breast cancer), so the ultimate cost for any one patient is still considerable. Comparison of provincial funding approvals The number of drugs not approved or funded by provincial government sources (designated as X in the table) is as follows: BC(2); AB(4); SK(6); MB(5); ON(4); QC(2); NB(5); PEI(13); NS(7); NL(8). The comparisons of provincial funding approvals for new cancer drugs and their availability are shown in Table 3 and summarized in Table 4. Column 2 of Table 3 identifies forms of access or reimbursement outside the usual cancer centre or pharmacare plans, including compassionate release, pharmaceutical assistance programs, or, in at least one instance, a multi-centre Canadian trial. As is evident in Table 3, there is an increased utilization of the self-pay option, third-party insurers, co-pay programs, and pharm a c e u t i c a l c o m p a n y - s p o n s o red payment assistant programs in Central and Eastern Canada. The drug with the most universal access as of December 2005 is rituximab (Rituxan) with standard chemotherapy (CHOP-R) for first-line treatment of aggressive non-hodgkins lymphoma (NHL). Funding and implementation timeframes for this life-saving treatment varied widely among the provinces, beginning in 2001 in British Columbia and New Brunswick several months after the preliminary results of the landmark GELA study 11. It was implemented as a standard of care in other provinces from 2002 to 2004 (see Your Money or Your Life, Part III in this issue). Trastuzumab (Herceptin) for adjuvant breast cancer demonstrates another life-saving drug but with rapid uptake in all provinces. Preliminary results of several landmark randomized clinical trials 9,10 presented in May 2005 were so impressive that by the fall of 2005 all provinces had implemented the treatment, even though formal additional new funding in many instances had yet to be flowed. In the provinces that have not approved additional funding for trastuzumab (Herceptin), the drug is being supplied from existing budgets, limiting access to other new drug treatments. In at least one instance, funding is temporarily being provided by the cancer agency s charitable foundation until a provincial allocation is made available. The rapidity of implementation was influenced not only by the striking clinical trial results, but also by the efforts of breast cancer advocacy groups. The drug with the most universal lack of access or support from any province is cetuximab (Erbitux) for metastatic colorectal cancer. 15,16 At $56,000 for six months of treatment with standard chemotherapy in a second- or third-line setting of incurable, advanced colorectal cancer, cetuximab (Erbitux) is one of the most expensive new drugs. Assistance programs In many provinces patients must access specific new cancer drugs extensively through assistance programs from pharmaceutical companies with significant co-pay components, as there is insufficient funding fro m provincial sources or existing drug or hospital global budgets. At least 11 of the drugs/indications studied had a pharmaceutical company sponsored drug assistance program currently available. Most pharmaceutical assistance programs, as well as public or third-party insurance drug programs, require divulgence of personal and family finances and assets to determine the degree of assistance to be provided. Many drugs, especially ones taken orally, can be provided by self-pay or thirdparty insurers as they are readily available through community pharmacies. 3 2 CANCER CARE IN CANADA, WINTER

33 Cancer drug access summarized by province British Columbia BC has the best funded and most timely access to cancer drugs within a strong, well-organized, population-based, cancer control program coordinated by the provincial cancer agency. As a result, population-based outcomes can be monitored for new interventions, such as the CHOP-rituximab story. BC also has the best cancer outcomes and lowest cancer mortality (see Report Cards for 2003 and 2004). The BCCA does not allow non-approved, non-funded drugs to be delivered at BCAA centres outside of clinical trials, but these drugs might be available in community cancer centres. Alberta Despite living in one of the richer provinces, Albertans have only modest access to new cancer drugs. The Alberta Cancer Board is hampered by not having a cancer drug budget separate from the ACB global operating budget. New cancer therapies continue to be made available through self-pay, third-party, pharmaceutical company assistance programs and in at least one instance (adjuvant trastuzumab/herceptin for breast cancer), through donated dollars. Saskatchewan Unlike other provinces, Saskatchewan provides supportive care drugs, such as anti-emetics, bisphophonate, and G-CSF (Neupogen) to cancer patients from its global provincial cancer drug budget. These supportive care drugs are not usually fully funded in other provinces. Both IV and oral cancer drugs are provided through the same provincial cancer agency drug budget. Manitoba As shown in Table 3, Manitoba provides many new d rugs but has not yet received formal additional funding for them. Oral cancer drugs are provided separately from IV cancer drugs through the Manitoba Pharmacare program. Ontario In Ontario, major organizational changes in cancer system delivery have occurred. The provincial health ministry instituted a new review and decision-making process for cancer drugs through a joint committee with CCO. CCO has a well-developed evaluative process for writing guidelines, based on its Program in Evidencebased Care (PEBC) 41. Orders for many of the drugs in Table 3 must be accompanied by extensive and timeconsuming paperwork from the attending oncologist. Ontario makes no provision for bort e z o m i d e (Velcade) for myeloma. It was one of the last provinces to fund CHOP-rituximab (Rituxan) for aggressive lymphoma for all ages. Oxaliplatin (Eloxatin) remains unfunded, but most centres provide the drug using pharmaceutical assistance programs and third-party payers. The emergence of private clinics, highlights some of the evolving private options entering the Canadian system because of the untimely access to care 40. Quebec Quebec has the widest scope for access to any cancer drug through individual hospital global drug budgets, since any drug can be funded once NOC is issued by Health Canada. However, there is great variability in access from hospital to hospital or within different regions of the province based on availability of oncology expertise. As in many other provinces, the hospital funding to provide these drugs often come some time after treatment has been implemented as a new standard of care. An evolving provincial cancer oversight body may be able to address provincial cancer issues, including drug access. New Brunswick A very good and timely drug access program is in place through global hospital budgets at the four main centres with oncology expertise. How an evolving provincial cancer process will impact this remains to be seen. Nova Scotia Currently, most IV cancer drugs are funded through hospital global budgets in individual regional authorities with issues arising as a result. A new funding process for expensive new cancer drugs is in development and may ameliorate this situation. In addition, significant numbers of Nova Scotians do not have a third-party drug plan, limiting the use of many new cancer drugs. Prince Edward Island Access to cancer drugs is probably better than indicated in Table 3 and Table 4. With a small population base and only two oncologists, many drugs are not evaluated until the need arises. Hence many drugs have not been approved or funded, and no proactive system is in place to vet them because the need to has not yet arisen. Most oral cancer drugs are not provided through the public plans but are accessed through third-party insurers, compassionate access, self-pay or pharmaceutical assistance programs. Newfoundland and Labrador NL has modest access to new cancer drugs but has CANCER CARE IN CANADA, WINTER

34 TABLE 3 CANCER DRUG ACCESS AND FUNDING BY DRUG AND PROVINCE (STATUS AS OF DEC. 25, 2005) DRUG AND INDICATION ACCESS BC AB SK MB ON QC NB PEI NS NL capecitabine (Xeloda) Adjuvant treatment of Duke C colon cancer oxaliplatin (Eloxatin) FOLFOX adjuvant treatment of colon cancer oxaliplatin (Eloxatin) Metastatic colorectal cancer pemetrexed (Alimta) With Cisplatin for mesothelioma temozolomide (Temodal) With XRT and 6 months maintenance for GBM trastuzumab (Herceptin) Adjuvant treatment of her2/neu positive breast cancer rituximab(rituxan) CHOP-Rituxan for DLC, B-cell non-hodgkin s lymphoma bevacizumab (Avastin) With chemotherapy for metastatic colorectal cancer cetuximab(erbitux) With chemotherapy for metastatic colorectal cancer alemtuzumab (Campath) Relapsed chronic lymphocytic leukemia I-131 tositumomab (Bexxar) Relapsed NHL yttrium-90 ibritumomab (Zevalin) Relapsed NHL AI anastrazole (Arimidex) Adjuvant treatment of ER positive breast cancer AI letrozole (Femara) Adjuvant treatment of ER positive breast cancer AI exemestane (Aromasin) Adjuvant treatment of ER positive breast cancer bisphophonate clodronate (Various/generic) Reduce bone complications from metastatic breast cancer P S L R L L L P L RL RL RL RL L L R L P L RL L L RL L L L L L PW L L L L R PS L XL RL L RLD RL RL P RL R R RL L L R R L L L L L L L T L T LT LT T L R L L CS R R RL RL RL L CL S R R RL RL RL L CL S R R RL RL L RL CL S L L L Continued on facing page Approved and funded in that province Not approved or funded in that province L Limited access: reliable or consistent drug access and public funding across a province could not be documented R Recommended for funding but not yet funded S Self pay or third-party insurer P Pharmaceutical company sponsored re-imbursement /assistance program C Compassionate release from pharmaceutical company W Funded through WCB (Workers Compensation Board) or WSIB (Workplace Safety and Insurance Board) in Ont. D Funded partly by donated monies from charitable source or Foundation T Available by multi-centre Canadian clinical trial currently open or soon to open as of December CANCER CARE IN CANADA, WINTER

35 DRUG AND INDICATION ACCESS BC AB SK MB ON QC NB PEI NS NL bisphophonates pamidronate (Various/generic) Reduce bone complications from metastatic breast cancer bisphophonate zoledronate (Zometa) Reduce bone complications from metastatic breast cancer thalidomide (Thalomid) Relapsed multiple myeloma bortezomib (Velcade) Relapsed multiple myeloma erlotinib (Tarceva) Non-small cell lung cancer gefitinib (Iressa) Non-small cell lung cancer imitanib(gleevec) Chronic myelogenous leukemia imatinib(gleevec) Gastrointestinal stromal tumour P L L L C L C L L RL L RL L RL RL L R RL L L RL L PCS L R L L L XL PCS L L PCS L L L L PCS L L L L L successfully approved and funded many of the largest, most important, and most costly new treatments, including CHOP-rituximab (Rituxan), adjuvant trastuzumab (Herceptin), and oxaliplatin (Eloxatin) for metastatic colon cancer. It had developed an effective cancer drug evaluation process through its Provincial Oncology P&T Committee and funded cancer drugs through a provincial oncology drug budget. The impact on the current drug approval and funding process of the recent reorganization of the provincial cancer agency remains to be seen. Newfoundland and Labrador remains one of the largest recipients of compassionate use cancer drugs in Canada. D I S C U S S I O N Costs, access and reimbursement All the new cancer drugs surveyed can produce better outcomes, but at considerable cost. Many, especially those in the palliative setting, offer only modest or marginal benefit. However, for some patients these drugs a re life-saving or life-prolonging, but the high cost hinders implementation and timely access. As a result, many cancer physicians become involved in finding alternate forms of access, including compassionate release, pharmaceutical company-sponsore d reimbursement or assistance programs, third - p a rt y insurers, and increasingly, combinations of all three to provide these new drug treatments for their patients. Out-of-country drug sources are available in some instances. One example is thalidomide, used for the treatment of relapsed multiple myeloma. The US manufacturer, who supplies the product under the Special Access Program in Canada, increased the price more than five-fold, straining the ability of many centres to provide the drug. In explanation, the manufacturer indicates that the increased cost is at least partially necessary to support the clinical trials necessary to precisely determine its utility in myeloma. In Mexico, thalidomide has been approved since 1988 for the treatment of leprosy, and a local manufacturer provides the drug in that country at a substantially lower price for leprosy than is charged in Canada and the US for myeloma. Although it is not possible to import thalidomide from Mexico, patients can travel there to acquire a supply for individual medical use and bring it back into Canada. Prices of patented medicines, which include the majority of these new cancer drugs, are regulated by the CANCER CARE IN CANADA, WINTER

36 TABLE 4 S U M M A RY OF CANCER DRUG APPROVAL AND PUBLIC FUNDING STAT U S (STATUS AS OF DEC. 25, 2005) British Columbia Alberta Saskatchewan Manitoba Ontario Quebec New Brunswick Nova Scotia Prince Edward Island Newfoundland and Labrador APPROVED AND FUNDED LIMITED ACCESS/ FUNDING* RECOMMENDED BUT NOT FUNDED NOT APPROVED OR FUNDED * Limited access refers to all situations where reliable or consistent drug access and public funding across a province could not be documented. Patented Medicines Prices Review Board (PMPRB). This arms-length, quasi-judicial independent body reports to Parliament through the federal Minister of Health and has a mandate to protect consumers and contribute to Canadian health care by ensuring that prices charged by manufacturers for patented medicines are not excessive, particularly when compared to prices in select Western nations. A PMPRB process is in place for reviewing individual drug prices on a regular basis, but keeping prices in line with other developed countries is insufficient to make these new treatments more readily available to those who need them. No single provincial pharm a c a re model pro t e c t s Canadians against catastrophic drug costs. Ontario and British Columbia come closest 38, and third-party insurers cover a significant proportion of the population when public programs do not. Increasingly, individuals are seeking additional insurance in the form of critical illness policies which cover catastrophic drug costs, but many Canadians cannot afford this type of coverage. Further, not all provinces or centres will administer self-pay or third-party covered drugs, citing contravention of the Canada Health Act. The availability of an open market system in the US provides some options for patients not able to access care in Canada. However, this is at much greater expense than if the drugs were administered in their home province. The inconvenience in terms of travel, and time spent away from home and family are extra burd e n s compounding a life-threatening illness. If patients can only access their best cancer treatment options south of the border, Canada is threatened with a loss of economic activity, specialized cancer knowledge and expertise, and potential brain drain. The west-east gradient in cancer mortality As is evident from Tables 3 and 4, cancer drugs are not evenly accessible for the same condition from province to province. Although the evidence for benefit for each drug in every condition undergoes expert medical evaluation in all provinces, the ensuing recommendations based on the same body of evidence can vary greatly. The resulting disparity in access and funding impacts implementation of potentially effective new therapies. From the data presented in Table 3, the number of drugs not approved or funded ( X drugs in the table) does increase from west to east, but it is less clear how this is related to the west-east gradient in cancer mortality. Many new treatments have only recently been introduced so their impact in improved patient outcomes has yet to be apparent. The processes, structures and resources in each province for providing timely access to new effective treatments (Table 1) may be a more important factor. Those provinces where access is an issue have an increased reciprocal reliance on alternate and less reliable sources of funding. 3 6 CANCER CARE IN CANADA, WINTER

37 TABLE 5 COMPONENTS OF CANCER CARE AND CANCER DRUG THERAPY AND THEIR R E L ATIONSHIP TO THE GUIDING PRINCIPLES OF THE CANADA HEALTH ACT 1 Accessibility Universal coverage Portability Comprehensiveness Public administration Surgery Yes Yes Yes Yes Yes Radiation Yes Yes Yes Yes Yes Cancer Drug Therapy Variable Canada Health Act guiding principles and cancer drug access As summarized in Table 5, it is clear that among the major modalities of cancer treatment, drug therapy is the least conforming to the guiding principles of the Canada Health Act. Accessibility can be highly variable. Coverage of new cancer drugs provided by cancer physicians in hospital-based clinics is no longer universal. The principle of comprehensiveness is not respected, as one of the key modalities of cancer treatment (cancer drug therapy) especially with new expensive agents may not be available, unlike surgery and radiation, which are provided as insured hospital services. What is available in one province as a standard of care is not funded for non-residents even though it is available, so portability is not ensured. Conclusions Evaluated on the guiding principles of the Canada Health Act, new cancer drugs are not accessible to all patients that require them, or universal in their coverage, or comprehensive in their overall integration with other cancer treatments, or portable from province to province, or even publicly administered or funded. There is marked variability in access to cancer drugs from province to province. It is less certain how the west-east gradient in cancer mortality coincides with access to new and effective cancer drug therapy. No No Variable No CACC recommendations As Canadians we are increasingly cognizant of the impact of cancer on our lives. Where a provincial health plan does not insure a service or cannot deliver an insured service in a timely manner the provincial health plan should not be a barrier to access. Patients should have the right to access such services that can save, extend or improve their lives, if necessary through other providers and payment systems in Canada. These alternate payers already exist in several jurisdictions for many new cancer drugs. In order to bring about more timely and equitable access to cancer drugs, CACC recommends: Establishment of a national catastrophic drug strategy to resolve the existing deficiencies of access and eliminate the great variability between the provinces. Inequitable access to life-saving cancer drugs is in direct contravention of the spirit and intent of the Canada Health Act and deserves immediate and careful attention. It is time for the various levels of government to develop an appropriate policy framework to ensure coast-to-coast consistency in the mix of public-private payers in a way that protects the vulnerable, honours the principles of the Canada Health Act, and allows cancer specialists to offer the best available treatments in a timely manner. A successful model providing access to cancer drugs could yield lessons applicable to a national catastrophic drug program covering other diseases. Development and implementation of Canada-wide guidelines in a timely and consistent manner to speed up access and provide more uniformity. For this purpose, provinces must collaborate to reduce the present duplication in effort, the delay and variability in conclusions. Increased translational research to ensure appropriate utilization by identifying subsets of patients who would best benefit from new therapies. In the meantime, empiric evaluation could be encouraged by allowing a limited trial of two-three cycles of therapy to identify those patients that may benefit. This would minimize inappropriate use, and reduce the cost impact of these expensive new drugs while broadening access. Introduction of an ongoing evaluation process for new cancer drugs. This would further corroborate the drugs effectiveness when given to patients in the general population, enable further pharm a c o - economic analysis and identify infrequent side effects and long term safety. Incorporate patient involvement and choice into decision-making. This must be transparently linked to funding sources, including government ministries, third-party insurers, research agencies, and compassionate assistance programs of pharmaceutical companies. CANCER CARE IN CANADA, WINTER

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39 In 1999 They Told Me I Was Cu re d BY SUZANNE AUCOIN If you are reading this article then you are already well aware of the challenges and stress of having to deal with cancer. I am a Stage IV colon cancer thrivor, and have been undergoing chemotherapy for two years. One of the many challenges of living with this kind of cancer is the lack of accessibility to the new targeted gene therapies. You may know that Canada is the last G8 country to approve and fund these leading edge drugs. It is so frustrating to know of drugs and treatments that one needs and not be able to access them. In my case, I needed the drugs Avastin and Erbitux as my other drugs were no longer effective. I began to fundraise as I knew these drugs would costs thousands of dollars. Initially I went to Roswell Park in Buffalo to learn more about these drugs from a United States oncologist. I paid out of pocket for this visit and that would be the first of many out of pocket expenses. (visit for more information) To coordinate and research drug options, I have had to attend conferences in the US, visit numerous doctors both in Ontario and New York State, call my primary oncologist s office weekly to ask for documents, applications, letters, and information to ultimately reach my goal of getting the latest and most effective drugs. I was fortunate to have a connection through a friend to a private clinic in West Seneca, New York. I began to receive Avastin on November 9, On October 25, 2005 I started Erbitux at the same clinic. Private clinics are much more affordable compared to larger cancer centres or hospitals in the United States. Due to the proximity between St. Catharines and Buffalo, the commute to the clinic is very tolerable. Lately, I have had to solicit media attention, meetings with local MPs and MPPs to make them aware of the barriers in the cancer care in Ontario, and take my fight to Queen s Park to try to receive fair and equal treatment in the access and receiving of lifesaving drugs. Press conferences, interviews and becoming a public figure in the fight for drugs was not something I had envisioned. This aspect of the overall fight with cancer was very draining and frustrating for me. I am an educator and want to share my story so that others can learn and hopefully assist the lives of others. But working with the health care and political systems is ridiculously exhausting as there are no straight answers, only inconsistent policies, ignorance and injustice. These are the last things a cancer patient needs to deal with. As a result of the injustices and inconsistencies within the health system, I have also hired a lawyer to assist me in my fight. This is another out of pocket expense but to tackle OHIP while trying to access my drugs is not a realistic task. It is a long and arduous challenge when trying to attain expensive and new drugs in a system that does not offer cancer patients equitable nor timely service. However, I am determined to live and that means exhausting all possibilities and circ u m v e n t i n g obstacles and institutions. This is my reality and this is my strategy to living well with cancer. Suzanne Aucoin is a 35 year old resident of St. Catharines, Ontario whose personal campaign to receive newer cancer treatments led the federal government to intervene: she is now allowed to pay for and receive her treatments in Ontario. 2006, Suzanne Aucoin. Used with the kind permission of the author. CANCER CARE IN CANADA, WINTER