Submission to the Senate Inquiry into the availability of new, innovative and specialist cancer drugs in Australia Executive Summary

Transcription

1 Submission to the Senate Inquiry into the availability of new, innovative and specialist cancer drugs in Australia Prepared by the Cancer Drugs Alliance, February 2015 Executive Summary Australia has the highest age- standardised incidence of cancer in the world. In 2015, the risk of being diagnosed with cancer before the age of 85 will be 1 in 2 for males and 1 in 3 for females; 1 in 5 will die from cancer before the age of 85 years. This year it is estimated that 45,780 people will die from cancer, an average of 125 deaths every day, accounting for about 3 in every 10 deaths in Australia. i However, Australian cancer patients face significant delays and expense in accessing new cancer drugs, or worse they are missing out altogether. Australian patients need, expect and deserve timely and affordable access to available cancer medicines. Investments in medical research have led to many dramatic advances in the way cancer is treated and will be treated in the future. With advances in medical research and our understanding of the individuality of the disease, we are now increasingly able to define cancers by their genetic abnormalities through molecular diagnosis. Targeted medicines to match the molecular diagnosis have brought more treatment options, improved patient quality of life and survival but have brought challenges to the regulatory and reimbursement processes; as a result the benefits are not flowing to Australian cancer patients. We must ensure that our universal healthcare system delivers access to new, innovative and specialist cancer medicines for all Australian patients, in a timely and affordable way; and the only way we can do that is by undertaking to modernise the current system so that it can efficiently and effectively assess these medicines for registration and reimbursement via the PBS. Undertaking to modernise the PBS is no small task, and may take a number of years to complete. Throughout 2014, the CDA have been working with stakeholders from all sectors of the cancer community in Australia to deliver a number of recommendations for improving access for patients - shifting from a static assessment of cost- effectiveness to an assessment of value and quality, greater consumer and specialist engagement, creating a national chemotherapy database and a mechanism for ensuring interim patient access. Until we have a system that is capable of assessing the true value of medicines, beyond the out- dated cost- effectiveness model, Australian patients of today, and those of tomorrow, will never have timely access to the medicines they need, when they most need them. The CDA is grateful for the opportunity to provide this submission to the Senate Community Affairs Committee and would welcome the opportunity to share the CDA s full recommendations for modernising the PBS, which will be published in the CDA White Paper: Improving Access to Cancer Medicine for All Australian Patients, in March

2 Introduction The Burden of Disease Australia has the highest age- standardised incidence of cancer in the world. In 2015, the risk of being diagnosed with cancer before the age of 85 will be 1 in 2 for males and 1 in 3 for females; 1 in 5 will die from cancer before the age of 85 years. This year it is estimated that 45,780 people will die from cancer, an average of 125 deaths every day, accounting for about 3 in every 10 deaths in Australia. ii In 2015, it is estimated that 123,920 Australians will be diagnosed with cancer (excluding basal and squamous cell carcinoma of the skin, as these cancers are not notifiable diseases in Australia). iii Few other developed countries face such a significant and urgent need to act and address this challenge for the long- term. Between 1982 and 2014, the number of new cancer cases diagnosed more than doubled from 47,417 to 123,920. This increase can be largely attributed to the rise in the incidence of prostate cancer, colorectal cancer, breast cancer and lung cancer. The increase can also be partly explained by the ageing and increasing size of the population, improved diagnoses through population health screening programs, and improvements in technologies and techniques used to identify and diagnose cancer. iv Cancer is an area of high clinical need it is not one disease, it is many hundred diseases and each of these can manifest differently in each cancer patient. Cancer presents the highest disease- related burden on society accounting for 19% of the total burden but despite this, Australian patients are either being denied potentially life- saving drugs that are available in other countries or experiencing considerable delays in accessing many new and innovative medicines. v Cancer represents an extremely complex challenge for our healthcare system. Cancer patients unfortunately do not have the luxury of time to wait months, or in some cases years, for the best medicines to become available. With advances in medical research and our understanding of the individuality of the disease, we are now increasingly able to define cancers by their genetic abnormalities through molecular diagnosis, target specific medicines to these genetic abnormalities and thereby increase the benefit of treatment. We now know that even amongst the commonest cancers, there are very small numbers of patients with rare genetic abnormalities. For example, lung cancer (10,193 total cases per annum in Australia vi ) is the leading cause of cancer - related death in Australia. A major subgroup of lung cancer is the non- small cell group (NSCLC). A small (4%) but significant cohort of this group have a genetic mutation (anaplastic lymphoma kinase or ALK) that renders these tumours (cancers) more sensitive, than other common lung tumours, to a specific drug that is available in over 70 countries around the world and approved by the Therapeutic Goods Administration (TGA) in Australia in September 2013, but not currently available to these patients on the PBS. In addition, many of the cancer treatments are end- of- life therapies (defined as treatment administered to patients with a prognosis of 2 years or less). To date, there has been no meaningful debate in Australia about the value- of- life, including end- of- life care, and what the community considers acceptable. It is timely now for all involved in cancer care to consider these values and assess how best Australia should provide access to these important medicines. 2

3 Access to Medicines via the PBS Australian cancer patients face significant delays and expense in accessing new cancer drugs, or worse they are missing out altogether. Australian patients need, expect and deserve timely and affordable access to available cancer medicines. Globally there are more than 900 cancer medicines currently under development. Research published in 2013 indicated there are more than 250 indications across 114 chemical entities currently in Phase II and Phase III trials in oncology being conducted by 16 major pharmaceutical companies. vii Approximately 44 new applications are likely to be submitted to the Pharmaceutical Benefits Advisory Committee (PBAC) by the end of Timely and affordable access to cancer medicines is a problem now and is likely to become considerably worse in coming years in the absence of fundamental system reforms. There continues to be significant investment in cancer research from public and private sectors throughout the world, including Australia which, in addition to existing investment, in 2014 pledged $20bn to create a Medical Research Future Fund. Investments in medical research have led to many dramatic advances in the way cancer is treated and will be treated in the future. The rapid scientific advances in global cancer research have shifted the treatment landscape towards targeted cancer therapies. These targeted medicines have brought more treatment options, improved patient quality of life and survival but have brought challenges to the regulatory and reimbursement processes. Ironically, the products of this research are not being rapidly assessed by our current system and therefore are often not funded by the Pharmaceutical Benefits Scheme (PBS) in a timely manner; as a result the benefits are not flowing to Australian cancer patients. Australia s reimbursement system has not sufficiently evolved to reflect these rapid scientific advances. The full potential of this fast paced research will only be realised if patients have timely access to the new and innovative drugs that are being discovered and developed at an increasing rate, through a modern regulatory and reimbursement system that works efficiently. Regulatory and reimbursement approval processes therefore need to evolve to provide a system that is fit- for- purpose and capable of meeting this changing treatment environment. In 1949 the Australian Government formed the PBS with the objective of providing government- subsidised medicines to the Australian community. The task of assessing those medicines proposed for inclusion on the PBS was given to the Pharmaceutical Benefits Advisory Committee (PBAC). The PBS is currently the only means of providing Australian cancer patients with broad and equitable access to cancer medicines. Then, in 1987, an amendment was made to the National Health Act to explicitly require the PBAC to take into consideration in its listing recommendation, both the effectiveness and cost of a medicine, compared with an appropriate drug or non- drug therapy. In the early 1990s, the PBS became the first national pharmaceutical reimbursement scheme to formally adopt an explicit cost- effectiveness criterion for the listing recommendation. viii While the PBS has served Australians well for over 65 years, it has not kept pace with technological advances in cancer treatments and clinical practice. With continuing advances in development of cancer medicines, historical approaches to determining cost- effectiveness rather than value, mean that the system is failing patients and clinicians. According to an analysis published in 2013, the average time from TGA registration to PBS listing was almost 20 months for new listings, and more than 24 months for subsequent listings, with the maximum time taking more than 52 months 3

4 and close to 80 months respectively. ix The same research found that the average time between TGA approvals to PBS listing is now 31 months, up from 15 months over the past 10 years. x While cancer patients and their families wait for cancer medicines to be approved by the PBAC, they face significant financial, physical and psychological burdens. Patients have few options other than to pay a significant amount of money out of their pocket for treatment or else accept that they will not receive the latest, most effective treatments. In addition, these delays put a significant limitation on a doctor s ability to deliver the best possible care to Australian cancer patients. Cancer physicians often encounter the moral and ethical dilemma of raising the issue of cancer medicines with the patient as there may be a treatment available internationally, but the patient may not be able to access the treatment unless it is reimbursed or they can afford to pay. In the period of , nine pharmaceutical companies provided more than 4,700 Australian patients with compassionate access to novel anti- cancer drugs with more than two- thirds (67.9%) of supplies used to cover the access gap between TGA registration and PBS listing (access was mostly provided free of charge, 85.2%). xi Compassionate access or cost- sharing programs are helpful in the immediate- term for a small number of specific patients, but do not provide long- term, sustainable and certainty for the majority of patients. The issues faced with access to cancer medicines are illustrative of the current challenges with medicines reimbursement via the PBS in general. There are many other medicines across different disease areas that face similar challenges in securing timely access for patients; however cancer medicines offer the greatest complexity for the health system and as such, resolving the issues faced in access to cancer medicines will enable the Government to improve access to other medicines that present a lesser challenge. A Global Issue The access to medicines issue is not confined to Australia. It is a challenge facing many Governments around the world, particularly comparable countries in Europe and North America. Some countries have already taken action and, as a result, cancer patients in these countries have access to new cancer medicines that Australian patients are being denied. For example, in 2010, a Cancer Drugs Fund was established in England in order to provide a means by which cancer patients could equitably access the latest safe and effective cancer drugs. A different mechanism called the pan- Canadian Oncology Drug Review was also established in Canada to improve access to cancer drugs. Although there have been criticisms of the English fund, it continues to cover approximately 59 cancer drugs and during the 5 years it has been in existence has allowed more than 60,000 cancer patients to receive treatment they would have not have otherwise had access to. Where countries have introduced change, clear improvements in access to cancer medicines have been seen both in terms of faster approval times, and more medicines being available. Analysis conducted in 2014 to compare Australia s performance with similar countries (Canada, France, Germany and the UK) found that on average it takes more time to achieve access to a subsidised medicine in Australia than in the other countries. xii In Australia, new cancer medicines 4

5 need to be submitted at least twice to the PBAC on average before being listed on the PBS, which can mean significant delays. There are a range of alternative policy options that have been adopted globally for addressing the financial challenges faced by patients that Australia can learn from. For example, patients in countries such as America and New Zealand are able to insure against the high cost of drugs, with options ranging from full drug insurance (where the patient pays no out- of- pocket expenses) to co- payments for a set amount per prescription. Australian cancer patients wait longer than counterparts in other comparable countries for access to cancer medicines and, as such, the CDA believes that in finding a solution for improving access and affordability for Australian cancer patients must be a priority. The Need to Modernise The CDA supports increasing investments in medical research as a means to delivering a cure for cancer and other important diseases. However, Australia must also have a system that works to more effectively assess the innovative medicines that are discovered through these significant investments in medical research. Ensuring the rapid translation of research findings into routine patient care is critical to improving cancer experiences and outcomes in Australia. It is worth noting that there are a number of important new medicines already available to patients in many other developed countries that have emerged as the result of previous investments in medical research, that Australian patients cannot access, as they have never been approved by the PBAC. For example, Australia has been a key contributor to the clinical development of new treatments for metastatic melanoma. Australia is the melanoma capital of the world; on average, 30 Australians will be diagnosed with melanoma every day and more than 1,200 will die from the disease each year. For decades, the 1- year overall survival for patients with advanced- stage or metastatic melanoma (stage IIIC unresectable or stage IV melanoma) was 30% 35%. xiii It is now greater than 70% 80% in clinical trials of targeted and immune drug therapies and thousands of Australians patients have been involved in the development programs. xiv While some of these new agents are now reimbursed via the PBS, Australia lags behind many other countries in funding these treatments, despite our incidence rates being so much higher. In the US, because so many of the patients in early testing showed significant long- lasting responses to these new agents, the FDA granted the drug breakthrough therapy status, allowing it to be fast- tracked for approval. While these drugs are currently being trialled in Australia, only patients on these trials have access to these new breakthrough therapies. Until we have a system that is capable of assessing the true value of medicines, beyond the out- dated cost- effectiveness model, Australian patients of today, and those of tomorrow, will never have timely access to the medicines they need, when they most need them. Modernising the current regulatory and reimbursement system must be a priority today; otherwise we will always fail the patients of tomorrow regardless of how much money is invested in medical research. 5

6 The CDA s Recommendations Australia needs a system that is capable of assessing the value of new and innovative medicines beyond the current measures of cost- effectiveness. Without such changes, Australian patients will never have timely and affordable access to the innovative medicines they need most, today or in the future. In March 2014, the CDA hosted a Forum in Canberra bringing together stakeholders from across Australia s cancer community to address the issues of timely and affordable access to medicines for Australian patients. The CDA Forum brought together more than 120 representatives from patient groups, oncologists, haematologists, nurses, pharmacists, politicians, policy makers, patients and patient organisations, international experts and industry to discuss and build sustainable strategies to support both short, but more notably, long- term access to cancer medicines. The CDA Forum identified five priority areas for improving access to cancer medicines for Australian patients. Those areas included: Building a meaningful and impactful consumer voice for cancer patients; Improving the current system of access with better processes within the current system; Exploring and developing innovative access models that take into account the complexity of cancer, while looking at international best practice models; Reducing the burden of red- tape on healthcare professionals and removing unnecessary processes 1 ; and Establishing a national chemotherapy registry to provide a database of outcomes following the use of chemotherapy and targeted medicines. Drawing on the expertise of attendees from the Forum, throughout 2014, the CDA have been working with stakeholders from all sectors of the cancer community in Australia to deliver a number of recommendations for modernising the PBS and improving access for patients. Recommendations include: Shifting from a static assessment of cost- effectiveness to an assessment of value and quality; Greater consumer and specialist engagement; Creation of a national chemotherapy database; and Mechanisms for ensuring interim access for patients. The CDA believes that if implemented, these strategies would improve access and outcomes for Australian patients in both the short and long- term. The CDA is in the process of finalising the full recommendations, which will be published in the CDA White Paper: Improving Access to Cancer Medicine for All Australian Patients, in March The CDA would be delighted to share the White Paper with the Senate Committee at its earliest availability. 1 Following the announcement in 2014 that the Department of Health would conduct a Post- market Review of Authority Required PBS Listings this work- stream, with specific objectives to improve patient safety and care by reducing red tape and administrative burden for health professionals, investment into this work- stream was halted. 6

7 Conclusion One consistent theme that ran throughout the discussions of the work- streams when trying to address the issues of availability of new, innovative and specialist cancer medicines in Australia, was the concept of affordability versus accessibility. Affordability may be defined as a patient s ability to receive a particular medicine based on their ability to afford the cost of the treatment i.e. a patient is wealthy enough to be able to pay. Accessibility on the other hand may be defined as a patient s ability to receive a particular medicine, because it is made available and reimbursed via the PBS, irrespective of a patient s ability to pay. The distinction between affordability and accessibility is fundamental to the reasoning for modernising the PBS. We must ensure that our universal healthcare system delivers access to new, innovative and specialist cancer medicines for all Australian patients, in a timely and affordable way; and the only way we can do that is by undertaking to modernise the current system so that it can efficiently and effectively assess these medicines for registration and reimbursement via the PBS. The CDA welcomes the opportunity to provide this submission to the Community Affairs Committee. Without a modern system, capable of assessing the true value of the new, innovative and specialist medicines, Australian patients of today, and those of tomorrow, will never have timely and affordable access to the medicines they urgently need. About the CDA The Cancer Drugs Alliance is a not for profit multi- stakeholder organisation committed to achieving the best outcomes for Australian cancer patients through timely and affordable access to new cancer medicines. The CDA is comprised of individuals and organisations including cancer patient support groups and advocacy organisations, practising haematologists, oncologists, and pharmaceutical companies currently providing oncology treatments to the Australian community. The CDA does not advocate for any one particular cancer treatment, it seeks to improve access for all Australian cancer patients. By bringing together the expertise of all those engaged in cancer care, treatment and support the CDA aims deliver world s best practice in cancer care and treatment in Australia. For more information about the CDA please see our website at: 7

8 i Australian Institute of Health and Welfare Cancer in Australia: an overview Cancer series No 90. Cat. no. CAN 88. Canberra: AIHW ii Australian Institute of Health and Welfare Cancer in Australia: an overview Cancer series No 90. Cat. no. CAN 88. Canberra: AIHW iii Australian Institute of Health and Welfare Cancer in Australia: an overview Cancer series No 90. Cat. no. CAN 88. Canberra: AIHW iv Australian Institute of Health and Welfare Cancer in Australia: an overview Cancer series No 90. Cat. no. CAN 88. Canberra: AIHW v Office of Health Economics (UK). International Comparison of Medicines Usage: Quantitative Analysis. November 2014 vi Australian Institute of Health and Welfare & Australasian Association of Cancer Registries Cancer in Australia: an overview, Cancer series no. 74. Cat. no. CAN 70. Canberra: AIHW. vii Deloitte Access Economics: Issues on access to cancer medicines in Australia, July 2013 viii Deloitte Access Economics: Issues on access to cancer medicines in Australia, July 2013 ix Reimbursement success rates and timelines for new medicines for cancer; an international comparison; Michael Wonder; March 2014 x Deloitte Access Economics: Issues on access to cancer medicines in Australia, July 2013 xi Deloitte Access Economics: Issues on access to cancer medicines in Australia, July 2013 xii Reimbursement success rates and timelines for new medicines for cancer; an international comparison; Michael Wonder; March 2014 xiii Balch CM, Gershenwald JE, Soong SJ, et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol 2009; 27: xiv Long GV. From dismal prognosis to rising star: melanoma leads the way with new generation cancer therapies. Med J Aust 2015; 202 (3):