Abiraterone: Reaching men who need it the most

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1 Abiraterone: Reaching men who need it the most Abiraterone a new, life extending drug for incurable prostate cancer has been making headlines for all the wrong reasons. The National Institute for Health and Clinical Excellence (NICE) has provisionally decided that, at a cost of around 3,000 a month, abiraterone is just too expensive for the NHS, a decision which has been echoed by the Scottish Medicines Consortium (SMC) in Scotland. This is a bitter blow to men in the very final stages of the disease who are rapidly running out of time and options. It is simply unbelievable to think that those men who need the drug the most could be denied on a basis of a technicality. A technicality, which means that this vital drug has not been assessed as an end of life treatment, despite, we believe, it fulfilling all of NICE s criteria. This breakthrough drug which is a simple pill taken four times a day has been proven to extend the lives of men dying from prostate cancer by an average of about four months. Four months may not appear to be very long, but those months could mean a man lives to see the birth of a grandchild or even just gives him the chance to do more of the things we all take for granted whilst still enjoying a good quality of life with much less pain and few side effects. We cannot levy all the blame for this decision with NICE and the SMC. I know that the NHS cannot afford to pay for every new drug and treatment that comes onto the market. Resources are limited, however the NHS must be able to make provision for such breakthrough developments, which do come at a higher cost. The company who made the drug needs to do much more to make it more affordable for the NHS. But the truth is that this drug can make a real difference to the lives of many men and it is deeply worrying that these men across the UK will be denied certainty of access due to a disagreement over cost. Thankfully, for men in England and Wales, this is just a draft decision. NICE is due to make a final announcement in a few months time. The SMC, however, has already announced it will not be making abiraterone available on the NHS in Scotland. We have a duty to stand up and fight on behalf of men to make sure these decisions are reversed. This is why The Prostate Cancer Charity is working hard to get those in charge, both at the drugs company and at NICE and the SMC, to change their minds and quickly. But we cannot do it alone, we need your support. Please back our campaign so that we can make sure that we are able to stand up for those who need it the most, before it is too late. Owen Sharp Chief Executive, The Prostate Cancer Charity #1163 The Prostate Cancer Charity is a charity registered in England and Wales ( ) and Scotland (SC039332). Registered company

2 Key facts Prostate cancer in the UK: Prostate cancer is the most common cancer in men 37,000 men are diagnosed with prostate cancer every year 10,000 men die as a result of prostate cancer every year 250,000 men are currently living with and beyond prostate cancer Men have a one in nine lifetime risk of developing prostate cancer The risk of developing prostate cancer increases with age Men are two and a half times more likely to develop prostate cancer if their father or brother has had it African Caribbean men are three times more likely to develop prostate cancer than white men of the same age The Charity s position These decisions by NICE and the SMC are a bitter blow to thousands of men and their families and must be overturned. Studies on abiraterone show that it can prolong the lives of men in the final stages of prostate cancer by an average of about four months, and improve the quality of their lives. The drug is one of the biggest breakthroughs in the treatment of the disease for many years. It offers men the possibility of extending their lives at a time when there are no other available treatment options, except those that just control the symptoms of the disease. The Charity also recognises that the drug manufacturer needs to do more to make abiraterone affordable for the NHS and we have approached them with this request. Abiraterone Abiraterone is a new drug which can help to extend the lives of men with advanced prostate cancer that has stopped responding to other available treatments. There currently isn t an alternative to abiraterone. Once a man s prostate cancer has spread to other parts of the body and has stopped responding to existing treatments such as hormone therapy and chemotherapy, there are limited options, with most men only having the choice of palliative care. Abiraterone is currently being appraised by the National Institute for Health and Clinical Excellence (NICE) for use on the NHS in England and Wales. NICE recently published a draft decision not to recommend abiraterone for use. A final decision is expected in June The Scottish Medicines Consortium (SMC) published their final decision in March not to recommend abiraterone for use on the NHS in Scotland.

3 Q&A Background on abiraterone Q: How is abiraterone used? A: Abiraterone is licensed for use in the UK for men who have advanced prostate cancer that has spread and has stopped responding to other hormone therapies and the chemotherapy drug docetaxel. It is taken as a pill four times a day along with the steroid prednisolone. Q: What are the benefits of abiraterone to men with prostate cancer? A: Once a man s prostate cancer has spread to other parts of the body and has stopped responding to existing treatments such as hormone therapy and chemotherapy, there are very few treatment options that remain. Most men only have the choice of palliative care. In a recent clinical trial 1, abiraterone was shown to extend the lives of men with advanced prostate cancer by an average of about four months, compared to men who took a placebo. Patients receiving abiraterone were also more likely to experience an improvement in symptoms, including pain and fatigue. Q: How many men will benefit from abiraterone? A: Currently the Government does not collect any information on how many men are diagnosed with advanced prostate cancer. However, the manufacturer of abiraterone (Janssen) has estimated that around 3,300 men a year in England and Wales could be eligible. Q: How much does abiraterone cost? A: Abiraterone costs 2,930 for 120 tablets (excluding VAT). This is equivalent to 30 days/ one month of treatment. On average, men in the recent phase III trial took abiraterone for eight months. Janssen have discounted the cost of abiraterone for the NHS, but the amount of the discount is confidential. NICE express the cost of a drug in terms of its cost per QALY (quality adjusted life year) how much it would cost to treat someone in order to give them a year of good health. This includes all costs to the NHS, not just the cost of the drug. In NICE s draft recommendation, they do not say how much they think abiraterone will cost, but they do state that they think the manufacturer s calculation of 63,200 per QALY is too low. Appraising abiraterone for use on the NHS Q: What is NICE s view on the use of abiraterone? A: NICE have issued a draft decision saying that they do not recommend abiraterone for use on the NHS. NICE recognise that abiraterone can extend the lives of men in the final stages of prostate cancer. They also acknowledge that it can improve a man s quality of life by reducing symptoms, including pain and fatigue. However, NICE believe abiraterone is too expensive for the NHS to routinely pay for. Since 2009, NICE have been willing to approve more expensive drugs for people with incurable diseases who are reaching the end of their lives, where the patient population is small 2. This is called their end of life drug criteria. Experts at NICE believe abiraterone does not meet the end of life criteria because the population of men who would be applicable to receive the treatment is too big. NICE have said they do not agree with Janssen s estimate that around 3,300 men a year in England and Wales could be eligible for abiraterone, but they do not provide any evidence as to why they have made this decision.

4 Q: What does NICE consider to be an end of life drug? A: Additional criteria can be taken into account when NICE is appraising treatments that may extend the life of patients who have an incurable illness. This allows NICE to make the decision to recommend a more expensive drug. The following criteria must be met: The treatment is licensed for patients with a short life expectancy, normally less than 24 months. There is sufficient evidence to indicate that the treatment offers an extension to life, normally of at least an additional three months, compared with current NHS treatment. The treatment is licensed or otherwise indicated for small patient populations. Q: What is the Charity s view about NICE s decision not to appraise abiraterone as and end of life drug? A: We believe that abiraterone fits NICE s end of life drug criteria. It should be considered as an end of life drug because the estimated number of men that would be eligible for the drug (3,300) falls well below the figure NICE defines as the normal maximum patient population size for end of life drugs (7,000 3 ). NICE has not provided clear evidence as to why they believe the eligible patient population for abiraterone is too large for it to be considered as an end of life drug. The All Wales Medicines Strategy Group (AWMSG) recently reviewed abiraterone and have considered it to be an end of life drug 4. We do not understand why NICE have not reached the same conclusion. Q: What is the SMC s view on the use of abiraterone in Scotland? A: The Scottish Medicines Consortium (SMC) have issued their decision saying that they do not recommend that the costs of abiraterone treatment should be routinely paid for by the NHS in Scotland. The SMC recognise that abiraterone can effectively extend the lives of men in the final stages of prostate cancer. However, the SMC have decided that the cost of abiraterone was too high for the drug to offer value for money. Unlike the NICE process in England, this is SMC s final decision. Any appeal needs to be made by the drug company. Q: What about Wales and Northern Ireland? A: The All Wales Medicines Strategy Group (AWMSG) has approved abiraterone for use in Wales until the NICE decision has been finalised. NICE appraisal recommendations are adopted in Wales, so the final NICE decision will over-ride this interim AWMSG decision. NICE guidance is normally adopted in Northern Ireland after local review. Q: What will be the impact on men if NICE and the SMC do not decide to recommend abiraterone for funding? A: If NICE and the SMC do not recommend that the NHS pays for abiraterone, it could mean men with prostate cancer in the UK will face a postcode lottery to access the drug. Although, in England, men should continue to be able to access the drug through the Cancer Drugs Fund, we are concerned about what will happen once the Cancer Drugs Fund stops at the end of 2013/14.

5 Current access to abiraterone Q: How can men with advanced prostate cancer currently access abiraterone? A: Abiraterone is licenced in the UK so doctors are able to prescribe abiraterone to men with advanced prostate cancer who they think would benefit from the drug. Currently, access to abiraterone varies across the UK. In some cases, a man s local healthcare provider will agree to pay for the drug following an application from his cancer specialist. If a man s local healthcare provider will not pay for the drug, his cancer specialist will be able to make an application to the Cancer Drugs Fund in England. In Scotland and Northern Ireland, a man s clinician will have to make an individual funding request through the local healthcare provider. Welsh men who have been prescribed abiraterone can now apply to have the drug funded through an approved Wales Patient Access Scheme. Applications for such funding take time to complete, at a point in a man s life where he has little time to waste. In some cases, men may also be able to access abiraterone through a clinical trial. We would recommend that any man with prostate cancer speaks to his specialist to find out if there any trials open that would be suitable for him. Q: What is the Cancer Drugs Fund? A: The Cancer Drugs Fund (CDF) is a new initiative in England set up by the Government to pay for cancer medicines that are licenced but have not yet been approved by NICE and are not available on the NHS, or where NICE has not recommended that they be paid for. However, the CDF is due to be wound up at the end of 2013/14. For a man to get access to abiraterone through this fund, his specialist would need to make an application on his behalf. A decision on whether or not an application is approved will be made within 31 days. Q: Have men in England been able to access the drug through the Cancer Drugs Fund? A: Abiraterone has become the fourth most approved treatment through the CDF with 480 applications for the drug approved between 1 st April and 20 th December While the Cancer Drugs Fund has helped improve access to new cancer drugs, it has led to variations in access across England. For example, early research into the operation of the funds conducted by the Rarer Cancers Foundation found significant variations in the way that regional Strategic Health Authorities (SHAs) were operating their funds 6. As of June 2011, there were variations in the requirements for applications for the funds, the treatments which would and would not be approved, the application rates and the approval rates. For example, SHAs in the south of England were approving a lower proportion of applications than elsewhere, while others, such as NHS North East, were approving every application they received. 1. In a phase III clinical trial, men with advanced prostate cancer that had spread and was no longer responding to hormone therapies or chemotherapy were given either abiraterone and a steroid drug (called prednisolone) or a placebo (dummy) drug and steroid. The men who had been given abiraterone lived on average for 3.9 months longer than the men on the placebo drug. Reference: de Bono J et al (2011) Abiraterone and increased survival in metastatic prostate cancer The New England Journal of Medicine 364(21): niceandcancerdrugsthefacts.jsp 3. endoflifemedicinesconsultation.jsp 4. All Wales Medicines Strategy Group Final Appraisal Recommendation 0612: Abiraterone (Zytiga ) February The Cancer Drugs Fund (CDF) An overview of progress so far. RCF. December Available at: index.php?option=com_content&view=article&id=235:cancer-drugsfund-makes-almost treatments-available-to-patients-givingpatients-with-rarer-cancers-better-access-to-the-treatments-theyneed&catid=43:england-news&itemid=5 6. Funding cancer drugs. An evaluation of the impact of policies to improve access to cancer treatments. RCF. June Available at: resources/funding_cancer_drugs.pdf

6 Abiraterone current availability in the UK Access to abiraterone currently varies across the UK. In addition to the methods listed below, in some cases, men across the UK may also be able to access abiraterone through a clinical trial. Northern Ireland NICE guidance on the use of drugs is normally adopted in Northern Ireland after local review. In the meantime, an application can be made for funding to a man s Local Health and Social Care Trust in Northern Ireland from their cancer specialist. Wales We are still awaiting a final decision from NICE on whether abiraterone will be available on the NHS in England and Wales. The All Wales Medicines Strategy Group (AWMSG) have appraised abiraterone for use in Wales. Welsh men who have been prescribed abiraterone can now apply to have the drug funded through an approved Wales Patient Access Scheme. The approved Wales Patient Access Scheme is not expected to continue after NICE s final decision as NICE guidance takes precedence over AWMSG guidance. Scotland The Scottish Medicines Consortium (SMC) have recommended that abiraterone should not be funded by the NHS in Scotland. A local Health Board can choose to make the drug available following an individual funding request from a cancer specialist on behalf of their patient. England We are still awaiting a final decision from NICE on whether abiraterone will be available on the NHS in England and Wales. Currently, a healthcare provider (such as a PCT) in England can choose to make abiraterone available to local patients before it is approved by NICE, if a cancer specialist applies for funds to cover it on behalf of their patient. If the local provider does not make the drug available, a man s cancer specialist may be able to make an application to the regional Cancer Drugs Fund (CDF) to cover the costs of treatment. The CDF is temporary. If NICE do not approve abiraterone, it is unclear how men with prostate cancer will access abiraterone after the CDF ceases to exist in 2013/14.

7 Real stories Many men in the final stages of prostate cancer credit abiraterone with giving them a chance to enjoy their lives again. Here are just some of their experiences: Hugh Gunn Hugh, 66, from Leicester, a married father of two grown up children, was diagnosed with advanced prostate cancer in Since retiring from running his own greengrocers business Hugh works to raise awareness of the disease and is the current Treasurer of the Prostate Cancer Support Federation a national support service for men diagnosed with the disease. He has been taking abiraterone for three months after an appeal to his Strategic Health Authority. Hugh explains: If I hadn t fought to gain access to abiraterone, I m quite sure I wouldn t be alive today. After feeling close to the end back in December last year, I have been able to enjoy a wonderful four months with my family and am now looking forward to the birth of my daughter s third child in a few months time. Prostate cancer has the reputation of being an old man s disease. It is not. More and more it is a disease of middle aged and this makes abiraterone all the more important. I understand the drug is expensive, but when you have had the shock of finding out you have much less time left than expected, extra time with loved ones is just so important. You just can t put a price on that. Ron and Terri McCoo Ron and Terri McCoo are recently retired from 30 years in the pub trade and live near Blackpool. Ron, 59, a grandfather of four, was diagnosed with advanced prostate cancer in 2010 and has been taking abiraterone for four months thanks to an application to his Strategic Health Authority. Terri, 51, explains: Ron was lucky to be offered abiraterone on the NHS. He started taking it in November, and since then he is almost free of pain entirely. We even joked last weekend that you almost wouldn t know he was unwell! I am so grateful to have my husband back. We believe very strongly that all men should have access to any treatment that could help them in their battle with this cruel disease. It is hard to describe the difference those extra moments can make. Ian Liston Ian, 63, is from West Sussex. The former Star Wars actor who has been married for over 18 years, gained access to abiraterone through a trial at the Royal Marsden in 2006, and took the drug for over three and a half years until it stopped being effective. Ian explains: Thanks to abiraterone, I am still feeling fit and well nine years after being told I had advanced prostate cancer. Thankfully, I am not the only one being given years of extra life as a result of taking this drug. Decisions by NICE not to recommend important life extending drugs for prostate cancer, feel like hammer blows to patients desperately waiting for a drug that will fight their disease.

8 Helping men with advanced prostate cancer access abiraterone Background Abiraterone is a new drug which can extend the lives of men with incurable prostate cancer. It is one of the biggest breakthroughs in the treatment of the disease for many years. The National Institute for Health and Clinical Excellence (NICE) recently published a draft decision not to recommend abiraterone for use on the NHS in England and Wales. A final decision is expected in June The Scottish Medicines Consortium (SMC) published their final decision in March not to recommend abiraterone for use on the NHS in Scotland. How MPs can help 1. Sign Early Day Motion 2706, tabled by John Leech MP, which calls on NICE to reconsider its draft guidance and recommend abiraterone for use on the NHS. 2. Write to decision makers in England Write to NICE: NICE are not expected to publish their final decision until June This means there is still time to share your constituents views while they consider their decision on this drug. You could also write to ministers at the Department of Health to express concern that: NICE is not willing to consider abiraterone as an end of life drug Men with incurable prostate cancer will not be able to access abiraterone after the Cancer Drugs Fund ceases to exist in 2013/14 if NICE do not approve it. in Wales Write to NICE: NICE are not expected to publish their final decision until June This means there is still time to share your constituents views while they consider their decision on this drug. You could also ask your colleagues in the Welsh Assembly to write to the ministers of Health and Social Services to flag: NICE s decision not to consider abiraterone as an end of life drug That the AWMSG agreement of a patient access scheme in Wales will be over-ridden by NICE guidance. If NICE do not approve abiraterone, men in Wales will face a postcode lottery to access the drug as there is no equivalent to the Cancer Drugs Fund. in Scotland Although health is devolved to Scotland and drug appraisals are undertaken by the SMC rather than NICE, you can work with your party colleagues in Scotland to express your disapproval about the SMC decision. You, and/or your MSP colleagues, can write to the Cabinet Secretary for Health, Wellbeing & Cities Strategy to highlight your concerns about the SMC s decision, which means that men in Scotland cannot access a drug that is currently available to men in England through the Cancer Drugs Fund and in Wales through the patient access scheme. in Northern Ireland Ask your colleagues in the Assembly to write to the Department of Health, Social Services and Public Safety to ask them to approve abiraterone for use. They have not yet made a formal decision as they normally follow NICE guidance after reviewing it. If NICE do not approve the drug, men in Northern Ireland will face a postcode lottery to access the drug as there is no equivalent to the Cancer Drugs Fund. For further information please contact Alexis Wieroniey (Senior Campaigns Officer) on or by at alexis.wieroniey@prostate-cancer.org.uk