Key to Survival - Unlocking access to new treatments
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- Gerard McDonald
- 6 years ago
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1 Key to Survival - Unlocking access to new treatments Our new Key to Survival campaign sets out to achieve nothing less than a step change. We want to make sure all pancreatic cancer patients can access on the NHS, right across the UK, more effective treatments options as they become available to help patients survive longer and improve their quality of life. In summary, the Key to Survival goals are: 1. Unlocking access to new treatments Campaigning to change how decisions are made about which new treatments are funded by the NHS We need to make sure that as soon as effective new treatments become available for pancreatic cancer they are funded on the NHS for patients across the whole of the UK. 2. Unlocking access to current clinical trials Helping patients make informed choices about clinical trials through increased awareness and support. We need to make sure that more patients are aware of their treatment options in order that they can take part in trials if they choose to. 3. Unlocking more clinical trials for the future Calling for changes that will improve the quality and quantity of pancreatic clinical trials. We need to work with others to ensure that we create an environment in which more, and more effective clinical trials can be carried out in the future.
2 This briefing paper provides background to the first of these goals, unlocking access to new treatments. Why we need to unlock more new treatments for pancreatic cancer patients: Very few treatment options exist for pancreatic cancer patients and survival rates are shockingly low, with just four per cent of people living for five years or more after diagnosis. These survival rates have barely changed over the past 40 years. There are a number of challenges that have led to this situation: pancreatic cancer is tough to diagnose, tough to treat, and there has been an historic lack of research investment to tackle these problems. New treatment options are urgently needed for this disease to improve survival and quality of life, and to give patients and families more precious time together. Sadly, even when there has been a rare advance in the form of a new treatment, it has not been approved for use on the NHS across the whole of the UK. For instance, in 2014/15 we finally saw a new treatment option become available for pancreatic cancer - Abraxane which was seen as the biggest breakthrough in nearly 20 years. Used in combination with standard chemotherapy, gemcitabine, it has been shown in trials to extend eligible patients lives for an average of just over two months, although in some cases significantly longer. Whilst this may not sound like much, when you consider that the average survival time for metastatic pancreatic cancer patients is just 2-6 months, an extra two months can mean a relatively large amount of extra time for patients to spend with their loved ones. Unfortunately, whilst Abraxane has been approved for use on the NHS in Scotland and Wales, it has not been approved in England and Northern Ireland, creating a postcode lottery in access to this treatment across the UK. We believe this situation is unacceptable, demonstrates that the drug appraisal system in England is not fit for purpose and does not deliver for people with pancreatic cancer.
3 Experts in the field share this belief, as the findings from our newly established expert panel, the PCUK 250, show. 46% of our panel members thought it likely that there would be new, effective, tolerable pancreatic cancer chemotherapy drugs licensed in the UK in the next 5 years, but only 23% thought they would also be made available to patients on the NHS over the same period. It is a sad commentary on the drug appraisal system that while it is anticipated that new effective treatments for the cancer type with the worst survival rate will be developed, is not expected they will be made available to the vast majority of pancreatic cancer patients on the NHS. Why doesn t the current treatment appraisal system work for pancreatic cancer patients? The current system that appraises new drugs to decide whether they should be funded does not work for pancreatic cancer patients. This is because the National Institute for Health and Care Excellence (NICE), which is the body that assesses new treatments in England (and whose decisions are generally followed in Wales and Northern Ireland) uses a method of assessment that has a one-size fits all nature 1. That NICE appraisal system has a narrow scoring and cost-benefit appraisal system. It does not offer flexible pricing for new drugs. It doesn t involve patients and clinicians enough to find out the possible wider benefits of a new drug outside those shown from clinical trials and economic modelling. And it particularly works against cancers with the worst survival rates, like pancreatic cancer, by failing to take into account the relative amount of extra survival a new drug may offer to patients - relative survival gain. For conditions like pancreatic cancer, where survival rates are low and patients may have a short prognosis an extra six weeks or two months is a very significant development in survival gain for patients and their families. 1 Scotland uses a slightly different system for appraising new treatments. We believe it to be slightly better, as it gives greater weight to the patient voice and thus to concerns about unmet need and poor survival rates. We believe that this is why Abraxane was approved for use in Scotland but not in England. As such, most of our calls for change are aimed at NICE for England, and by extension to Wales and Northern Ireland, although the principles expressed should also be followed in Scotland.
4 What we want to see changed: An opportunity for us to begin to lobby for these changes opened up in February 2016, when NICE and NHS England carried out a consultation on the future of the Cancer Drugs Fund (CDF), together with some minor suggestions to change the way NICE works. We made a full response to that consultation setting out three key changes we believe are needed: NICE to introduce a new, separate assessment route for rare cancers, and cancers with the worst survival rates like pancreatic cancer. This route should include an additional stage in the appraisal process to enable more patient and clinician participation. This would allow greater exploration of the potential benefits of the new treatment being assessed for patients, above and beyond the cost-benefit and trial data analysis currently used. A new approach should be based on the Patient and Clinician Engagement (PACE) system used by the Scottish Medicines Consortium (SMC) in Scotland. We believe that it was due to the PACE system being in place that Abraxane was approved for use on the NHS in Scotland, even though it had been rejected by NICE in England. NICE Technology Appraisal Committees to take into account relative survival gain offered by a new drug if it is for a cancer with clearly identified unmet need, like pancreatic cancer. At the moment, drugs that are deemed to assist patients at end-of-life can be approved by NICE at a higher cost threshold than other drugs. However, one of the rules is that before this higher threshold can be applied the drug must usually give a minimum of three extra months life extension to patients. We believe this is too high a threshold for cancer types with the worst survival rates. For instance, the average survival time for a metastatic pancreatic cancer patients is just 2-6 months - if a new drug comes along that can offer two extra months for those patients, it represents a relatively large survival gain for patients and their families. At the moment the CDF/NICE consultation proposed only very minor changes to the 3 month rule that do not go far enough. To fix this issue we want NICE to waive the requirement for a new drug to offer at least three months extra life extension, when assessing drugs with the worst survival rates.
5 A much more fundamental overhaul of the NICE appraisal system. Even if NICE ring-fenced money to continue the CDF, even if they introduce a PACE system and waive the 3 month for cancers of unmet need, a more equitable and sustainable solution is still needed to increase the likelihood of more cancer treatments, including for pancreatic cancer, being approved in future. Therefore we are also calling for a much more thorough overhaul of the NICE appraisal system, above and beyond the proposals contained in the current consultation, to take place as soon as possible. This should include examining ways to introduce flexible pricing; replace the current Quality Adjusted Life Years gained (QALY) scoring system; look to include processes that take a wider definition of quality of life and societal benefit; allow greater patient and clinician input; and look to prioritise new beneficial treatments for rare cancers and cancers with the worst survival rates. What are our next steps for the campaign? We will, through Key to Survival, continue to lobby NICE and NHS England to overhaul the treatment appraisal system in a way that will better take into account the needs of pancreatic cancer patients. We will also look at other ways we can ensure patients access new treatments in future by: Continuing our Two More Months Campaign to get Abraxane approved for use across the whole of the UK. It is currently available in Scotland and Wales and we want to see NICE reappraise the drug at the earliest opportunity which we hope will lead to it being approved in England and Northern Ireland as well. As and when other new treatments emerge that show promise for pancreatic cancer patients, campaigning to make sure they are made available on the NHS as soon as possible. Playing a direct role in helping to gather evidence about new potential treatment options for pancreatic cancer patients. For instance, we are currently sponsoring a project to collect data on Irreversible Electroporation (Nanoknife). Our support will enable UK centres who are currently testing this procedure, to
6 standardise and share data on this treatment to look at the safety of this treatment, how best to use it and what potential impact it has on improving patient outcomes and survival. It is hoped that if this data shows positive results it can be used to support applications to ensure patients have access to the treatment across the UK in future. Addressing concerns about the low number of pancreatic cancer patients currently taking part in clinical trials. More needs to be done to enable pancreatic cancer patients to take part in clinical trials and we will be working to address this issue through Key to Survival goals 2 and 3. We will provide updates on how we seek to further these and other initiatives that support our campaign goals over the coming months.
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