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Cancer Drugs Fund changes and what it could mean to you
Changes to Cancer Drug Fund in April 2016.
Currently the Cancer Drug Fund (CDF) enables health professionals to prescribe drugs for cancer patients which are not routinely available on the NHS. In 2011 the government set aside £200 million per annum to fund the cost of drugs which hopefully extend the life of people with cancer. The CDF was always intended to be a bridge to a new value-based pricing system to be introduced in 2014. The current CDF has allowed many people to access drugs but has been running over budget: in 2014 the CDF overspent by £30 million; a situation which is unsustainable.
The NHS is highly praised for offering a wide range of services and treatments that are free at the point of use: enabling a growing number of people to have world-class treatment, which for those in need, is free. The increasing number of new treatments developed is always good news but also continually puts the NHS system under financial pressure. A rational system is required to evaluate whether new treatments really are effective and are fairly priced. One criticism of the current CDF is that very little data has been collected, so it is very difficult to evaluate how effective the drugs on the fund have been.
In April 2016, a new system will be introduced called the Managed Access Fund.
The Managed Access Fund will allow NHS England and NICE to have more control over the spending on cancer drugs and most importantly make sure that the drugs are effective and the side-effects are manageable.
The Managed Access Fund has clear entry and exit points for each drug in the NICE evaluation system. Pharmaceutical companies will have to be clear about the price they are willing to sell the drug for, at the beginning of the process. The drug will be available for two years, during which time data on the effectiveness of the drug will be collected and NICE will then publish their guidance into whether the drug will be recommended or not. NICE have pledged that their final guidance will be issued within 90 days. The new system will put more pressure on pharmaceutical companies to price the drugs competitively because the drugs will be assessed at the end of the appraisal, based on cost-effectiveness. This system is described in great detail on the NICE website. http://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/Guide-to-the-single-technology-appraisal-process.pdf
NICE have said that the new system should allow people access to a wider variety of drugs and that new drugs should be available quicker because the appraisal system can start towards the end of a clinical trial. Other drugs that have never been looked at by NICE can also come back and go through the appraisal system. All of the drugs on the current CDF will be entering a rapid reconsideration process and will be appraised quickly. Drug companies will be asked if they want each drug on the current fund to be considered for appraisal and they will have a chance to submit a new application and price for their drug.
What will this mean for people already on drugs funded by the current Cancer Drug Fund?
We have been assured that no one already on a drug will have that drug stopped. It is thought that the pharmaceutical companies will pay for the continued treatment of any patients who are on an existing drug, if it is not recommended by NICE. NHS England should shortly be issuing more details about this, but it is clear that people already on drugs will not have them discontinued.
The end of the Cancer Drug Fund, as we know it, could be viewed as restrictive due to the limited timeframe that new drugs will be available for, but it makes sense that the drugs are put under proper scrutiny. The drugs that are used to extend lives by a few months are precious, but we also need to make sure that they really do work and are not preventing funding for prevention and good palliative care, as well as ensuring that the side-effects are worth it. Equally the new Access Managed Funds need to run smoothly and keep to the strict timescales that NICE has proposed, in order to deliver the promise of evaluating more drugs and getting the new drugs to the public quicker. We will keep you updated on developments in this area.
How will the CDF changes affect the drugs available for advanced kidney cancer?
Currently the drugs recommended by NICE for people with advanced kidney cancer are pazopanib and sunitinib as first line treatments and axitinib as a second line treatment. Bevacizumab, sorafenib, temsirolimus and everolimus are NOT recommended by NICE. However, under the current CDF system it is possible for doctors to prescribe everolimus and temsirolimus but only if strict criteria are met. For example, everolimus will only be prescribed if you have only previously taken one tyrosine kinase inhibitor and you have a contraindication, or excessive toxicity, to axitinib. Equally, temsirolimus can only be prescribed if you have more than three out of six ‘poor risk factors’ and it is the first treatment you will take.
When the new Managed Access Fund is introduced everolimus and temsirolimus will enter a ‘rapid reconsideration process’. The drug companies will be invited to submit any new evidence which will support the drug’s effectiveness. It may also be an opportunity for drug companies to alter the price of the drug, especially as NICE appraise drugs on a cost-effectiveness basis. These two drugs will be appraised in a fast-track system and NICE will give a clear decision on whether they will be approved or not. If you are currently taking these drugs via CDF funding, you will be able to continue using them, but for new patients their use in the future may, or may not, be limited, depending on whether NICE approve them. Everolimus is also being appraised in a multi-technology appraisal over the next year, along with axitinib, sorafenib and sunitinib, and is due to be completed in April 2017. In summary, the treatment of advanced kidney cancer as a whole is currently under review, but existing drug treatments will NOT suddenly be discontinued.
Hopefully the new system will allow quicker access to new drugs. Drugs that are showing promise in clinical trials can enter the system via the two-year managed appraisal fund before the trial is completely finished. New promising drugs for kidney cancer include nivolumab, a monoclonal antibody for PD-1. It has just been approved by NICE for melanoma and is currently being appraised for lung cancer. A clinical trial (phase III, checkmate-025) has shown promise for its use in advanced kidney cancer and it is thought that NICE will soon be appraising its use as a second line treatment.
We hope that the new system will allow more drugs to enter the system for review and that the NHS is charged a fair price for them, allowing the NHS to use its resources fairly across all areas of cancer care. We understand that drugs should be put under scrutiny and only be available if they offer real benefits to people and are offered at a fair price. We hope that NICE sticks to the tight deadlines that it has set itself and that new and promising drugs reach people who need them as quickly as possible.
‘Cancer Drugs Fund changes and what it could mean to you’ by Dr Rebecca Case-Upton BSc (Hons), PhD, Medical Publications for Kidney Cancer UK