NHS England has published a Standard Operating Procedure setting out how the new Cancer Drugs Fund (CDF) will work.
Under the new system, which is due to come into force on 29 July, all cancer drugs will be appraised through the National Institute for Health and Care Excellence (NICE). There are three possible outcomes: NICE can either recommend these drugs for routine commissioning, reject the drug for use on the NHS, or recommend that it be made available for an agreed period of time, usually 24 months, through the new Cancer Drugs Fund. This last option can be used in cases where further evidence of a drug’s clinical and cost effectiveness is required before NICE can give either a definitive positive or negative recommendation.
Why do we need a new CDF system?
The new system replaces the previous Cancer Drugs Fund, which closed on 31 March 2016 following calls for reform. The Cancer Drugs Fund was originally established in 2011 after it was recognised that not enough new cancer drugs were being approved for use on the NHS under the NICE system. A 2010 report showed that compared to 13 countries similar to the UK in terms of economic development, the UK’s usage of new cancer drugs was just 45% of the average.
The previous CDF benefitted over 95,000 patients, and in 2014 pancreatic cancer drug Abraxane was made available to patients via the CDF. However, increasing financial pressure on the fund led to the delisting of many drugs last year, and we were extremely disappointed to see Abraxane removed in November 2015. The new system has been designed following urgent calls for a sustainable solution to new drug funding.
NHS England and NICE consulted on the proposed changes in February 2016. You can read our response to this consultation here.
How does the new system differ from the old CDF?
The new CDF system differs from the previous one in that all new cancer drugs will now be appraised by NICE. Pharmaceutical companies will enter into Managed Access Agreements with NHS England, which will set out the terms of a drugs entry into the CDF and the means by which data will be collected to resolve any uncertainty relating to a drugs clinical and cost-effectiveness. Interim funding arrangements will also be available to enable the earlier introduction of new treatments that receive a draft NICE recommendation for routine commissioning or use in the CDF.
Under the new system, drugs will only be available on the CDF for a fixed period of time (usually two years) whist additional clinical evidence is collected. To make the system financially sustainable, there will be a fixed CDF budget of £340m and an expenditure control mechanism in place to ensure any overspend is met by industry. The new system also involves closer working with pharmaceutical companies to encourage the responsible pricing of cancer drugs, as well as the development of a joint NHS England/NICE CDF Investment Group to oversee the CDF budget.
Pancreatic Cancer UK’s thoughts and concerns
We welcome that interim funding arrangements will provide an early funding option for drugs that receive a draft NICE recommendation for routine commissioning or use on the CDF, meaning faster access to drugs for patients.
In addition, moves to ensure pharmaceutical companies are appropriately pricing their drugs is important. However, we are concerned that the new arrangements may result in an overbearing financial pressure on industry, deterring pharmaceutical companies from entering into the CDF process.
We are also concerned that the NICE appraisal system is not flexible enough to ensure new, effective treatments will be made available to cancer patients. We joined 14 other cancer charities in writing a letter to Prime Minister David Cameron calling for him to rethink the changes to the CDF, warning that it could result in patients losing access to effective treatments. Estimates suggest that 20,000 patients a year could lose access to treatments under the proposals.
This is because the NICE appraisal system is seen as too inflexible with its methodology not having changed since 1999. It is important to remember that the CDF was established as an emergency measure to bypass the NICE appraisal process as it was not working for cancer patients. There is real concern that without a more fundamental reform of the NICE appraisal system, effective cancer treatments will struggle to gain approval under the new CDF process.
We would like to see a complete overhaul of the NICE appraisal system, with the flexibilities to ensure all cancer patients are able to access effective new treatments.
This should include arrangements for addressing barriers to accessing new treatments facing less survivable cancers. We believe that there need to be more specific, concrete proposals to ensure new drugs are approved for patients less survivable cancers, such as pancreatic cancer, when they become available.
We would like to see the introduction of a new route for assessing new treatments for less survivable cancers where progress and new treatments are desperately needed. This should include an additional stage to enable more patient and clinician engagement. More substantial changes to the end-of-life criteria used by NICE are also needed, with a specific mention of the need for NICE Technology Appraisal committees to take note of the relative survival benefit of a new drug for cancers with the lowest survival rates, even if the absolute survival benefit falls below the usual three month threshold. In addition, we are calling for an essential overhaul of the NICE system to take into account much broader measures of quality of life and other potential benefits of new treatments to cancer patients, rather than just focussing on the costs and clinical benefits as recorded in a trial setting.
How you can help
You can help us make the case for changing the drug appraisal system, so that more new treatments for pancreatic cancer are made available, by supporting our Key to Survival campaign.
The campaign aims to make sure all pancreatic cancer patients in the UK have access to new treatments on the NHS to help them survive longer by unlocking access to new treatments, unlocking access to clinical trials and unlocking access to more clinical trials in the future.
You can read the Standard Operating Procedure in full here.