The recent board minutes from NHS England have proposed that NICE should take a more direct role in determining which products should be included / removed from the Cancer Drug Fund (CDF). How has NICE managed to secure management of a fund that was initially set-up to fund cancer treatments that had not been reviewed or rejected by NICE?
Since its inception in 2010, the CDF in the UK has never been far from the headlines. Originally established to provide access for patients whose individual circumstances imply they will benefit from cancer drugs not approved or reviewed by NICE, the fund received a significant number of requests and quickly utilised the £200m annual budget. Since then, the CDF budget has been increased twice, most recently to £340m for 2015/16.
Why has the CDF generated such controversy?
The CDF was initially set up by politicians to appease the public’s concern over the lack of access to novel cancer treatments, given the high rate of NICE rejection to cancer drugs. Once established, the CDF came in for a significant level of criticisms, notably from NICE, for being a poor use of money compared to other treatments which had demonstrated cost-effectiveness and thereby not an efficient use of NHS healthcare resources. In contrast Pharma companies saw the CDF as a great tool to gain access to the UK market and have, unsurprisingly, been a key supporter of the CDF.
Originally, the CDF did not conduct clinical or economic value assessments for the products to gain access to the fund. In 2014, the UK government announced that the fund must conduct clinical effectiveness assessments and price discussions, as a condition for receiving increased funding in 2015. Assessments are now being conducted on all current and future CDF drugs. Drugs which do not meet the assessment criteria are being excluded. To date this has resulted in 16 drugs covering 25 indications being excluded from the CDF.
What is the future of the Cancer Drug Fund?
In December 2014, a working party was established, tasked with identifying a long term, sustainable solution for the CDF from April 2015. The working party identified that the current process “has also enabled some pharmaceutical companies to bypass NICE cost-effectiveness assessments” and “a solution is needed that ensures patients have routine access to a greater range of cancer drugs, including earlier access to innovative drugs, while ensuring that cost-effectiveness is maintained”. Any future solution should enable “NHS England to confirm clinical utility of the drug, whilst managing within a defined budget, and should be aligned with NICE appraisal processes.”
The current proposal, which is out to public consultation, would see the CDF evolve into a ‘managed access’ fund for new cancer drugs, under the remit of NICE. In practice, rather than the current failure to recommend, the drug would be given a ‘conditional approval’ by NICE and the drug funded for a defined period whilst additional real world evidence was collected. After the defined period, the drug would go through an abbreviated NICE appraisal, with the outcome being either a positive or negative recommendation. Positive recommendations would be funded on the NHS, whilst negative recommendations would see the drug moved out of the CDF.
These proposal address a number of key issues that have plagued the CDF, such as lack of cost effectiveness assessments and duplication of responsibilities with NICE. It would also provide a clearer, more transparent process for cancer drugs. At the same time, a return to cost effectiveness assessments may not be in pharmaceutical companies’ best interests, as cancer drugs have always struggled to demonstrate effectiveness. This proposed approach may result in more drugs initially being funded in the short term to gain additional ‘real world’ evidence, but in the longer term many cancer drugs are likely to have their funding removed as they will be unable to demonstrate that the treatment is cost-effective to the NHS.