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February 17, 2016.
England’s Cancer Drugs Fund (CDF) - a ring-fenced fund for those new cancer drugs that are either too expensive, have not been appraised by the National Institute for Health and Care Excellence (NICE), or are used out of their license - is due to undergo its latest evolution in April 2016.
Exactly what it will look like is still unclear as the consultation on its future closed on the February 11, 2016 and a period of reflection is likely as both NICE and NHS England (NHSE) ponder responses they received from stakeholders. Are there clues in what some of the key stakeholders have said? (Although worth noting that some organizations don’t seem to have put any comment or their response on their websites, perversely, making it harder for their views to be heard).
Focus on price and access
Commentary on pricing and access to new cancer drugs never seems to abate, both across the UK and globally. In England the spotlight has been on the CDF with what feels like everyone fed up with what was always supposed to be a temporary policy to prop up access whilst bigger issues of defining and paying for value were worked through. Six years on and the CDF is now tipped to become a ‘managed access fund’.
A more streamlined system
The proposals essentially try to make more sense of having both NICE and NHS NHSE assessing new cancer drugs. The ‘old’ approach was to have NICE appraise new cancer drugs (although not all of them) and if they didn’t recommend use they could then be considered for the CDF. That involved another, more quick and dirty, appraisal by the National CDF panel hosted at NHSE, who actually pay for these drugs.
A key proposal is therefore to remove the NCDF appraisal and instead use the NICE appraisal - with some tweaks such as a more generous application of flexibilities for end of life drugs - as the single initial appraisal conducted for all new cancer drugs. If this produced a faster ‘maybe’ recommendation then NICE, NHSE and the company would work up a managed access approach. That could entail further data collection and likely some sort of discount (which could be increased if there is an overspend in-year) with NHS reimbursement.
NICE would look again, typically after 2 years, and decide if the drug should go into routine commissioning or instead, no longer be available on the NHS. Even if NICE then says no, there is the option of requesting individual access (although that is unpopular because it is seen as difficult to make a case and creates paperwork and bureaucracy).
The patient perspective
Breast Cancer Now, representing patients with one of the 'big four' common cancers, has an active campaign on ‘unlocking drugs’ and has been vocal on both pricing and access to new breast cancer drugs. Breast Cancer Now say that they are “doubtful” about the proposals really addressing the problems in accessing cancer drugs. They seem disappointed that there is little change to how NICE works, and also says that there is little to allow companies to offer flexible pricing schemes. They fear that access to cancer drugs with the new CDF could be worse, not better.
The Rarer Cancers Foundation, representing those with rarer cancers outside of the big four, share the concern of things getting worse, not better. Their analysis suggested that over 12,000 patients could lose out on accessing treatments. They want more reform at NICE.
The research perspective
Cancer Research UK seems more positive on the new CDF. It’s a step, they say, towards fixing how the NHS provides the best medicines. They like the proposals for NICE to make a faster initial recommendation and the introduction of a ‘maybe’ style of recommendation with data collection included. They point out that it’s not clear though, how the new CDF works alongside the Early Access to Medicines Scheme (EAMS) – this allows unfunded earlier access to promising products before marketing authorisation – which has included new cancer drugs such as pembrolizumab (Keytruda).
The industry perspective
The Association of the British Pharmaceutical Industry (ABPI) takes the opportunity of the CDF consultation to remind us that the UK has some of the lowest prices for medicines and the Pharmaceutical Price Regulation Scheme (PPRS) which has paid back into the NHS some £1billion. Put that against the budget of the CDF – currently £340million – and it looks small fry. The ABPI, just as Breast Cancer Now do, also call for changes to NICE.
From consultation to implementation
NICE and NHSE have just a few short weeks to reflect on consultation responses with the new CDF due to go live on the April 1 (albeit with a year of transition). They’re likely to have quite a few responses to go through too; 189 responses were received the last time NHSE consulted. That said, given the focus these days on online forms, you can bet that they already have the headlines for agreement or disagreement with their consultation responses already. My guess is that there will be quite a lot of “unsures” ticked.
Leela Barham is an independent health economist and policy expert. You can access her website here and contact her at email@example.com