OR WAIT 15 SECS
November 25, 2015.
The much awaited consultation on a ‘new’ Cancer Drugs Fund (CDF) in England has finally emerged. The CDF is an English ring-fenced fund to pay for those new cancer drugs that aren’t appraised by the National Institute for Health and Care Excellence (NICE), or are but considered too expensive for the benefits they bring, or used outside of their licensed indication. It’s run centrally by NHS England who, with input from a National Cancer Drugs Fund Panel, decide which new products can go on the list to be funded, as well which can stay given the fund has run out of money (on more than one occasion).
The CDF turned from an election promise by the Conservatives in 2010 to a problem child by 2015 with overspends and unpopular de-listings. The CDF has not shown any party in a good light; it’s highlighted the inevitable political interventions in the NHS, divided the cancer patient groups from those representing other diseases, created red tape, and concern that the fund has had the perverse effect of leading to higher prices. The constant to-ing and fro-ing between companies and NHS England about what’s on the list, and what’s not, with deals struck at the last minute, has not helped clinicians and patients know what their options are and arguably suggests that companies will only cut prices when push comes to shove. But we should not forget that over 72,000 patients have benefited (although we don’t know by how much as an audit of the CDF has never been published).
A ‘new’ CDF has been on the cards for some time. Initial ideas emerged as early as October 2014 with a new approach converging its assessment and prioritorisation processes with a revised approach from NICE described in the ground breaking Five Year Forward View, setting out a new strategy for the NHS. The Independent Cancer Taskforce who published the latest
for 2015-2020 in July 2015 suggested that the fund would continue but with “conditional approval.” It also suggested that the new process should be consulted on in summer 2015, ready to be implemented by April 2016. Apparently the cause of the delay in consulting has been the need for Prime Minister, David Cameron, to have the final say. Not only has the consultation been delayed, but the proposals suggest that from April 2016 to March 2017 will be a year of transition. That means a year of working through the inevitable wrinkles.
The new CDF is being rebranded as a “managed access” fund for new cancer drugs. Basically the CDF will temporarily fund those drugs where NICE thinks, based on a speedy appraisal, a drug is promising, but the available evidence isn’t available to support a positive recommendation. So far, so pro-innovation. Further evidence will then be collected for these drugs, allowing a later NICE re-appraisal, hopefully then moving out of the fund and more quickly into routine funding. Patients get access, companies get a chance to prove that their drug is valuable and get paid by NHS England, and the NHS doesn’t continue to pay for drugs that can’t cut the mustard. Even if the later NICE appraisal says no, individual funding requests are still possible for those patients where a case can be made for exceptionality. So far, so reasonable.
But, and there is always a but, the proposals include some phrases that aren’t likely to please companies. “Investment control arrangements”, “commercial access arrangement”, “prospective contingency provision” and “capping the cost” are just some of those. In layman’s terms, companies will still need to come to the table to strike a deal on price to get funding under the new CDF. Not only that, but they’ll also have to potentially take a hit on what they will actually get paid if the CDF gets overspent in the financial year. NHS England are intending to use pretty much every and any tool to make sure they stay in the CDF budget.
Funding cancer drugs is a divisive issue. But the consultation is trying, albeit in a somewhat murky way, to come to a more reasonable approach (although debate still rages on whether it’s ever reasonable to single out cancer versus other conditions). It’s a shame though that it misses the opportunity to think through how the Early Access to Medicines Scheme (EAMS) from the regulator, the Medicines and Healthcare Regulatory Authority (MHRA) could play in. Determining what is ‘promising’ is often where the rubber hits the road and EAMS is already providing a view on that as well as potentially collecting further data on real world use before marketing authorization. What message would it send out if MHRA think a product is promising, but NICE and NHS England don’t? It’s a shame too that it seems to stick with what feels like a simple, yet arbitrary way to set the value of the fund (basically using last years spend).
The consultation closes on February 11, 2016, and as the consultation recognises itself, there will be many responses. The bigger issue is whether these proposals offer a potential blue print for access to other new innovative drugs outside of cancer, and how this will fit with the aim to “speed up access to innovative drugs” as set out by the Accelerated Access Review that is going on at the same time as the CDF consultation.