Future prospects for an Innovative Medicines Fund for England
On the 12 December 2019, the UK general public voted for a further five years of Conservative government. Whilst a big part of the Conservative campaign was ‘to get Brexit done’, other promises affecting the industry were made too. One of these was to extend the Cancer Drugs Fund (CDF) into an ‘Innovative Medicines Fund’. Leela Barham takes a look at what that might mean.
The CDF was an election promise made by the then prime minister David Cameron back in 2010. Boris Johnson, the current prime minister, took a leaf out of the same play book and has promised a new Innovative Medicines Fund. The promise is that “doctors can use the most advanced, life-saving treatments for conditions such as cancer or autoimmune diseases, or for children with other rare diseases,” as set out in the Conservative Manifesto.
The Innovative Medicines Fund could add £160 million to the CDF’s current pot of £340 million.
Treatments to go into the Innovative Medicines Fund
There are questions about just what drugs could quality – outside of cancer – to go into the new fund.
There might be candidates from medicines selected for the Early Access to Medicines Fund (EAMS) – a pre-licensing indicator of promising innovation given by the Medicines and Healthcare products Regulatory Authority (MHRA) – allowing them to be funded whilst further evidence is generated. Given the focus on innovation, and the very reason for EAMS to designate a drug as a promising innovative medicine (a prerequisite for any drug to get a full positive EAMS designation), there looks to be a good fit.
It is however likely that the criteria used by the CDF will apply to any prospective drug for the fund. There are key questions that the NICE committee consider for funding under the CDF:
- Why is the drug not recommended? Is it due to clinical uncertainty?
- Does the drug have plausible potential to be cost-effective at the current price, taking into account end of life criteria?
- Could data collection reduce clinical uncertainty?
- Will ongoing studies provide useful data?
- Is CDF data collection feasible?
Just changing the last question to the renamed fund is really all that is required. This will however still keep a focus on end of life, since this allows companies to have higher cost-per-Quality Adjusted Life Years (QALYs) given a higher cost-effectiveness threshold, around £50,000 per QALY, although there are a range in estimates seen in practice.
Maybe the criteria will be widened to echo some of the criteria that are included within Highly Specialised Technologies (HST), where NICE takes a different approach for treatments for some of the rarest conditions. The potential then is for the threshold to be as high as £300,000 per QALY.
There is also a need to reflect on the scope for new evidence to be generated that sits outside oncology – which may well differ according to therapy. This may make it hard for those therapies where there aren’t already good data collection infrastructures already in place to qualify.
Lessons learnt from the CDF
The CDF has gone through changes since it began. Not least has been moving it under the remit of the National Institute for Health and Care Excellence (NICE) back in 2016, as well as adding in features such as the potential for companies to pay back should the fund go over the £340 million annual allocation. These were hard lessons learnt from what might be charitably described as ‘learning by doing’, rather than planning and appraising risks from a politically driven policy.
Even with these changes the fund is still not necessarily popular; critiques of the fund have been published throughout its lifetime, and still they keep coming, including the latest in December 2019.
It will make sense for the Innovative Medicines Fund to continue with the financial controls – at least from the perspective of NHS England who will be paying the bill – so as to avoid the embarrassment of overspending the new total of £500 million a year.
England is not alone in wanting to provide ring-fenced funding for drugs, so alongside a proper look at the critiques of the CDF, it could be useful to look at the innovative medicines fund in Scotland, for example, to see what lessons could be learnt from their approach.
Benefit in increasing spend not subject to VPAS payments
The link between the new fund and the wider Voluntary Scheme for Branded Medicines and Access (VPAS) – an agreement that has capped total NHS spend on branded medicines – will likely also be based on the precedent set under the CDF and the VPAS predecessor, the Pharmaceutical Price Regulation Scheme (PPRS) agreed in 2014.
Under that scheme, CDF spending was not subject to paybacks required to be made by companies to the Department of Health and Social Care. This means that the adjustment will go up by £160 million, reducing (but very marginally) paybacks for VPAS members.
Not a panacea for challenges in securing access
The CDF cannot always solve the reasons that NICE say no. For example, NICE doesn’t believe that more data can solve the uncertainties relating to Roche’s Tecentriq (atezolizumab). A fund will not mean access to everything where there are controversies about the clinical evidence, or the cost-effectiveness of a drug.
It’s also clear that companies still need to offer deals in order to get on to the CDF too. The fund really only offers access – albeit in a way that can add to the evidence base – but does not mean companies can side-step pressures on price. That access is important though, as the majority of cancer drugs that have been re-reviewed on the CDF have made it into routine funding.
We can probably expect as much controversy as has been seen for the CDF from the new Innovative Medicines Fund.
About the author
Leela Barham is a researcher and writer on health and pharmaceuticals, from a health and policy perspective. Leela has worked with all stakeholders across the health care system, both in the UK and internationally, working on the economics of the pharmaceutical industry. Leela worked as an advisor to the Department of Health and Social Care on the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).
