The Innovative Medicines Fund - Good news for patients but has an opportunity been missed to be more ambitious?

NHS England and Improvement (NHSE/I) has announced the launch of the Innovative Medicines Fund. The ABPI’s Director of Value and Access Policy, Paul Catchpole, provides further commentary on the announcement.

It’s really good news for patients that the Innovative Medicines Fund (IMF) is now available to provide earlier access to some promising new medicines whilst additional evidence is generated about their use.  This addresses a previous inequity where such access was only possible for cancer patients through the Cancer Drugs Fund (CDF).  It’s hard to believe that it’s over 10 years now since that Fund was created, with tens of thousands of cancer patients since benefiting.

Getting the design of the Fund right

Industry supports the IMF and wants to ensure it works for patients. However, some concerns were shared with NICE and NHSE/I about how the proposed design of the Fund would make it difficult for some companies to make use of it. These included the mandatory requirement for companies to pay the full costs of treatment in perpetuity for patients using the Fund should a medicine not be recommended by NICE for routine commissioning after the managed access period. This is challenging because many of the medicines expected to go into the Fund, such as those for rare diseases, need to be used life long and sometimes from childhood. 

Concerns were also raised about the requirement for companies to pay back any expenditure which exceeds the IMF’s annual budget, something which individual companies have no control over. This requirement duplicates the national cap already in place on annual medicines bill expenditure through the Voluntary Scheme. 

Stakeholders responding to the engagement exercise on the IMF proposals also raised other challenges and concerns, but no substantial changes have been made been to the design of the Fund to address them. Whilst it was encouraging to see a clear summary of stakeholder feedback published by NHSE/I, the lack of changes in response to it is somewhat disappointing. The transparent approach taken by NHSE/I to sharing stakeholder feedback though is such an important part of good policy development work and should be commended.

Time will tell if the design of the Fund as it is now being taken forward is right in terms of optimising patient access. Fortunately, this will be relatively straightforward to measure by looking at the number and type of medicines which go into the Fund over time, and how much of the available £340m of expenditure is used each year. 

Calibrating the entry and exit criteria for medicines and the appropriateness, or not, of the commercial terms for companies based on studies achieved in practice will be important to make the most of the money set aside for the Fund.

Is there a missed an opportunity on the level of ambition?

Whilst the IMF is aimed largely at providing earlier access to new medicines which have a gap in their evidence base for health technology assessment (HTA) purposes at the point they are licensed, what is being done to support medicines where the HTA evidence base is fully sufficient at the time of appraisal?  It is these medicines which are ready to go straight into routine commissioning following a positive NICE appraisal. Shouldn’t we be trying to deliver earlier patient access for these medicines too?

The IMF would be ideally placed to support commercial approaches which can deliver earlier patient access to some new medicines from the point of marketing authorisation (where there is a high unmet need) or from a point in the NICE appraisal process where the outcome is more certain.  Some types of innovative payment model can also help the NHS manage long-term uncertainty (something that ring-fenced funds such as the IMF and CDF cannot achieve because of their time limited nature) and help to address cumulative NHS affordability challenges, for example for cell and gene therapies. 

More creativity and a willingness to explore new ideas and approaches for medicines in the early access space beyond those subject to conditional approval would really help cement and demonstrate the value of early access mechanisms such as the Innovative Licensing and Access Pathway (ILAP), the Early Access to Medicines Scheme (EAMS) and Project Orbis. These significant policy and regulatory commitments are undermined if the medicines which progress through them have to be given away for free by companies until NICE guidance is finalised and published.   

Competition between countries is high when it comes to early launch of new medicines and the UK needs a coherent end-to-end aligned offer if it is to remain an attractive early launch market. There are emerging signs this may be at risk which will mean patients in the UK will miss out.

The IMF represents an ideal place to deliver commercial approaches which support earlier patient access. It can also be a great test bed to try out and learn from new commercial approaches for priority new medicines such as some cell and gene therapies. This can support patients, the NHS and the industry.  

The launch of the IMF is excellent news for everyone but if we can evolve the level of ambition over time, we will have a truly innovative medicines fund.