One year on, ABPI asks why IMF hasn't funded any drugs

The Innovative Medicines Fund (IMF), set up in the UK last year to fast-track NHS access to promising new drugs, still hasn't provided any funding for a new medicine, and the pharma industry has called for a concerted effort to set the scheme back on track.

The IMF came into being as a companion to the Cancer Drugs Fund (CDF), in operation since 2010, and is designed to extend conditional access to new therapies with limited data backing them up beyond the cancer category into areas like rare diseases. First announced in 2021 with £340 million in funding, it started operating in June 2022.

A just-published report on the IMF in the Journal of the Royal Society of Medicine – which highlights its potential to become a universal model for faster and fairer access to new medicines, but also cautions against incentivising the market entry of high-priced drugs for rare diseases with weak evidence – prompted the response from the Association of the British Pharmaceutical Industry (ABPI).

Noting that the CDF allowed tens of thousands of patients to access cancer drugs, ABPI's director of value and access policy, Paul Catchpole, asked why no medicines have yet entered the fund on this basis.

"We would like to work with NHS England and NICE to better understand why and help bring the fund to life, so that patients can benefit," he added.

The ABPI has previously pointed to a number of problems with the IMF, including the 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 additional evidence is collected.

That is challenging because many of the medicines that could go into the IMF, such as those for rare diseases, need to be used lifelong and sometimes from childhood, according to the trade body.

It also has concerns about the requirement for companies to pay back any expenditure that exceeds the IMF's annual budget, arguing this is something over which individual companies have no control.

When it was set up, the IMF was trumpeted by the government as a key component in the UK's effort to become an attractive market for life sciences companies and bring cutting-edge therapies to patients.

The RSM report is "broadly supportive" of the guiding principles of the IMF, but it does voice concerns about various aspects of the programme, including vague entry criteria for candidate drugs, reliance on observational studies, and the fact that its scope is limited to drug therapies.

It also raises questions about the funding in perpetuity and expenditure clawback aspects highlighted by the ABPI.