25 Nov Innovative Medicines Fund Shows The Scale Of The Challenge With Innovative Medicines Adoption
Since its announcement in July, we have been awaiting the publication of the Government’s Innovative Medicines Fund (IMF) consultation with trepidation. Initially announced in 2019 in the Conservative manifesto, the Fund was a pledge to fast-track new drugs for cancer (and now a range of other conditions) to patients.
Like its predecessor, the 2016 Cancer Drugs Fund (CDF), this political announcement has collided with the reality of NHSE and Treasury limitations to create a fund that limits budget impact and can be managed and delivered in a pragmatic fashion within the broader medicines access landscape. And herein lies the challenge. It is a welcome and important milestone highlighting the desire to deliver medicines to patients outside of the restrictions placed by NICE. But fundamentally it does not – and was not intended to – overhaul the approach towards innovative medicines.
Take the most innovative medicines coming to market now, gene therapies. The IMF states a key ambition is to provide early access to cutting-edge gene therapies.
The entry criteria to the IMF are such that medicines must deliver significant clinical benefits, have potential for evidential uncertainties to be resolved in reasonable time, and demonstrate plausible potential to be cost effective. In other words, companies submitting to the IMF need to be fairly certain their medicine will meet the cost and clinically effective criteria of NICE. Cell and gene therapies have struggled to meet these criteria, and so will surely not be considered. It defeats the entire purpose of the IMF in the first place – to provide managed access to the most innovative medicines with data uncertainty.
Gene therapies can offer potentially curative outcomes with one-off treatments, and the very reason a fund like the IMF is needed is so we can explore and test new systems before these types of treatments become more common in the NHS. By keeping an artificial split between cancer and non-cancer indications, it seems likely CAR-T for cancer indications will remain in the CDF, with no prospect for improvement in the way these transformative treatments are assessed.
For a fleeting moment, the procurement of vaccines throughout the COVID-19 pandemic gave a glimpse of what medicines delivery could look like if the Government did away with siloed, fixed budget pots and instead aimed for system-wide savings and societal impact. Health and society became intrinsically linked, and the value of the former to the latter was truly recognised.
If we are going to see true system change when it comes to innovative medicines access, this is the type of thinking that needs to become prominent within Government. We can’t keep papering over the cracks, especially when there is in place a safety net for Government in the shape of the voluntary schemes where the pharmaceutical sector rebates expenditure over a certain threshold.
If you have a question or a challenge relating to the Innovative Medicines Fund, get in touch with us at [email protected].