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The Innovative Medicines Fund – engaging early and meaningfully with the NHS

Finally, after two years of deliberation, the detail of the Government’s Innovative Medicines Fund (IMF) has been published. Does it live up to expectations and will it deliver meaningful improvement to patient access to medicines?

The IMF was first announced in the Conservative Party’s Manifesto on 24 November 2019, when Matt Hancock was Health and Social Care Secretary. It was not until the summer of 2021 that we were told that the NHS would receive a ring-fenced £340m per year for the IMF and it was not until 19 November this year that the proposals were published by NHS England and Improvement (NHSE&I) for consultation.

The public has until 11 February 2022 to respond. The Government introduced the IMF “so that doctors can use the most advanced, life-saving treatments for conditions such as cancer or autoimmune disease, or for children with other rare diseases.” What else do we know about the IMF? We know that it aims to build on the success of the Cancer Drugs Fund (CDF) and will operate a managed access agreement (MAA) to address the uncertainties which may exist for new and promising medicines.

The time limit for this data collection in the IMF is five years maximum, which is longer than the CDF but for treatments for rare diseases, this may still not give enough time to conduct research, particularly for innovative technologies such as cell and gene therapies. The IMF will provide interim funding which can enable earlier access for patients in instances where NICE would not be able to recommend a medicine due to uncertainty. This will help companies to collect further data which can support a NICE appraisal at the end of the period of managed access.

Pharmaceutical companies in rare diseases still need to work collaboratively with the various agencies involved – the MHRA, NICE and NHSE&I. Price will continue to be crucial and there is a requirement to demonstrate that a medicine has the plausible potential to be cost-effective. These are still just proposals and therefore subject to change following consultation. It is hard to second guess to what extent the views of stakeholders will be taken on board and it is important that the perspectives of small pharmaceutical companies, some of whom have just one or two medicines in their pipeline, are given adequate consideration. While there are positives, there are also significant concerns. NICE will re-evaluate these treatments at the end of the period of managed access with the possibility of price adjustments. If NICE decides not to recommend the medicines for routine use, the onus is on the company to continue to fund the treatment of patients at its own expense. This may be a significant concern for companies with medicines for rare conditions where treatment may be life-long and initiated during childhood. Companies receiving funding from the IMF will have to agree to an Expenditure Control Mechanism (ECM) so any spend above the £340m cap will be proportionally returned by companies as a rebate.

Finally, there are implications should a company decide to withdraw from the MAA or NICE guidance update. Details of the evidence collected will be presented to stakeholders at an engagement event and the outcome of this process published by NICE. It is perhaps unrealistic to expect the IMF to match the unprecedented innovation seen in healthcare in the past two years and given the size of the fund, and the fact that it will be open to all non-cancer medicines which meet the criteria, it is clear that for rare diseases, access challenges will remain which cannot be addressed by the IMF alone.

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