Innovative Medicines Fund: Accelerating treatments to the rare disease community

Yesterday, Tuesday the 7th of June, saw the launch of the Innovative Medicines Fund (IMF) - a scheme which will give NHS patients living in England, including those with rare diseases like scleroderma, the chance to have ‘early’ access to cutting-edge treatments offering them the best chances of a longer and healthier life.

The IMF draws inspiration from the success of the Cancer Drugs Fund, established by the UK Government in 2011 and reformed in 2016. This fund allowed clinicians to prescribe, and patients to access, novel and often expensive but potentially life-extending treatments which were not yet approved by the National Institute for Health and Care Excellence (NICE) for use within the NHS. In the past five years alone, over 80,000 people have benefitted from the Cancer Drugs Fund through earlier access to potentially lifesaving treatments.

How much funding is on offer and how will the scheme work?

£340 million has been ringfenced for the Innovative Medicines Fund to support NHS England in purchasing and fast-tracking transformative new treatments to NHS patients. This is the same amount which has been allocated to the Cancer Drugs Fund and the two schemes will run side-by-side with separate budgets. The IMF will level up drug access between England and the devolved nations who already have similar schemes like the Scottish New Medicines Fund and the Welsh New Treatment Fund in operation.  

As part of the managed access to new treatments provided by the IMF real-world evidence will be collected on these transformative new drugs. Real world evidence differs from the clinical evidence collected during the tightly controlled clinical trial environment instead focussing on how patients taking a particular treatment perform in the ‘real world’. It is drawn from data such as health service usage including hospital visits/ admissions, prescription usage and quality of life. It can be a valuable addition to clinical trial data to assist decision making bodies such as NICE in deciding whether a drug is clinically and cost effective and should be approved for routine use within the NHS in patients with a particular condition.

Why is this valuable to those living with rare diseases like scleroderma? 

Whilst those living with a rare condition like scleroderma can feel isolated, they are part of a much larger rare disease community. There are more than 7,000 rare diseases affecting in the region of 3.5 million people living in the UK. It is estimated that 1 in 17 people in England will be affected by a rare disease during their lifetime. The Innovative Medicines Fund will help deliver the Rare Diseases Action Plan which will aims to improve the diagnosis, treatment and support offered to those living with rare conditions.

It is extremely challenging, taking substantially longer periods of time to generate the robust clinical and cost-effectiveness data needed for a treatment to be approved by NICE in a rare condition like scleroderma compared to more common conditions like heart disease or stroke. This is due to the limitations in size of the patient group as a whole and the variability of a condition like scleroderma in terms of disease subtype and the organs affected. This means that rare disease patients with conditions like scleroderma can often experience delays in accessing vital treatments, meaning that the IMF could be a game changer.  

SRUK is hopeful that the IMF will help fast track the today’s advanced clinical trial drugs to the rare disease community in the not-too-distant future.