NHS England has launched an Innovative Medicines Fund (IMF), which is designed to give patients access to clinically promising treatments before they become more widely available. The plan was announced last year, and is now set to become fully operational.

It should benefit those who suffer from rare and genetic diseases the most, in cases where early access to potentially life-saving treatments may be vital. The patients will be treated with drugs which have undergone clinical trials, but are still awaiting a final decision by the National Institute for Clinical Excellence (NICE) on use within the NHS.

Paul Catchpole, director of value and access policy at the Association of the British Pharmaceutical Industry (ABPI), a trade group that represents the interests of pharma in the UK, has supported the IMF. Previously, only cancer patients had early access to newer treatments, but now a much wider range of patients will benefit.

However, Mr Catchpole also raised a few concerns about the scheme. The Pharma Letter reports that he has reservations about funding, in the eventuality that NICE rejected the treatment for more widespread use within the NHS.

Mr Catchpole commented: “Industry supports the IMF and wants to ensure it works for patients. However, some concerns were shared with the National Institute of Health and Care Excellence (NICE) and NHSE/I about how the proposed design of the fund would make it difficult for some companies to make use of it.”

He added: “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 lifelong and sometimes from childhood.”

Concerns were also raised that equal emphasis was not being given to new medicines which were still under appraisal, but had sufficient evidence base to avoid any doubt about their efficacy. This may be necessary to ensure early access schemes remain financially viable and deliver a globally competitive approach.

£680m per year has been allocated to the NHS by the UK government, in order to fast-track the most promising treatments, regardless of cost. NICE normally carries out a lengthy cost-benefit analysis before recommending a treatment for routine use in the NHS.

It was recognised that this approach was depriving some cancer patients of potentially life-saving treatments, so the Cancer Drugs Fund (CDF) was formed to widen access, at a cost of £340m per year. It has now been in operation for 10 years, and is thought to have saved tens of thousands of lives.

The IMF scheme has already helped young children with spinal muscular atrophy to help them to walk. A gene therapy treatment called Zolgensma, which costs £1.79m, has also been used to successfully treat a small handful of young children.

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