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England’s Innovative Medicines Fund Raises Expectations
Sep 17, 2021
NEWS THAT NATIONAL HEALTH SERVICE (NHS) PATIENTS IN ENGLAND ARE TO BENEFIT FROM A NEW £340 MILLION (US$473 MILLION; €398 MILLION) PER ANNUM INNOVATIVE MEDICINES FUND (IMF) – ORIGINALLY PROMISED BY THE CONSERVATIVE GOVERNMENT IN ITS 2019 RE-ELECTION MANIFESTO – HAS BEEN WARMLY GREETED BY STAKEHOLDERS ACROSS THE SPECTRUM. EXPECTATIONS ARE HIGH THAT THE FUND WILL DELIVER FAST-TRACK ACCESS TO THE MOST INNOVATIVE NEW TREATMENTS, INCLUDING FOR ORPHAN AND RARE DISEASES. BUT WITH DETAILS OF THE SCHEME STILL THIN ON THE GROUND, IT’S NOT YET CLEAR HOW AND WHEN PATIENTS WILL BEGIN TO BENEFIT FROM THE INITIATIVE.
NHS England on 21 July stated that the IMF is to be implemented alongside the existing cancer drugs fund (CDF) and will “support the NHS to fast-track patient access to treatments which can demonstrate substantial clinical promise but still have significant uncertainty around their clinical and cost effectiveness and hence long term value for taxpayers”. With the CDF also benefiting from an annual budget of £340 million, the establishment of the new Fund will, according to NHS England, mean that a total of £680 million in ring-fenced funding will be available annually to expedite access to new treatments.
On the face of it, the IMF is undoubtedly good news for patients. According to Health and Social Care Secretary Sajid Javid, the new Fund will extend the CDF model to cover a greater number of treatments. In practice, this is likely to mean that the IMF will function as a conditional reimbursement scheme, enabling selected drugs to be covered in the NHS while further evidence is gathered on their effectiveness, prior to a final evaluation by the National Institute for Health and Care Excellence (NICE). This model, which has been used by the CDF since 2016, has proved durable and has won support from patient advocates such as Cancer Research UK, despite initial opposition from industry.
Basing the IMF on the existing CDF model would also ensure that the new Fund avoids much of the controversy that the cancer fund faced upon its establishment back in 2011. Then, the open-ended nature of the CDF left it vulnerable to criticism that it might be used to circumvent the NICE evaluation process – a criticism that the 2016 overhaul of the CDF has since largely addressed. The launch of the IMF has the advantage, too, of addressing another key criticism levelled at the CDF, namely that the cancer fund “privileges” oncology over other therapy areas. By providing dedicated funding for the most promising treatments, regardless of the condition to be treated, the new IMF could enable many more patients to benefit from faster access to new medicines.
In addition, the IMF could help to address some of the regional inequalities that blight the UK health system. In Scotland, patients have since 2014 been able to access funding for innovative ultra-orphan, orphan and end-of-life treatments via a dedicated New Medicines Fund, and in this regard the IMF may bring similar benefits for patients suffering from such conditions in England. Yet at the same time, other inequities will persist: such funding will still not be available to residents of Wales or Northern Ireland, and the separate cancer fund will remain open only to patients in England.
Furthermore, despite assurances that the new IMF will mimic the existing CDF, NHS England has not yet published details of how the Fund will work in practice. It is not clear how the NHS will select products for funding via the scheme, nor how the IMF will interact with NICE. Depending on the criteria for admission to the scheme, some products are likely to remain ineligible – and with a limited funding pool available, some patients will inevitably be disappointed.
For now, the Association of the British Pharmaceutical Industry (ABPI) and others have welcomed the Fund as an “important step towards improving access to new medicines for NHS patients”. With a stakeholder consultation due later in 2021, manufacturers may not have long to wait to find out just how big a step forward the IMF really is.
IQVIA Pharma Pricing & Reimbursement (PPR) draws on decades of experience in the market access space to bring you the latest global developments in pricing and reimbursement. With access to IQVIA’s network of local offices, and extensive contacts within government and industry, the PPR service offers timely news and articles alongside comprehensive guides to P&R regulations around the world. Fore more information about IQVIA Pharma Pricing & Reimbursement, contact us here.