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NHS England Moves Forward With Exciting Innovative Medicines Fund Consultation

on Wednesday, 24 November 2021.

NHS England has published its widely anticipated consultation on the Innovative Medicines Fund (IMF). It is open for responses until 11 February 2022, after which NHS England will publish a feedback report capturing input from the consultation.

What Is the Innovative Medicines Fund?

The IMF will have £340m a year of funding. This is in addition to the £340m already available for the Cancer Drugs Fund (CDF), creating a ringfenced funding total of £680m.

The IMF will support patients with any condition, including those with rare and genetic diseases, to get early access to the most clinically promising treatments where further data is needed to support the National Institute for Health and Care Excellence (NICE) in making final recommendations around their routine use in the NHS.

An estimated one in 17 people will be affected by a rare disease in their lifetime. The aim of the IMF is to support the NHS with fast-tracking patient access to treatments that demonstrate substantial clinical promise but face significant uncertainty around their clinical and cost effectiveness and hence long-term value for taxpayers.

What Is in the Consultation?

NHS England has provided the following eight principles for the IMF in the consultation:

  • It will operate as a managed access fund for non-cancer medicines, extending the principles of the CDF.
  • The IMF must target the most promising medicines recommended by NICE for which there is significant remaining uncertainty around the level of clinical benefit. The criteria are:

- the product addresses a high unmet need

- the product provides significant clinical benefits

- the product represents a step-change in treatment for patients and clinicians

- evidential uncertainties can be resolved in a reasonable time

  • IMF recommendations should be reserved for medicines showing plausible potential to be cost-effective and which are priced responsibly during the period of managed access.
  • Managed access should be for the shortest time necessary so as to collect data to resolve uncertainties identified by NICE - in any event, not to exceed five years.
  • All the eligible patient population, as determined by NICE, should be able to access the medicines in the managed access period, without any cap on numbers.
  • The medicines will be re-evaluated by NICE, and the price may be revised upwards or downwards.
  • Any patient starting treatment through the IMF should be able to continue treatment at the company’s cost even if NICE does not recommend its routine use in the NHS at the point of re-evaluation.
  • The IMF should not close to potential new entrants. The £340m budget will be fixed and any spend above that will be repaid on a proportional basis by all companies receiving IMF funding.

The consultation which asks a series of questions is now available on the NHS England web site.

Exciting Times for Uptake of Innovation

This is all part of the Government's commitment to backing the life sciences industry and driving innovation, including through early adoption of new treatments within the NHS. It is an initiative that has widely excited pharma. Great policies like the IMF help to explain why, in a recent survey of 220 global C-suite respondents in pharma carried out by IQVIA, 88% said they were going to place more clinical trials and launch more medicines in the UK.

The consultation had been delayed due to the focus on other priorities during the COVID-19 pandemic, so it is pleasing to see that it is now published. In the meantime, even before the commencement of the IMF, NHS England has entered into deals to enable access to medicines that had promise, such as crizanlizumab for people with sickle cell disease.

At the 2021 PING Conference, which was held in collaboration with IQVIA, entitled "UK Life Sciences Opportunities in a Changed World", we heard from Claire Foreman, the Director of Medicines Policy and Strategy at NHS England. Claire discussed the support for adoption of medicines throughout the NHS and the Innovative Medicines Fund amongst other changes in medicines priorities including opportunities for re-purposing medicines. Other speakers at the conference including the Pfizer UK Country Manager and ABPI President, Ben Osborn, also talked about the importance of valuing innovation and the NHS being an early adopter of innovation.

If you would be interested in hearing more about these issues and seeing recordings from the PING Conference, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 07795 570072, or complete the form below.


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