England’s Innovative Medicines Fund hits another milestone

Leela Barham takes a look at the latest milestone on what will have been a close to three-year journey to an Innovative Medicines Fund (IMF) in England. Whilst it might provide political capital, the real difference the IMF will make to the speed of patient access to treatments that have the potential to be clinically and cost-effective, especially for those with rare diseases, remains to be seen.

In part one of this article, Leela explains what the IMF is and what is known on how it will work. In part two, Leela explores the questions that remain about whether the IMF will add value and serve its purpose.

Political beginnings

Just like the Cancer Drugs Fund (CDF), the time-limited fund for the most promising cancer drugs introduced back in 2010, the IMF also started out as a political promise.

The 2019 Conservative Manifesto made some big promises on the NHS and one of those was to “extend the successful Cancer Drugs Fund into an Innovative Medicines Fund 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. If you or a loved one is unlucky enough to fall ill, we’ll ensure you have access to the best medicines.”

Time to work through the details

Fast-forward to 7 June 2022 and the Department of Health and Social Care (DHSC) put out a press release about how patients will have earlier access to cutting-edge treatments from NHS, launching the IMF.

That it took close to three years to move from political promise to an actual fund suggests that it wasn’t that straightforward to go from CDF to IMF (or less charitably, that it wasn’t actually a big priority, although in fairness the manifesto commitment was made in November 2019 and by December 2019 came the beginnings of the COVID-19 pandemic).

Promoting the UK

The latest announcement is an(other) advertorial for the UK, common in these post-Brexit times. There’s an emphasis on the NHS supporting the use of innovation with phrases like ‘cutting-edge drugs and treatments’, ‘revolutionary treatments’ ‘promising innovations’ and, just to sprinkle in another way of saying innovation, ‘transformational.’

The DHSC release is just the latest on the IMF. Simon Stevens, then chief executive of the NHS, issued an NHS one back in July 2021. That too puts in the buzzwords ‘promising’, ‘innovative treatments’ ‘cutting-edge therapies.’

Both press releases set out the ambition for patients in the UK to be the first in the world to get access to these treatments. The message is clear to industry; bring your best drugs and the NHS will use them. Although there are strings attached: they have to be priced right.

The way the fund will work still not fully known

The details for the IMF have emerged over time. The 2019 manifesto commitment was light on key details, including just how much money would be in the fund and whether it was going to be one fund for cancer and other treatments, or if the CDF would stay.

It’s become clear that the IMF is a separate fund, but funded to the same value as the CDF, with a pot worth £340 million a year (that’s levelling up in action!). Quite why £340 million is the magic number, for promising cancer drugs, or for promising drugs outside of cancer, is a mystery.

There are now confirmed principles for how the IMF will work (Box 1), although these will not be rigidly applied. Cynical perhaps, but that most likely means changed according to the priorities of NHSE, not companies or patients.

Guiding principles for the Innovative Medicines Fund

Principle 1: The Innovative Medicines Fund should operate as a managed access fund for non-cancer medicines so that any patient, regardless of their condition, has equal potential opportunity to benefit from promising but uncertain medicines.

Principle 2: The Innovative Medicines Fund should target the most promising medicines for which there is significant remaining uncertainty around the level of clinical benefit and cost-effectiveness

Principle 3: Recommendations with managed access should be reserved for medicines that (a) demonstrate plausible potential to be cost-effective; and (b) are priced responsibly during the period of managed access, reflecting their uncertain cost effectiveness.

Principle 4: Managed access should be for the shortest time necessary to collect the data required to resolve any uncertainties identified by NICE

Principle 5: The entire eligible patient population, as determined by NICE, should have the opportunity to access medicines recommended for the Innovative Medicines Fund in the managed access period

Principle 6: All medicines that enter the Innovative Medicines Fund must be re-evaluated by NICE, who will make final recommendations on whether the medicine should be routinely available on the NHS

Principle 7: Any patient who starts treatment with an Innovative Medicines Fund recommended medicine during the period of managed access should have the option of continuing that medicine in the event that NICE is unable to recommend its routine use in the NHS at the end of the NICE guidance update

Principle 8: The Innovative Medicines Fund should never have to close to potential new entrants

Source: NICE and NHS. (June 2022). The Innovative Medicines Fund Principles.

Companies who want to put their product into the IMF need to meet certain conditions including:

the technology has the potential to address a high unmet need;
the technology has the potential to provide significant clinical benefits to patients; or
the technology represents a step-change in medicine for patients and clinicians; and
the new evidence to be generated is considered meaningful and could sufficiently reduce uncertainty.

It’s also now clear that eligibility for the IMF is not going to be formally linked to regulatory initiatives that seek to speed up access to the most promising treatments like the Early Access to Medicines Scheme (EAMS) or the Innovative Licensing and Access Pathway (ILAP).

However, companies are still waiting for more detail. The ABPI has said it is “look[ing] forward to seeing more detail on how the fund will work in practice.”

Read part 2 of this article here.

About the author

Leela Barham is a researcher and writer who has worked with all stakeholders across the health care system, both in the UK and internationally, on the economics of the pharmaceutical industry. Leela worked as an advisor to the Department of Health and Social Care on the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).