The Innovative Medicines Fund: Regressive Measures or A Worthy Successor?
A new Innovative Medicines Fund (IMF), the NHS England consultation on which closed last Friday, has the potential to make a meaningful impact on patient access to innovative, new medicines in England for years to come. In our extensive and detailed response to the consultation, Newmarket Strategy welcomed this important opportunity to widen “early access to potentially life-saving new medicines”, and “accelerate the introduction of proven treatments” for routine commissioning in the NHS. The IMF holds much hope, particularly for therapies for rare disease, which are notoriously difficult for the system to evaluate.
The proposals outlined in the consultation materials suggest the IMF will follow the same principles as its closest precedent, the Cancer Drugs Fund (CDF). The IMF intends to codify and standardise the way that managed access agreements are agreed upon and implemented, almost completely replacing bespoke deals (other than for a minority of breakthrough products). The CDF has arguably delivered on its goals for oncology medicines, with approximately 71,500 cancer patients having gained access to 91 drugs treating 204 different conditions[i].
Yet the question remains, should the model used for the Cancer Drug Fund translate to the new Innovative Medicines Fund? In welcoming these efforts by NHS England to meet head-on the challenge of a reimbursement mechanism for ambitious new treatments, such as how to fund the one-off costs of gene therapies for example, what advice can we offer to ensure the IMF works for patients, the NHS and industry?
There are fundamental differences between oncology and non-oncology medicines that call for a differential approach to managed access. There are also good lessons from a range of managed access agreements recently adopted, and we drew on these experiences in our consultation response. We found that features of the current proposal, such as the Expenditure Control Mechanism, the stringent definition of ‘plausible cost-effectiveness’ and a set of exit criteria, such as that which would require a company to continue to fund a treatment indefinitely if it is not recommended following re-evaluation, are mired with potential problems.
Even in comparison to existing managed access options, we are concerned that the IMF in its current form would not make an attractive or feasible option for manufacturers. Companies with potentially transformative medicines may deem there to be too high or imbalanced degree of risk in return for interim access. More equitable risk-sharing between the NHS and manufacturers is a key component of successful commercial deals, where there is a considerable and often inevitable level of uncertainty. A new funding mechanism must reflect or improve upon the level of flexibility and rules of engagement of the existing options if the fund is going to achieve its twin goals of widening early access where there is strong potential, and accelerating adoption where there is proven benefit.
Many knowledgeable and dedicated stakeholders, including Newmarket Strategy, have taken the time to share carefully considered perspectives on the IMF proposals with NHS England and NICE. We look forward to the next iteration and the open, ongoing dialogue required to make the IMF vision a success.
For further insight on the IMF or Managed Access Agreements, please contact us at firstname.lastname@example.org for a no-obligation, confidential conversation.