Analogue analysis of treatments funded via the Innovative Medicines Fund (IMF)
What is the Innovative Medicines Fund (IMF)? (1,2)
Building on the success of the Cancer Drugs Fund (CDF), the IMF launched in June 2022 for any non-cancer medicine that NICE recommends with managed access.
- “Managed access is an approach that the NHS takes to ensure patients can access promising but still clinically uncertain medicines, while supplementary data is collected (over a time limited period) to allow more informed decision making about patient access and long-term NHS funding.” (2)
When NICE finds that further data is necessary to resolve outstanding uncertainty, the IMF, as a managed access fund, opens the opportunity for the access of promising new medicines whilst data is collected.
Along with the CDF, the IMF will support faster access to medicines and provide £680 million of NHS funding for innovative medicines. By offering accelerated pathways to access, the IMF ensures that the latest health technologies can begin without delay.
Principles guiding the IMF (2)
The principles outlined by NHS England underpin the primary role of the IMF:
- Principle 1: The IMF 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 IMF 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 IMF in the managed access period.
- Principle 6: All medicines that enter the IMF 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 IMF 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 IMF should never have to close to potential new entrants.
Entry to the IMF (2)
Early engagement with NICE and the NHS is key for potential candidates of managed access. It is important for companies to demonstrate that their technology is suitable for the IMF based on the following factors:
- 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.
What can we learn from treatments added to the IMF?
It is important to note that NICE has not yet made a recommendation for the IMF. The Government recently reported:
- “The National Institute for Health and Care Excellence (NICE) has not yet made a recommendation for managed access under the Innovative Medicines Fund (IMF), and so the fund has been used exclusively for interim funding to accelerate patient access to medicines recommended by NICE for routine commissioning. To date, four medicines have received interim funding through the IMF.” (3)
To date, four drugs have received interim funding through the IMF (3). The technology appraisals for the four analogues do not specify that these treatments are funded through the IMF. IMF funding of these analogues was based on publicly available sources such as press releases. There is a simple discount patient access scheme for each of the four drugs. Secukinumab for hidradenitis suppurativa also has a complex patient access scheme (4-7). An overview of the four technology appraisals is reported in Table 1.
Table 1: Analogue analysis of non-cancer drugs added to the IMF (interim funding)
What does this mean for access?
NICE has not yet made a recommendation for managed access under the IMF. For the four drugs that have received interim funding through the IMF, there is limited information publicly available on the decision-making criteria.
‘The Innovative Medicines Fund Principles’ published by NHS England states that suitability for the IMF is based on key factors such as addressing a high unmet need or providing significant clinical benefit to patient. However, specific criteria are not defined.
For the four analogues assessed, these technology appraisals were all:
- In indications with a high level of unmet need (e.g. based on impact on quality of life or lack of alternative treatments)
- For treatments which had uncertainty in the clinical and/or economic evidence
- Within or most likely within a cost-effectiveness range NICE normally considers an acceptable use of NHS resources.
Based on the available information, it is unclear what the specific decision-making criteria are to make a recommendation for managed access under the IMF.
For potential candidates of IMF, companies are advised to engage early with NICE and NHS England. Assessing any future treatments recommended under the IMF will be important to better understand this managed access agreement and which treatments are suitable candidates.
References
1. NHS England, Innovative Medicines Fund, available at: https://www.england.nhs.uk/medicines-2/innovative-medicines-fund/ [accessed 05/03/2024]
2. NHS England, The Innovative Medicines Fund Principles, June 2022, available at: https://www.england.nhs.uk/publication/the-innovative-medicines-fund-principles/ [accessed 05/03/2024]
3. UK Parliament, Innovative Medicines Fund, Question for Department of Health and Social Care, available at: https://questions-statements.parliament.uk/written-questions/detail/2024-02-05/HL2187 [accessed 05/03/2024]
4. NICE, Belumosudil for treating chronic graft-versus-host disease after 2 or more systemic treatments in people 12 years and over [TA949], available at: https://www.nice.org.uk/guidance/ta949 [accessed 05/03/2024]
5. NICE, Sebelipase alfa for treating Wolman disease [HST30], available at: https://www.nice.org.uk/guidance/hst30 [accessed 05/03/2024]
6. NICE, Secukinumab for treating moderate to severe hidradenitis suppurativa [TA935], available at: https://www.nice.org.uk/guidance/ta935 [accessed 05/03/2024]
7. NICE, Bulevirtide for treating chronic hepatitis D [TA896], available at: https://www.nice.org.uk/guidance/ta896 [accessed 05/03/2024]
Written by Megan Watts
Decisive Dialogue 6th March 2024
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