What is the New Innovative Medicines Fund and What Does it Mean for Patients and for Pharma?

The Innovative Medicines Fund launched on 7^th June 2022

The Innovative Medicines Fund (IMF), which was first announced in July 2021 by NHS England,¹ officially launched on the 7^th of this month (June 2022).² For a brief summary of the announcement made by the Department of Health and Social Care, check out our Insider Insights piece published on the day of the launch.³ In this article, we will be taking a deeper dive into the IMF, exploring what it is and what it means for the NHS, for patients and for Pharma.

What is the IMF?

The IMF builds upon the success of the Cancer Drugs Fund (CDF) and is expected to work in the same way. Like the CDF, £340 million a year has been allocated to fund treatments that are promising but have uncertainty surrounding their cost-effectiveness. These funds – together worth £680 million per year – allow the NHS to prescribe these treatments to patients while further data is gathered to address uncertainty. Unlike the CDF, the IMF will focus on innovative but non-oncological drugs.²

Why is the IMF important?

If successful, the IMF will facilitate speedy access to medicines where patients may have otherwise had to wait far longer, or not had access at all. In particular, it is hoped that the IMF will improve the treatment of rare diseases for patients in England.² These aims are in line with several other health policies being pursued, including:

• The priority to “improving access to specialist care, treatment and drugs”, outlined in the England Rare Disease Action Plan, published in February 2022⁴
• The commitment to allow more flexibility in NICE assessments when it is particularly difficult to generate sufficient evidence, outlined in NICE’s new methods, published in January 2022⁵

The IMF is expected to reflect the success seen in other strategies already in place. The CDF has provided access to over 80,000 patients since it was reformed five years ago. The NHS has also made news by securing access for other expensive, innovative treatments that cannot be considered cost-effectiveness to ‘regular’ NICE standards. Last year, a deal was struck with Novartis to ensure funding for Zolgensma, the “world’s most expensive” gene therapy.⁶ It is hoped the IMF will allow more innovative, but expensive drugs to be made available for NHS patients.

NHS Commercial Medicines Director, Blake Dark, has said that the IMF will “ensure the NHS remains at the forefront of securing the best revolutionary treatments for patients”. Dr Samantha Roberts, Chief Executive of NICE, praises the IMF as a solution that will “bring real benefits to thousands of people and offer high value to the NHS”.

How will the IMF work?

Like the CDF, the IMF will be utilised as part of standard NICE appraisals, offered as an option where products might otherwise be ‘not recommended’. The criteria for drugs to enter the IMF is as follows:⁷

• An innovative, non-oncological technology of clinical promise (i.e., it provides significant clinical benefits to patients or represents a step-change in medicine)
• The technology addresses a high unmet need
• The technology is associated with significant uncertainty surrounding the cost-effectiveness
• The uncertainty can be addressed with further evidence generation in the next two to three years

In line with the new NICE methods, all proposals for managed access agreements should now be made at the start of a NICE submission process.⁵ This includes proposed entry into the CDF or IMF. Consequently, companies should not wait to receive a draft ‘not recommended’ opinion before considering the IMF as an option for their innovative drug. The full stepwise process for utilising the IMF is outlined in Figure 1.⁷

What does this mean for Manufacturers?

The launch of the IMF will potentially allow companies to secure access for their innovative products, particularly those targeted at the treatment of rare diseases, where this may not have been possible before. With specific funding allocated to facilitate this access, this may also be possible without the need for companies to sacrifice their net price expectations. However, there are also several points companies must consider regarding utilisation of the IMF:

• Companies must consider whether the IMF will be appropriate for their product before the start of a NICE submission
• Although there is funding allocated for the managed access of products through the IMF, a ‘commercial proposal’ will be expected which is likely to take the form of a confidential discount
• Companies must be prepared to lay out how they plan to generate more evidence during the data-collection period
• The managed-access period should be the shortest possible time needed to generate evidence that can address the uncertainty, usually just two or three years and a maximum of 5; after this the product will be re-assessed by NICE and there is no guarantee that products leaving the IMF will be recommended for routine use and funding within the NHS
• If a negative decision is reached at the end of the IMF, the manufacturer will be liable to continue to fund the treatment for existing patients until the physician and patient decides to end treatment

We will continue to gather insights on the IMF

We expect the IMF to secure access to patients, where otherwise access may have been delayed or not possible at all. If it can deliver similar results to that of the CDF, it should be a positive step towards better patient access in England.

We will continue to gather further insights as we begin to see the first use of the IMF, evaluating how many innovative and rare-disease treatments are able to benefit from the fund and if any patterns emerge in the types of products that do so. Further down the line, we will also be able to identify long-term success of the fund, as IMF products are re-assessed, as we are now seeing for CDF drugs.

To learn more about the IMF and whether this could be an appropriate route to access for your product, or to find out how we can help facilitate your UK launch, please get in touch.

Sources:

1. NHS England announces new Innovative Medicines Fund to fast-track promising new drugs. NHS. https://www.england.nhs.uk/2021/07/nhs-england-announces-new-innovative-medicines-fund-to-fast-track-promising-new-drugs/ Accessed 8^th June 2022.
2. Press Release: Patients to have earlier access to cutting-edge treatments on NHS. Gov.uk. https://www.gov.uk/government/news/patients-to-have-earlier-access-to-cutting-edge-treatments-on-nhs Accessed 8th June 2022.
3. UK: Launch of Innovative Medicines Fund. LinkedIn: Remap Consulting. https://www.linkedin.com/posts/remap-consulting_imf-nice-cdf-activity-6939943653234630656-da9v/?utm_source=linkedin_share&utm_medium=member_desktop_web Accessed 8^th June 2022.
4. Policy Paper: England Rare Diseases Action Plan 2022. Department of Health and Social Care. https://www.gov.uk/government/publications/england-rare-diseases-action-plan-2022/england-rare-diseases-action-plan-2022 Accessed 8th June 2022.
5. Changes we’re making to health technology evaluation. NICE. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/changes-to-health-technology-evaluation Accessed 8th June 2022.
6. Innovative Medicines Fund launched to fast-track drugs. BBC. https://www.bbc.co.uk/news/health-61709542 Accessed 8th June 2022.
7. The Innovative Medicines Fund Principles. London: NICE and NHS England and NHS Improvement; 2022. Available at https://www.england.nhs.uk/wp-content/uploads/2022/06/B1686-the-innovate-medicines-fund-principles-june-2022.pdf Accessed 8^th June 2022.