Public consultation period for the new (proposed) Innovative Medicines Fund is now open, formalising details released by NHSE&I in June this year. Interesting reading and we’ve summarised the key takeaways below 👇
One interesting point was the lack of clarity on the criteria for entry. The proposals state medicines should have “the potential to address an unmet need”, and the “potential to provide clinically significant benefits to patients”. Pretty vague.
The Innovative Licensing and Access Pathway (ILAP) is mentioned as a means of identifying potential candidates (highlighting the potential relevance of an Innovation Passport and/or PIM designation). But this isn’t mandatory; just a potential way to identify IMF candidates earlier (more on early stakeholder interactions below).
🚀 As trailed previously, it’s essentially a non-cancer Cancer Drugs Fund. Separate, ringfenced £340m annual funding with similar conditions and requirements as the CDF.
🚀 As for the CDF, it’s mostly for therapies for which further data collection would likely reduce uncertainty and help determine whether it’s cost effective (currently that’s where about 90% of the CDF budget is spent). The IMF will also – like the CDF – potentially give an opportunity to bridge the non-reimbursed period between a NICE confidential “yes” and entry into routine commissioning (accelerating access/funding by about 5 months).
🚀 Data collection (and re-assessment by NICE using the data collected*) is mandatory. Any drug using the fund will require both a Data Collection Agreement (DCA) and a commercial access agreement (CAA), collectively known as a Managed Access Agreement (MAA).
🚀 Companies are responsible for paying a proportionate share of the cost of data collection, validation and analysis, and covering the cost for any patients who were prescribed the medicine within the IMF if NICE is unable to recommend its routine use at re-evaluation. An Expenditure Control Mechanism will ensure the fund stays within budget, and companies will pay proportional rebates for any overspend.
🚀 The ILAP *may* help NICE and NHSE&I identify potential candidates for the fund. This isn’t mandatory – or even confirmed – yet. However, the link to ILAP (which is an early dialogue process) highlights the need for early engagement. This is explicitly stated at multiple points in the proposals.
The eight guiding principles on pages 9–11 are worth a quick read too.
*Technically the proposals don’t *require* re-assessment for all medicines; but re-assessment will be the norm, and even if the company withdraws from the MAA or decides not to proceed with updated NICE guidance, it will be required to make the new evidence available publicly (via NICE).