Something I haven't see anyone mention so far with regards the inclusion of Murcidencel to the NHS HCD list is that the NHS have a group called the Accelerated Access Collaborative who conduct 'Horizon Scanning and Demand Signalling'.
Here are a few notable excerpts from their 'What We Do' page here:
The Horizon scanning and demand signalling team works with a range of stakeholders to identify the research and innovation opportunities which have the potential to transform care in high priority clinical areas, where innovations can make a positive impact for large communities. It can typically take a long time before innovations are used as part of a patient’s care or treatment plan; the Horizon scanning and demand signalling team helps to speed up this process by identifying gaps in research and advising where new innovations can help to transform care pathways.
and
Horizon scanning helps us to better understand emerging trends and early-stage technologies. The process of horizon scanning is to provide a clear view of new innovations, drugs and technologies, which have the potential to improve care for patients.
During 2022/23, the team completed a range of scans to better understand drugs and medical devices in the pipeline for a range of clinical areas, including: ... Advanced therapy medicinal products (ATMPs): ATMPs include a range of medicines which treat the root cause of diseases and disorders by repairing or regenerating organs, tissues, cells, and genes. The ATMP horizon scan will be used to ensure that the NHS is prepared to deliver innovative technologies before they are approved by the National Institute for Clinical Excellence...
So this is a clear pathway of how DCVax-L has ended up with an IFR. Since an IFR provides a formal NHS funding route for individual patients to access treatments identified by AAC (or other bodies) before routine NHS commissioning or NICE approval. It is a clinician-led, exception-based process that supports early, case-specific access to innovative or non-standard treatments when broader funding pathways are not yet established.
Thus, IFRs fit into the overall AAC and NHS early access framework as a complementary, patient-specific funding mechanism bridging the gap prior to systematic adoption and funding of new treatments.
And for those interested, here is Perplexity's take on whether MHRA approval is required before a treatment can be considered for an IFR:
An Individual Funding Request (IFR) approval for a specific treatment by the NHS or bodies like the AAC does require that the treatment has appropriate regulatory approval, such as from the MHRA, before funding can be granted.
Explanation based on publicly available NHS IFR guidance:
- IFRs are intended for treatments that are not routinely commissioned by the NHS but have some evidence of clinical effectiveness and are considered appropriate for exceptional clinical circumstances.
- The treatment must be clinically appropriate and safe, which implies it should have necessary regulatory authorization (e.g., MHRA approval for medicines or medical devices) before it can be considered for NHS funding via an IFR.
- NHS IFR policies explicitly state that funding approval must be obtained prior to treatment commencing, and treatments without regulatory approval would generally not be considered appropriate or safe to fund.
- There is no indication in NHS IFR policy documents that funding is granted for unlicensed or unapproved medicines outside specific early access schemes (like EAMS), which have their own regulatory frameworks.
- IFR panels review clinical evidence including regulatory status and effectiveness; lack of MHRA approval would typically be a barrier to approval unless the treatment is accessed via a formal early access scheme.
Summary
- MHRA approval or equivalent regulatory authorization is generally required before an IFR can be approved to fund a treatment.
- IFRs are for exceptional clinical cases where routine commissioning is not in place, but safety and regulatory compliance remain prerequisites.
- Treatments without MHRA approval would usually need to be accessed through separate early access schemes rather than IFR funding.
- Therefore, NHS funding via an IFR depends on the treatment being appropriately authorized by the MHRA beforehand, ensuring patient safety and regulatory compliance.
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