NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Thank you Lykiri. This is HUGE! This document that you posted provides the details on how the new Innovative Medicines Fund will operate. I thought Northwest Bio might be able to access this new funding to provide early access to DCVax for Glioblastoma patients in the UK, but after reading through this, I’m now convinced that this is the plan to fund DCVax for compassionate use until the Flaskworks automated process development work is completed and approved.

The Innovative Medicines Fund Principles
6 June 2022

Background and purpose

1. This document sets out our guidance and policy approach for the Innovative Medicines Fund, which will operate alongside, and on similar terms to, the Cancer Drugs Fund (CDF). Like the CDF, the Innovative Medicines Fund will have a fixed funding envelope of £340 million per annum, creating a total of £680 million of ringfenced NHS England funding for early access to the most promising medicines.

2. Since 2016 the CDF has provided earlier, time-limited access to promising new cancer medicines via managed access agreements (MAAs), while further evidence is collected on their clinical and cost-effectiveness. This has benefitted over 80,000 patients who have been able to access 96 CDF funded medicines treating 218 cancers.

3. This managed access approach has played a key role in responding to a long- standing challenge in the evaluation of cancer medicines, where the data available to NICE is not always sufficient to make long-term decisions regarding the clinical effectiveness and value for money of new medicines or indications.

4. In these situations, the CDF and use of MAAs has meant that NICE can recommend medicines for a limited time while further data is collected to clarify any identified uncertainties. NICE then uses this data to recommend whether or not the medicine should be made routinely available on the NHS. . . .

11. The fastest way for a medicine to reach NHS patients is for a company to submit evidence of its clinical-and cost-effectiveness through a NICE health technology evaluation (i.e. technology appraisal or highly specialised technologies).

12. Where NICE finds the case has not been made for routine use in the NHS because it needs further data to resolve the outstanding uncertainty, the Innovative Medicines Fund, as a managed access fund, has the potential to significantly benefit patients by opening the opportunity for them to access promising new medicines whilst this data is collected.

13. The Innovative Medicines Fund will provide a consistent and transparent managed access process for companies offering promising non-cancer medicines at a responsible price.

https://www.england.nhs.uk/wp-content/uploads/2022/06/B1686-the-innovate-medicines-fund-principles-june-2022.pdf