If NICE won't be pursued until EDEN is ready, how will the artisan manufactured DCVax-L vaccines going to be paid for? NWBO will probably have to utilize the artisan manufacturing method for many months before the EDEN methodology is ready and therefore an agreement with NICE is imperative for setting the price for those manually produced vaccines.
There are interim alternatives for funding aside from NICE. Clearly, NICE wont be pursued until Eden is ready. IMO.
The CDF does not apply prior to NICE: From the NHS it is for 2 cases.
. Access to promising new treatments, via managed access arrangement, while further evidence is collected to address clinical uncertainty. . Interim funding for all newly recommended cancer drugs, giving patients access to these treatments many months earlier than before.
The new approach provides earlier access to treatments. The NICE appraisal process now starts much earlier, to enable final guidance to be published soon after a drug received its license. In addition, all cancer drugs that are recommended for either routine or CDF managed access funding are funded from the very first positive recommendations from NICE – usually the Final Appraisal Determination (FAD) – which provides patients with access to new treatments much earlier than before.
The MHRA would not care at all about Flaskworks. They care about the prices they pay and the benefit. What is the reason for waiting?