Replies to post #799383 on NorthWest Biotherapeutics Inc (NWBO)

[Steady_T]

The EU did that with Leqembi and Kisunla, the mabs.

It would seem rather strange to give approval for treatment and choose not to pay for it because the cost is too high.

[Baxers]

Yako. Cheers for the reply.

To try and answer your questions, there are other examples of treatments that the MHRA has approved but NICE has rejected for coverage on the NHS such as Bevacizumab (for certain indications) which only had marginal survival gains and simply was not deemed cost-effective versus standard care according to their QALY methodology. If NICE will not fund a treatment then there are other methods for funding besides NICE such as the Cancer Drugs Fund (CDF) and Individual Funding Request (IFR). These are more cumbersome for the patient and the prescribing doctor than NICE - more paperwork and longer leadtimes, but do ultimately allow fully funded 'managed' access. As we know DCVax-L is already on the IFR list and I think will probably be added to the Cancer Drugs Fund (CDF) fairly quickly upon initial approval. The CDF is orders of magnitude easier for patients to access and for doctors to prescribe than IFR, which needs a 20 page application and a 30-90 screening time - not exactly ideal if you are dying of GBM! In fact, supposedly CDF funding is not too far behind NICE coverage in terms of ease of use, so it can be seen as a good stop-gap funding methodology between MA and NICE approval using FW.

I beleive this is likely what we are probably looking at:

- MA with manual production with coverage under CDF (should in theory take about 90 days for CDF approval after MA)
- Then upon the competion of the Type II variation to include automation (and costdown) with FW then NICE will be able to complete their coverage validation likely based on a pay-per-injection basis like Senti suggests in his reply to my message earlier here. Pay-per-injection is probably an easier pill to swallow for the cash-strapped NHS!