NorthWest Biotherapeutics Inc (NWBO)

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NICE Single Technology Appraisal (STA) responses

Thanks Lykiri, for posting this!

The paper that interested me the most was the response to consult and the commentator comments on the draft remit and draft scope (pre-referral).

This is the link...
https://www.nice.org.uk/guidance/gid-ta10143/documents/scope-consultation-comments-and-responses

I'll provide a quick synopsis of the things that stood out to me.

First... all comments on this pdf were provided by the Association of British Neurologists (ABN).

Second, first there is a topic, then a topic question, then a comment from the ABN, and then an action.

Topic: Timing

Question:
What is the relative urgency of this appraisal to the NHS?

Comment:
Given the current absence of phase III trials for DCVaxL but the pending results of a phase III RCT trial, this NICE single technology appraisal would be better completed following publication of that study.

Action:
Comment noted. NICE aims to publish guidance on cancer drugs within 90 days of marketing authorisation. Any requirements for potential delays will be taken into account as appropriate.

Topic: Additional Comments

Question: None - this is just for additional comments

Comments:
Could/was DCVaxL for GBM (and this remit therefore) covered in the Primary brain tumours and cerebral metastases. NICE clinical guideline which is currently in development? And therefore is this separate remit required at this point?

Action:
Comment noted. This remit is specifically for a technology appraisal of DCVaxL for GBM. NICE has committed to appraising all new cancer drugs and new indications for existing cancer drugs. Therefore, a technology appraisal of this drug is considered necessary at this stage.

Topic: Innovation

Questions:
1.
Do you consider the technology to be innovative in its potential to make a significant and substantial impact on health-related benefits and how it might improve the way that current need is met (is this a ‘step-change’ in the management of the condition)?
2.
Do you consider that the use of the technology can result in any potential significant and substantial health-related benefits that are unlikely to be included in the QALY calculation? Please identify the nature of the data which you understand to be available to enable the Appraisal Committee to take account of these benefits.

Comments:
1.
Yes – if it shown to work in a phase III clinical trial (still awaited)
2.
Data is currently awaited for phase III RCT. Data is available for phase I and II trials.

Action:
Comment noted. The committee will consider the innovative nature of the technology at the time of the appraisal. No changes to the scope are needed


https://www.nice.org.uk/guidance/gid-ta10143/documents/scope-consultation-comments-and-responses

So... what to make of all that? Well, it seems the ABN thinks the appraisal should be completed following the publication of the P3 unblinded results. However, the action is to note first, that they plan to publish guidance within 90 days of marketing authorization, and second, they will take this into consideration as appropriate. Then pertaining to the second set of comments, the action is that NICE considers the technology appraisal necessary at this stage.

Now on this link - NICE indicates that they have a provisional schedule to hold a Committee Meeting for DCVax-L on
November 8, 2018.
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143

That's a new development as well.

So all in all, it seems that NICE at least feels that now is the appropriate time to move forward on the Single Technology Appraisal (STA) on DCVax. I will note that ABN didn't comment that the process shouldn't begin now, simply that it was their recommendation that it should be completed after publication of the unblinded P3 data.