Replies to post #727768 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

She did not “say” that she had not submitted an evidence submission, but all my posts from the ASM forward assumed she had not for a NICE STA and was hopefully pursuing an interim cdf. You seem confused. Here, read the prior discussion (below).

The economic modeling submission (that Linda referred to at the ASM) for a NICE STA review can come after a CDF evidence submission (which also goes to Nice), and that’s because CDF is meant to be interim while the rest of the pieces are put together, before the economic modeling is available to make a NICE reimbursement decision,

flipper44
Member Level
Re: exwannabe post# 720616
Wednesday, 09/18/2024 7:20:23 AM
On CDF possibility. Instead, LP told you more than you thought at the June 2024 ASM. She discussed future “health economics modeling” for NICE. To me that means they are much further along than you suspect.

https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisal-guidance/cancer-drugs-fund/data-collection-specification.pdf

Here are a couple important passages.

1 Introduction
1.1 A cancer drug can be formally identified for entry into the Cancer Drugs Fund
(CDF) at several time points during a technology appraisal:

The first time point is when the company sends its evidence submission to
NICE for a technology appraisal, and includes a proposal for data collection
in this submission, covering details set out below. Identification of potential
candidates for the CDF at this time point allows NICE and NHS England time
to develop the potential data collection arrangements before the appraisal
committee meeting;

A second time point is during the assessment phase, at which time NICE
may indicate that a drug could be a CDF candidate;

The last time point is at the first appraisal committee meeting when the
committee identifies that a drug is a CDF candidate;

In exceptional circumstances, it is possible that entry into the CDF could be
formally identified at other time points….
Companies may also informally signal to NICE early in the process that a
treatment is a potential CDF candidate (for example, during scoping).


Pay attention


Steps for data collection arrangements
After the commitee has specified the key clinical uncertainties that need to be addressed through data collection to inform guidance review, a data collection arrangement (DCA) working group is formed. This has representation from NICE, the appraisal committee (normally the chair or vice-chair) and the NHS England CDF clinical lead:

• When the committee has been presented with the company's data collection proposal as part of the evidence submission and agreed this in principle, the DCA group will review the data collection proposal, with independent academic input, and provide commentary to the appraisal committee;

• When it is the committee that has identified the drug as a potential CDF candidate, the DCA working group will, with independent academic input translate the committee's key uncertainties related to clinical outcomes into a defined data collection question. This specification might include using results from studies or data sources already in progress plus Public Health England data including SACT data, or by Public Health England data including SACT data collection alone, or by new studies plus Public Health England data including SACT data collection. Public Health England will be involved when the data collection is through Public Health England data sources, and the company will be involved when data collection is from company-run clinical trials.

The population of patients to be treated, the numbers of patients needed for robust analysis in the data collection, comparators (where appropriate), the key outcomes to address the appraisal committee's issues of uncertainty

(which will subsequently be used in economic modeling in the appraisal review after the CDF),

analysis plan and the timeframe for the studies and/or Public Health England data, including SACT data, will be identified by the DCA working group. Relevant stakeholders, including the company, and clinical and patient experts present at the appraisal committee meeting, will be asked to comment. — NICE


So, now think back to the ASM

What we will need to do is, we'll need to engage specialized consultants to develop, what's referred to, as a health economics model. — Linda Powers, June 29, 2024


She’s a step ahead of you.