Updating technology appraisal recommendations for COVID-19 medicines: revised approach
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3 What we plan to do
Surveillance
Surveillance of clinical evidence will continue, but it is anticipated that because the amount of data has reduced, the likelihood of triggers for review arising will to be lower.
If the surveillance activity highlights new information that may trigger an update of the TA recommendations, this will be passed to the TA team to consider.
Stakeholders may also submit new information to NICE, and should send information to nice@nice.org.uk, stating the guidance topic it relates to.
The decision-making about whether to review the recommendation will then follow section 8 of the Health Technology Evaluation Manual. Section 8.4 of the Manual describes that NICE considers the surveillance review and determines if it should have a public consultation. A consultation will only take place when the review has identified significant uncertainty in the appropriate decision option. NICE expects that consultations will not be needed routinely.
Update Process
An update will be initiated when an invitation to participate is sent to stakeholders. NICE will aim to minimise the time between a review decision and starting the update process.
Submissions
As outlined in section 1, stakeholders expressed concerns that several steps had been omitted from the process. In particular stakeholders were keen to make submissions. NICE recognises the importance of stakeholder submissions so the revised process will allow stakeholders to make an evidence submission. NICE will give stakeholders 4 weeks to make a submission from invitation to participate.
This is 4 weeks shorter than the usual time allowed for submissions. We will also shorten the external assessment group's (EAG) review to 4 weeks from 8 weeks. This includes a 1 week period for the EAG to seek clarification from the company.
The only way to achieve these shorted submission time frames is for companies to agree to use the existing economic model from the original appraisal. If the company does not agree to this and wants to submit a new model, this will require a full review, with associated longer timelines.
Stakeholder involvement
Stakeholders were concerned with the proposal to have standing patient and clinical experts involved in the committee meetings. In addition it was noted that commissioning experts were not mentioned in the draft process statement. To address these points, stakeholders will be invited to nominate patient, clinical and commissioning experts when a review of the recommendation is initiated, in line with the usual process.
Decision-making committee
Stakeholders requested that the committee meeting is held in public to increase transparency. NICE recognises the importance of transparency, although public committee meetings require more notice to arrange and to facilitate. In addition, given the changes to expert involvement outlined above, topics will be considered at public meetings of the full standing technology appraisal committees, rather than by a subset of the committee.
Consultation on draft guidance
Stakeholders were concerned that the proposed consultation period of 1 week would not allow adequate time for them to respond. So we will revert to a 4 week consultation period when draft guidance is issued.
Appeals and publication
The appeal process and timelines will follow NICE's technology appraisal appeals process guide. Following resolution of any appeals, NICE publishes the final guidance. At this point, the 90 ‑day funding implementation period applies for commissioners. Requests to vary the funding requirement to take account of net budget impact will be considered in line with section 5.9 of the health technology evaluation manual.
Overall summary
Overall, because steps have been added back into the process (or lengthened) in response to stakeholder feedback, the process is now more similar to the technology appraisal review process, which follows the single technology appraisal process and timeline. Therefore, in order to increase clarity for all stakeholders, there will not be a separate process statement. Instead reviews will follow the health technology evaluation manual, with the exceptions of the shorter submission period and shorter evidence review stage (as outlined above) and no technical engagement. There will also be less time allocated to NICE internal teams to prepare materials for the committee and to draft the guidance documents.
These changes will be clearly documented in the invitation to participate letter issued to stakeholders and must be accepted by the company to proceed. This will result in the following timeline, if a positive recommendation is made at the first committee meeting:
Week | Proposed process | Standard process |
|---|---|---|
Week -4 | Surveillance trigger identified | Scoping |
Week -3 | Surveillance review done | |
Week -2 | Decision to update communicated | |
Week -1 | Planning update into programme | |
Week 0 | Issue Invitation to Participate | Issue Invitation to Participate |
Week 1 | ||
Week 2 | ||
Week 3 | ||
Week 4 | Stakeholder submissions | |
Week 5 | Clarification step | |
Week 6 | ||
Week 7 | ||
Week 8 | EAG critique due | Submissions |
Week 9 | ||
Week 10 | ||
Week 11 | Clarification step | |
Week 12 | Committee meeting | |
week 13 | Preparation of guidance document | |
Week 14 | ||
week 15 | Positive recommendation: guidance issued for appeal (3 weeks) | |
Week 16 | ||
Week 17 | EAG report due | |
Week 18 | Appeal period ends | |
week 19 | Company Factual Accuracy Check | |
week 20 | No appeals, final guidance | Progression decision point meeting |
week 21 | Response to Factual Accuracy Check | |
week 22 | ||
week 23 | ||
week 24 | ||
week 25 | Pre-meeting briefing | |
week 26 | ||
week 27 | ||
week 28 | Committee meeting | |
week 29 | Preparation of guidance document | |
week 30 | ||
week 31 | Guidance executive meeting | |
week 32 | Guidance issued for appeal (3 wks) | |
week 33 | ||
week 34 | ||
week 35 | Appeal period ends | |
week 36 | ||
week 37 | ||
week 38 | If no appeals, final guidance |
In addition, a company may propose to further expedite the timelines if it is happy for the review to proceed without a company submission and the need for consequent external academic review. Timelines are subject to NICE and EAG resource availability and capacity.
Cost recovery
Concerns were raised about the proposed cost-recovery charge and the inclusion of costs for the continuous surveillance process. As we now anticipate smaller data flows, this element can be removed from the charging.
The applicable charge will be £106,200 for 2023/24 in line with the charge for a rapid review, if companies agree to use the existing model from the original appraisal (see above: 3. Submissions). If companies instead wish to submit new modelling the standard STA charge will apply - £151,700 for 2023/24.
Because of the speed of potential reviews, it may not be possible to issue the charging invoice and receive payment before starting the rapid update. However, as part of the charging process the company will still need to provide NICE with a Unique Reference Number (URN) as their commitment to pay for the update. NICE reserves the right to not publish final guidance until payment in full has been received.
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