Draft monograph: semaglutide, version 3
Consultation on the third version of the semaglutide monograph. The revision incorporates the cardiovascular outcome evidence from SELECT, reported in the New England Journal of Medicine in 2023, and the kidney outcome evidence from FLOW, reported in the same…
§1Consultation and window
§1.1Window
- Opened
- 3 February 2025
- Closed
- 20 March 2025
- Duration
- 45 days
- Status
- Closed — the disposition is published
- Document under consultation
- Monograph: Semaglutide
- Submissions received
- 14
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Is the high certainty rating for the weight-reduction outcome correctly drawn from the contributing STEP trials, and is the population to which it applies stated with sufficient precision?
- Should the cardiovascular outcome evidence from SELECT be presented as a separate assessed outcome rather than as context to the weight-reduction estimate?
- Are the evidence gaps recorded in the monograph complete, in particular in relation to weight trajectory after discontinuation?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The monograph was amended before ratification. The cardiovascular and kidney outcomes were given their own assessed-outcome rows with their own certainty ratings, and the discontinuation trajectory was moved from the discussion into the recorded evidence gaps.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.