Setmelanotide: where the agencies disagree
This page collects every recorded health technology assessment decision for one molecule across the agencies in our archive, and compares them. The comparison is the point: each agency publishes its own verdict, none publishes how that verdict sits against the others.
What the record shows
AIFA (Italy), G-BA (Germany) and HAS (France) recommended or restricted setmelanotide, while DMC (Denmark), NYE METODER (Norway) and TLV (Sweden), among others, did not recommend it.
The record spans 4.5 years, opening at AWMSG (Wales) on 21 Jun 2021 and running to 7 Dec 2025.
CIPM (Spain) changed its position: not recommended on 23 Oct 2023, recommended by 23 Oct 2024, after a resubmission.
No assessment is on file from PBAC (Australia) and PHARMAC (New Zealand), each among the eight highest-volume agencies here.
Not every gap is a refusal: for setmelanotide, 2 submissions were never made — an outcome set by the company rather than the assessor.
The file is active: 16 of 23 records date from 2023 or later.
5 distinct indication wordings are recorded for setmelanotide by the agencies that label one in English (AWMSG and SMC).
AWMSG (Wales) was first to assess setmelanotide, on 21 Jun 2021; NYE METODER (Norway) did not open a file until 27 Apr 2025 — a wide spread of 3.8 years between the earliest and latest system to look at it.
The record arrives in waves: 5 separate years each carry two or more decisions, spread across 5 years in total.
8 of the 10 agencies here assessed setmelanotide more than once, HAS (France) most often at 4 entries — repeat review is the norm for this molecule rather than the exception.
10 of the 18 agencies in this archive hold a record for setmelanotide.
The full ledger for setmelanotide reads 7 recommended, 5 not recommended, 3 restricted and 3 deferred to NICE, with 5 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| G-BA (Germany) | 21 Aug 2025 | Imcivree — benefit assessment §35a | added benefit: non-quantifiable (hint) | source |
| HAS (France) | 28 May 2025 | Listing (Transparency Committee) | SMR substantial · ASMR IV | source |
| AIFA (Italy) | 15 May 2025 | Trattamento dell’obesità e controllo della fame associati a deficit di pro-opiomelanocortina (POMC), compreso PCSK1, con… | fully innovative, since expired | source |
| NYE METODER (Norway) | 27 Apr 2025 | Behandling av fedme og kontroll av sult assosiert med genetisk bekreftet Bardet-Biedl syndrom (BBS) hos voksne og barn f… | not introduced | source |
| ZIN (Netherlands) | 8 Jul 2022 | GVS-advies setmelanotide (Imcivree®) voor de behandeling van een zeldzame vorm van obesitas | advice published (GVS) | source |
18 further decisions for setmelanotide, across 10 agencies, are not shown here. They include the most recent record on file, 7 Dec 2025 from NYE METODER (Norway); its outcome is in the subscriber dataset. They link to 15 further source documents.
Related molecules
- bupropion / naltrexone — same ATC class A08A — Antiobesity preparations
- guselkumab — also decided by NYE METODER in 2025Q4
- nemolizumab — also decided by NYE METODER in 2025Q4
- garadacimab — also decided by NYE METODER in 2025Q4
- rucaparib — also decided by NYE METODER in 2025Q4
- solriamfetol — also decided by NYE METODER in 2025Q4
Coverage: 23 decisions for setmelanotide from 10 agencies, 2021 to 2025. Data to 7 Sep 2026. ATC class A08A — Antiobesity preparations. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.