Sotatercept: 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), AOTMIT (Poland) and DMC (Denmark), among others, recommended or restricted sotatercept, while PBAC (Australia) did not recommend it.
Every record falls within a 1.5-year window, 6 Mar 2025 to 24 Sep 2026 — a compressed review cycle.
CIPM (Spain) changed its position: not recommended on 21 May 2025, recommended by 19 Jun 2025, after a resubmission.
No assessment is on file from PHARMAC (New Zealand) and TLV (Sweden), each among the eight highest-volume agencies here.
The file is active: 13 of 13 records date from 2023 or later.
3 distinct indication wordings are recorded for sotatercept by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
1 of these 13 records carries a year of decision but no day, so any interval quoted here is approximate to within a year.
G-BA (Germany) was first to assess sotatercept, on 6 Mar 2025; ZIN (Netherlands) did not open a file until 24 Sep 2026 — a moderate spread of 1.5 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 7 of 13 dated records fall in 2025 alone.
Restriction is doing real work here: 3 of 10 decisive outcomes narrowed sotatercept to a subgroup rather than accepting or refusing it outright, at AOTMIT (Poland), SMC (Scotland) and ZIN (Netherlands).
CIPM (Spain) is the only agency to have returned to sotatercept, recording 2 separate entries.
sotatercept has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for sotatercept reads 5 recommended, 3 restricted, 2 not recommended and 1 appraised, with 2 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| DMC (Denmark) | 24 Jun 2026 | Behandling af pulmonal arteriel hypertension hos voksne patienter i WHO-funktionsklasse (FC) II til III for at forbedre … | Anbefalet | source |
| NICE (England) | 3 Jun 2026 | NICE TA1161 | published appraisal | source |
| AWMSG (Wales) | 8 May 2026 | Treatment for pulmonary arterial hypertension | excluded, NICE appraised | source |
| SMC (Scotland) | 13 Apr 2026 | In combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II to II… | accepted (restricted) | source |
| AIFA (Italy) | 17 Feb 2026 | Winrevair, in associazione ad altre terapie per l’ipertensione arteriosa polmonare (pulmonary arterial hypertension, PAH… | innovative · reimbursed class A | source |
8 further decisions for sotatercept, across 7 agencies, are not shown here. They include the most recent record on file, 24 Sep 2026 from ZIN (Netherlands); its outcome is in the subscriber dataset. They link to 8 further source documents.
Related molecules
- macitentan — divergent outcome (recommended vs restricted) on a shared indication
- bosentan — same ATC class C02K — Antihypertensives
- riociguat — same ATC class C02K — Antihypertensives
- ambrisentan — same ATC class C02K — Antihypertensives
- daratumumab — also decided by ZIN in 2026Q3
- zanubrutinib — also decided by ZIN in 2026Q3
Coverage: 13 decisions for sotatercept from 12 agencies, 2025 to 2026. Data to 7 Sep 2026. ATC class C02K — Antihypertensives. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.