Givosiran: 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 CHUIKYO (Japan), among others, recommended or restricted givosiran, while DMC (Denmark), HAS (France) and NYE METODER (Norway) did not recommend it.
Assessment has run over 5.2 years, from 24 Jun 2020 at HAS (France) to 29 Sep 2025 at AOTMIT (Poland).
No assessment is on file from PHARMAC (New Zealand) and CIPM (Spain), each among the eight highest-volume agencies here.
Not every gap is a refusal: for givosiran, 1 submission was never made — an outcome set by the company rather than the assessor.
The file is active: 5 of 15 records date from 2023 or later.
2 of these 15 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
HAS (France) was first to assess givosiran, on 24 Jun 2020; AOTMIT (Poland) did not open a file until 29 Sep 2025 — a wide spread of 5.2 years between the earliest and latest system to look at it.
The record arrives in waves: 4 separate years each carry two or more decisions, spread across 5 years in total.
Restriction is doing real work here: 3 of 12 decisive outcomes narrowed givosiran to a subgroup rather than accepting or refusing it outright, at AOTMIT (Poland), TLV (Sweden) and ZIN (Netherlands).
3 of the 12 agencies here assessed givosiran more than once, PBAC (Australia) most often at 2 entries — repeat review is the norm for this molecule rather than the exception.
givosiran has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for givosiran reads 5 recommended, 4 not recommended, 3 restricted and 1 deferred, with 2 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| AOTMIT (Poland) | 29 Sep 2025 | programu lekowego B.128.FM. „Leczenie chorych na ostrą porfirię wątrobową (AHP) u dorosłych i młodzieży w wieku od 12 la… | recommended conditionally | source |
| PBAC (Australia) | 2025 | Acute hepatic porphyria (AHP) | Deferred | source |
| NYE METODER (Norway) | 27 Apr 2025 | Behandling av akutt hepatisk porfyri (AHP) hos voksne og ungdom fra 12 år og eldre | not introduced | source |
| DMC (Denmark) | 22 Feb 2023 | Akut hepatisk porfyri | Ikke anbefalet | source |
| TLV (Sweden) | 17 Jun 2022 | Givlaari ingår i högkostnadsskyddet med begränsning | restricted subsidy | source |
10 further decisions for givosiran, across 8 agencies, are not shown here. They link to 7 further source documents.
Related molecules
- teduglutide — same ATC class A16A — Other alimentary tract and metabolism
- sapropterin — same ATC class A16A — Other alimentary tract and metabolism
- miglustat — same ATC class A16A — Other alimentary tract and metabolism
- migalastat — same ATC class A16A — Other alimentary tract and metabolism
- cerliponase alfa — same ATC class A16A — Other alimentary tract and metabolism
- velmanase alfa — same ATC class A16A — Other alimentary tract and metabolism
Coverage: 15 decisions for givosiran from 12 agencies, 2020 to 2025. Data to 7 Sep 2026. ATC class A16A — Other alimentary tract and metabolism. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.