Lumasiran: 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 G-BA (Germany), among others, recommended or restricted lumasiran, while CIPM (Spain) did not recommend it.
Assessment has run over 5.4 years, from 25 Feb 2021 at AWMSG (Wales) to 2 Jul 2026 at HIRA (South Korea).
No assessment is on file from PHARMAC (New Zealand) and TLV (Sweden), each among the eight highest-volume agencies here.
Not every gap is a refusal: for lumasiran, 1 submission was never made — an outcome set by the company rather than the assessor.
The file is active: 5 of 10 records date from 2023 or later.
1 of these 10 records carries a year of decision but no day, so any interval quoted here is approximate to within a year.
AWMSG (Wales) was first to assess lumasiran, on 25 Feb 2021; HIRA (South Korea) did not open a file until 2 Jul 2026 — a wide spread of 5.4 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: 2 of 7 decisive outcomes narrowed lumasiran to a subgroup rather than accepting or refusing it outright, at AOTMIT (Poland) and G-BA (Germany).
10 of the 18 agencies in this archive hold a record for lumasiran.
The full ledger for lumasiran reads 4 recommended, 2 restricted, 1 non-submission and 1 other, with 2 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| AOTMIT (Poland) | 23 Dec 2025 | programu lekowego B.129.FM. „Leczenie chorych na pierwotną hiperoksalurię typu 1 (ICD-10: E74.8) | recommended conditionally | source |
| PBAC (Australia) | 2025 | Primary hyperoxaluria type 1 (PH1) | Recommended | source |
| SMC (Scotland) | 11 Dec 2023 | For treatment of primary hyperoxaluria type 1 (PH1) in all age groups. | not recommended | source |
| NYE METODER (Norway) | 22 Oct 2023 | Behandling av primær hyperoksaluri type 1 hos alle aldersgrupper | decision recorded | source |
| AIFA (Italy) | 4 Apr 2022 | trattamento dell’iperossaluria primitiva di tipo 1 (PH1) in tutte le fasce d’età | fully innovative, since expired | source |
5 further decisions for lumasiran, across 5 agencies, are not shown here. They include the most recent record on file, 2 Jul 2026 from HIRA (South Korea); its outcome is in the subscriber dataset. They link to 5 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
- givosiran — same ATC class A16A — Other alimentary tract and metabolism
Coverage: 10 decisions for lumasiran from 10 agencies, 2021 to 2026. 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.