Pegunigalsidase Alfa: 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
DMC (Denmark), NICE (England) and PBAC (Australia), among others, recommended or restricted pegunigalsidase alfa, while NYE METODER (Norway) did not recommend it.
The record spans 2 years, opening at AWMSG (Wales) on 8 Aug 2023 and running to 1 Aug 2025.
No assessment is on file from HAS (France), PHARMAC (New Zealand) and CIPM (Spain), each among the eight highest-volume agencies here.
The file is active: 9 of 9 records date from 2023 or later.
3 distinct indication wordings are recorded for pegunigalsidase alfa by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
1 of these 9 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 pegunigalsidase alfa, on 8 Aug 2023; DMC (Denmark) did not open a file until 1 Aug 2025 — a moderate spread of 2 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 4 of 9 dated records fall in 2023 alone.
Restriction is doing real work here: 2 of 7 decisive outcomes narrowed pegunigalsidase alfa to a subgroup rather than accepting or refusing it outright, at NICE (England) and SMC (Scotland).
9 of the 18 agencies in this archive hold a record for pegunigalsidase alfa.
The full ledger for pegunigalsidase alfa reads 4 recommended, 2 restricted, 1 no benefit and 1 not recommended, with 1 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| DMC (Denmark) | 1 Aug 2025 | Fabrys sygdom | Anbefalet | source |
| PBAC (Australia) | 2025 | Fabry disease | Recommended | source |
| SMC (Scotland) | 8 Jul 2024 | Long-term enzyme replacement therapy (ERT) in adult patients with confirmed diagnosis of Fabry disease (FD) (deficiency of alpha galactosidase). | accepted (restricted) | source |
| ZIN (Netherlands) | 12 Jun 2024 | Advies - vergoed pegunigalsidase alfa (Elfabrio®) voor de behandeling van de ziekte van Fabry | reimbursed | source |
| G-BA (Germany) | 21 Mar 2024 | Elfabrio — benefit assessment §35a | added benefit: not proven | source |
4 further decisions for pegunigalsidase alfa, across 4 agencies, are not shown here. They link to 4 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: 9 decisions for pegunigalsidase alfa from 9 agencies, 2023 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.