Migalastat: 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
AWMSG (Wales), HAS (France) and PHARMAC (New Zealand), among others, recommended or restricted migalastat, while CONITEC (Brazil) and ZIN (Netherlands) did not recommend it.
Assessment has run over 9.4 years, from 1 Nov 2016 at TLV (Sweden) to 15 Apr 2026 at HAS (France).
PBAC (Australia) changed its position: not recommended in 2017, recommended by 2025, after a resubmission.
No assessment is on file from CIPM (Spain), which is among the eight highest-volume agencies here.
The file is active: 8 of 19 records date from 2023 or later.
4 distinct indication wordings are recorded for migalastat by the agencies that label one in English (AWMSG, PBAC and SMC).
7 of these 19 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
TLV (Sweden) was first to assess migalastat, on 1 Nov 2016; G-BA (Germany) did not open a file until 15 Feb 2024 — a wide spread of 7.2 years between the earliest and latest system to look at it.
The record arrives in waves: 6 separate years each carry two or more decisions, spread across 8 years in total.
5 of the 9 agencies here assessed migalastat more than once, PBAC (Australia) most often at 7 entries — repeat review is the norm for this molecule rather than the exception.
9 of the 18 agencies in this archive hold a record for migalastat.
The full ledger for migalastat reads 9 recommended, 4 not recommended, 2 restricted and 1 no benefit, with 3 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| PBAC (Australia) | 2025 | Fabry disease | The PBAC recommended amending the existing PBS listing of migalastat for initial, continui… | source |
| CONITEC (Brazil) | 7 May 2025 | Tratamento de pacientes adultos e adolescentes de 12 anos ou mais, com diagnóstico de doença de Fabry e que possuam uma … | not incorporated | source |
| G-BA (Germany) | 15 Feb 2024 | Galafold — benefit assessment §35a | added benefit: not proven | source |
| PHARMAC (New Zealand) | 11 Aug 2023 | Fabry disease | PTAC advice: Medium | source |
| ZIN (Netherlands) | 25 Apr 2017 | GVS-advies migalastat (Galafold®) bij de ziekte van Fabry met een behandelbare α-galactosidase A (GLA)-mutatie | advice published (GVS) | source |
14 further decisions for migalastat, across 7 agencies, are not shown here. They include the most recent record on file, 15 Apr 2026 from HAS (France); its outcome is in the subscriber dataset. They link to 6 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
- cerliponase alfa — same ATC class A16A — Other alimentary tract and metabolism
- givosiran — same ATC class A16A — Other alimentary tract and metabolism
- velmanase alfa — same ATC class A16A — Other alimentary tract and metabolism
Coverage: 19 decisions for migalastat from 9 agencies, 2016 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.