Omaveloxolone: 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
HAS (France) recommended or restricted omaveloxolone, while AOTMIT (Poland), DMC (Denmark) and SMC (Scotland), among others, did not recommend it.
Every record falls within a 1.8-year window, 11 Sep 2024 to 8 Jul 2026 — a compressed review cycle.
CIPM (Spain) changed its position: not recommended on 29 Jan 2025, recommended by 28 Jan 2026, after a resubmission.
No assessment is on file from PHARMAC (New Zealand) and AWMSG (Wales), each among the eight highest-volume agencies here.
Not every gap is a refusal: for omaveloxolone, 1 was withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
The file is active: 15 of 15 records date from 2023 or later.
Against its own class, omaveloxolone is an outlier: 31% of its decisive outcomes were positive, where molecules sharing ATC class N07X average 56%.
3 distinct indication wordings are recorded for omaveloxolone by the agencies that label one in English (NICE, PBAC and SMC).
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 omaveloxolone, on 11 Sep 2024; SMC (Scotland) did not open a file until 9 Mar 2026 — a moderate spread of 1.5 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 10 of 15 dated records fall in 2025 alone.
3 of the 10 agencies here assessed omaveloxolone more than once, CIPM (Spain) most often at 4 entries — repeat review is the norm for this molecule rather than the exception.
10 of the 18 agencies in this archive hold a record for omaveloxolone.
The full ledger for omaveloxolone reads 9 not recommended, 4 recommended, 1 no benefit and 1 terminated.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| SMC (Scotland) | 9 Mar 2026 | For the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. | not recommended | source |
| CIPM (Spain) | 28 Jan 2026 | Indicación terapéutica autorizada: Tratamiento de la ataxia de Friedreich en adultos y adolescentes a partir de los 16 a… | financed by the SNS, on appeal | source |
| G-BA (Germany) | 18 Dec 2025 | Skyclarys — benefit assessment §35a | added benefit: not proven | source |
| ZIN (Netherlands) | 31 Jul 2025 | Advies - niet vergoeden omaveloxolon (Skyclarys®) voor de behandeling van ataxie van Friedreich | not reimbursed | source |
| PBAC (Australia) | 2025 | Friedreich’s ataxia | Not recommended | source |
10 further decisions for omaveloxolone, across 7 agencies, are not shown here. They include the most recent record on file, 8 Jul 2026 from HAS (France); its outcome is in the subscriber dataset. They link to 8 further source documents.
Related molecules
- tafamidis — same ATC class N07X — Other nervous system
- vutrisiran — same ATC class N07X — Other nervous system
- pitolisant — same ATC class N07X — Other nervous system
- fampridine — same ATC class N07X — Other nervous system
- patisiran — same ATC class N07X — Other nervous system
- tofersen — same ATC class N07X — Other nervous system
Coverage: 15 decisions for omaveloxolone from 10 agencies, 2024 to 2026. Data to 7 Sep 2026. ATC class N07X — Other nervous system. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.