Rozanolixizumab: 10 agencies, 2024–2026
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
The record spans 2.1 years, opening at HAS (France) on 24 Apr 2024 and running to 20 May 2026.
CIPM (Spain) changed its position: not recommended on 23 Oct 2024, recommended by 26 Feb 2025, after a resubmission.
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 rozanolixizumab, 1 submission was never made — an outcome set by the company rather than the assessor.
The file is active: 11 of 12 records date from 2023 or later.
4 distinct indication wordings are recorded for rozanolixizumab by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
1 of these 12 records carries a year of decision but no day, so any interval quoted here is approximate to within a year.
HAS (France) was first to assess rozanolixizumab, on 24 Apr 2024; NICE (England) did not open a file until 20 May 2026 — a moderate spread of 2.1 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 7 of 11 dated records fall in 2025 alone.
2 of the 10 agencies here assessed rozanolixizumab more than once, HAS (France) most often at 2 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 rozanolixizumab.
The full ledger for rozanolixizumab reads 6 recommended, 2 not recommended, 1 appraised and 1 restricted, with 2 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| AOTMIT (Poland) | 17 Nov 2025 | programu lekowego B.157. „Leczenie chorych z uogólnioną postacią miastenii (ICD-10: G.70.0) | recommended conditionally | source |
| PBAC (Australia) | 2025 | Generalised myasthenia gravis (gMG) | Recommended | source |
| AIFA (Italy) | 20 May 2025 | RYSTIGGO è indicato in aggiunta alla terapia standard per il trattamento dei pazienti adulti con Miastenia gravis genera… | fully innovative · reimbursed class H | source |
| HAS (France) | 26 Feb 2025 | Listing (Transparency Committee) | SMR insufficient · ASMR V | source |
| CIPM (Spain) | 26 Feb 2025 | Indicaciones terapéuticas autorizadas: Rystiggo está indicado como complemento de la terapia estándar para el tratamient… | financed by the SNS, on appeal · art. 92 a, c | source |
7 further decisions for rozanolixizumab, across 7 agencies, are not shown here. They include the most recent record on file, 20 May 2026 from NICE (England); its outcome is in the subscriber dataset. They link to 6 further source documents.
Related molecules
- ravulizumab — divergent outcome (recommended vs not recommended) on a shared indication
- adalimumab — same ATC class L04A — Immunosuppressants
- upadacitinib — same ATC class L04A — Immunosuppressants
- secukinumab — same ATC class L04A — Immunosuppressants
- tocilizumab — same ATC class L04A — Immunosuppressants
- ustekinumab — same ATC class L04A — Immunosuppressants
Coverage: 12 decisions for rozanolixizumab from 10 agencies, 2024 to 2026. Data to 7 Sep 2026. ATC class L04A — Immunosuppressants. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.