Iptacopan: 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), DMC (Denmark) and NICE (England), among others, recommended or restricted iptacopan, while HAS (France) did not recommend it.
The record spans 2.1 years, opening at AWMSG (Wales) on 10 May 2024 and running to 4 Jun 2026.
CIPM (Spain) changed its position: not recommended on 26 Mar 2025, recommended by 20 May 2026, after a resubmission.
Every one of the eight highest-volume agencies in this archive has a record for iptacopan.
Not every gap is a refusal: for iptacopan, 1 submission was never made and 1 was withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
The file is active: 23 of 24 records date from 2023 or later.
7 distinct indication wordings are recorded for iptacopan by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
2 of these 24 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
AWMSG (Wales) was first to assess iptacopan, on 10 May 2024; G-BA (Germany) did not open a file until 4 Jun 2026 — a moderate spread of 2.1 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 14 of 23 dated records fall in 2025 alone.
9 of the 12 agencies here assessed iptacopan more than once, CIPM (Spain) most often at 5 entries — repeat review is the norm for this molecule rather than the exception.
iptacopan has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for iptacopan reads 7 recommended, 7 not recommended, 3 restricted and 2 no benefit, with 5 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| G-BA (Germany) | 4 Jun 2026 | Fabhalta — benefit assessment §35a | added benefit: not proven | source |
| CIPM (Spain) | 20 May 2026 | Indicaciones terapéuticas autorizadas: Hemoglobinuria paroxística nocturna Fabhalta está indicado como monoterapia en el… | financed by the SNS · art. 92 a, c | source |
| TLV (Sweden) | 28 Apr 2026 | Fabhalta ingår i högkostnadsskyddet med begränsning | restricted subsidy | source |
| AIFA (Italy) | 26 Mar 2026 | FABHALTA è indicato per il trattamento dei pazienti adulti con glomerulopatia da C3 (C3G) in associazione con un inibito… | innovative · reimbursed class H | source |
| DMC (Denmark) | 17 Dec 2025 | Behandling af voksne patienter med paroksystisk nokturn hæmoglobinuri (PNH), som har hæmolytisk anæmi | Direkte indplacering | source |
19 further decisions for iptacopan, across 11 agencies, are not shown here. They include the most recent record on file, 4 Jun 2026 from G-BA (Germany); its outcome is in the subscriber dataset. They link to 17 further source documents.
Related molecules
- 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
- infliximab — same ATC class L04A — Immunosuppressants
Coverage: 24 decisions for iptacopan from 12 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.