Eculizumab: 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) recommended or restricted eculizumab, while DMC (Denmark) did not recommend it.
On the same population the two systems disagree outright: AWMSG (Wales) recorded recommended for “Treatment of patients with atypical haemolytic uraemic syndrome (aHUS)”, while PBAC (Australia) recorded not recommended for “atypical Haemolytic Uraemic Syndrome (aHUS) following kidney transplantation”.
PBAC (Australia) has been harder on eculizumab than on its own caseload: it refused 4 of 5 decisive submissions here (80%), against a base rate of 24% across everything it has assessed.
The file has been open for more than a decade: 18.2 years separate the first record, 24 Oct 2007 at HAS (France), from the most recent, 16 Dec 2025 at PHARMAC (New Zealand).
PHARMAC (New Zealand) changed its position: not recommended on 18 Mar 2013, recommended by 16 Dec 2025, after a resubmission.
No assessment is on file from TLV (Sweden) and G-BA (Germany), each among the eight highest-volume agencies here.
Not every gap is a refusal: for eculizumab, 2 submissions were never made and 2 were withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
The file is active: 10 of 39 records date from 2023 or later.
Against its own class, eculizumab is an outlier: 50% of its decisive outcomes were positive, where molecules sharing ATC class L04A average 78%.
The programme is broad: 10 distinct indication wordings are recorded for eculizumab by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
5 of these 39 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 eculizumab, on 24 Oct 2007; AIFA (Italy) did not open a file until 8 Sep 2022 — an unusually long tail of 14.9 years between the earliest and latest system to look at it.
The record arrives in waves: 9 separate years each carry two or more decisions, spread across 15 years in total.
10 of the 11 agencies here assessed eculizumab more than once, ZIN (Netherlands) most often at 8 entries — repeat review is the norm for this molecule rather than the exception.
11 of the 18 agencies in this archive hold a record for eculizumab.
The full ledger for eculizumab reads 15 not recommended, 12 recommended, 5 advice and 3 restricted, with 4 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| CIPM (Spain) | 22 May 2024 | Indicaciones terapéuticas autorizadas: Epysqli® está indicado en adultos y niños para el tratamiento de: - Hemoglobinuri… | financed by the SNS · art. 92 a, d, e | source |
| HAS (France) | 24 Apr 2024 | Indication extension | SMR insufficient | source |
| ZIN (Netherlands) | 17 Jul 2023 | Weesgeneesmiddelenarrangement eculizumab (Soliris®) en ravulizumab (Ultomiris®) bij de indicatie PNH | advice published | source |
| PHARMAC (New Zealand) | 17 Mar 2023 | atypical Haemolytic Uraemic Syndrome (aHUS) | PTAC advice: Low | source |
| AIFA (Italy) | 8 Sep 2022 | SOLIRIS è indicato nel trattamento di adulti affetti da Miastenia gravis generalizzata refrattaria (MGg) in pazienti pos… | innovative, since expired | source |
34 further decisions for eculizumab, across 11 agencies, are not shown here. They include the most recent record on file, 16 Dec 2025 from PHARMAC (New Zealand); its outcome is in the subscriber dataset. They link to 23 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: 39 decisions for eculizumab from 11 agencies, 2007 to 2025. Data to 7 Sep 2026. ATC class L04A — Immunosuppressants. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.