Pegcetacoplan: 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), CHUIKYO (Japan) and G-BA (Germany), among others, recommended or restricted pegcetacoplan, while AOTMIT (Poland), CONITEC (Brazil) and NYE METODER (Norway), among others, did not recommend it.
On the same population the two systems disagree outright: NICE (England) recorded restricted in TA778, while PBAC (Australia) recorded not recommended for “Paroxysmal nocturnal haemoglobinuria”.
The record spans 4.6 years, opening at AWMSG (Wales) on 9 Dec 2021 and running to 2026.
HAS (France) changed its position: not recommended on 16 Feb 2022, recommended by 28 May 2025, after a resubmission.
No assessment is on file from PHARMAC (New Zealand), which is among the eight highest-volume agencies here.
Not every gap is a refusal: for pegcetacoplan, 1 submission was never made — an outcome set by the company rather than the assessor.
The file is active: 21 of 33 records date from 2023 or later.
The programme is broad: 8 distinct indication wordings are recorded for pegcetacoplan by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
7 of these 33 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 pegcetacoplan, on 9 Dec 2021; CONITEC (Brazil) did not open a file until 3 Feb 2025 — a wide spread of 3.2 years between the earliest and latest system to look at it.
The record arrives in waves: 5 separate years each carry two or more decisions, spread across 6 years in total.
8 of the 16 agencies here assessed pegcetacoplan more than once, PBAC (Australia) most often at 7 entries — repeat review is the norm for this molecule rather than the exception.
pegcetacoplan has been through 16 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for pegcetacoplan reads 12 recommended, 12 not recommended, 5 restricted and 1 non-submission, with 3 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| PBAC (Australia) | 2026 | Complement 3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) | Not Recommended | source |
| CIPM (Spain) | 25 Mar 2026 | Indicaciones terapéuticas autorizadas: ASPAVELI está indicado en monoterapia en el tratamiento de pacientes adultos con … | financed by the SNS · art. 92 a, c | source |
| HAS (France) | 28 May 2025 | Re-assessment of SMR and ASMR | SMR substantial · ASMR III | source |
| CONITEC (Brazil) | 20 Feb 2025 | Tratamento de pacientes adultos com hemoglobinúria paroxística noturna previamente tratados com inibidores do complement… | not incorporated | source |
| G-BA (Germany) | 22 Nov 2024 | Aspaveli — benefit assessment §35a | added benefit: non-quantifiable (hint) | source |
28 further decisions for pegcetacoplan, across 16 agencies, are not shown here. They include the most recent record on file, 2026 from PBAC (Australia); its outcome is in the subscriber dataset. They link to 19 further source documents.
Related molecules
- eculizumab — divergent outcome (recommended vs not recommended) on a shared indication
- ravulizumab — divergent outcome (recommended vs not recommended) on a shared indication
- ciclosporin — same ATC class S01X — Ophthalmologicals
- mercaptamine — same ATC class S01X — Ophthalmologicals
- voretigene neparvovec — same ATC class S01X — Ophthalmologicals
- ocriplasmin — same ATC class S01X — Ophthalmologicals
Coverage: 33 decisions for pegcetacoplan from 16 agencies, 2021 to 2026. Data to 7 Sep 2026. ATC class S01X — Ophthalmologicals. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.