Cerliponase Alfa: 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), AOTMIT (Poland) and G-BA (Germany), among others, recommended or restricted cerliponase alfa, while NYE METODER (Norway) and PBAC (Australia) did not recommend it.
Assessment has run over 8.9 years, from 13 Jul 2017 at AWMSG (Wales) to 30 Jun 2026 at AOTMIT (Poland).
CIPM (Spain) changed its position: not recommended on 4 Apr 2022, recommended by 18 Dec 2024, after a resubmission.
No assessment is on file from PHARMAC (New Zealand) and TLV (Sweden), each among the eight highest-volume agencies here.
The file is active: 4 of 15 records date from 2023 or later.
1 of these 15 records carries a year of decision but no day, so any interval quoted here is approximate to within a year.
AWMSG (Wales) was first to assess cerliponase alfa, on 13 Jul 2017; G-BA (Germany) did not open a file until 15 Dec 2022 — a wide spread of 5.4 years between the earliest and latest system to look at it.
The record arrives in waves: 4 separate years each carry two or more decisions, spread across 8 years in total.
4 of the 9 agencies here assessed cerliponase alfa more than once, CIPM (Spain) most often at 4 entries — repeat review is the norm for this molecule rather than the exception.
9 of the 18 agencies in this archive hold a record for cerliponase alfa.
The full ledger for cerliponase alfa reads 6 recommended, 5 not recommended, 2 restricted and 1 other, with 1 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| CIPM (Spain) | 18 Dec 2024 | Indicación terapéutica autorizada: Brineura está indicado para el tratamiento de la enfermedad lipofuscinosis neuronal c… | financed by the SNS, on appeal · art. 92 d | source |
| HAS (France) | 27 Nov 2024 | Re-assessment following post-listing study results | SMR substantial · ASMR III | source |
| G-BA (Germany) | 15 Dec 2022 | Brineura — benefit assessment §35a | added benefit: major (hint) | source |
| NYE METODER (Norway) | 24 Oct 2021 | Behandling av nevronal ceroid lipofuscinose type 2-sykdom, også kjent som tripeptidyl-peptidase 1-mangel. | not introduced | source |
| SMC (Scotland) | 12 Oct 2020 | For the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency. | unknown | source |
10 further decisions for cerliponase alfa, across 6 agencies, are not shown here. They include the most recent record on file, 30 Jun 2026 from AOTMIT (Poland); its outcome is in the subscriber dataset. They link to 8 further source documents.
Related molecules
- teduglutide — same ATC class A16A — Other alimentary tract and metabolism
- sapropterin — same ATC class A16A — Other alimentary tract and metabolism
- miglustat — same ATC class A16A — Other alimentary tract and metabolism
- migalastat — same ATC class A16A — Other alimentary tract and metabolism
- givosiran — same ATC class A16A — Other alimentary tract and metabolism
- velmanase alfa — same ATC class A16A — Other alimentary tract and metabolism
Coverage: 15 decisions for cerliponase alfa from 9 agencies, 2017 to 2026. Data to 7 Sep 2026. ATC class A16A — Other alimentary tract and metabolism. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.