Sebelipase 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
G-BA (Germany) and HAS (France) recommended or restricted sebelipase alfa, while AOTMIT (Poland) and PBAC (Australia) did not recommend it.
Assessment has run over 9.1 years, from 30 Jun 2015 at ZIN (Netherlands) to 10 Jul 2024 at AOTMIT (Poland).
No assessment is on file from PHARMAC (New Zealand), TLV (Sweden) and CIPM (Spain), each among the eight highest-volume agencies here.
Not every gap is a refusal: for sebelipase alfa, 1 submission was never made and 1 was withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
Against its own class, sebelipase alfa is an outlier: 40% of its decisive outcomes were positive, where molecules sharing ATC class A16A average 72%.
3 distinct indication wordings are recorded for sebelipase alfa by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
1 of these 9 records carries a year of decision but no day, so any interval quoted here is approximate to within a year.
ZIN (Netherlands) was first to assess sebelipase alfa, on 30 Jun 2015; NICE (England) did not open a file until 28 Mar 2024 — an unusually long tail of 8.8 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 4 of 9 dated records fall in 2021 alone.
AOTMIT (Poland) is the only agency to have returned to sebelipase alfa, recording 2 separate entries.
8 of the 18 agencies in this archive hold a record for sebelipase alfa.
The full ledger for sebelipase alfa reads 3 not recommended, 1 terminated, 1 deferred to NICE and 1 non-submission, with 3 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| AOTMIT (Poland) | 10 Jul 2024 | programu lekowego „Leczenie chorych z niedoborem lizosomalnej kwaśnej lipazy (ICD-10 E75.5 E75.6) | not recommended | source |
| NICE (England) | 28 Mar 2024 | NICE TA961 | terminated appraisal | source |
| PBAC (Australia) | 2022 | Infantile onset lysosomal acid lipase deficiency | Not Recommended | source |
| AWMSG (Wales) | 17 Dec 2021 | For long-term enzyme replacement therapy in patients of all ages with lysosomal acid lipase deficiency | excluded, NICE appraised | source |
| SMC (Scotland) | 8 Nov 2021 | Long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency. | not recommended | source |
4 further decisions for sebelipase alfa, across 4 agencies, are not shown here. They link to 4 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
- cerliponase alfa — same ATC class A16A — Other alimentary tract and metabolism
- givosiran — same ATC class A16A — Other alimentary tract and metabolism
Coverage: 9 decisions for sebelipase alfa from 8 agencies, 2015 to 2024. 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.