Asfotase 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), HAS (France) and HIRA (South Korea), among others, recommended or restricted asfotase alfa, while AOTMIT (Poland), CIPM (Spain) and NYE METODER (Norway) did not recommend it.
Assessment has run over 9.9 years, from 16 Mar 2016 at HAS (France) to 23 Feb 2026 at TLV (Sweden).
No assessment is on file from PBAC (Australia) and PHARMAC (New Zealand), each among the eight highest-volume agencies here.
Not every gap is a refusal: for asfotase alfa, 1 submission was never made — an outcome set by the company rather than the assessor.
The file is active: 5 of 12 records date from 2023 or later.
HAS (France) was first to assess asfotase alfa, on 16 Mar 2016; TLV (Sweden) did not open a file until 23 Feb 2026 — an unusually long tail of 9.9 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.
Restriction is doing real work here: 3 of 10 decisive outcomes narrowed asfotase alfa to a subgroup rather than accepting or refusing it outright, at G-BA (Germany), TLV (Sweden) and ZIN (Netherlands).
2 of the 10 agencies here assessed asfotase alfa more than once, CIPM (Spain) most often at 2 entries — repeat review is the norm for this molecule rather than the exception.
10 of the 18 agencies in this archive hold a record for asfotase alfa.
The full ledger for asfotase alfa reads 4 not recommended, 3 restricted, 3 recommended and 1 non-submission, with 1 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| CIPM (Spain) | 22 May 2024 | Indicaciones terapéuticas autorizadas: STRENSIQ está indicado como tratamiento prolongado de sustitución enzimática en p… | not financed by the SNS · art. 92 d | source |
| AOTMIT (Poland) | 11 Sep 2023 | Strensiq reimbursement recommendation | not recommended | source |
| HAS (France) | 5 Jul 2023 | Re-assessment following post-listing study results | SMR substantial | source |
| SMC (Scotland) | 8 Nov 2021 | Long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease. | not recommended | source |
| NYE METODER (Norway) | 26 Sep 2021 | Langtids enzymerstatningsbehandling hos pasienter i alle aldre med hypofosfatasi med pediatrisk symptomdebut for å behan… | not introduced | source |
7 further decisions for asfotase alfa, across 7 agencies, are not shown here. They include the most recent record on file, 23 Feb 2026 from TLV (Sweden); its outcome is in the subscriber dataset. They link to 6 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: 12 decisions for asfotase alfa from 10 agencies, 2016 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.