Pegvaliase: 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) and G-BA (Germany) recommended or restricted pegvaliase, while AWMSG (Wales), CIPM (Spain) and DMC (Denmark), among others, did not recommend it.
Assessment has run over 6.8 years, from 18 Sep 2019 at AWMSG (Wales) to 2026 at PBAC (Australia).
PBAC (Australia) changed its position: not recommended in 2022, recommended by 2026, after a resubmission.
No assessment is on file from HAS (France), SMC (Scotland), PHARMAC (New Zealand) and TLV (Sweden), each among the eight highest-volume agencies here.
Against its own class, pegvaliase is an outlier: 36% of its decisive outcomes were positive, where molecules sharing ATC class A16A average 72%.
3 distinct indication wordings are recorded for pegvaliase by the agencies that label one in English (AWMSG and PBAC).
3 of these 12 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 pegvaliase, on 18 Sep 2019; PBAC (Australia) did not open a file until 2022 — a moderate spread of 2.8 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 5 of 12 dated records fall in 2021 alone.
3 of the 7 agencies here assessed pegvaliase more than once, PBAC (Australia) most often at 3 entries — repeat review is the norm for this molecule rather than the exception.
7 of the 18 agencies in this archive hold a record for pegvaliase.
The full ledger for pegvaliase reads 7 not recommended, 2 recommended, 2 restricted and 1 deferred.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| PBAC (Australia) | 2026 | Phenylketonuria (PKU) | Deferred | source |
| CIPM (Spain) | 2 Jun 2022 | Indicaciones terapéuticas autorizadas: Palynziq está indicado para el tratamiento de pacientes de 16 años o más con feni… | not financed by the SNS · art. 92 c, d | source |
| NYE METODER (Norway) | 30 May 2021 | Til behandling av Føllings sykdom (fenylketonuri) | not introduced | source |
| DMC (Denmark) | 26 May 2021 | Phenylketonuri (PKU) | Ikke anbefalet | source |
| AIFA (Italy) | 9 Jan 2021 | PALYNZIQ e' indicato per il trattamento di pazienti affetti da fenilchetonuria (PKU), di eta' pari e superiore ai sedici… | innovative, since expired | source |
7 further decisions for pegvaliase, across 5 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 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: 12 decisions for pegvaliase from 7 agencies, 2019 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.