Phenylbutyrate: 4 agencies, 2004–2025
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
No agency in this archive has refused phenylbutyrate: all 6 decisive outcomes across 3 agencies were positive or positive with restrictions.
The file has been open for more than a decade: 21.2 years separate the first record, 25 May 2004 at AWMSG (Wales), from the most recent, 15 Jul 2025 at TLV (Sweden).
No assessment is on file from HAS (France), PBAC (Australia), CIPM (Spain) and G-BA (Germany), each among the eight highest-volume agencies here.
Against its own class, phenylbutyrate is an outlier: 100% of its decisive outcomes were positive, where molecules sharing ATC class A16A average 72%.
3 distinct indication wordings are recorded for phenylbutyrate by the agencies that label one in English (AWMSG and SMC).
AWMSG (Wales) was first to assess phenylbutyrate, on 25 May 2004; PHARMAC (New Zealand) did not open a file until 10 Jun 2016 — an unusually long tail of 12.1 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 3 of 7 dated records fall in 2013 alone.
2 of the 4 agencies here assessed phenylbutyrate more than once, TLV (Sweden) most often at 3 entries — repeat review is the norm for this molecule rather than the exception.
Coverage is narrow: only 4 of the 18 agencies here have assessed phenylbutyrate.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| TLV (Sweden) | 15 Jul 2025 | Ny beredningsform av Pheburane ingår i högkostnadsskyddet | general subsidy | source |
| PHARMAC (New Zealand) | 10 Jun 2016 | Urea cycle disorders | funding application decided · decision reached | source |
| TLV (Sweden) | 27 Dec 2013 | Pheburane ingår i högkostnadsskyddet | general subsidy | source |
| AWMSG (Wales) | 13 Dec 2013 | Adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthe… | recommended (limited) | source |
| SMC (Scotland) | 11 Nov 2013 | Adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccin… | accepted | source |
2 further decisions for phenylbutyrate, across 2 agencies, are not shown here. They link to 2 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: 7 decisions for phenylbutyrate from 4 agencies, 2004 to 2025. 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.