Berotralstat: 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
CIPM (Spain), DMC (Denmark) and HAS (France), among others, recommended or restricted berotralstat, while AOTMIT (Poland) did not recommend it.
Where berotralstat met resistance it was usually narrowed rather than refused: 4 of 9 decisive outcomes were recommendations with restrictions, against 1 outright refusal.
The record spans 4.4 years, opening at AWMSG (Wales) on 17 Mar 2021 and running to 21 Aug 2025.
No assessment is on file from PBAC (Australia) and PHARMAC (New Zealand), each among the eight highest-volume agencies here.
The file is active: 3 of 11 records date from 2023 or later.
AWMSG (Wales) was first to assess berotralstat, on 17 Mar 2021; AOTMIT (Poland) did not open a file until 21 Aug 2025 — a wide spread of 4.4 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 6 of 11 dated records fall in 2021 alone.
Restriction is doing real work here: 4 of 9 decisive outcomes narrowed berotralstat to a subgroup rather than accepting or refusing it outright, at NICE (England), NYE METODER (Norway) and SMC (Scotland) among others.
11 of the 18 agencies in this archive hold a record for berotralstat.
The full ledger for berotralstat reads 4 recommended, 4 restricted, 1 not recommended and 1 no benefit, with 1 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| AOTMIT (Poland) | 21 Aug 2025 | Orladeyo reimbursement recommendation | not recommended | source |
| ZIN (Netherlands) | 24 Mar 2025 | Advies - vergoed berotralstat (Orladeyo®) voor het voorkomen van terugkerende aanvallen van hereditair angio-oedeem (HAE… | reimbursed | source |
| CIPM (Spain) | 20 Sep 2023 | Indicacio nes terapéutica s autorizada s: Orladeyo está indicado para la prevención rutinaria de las crisis recurrentes … | financed by the SNS · art. 92 a, c | source |
| DMC (Denmark) | 23 Mar 2022 | Forebyggende behandling af arveligt angioødem | Anbefalet | source |
| SMC (Scotland) | 7 Mar 2022 | Routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. | accepted (restricted) | source |
6 further decisions for berotralstat, across 6 agencies, are not shown here. They link to 6 further source documents.
Related molecules
- lanadelumab — same ATC class B06A — Other hematological agents
- exagamglogene autotemcel — same ATC class B06A — Other hematological agents
- icatibant — same ATC class B06A — Other hematological agents
- garadacimab — same ATC class B06A — Other hematological agents
- conestat alfa — same ATC class B06A — Other hematological agents
- donidalorsen — same ATC class B06A — Other hematological agents
Coverage: 11 decisions for berotralstat from 11 agencies, 2021 to 2025. Data to 7 Sep 2026. ATC class B06A — Other hematological agents. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.