Bedaquiline: 6 agencies, 2015–2025
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 bedaquiline: all 12 decisive outcomes across 6 agencies were positive or positive with restrictions.
Assessment has run over 10.2 years, from 22 Jul 2015 at HAS (France) to 10 Sep 2025 at HAS (France).
G-BA (Germany) changed its position: restricted on 20 Aug 2020, recommended by 1 Feb 2024.
No assessment is on file from PBAC (Australia), SMC (Scotland) and TLV (Sweden), each among the eight highest-volume agencies here.
Not every gap is a refusal: for bedaquiline, 1 was withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
The file is active: 3 of 13 records date from 2023 or later.
HAS (France) was first to assess bedaquiline, on 22 Jul 2015; CIPM (Spain) did not open a file until 7 Jul 2022 — a wide spread of 7 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 5 of 11 dated records fall in 2020 alone.
4 of the 6 agencies here assessed bedaquiline more than once, HAS (France) most often at 3 entries — repeat review is the norm for this molecule rather than the exception.
6 of the 18 agencies in this archive hold a record for bedaquiline.
The full ledger for bedaquiline reads 10 recommended, 2 restricted and 1 withdrawn.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| HAS (France) | 10 Sep 2025 | Indication extension | SMR substantial · ASMR III | source |
| CIPM (Spain) | 18 Dec 2024 | Indicación terapéutica autorizada: SIRTURO está indicado para ser utilizado como parte de un adecuado tratamiento combin… | financed by the SNS · art. 92 a, c | source |
| G-BA (Germany) | 16 Sep 2021 | Sirturo — benefit assessment §35a | added benefit: non-quantifiable (hint) | source |
| CONITEC (Brazil) | 1 Sep 2020 | Pacientes com tuberculose resistente à rifampicina, multirresistente e extensivamente resistentes a medicamentos | incorporated into SUS | source |
| PHARMAC (New Zealand) | 20 May 2020 | Extensively drug-resistant tuberculosis (XDR-TB) | PTAC advice: High · decision reached | source |
8 further decisions for bedaquiline, across 5 agencies, are not shown here. They link to 4 further source documents.
Related molecules
- delamanid — same ATC class J04A — Antimycobacterials
- dydrogesterone — also decided by HAS in 2025Q3
- cefazolin — also decided by HAS in 2025Q3
- ciltacabtagene autoleucel — also decided by HAS in 2025Q3
- latanoprost — also decided by HAS in 2025Q3
- concizumab — also decided by HAS in 2025Q3
Coverage: 13 decisions for bedaquiline from 6 agencies, 2015 to 2025. Data to 7 Sep 2026. ATC class J04A — Antimycobacterials. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.