Darolutamide: 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
AOTMIT (Poland), CHUIKYO (Japan) and G-BA (Germany), among others, recommended or restricted darolutamide, while DMC (Denmark) did not recommend it.
Assessment has run over 6.4 years, from 13 Feb 2020 at AWMSG (Wales) to 17 Jul 2026 at ZIN (Netherlands).
CIPM (Spain) changed its position: not recommended on 20 Sep 2023, recommended by 19 Nov 2025, after a resubmission.
Every one of the eight highest-volume agencies in this archive has a record for darolutamide.
Not every gap is a refusal: for darolutamide, 1 submission was never made — an outcome set by the company rather than the assessor.
The file is active: 23 of 38 records date from 2023 or later.
The programme is broad: 9 distinct indication wordings are recorded for darolutamide by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
5 of these 38 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 darolutamide, on 13 Feb 2020; HIRA (South Korea) did not open a file until 5 Mar 2026 — a wide spread of 6.1 years between the earliest and latest system to look at it.
The record arrives in waves: 7 separate years each carry two or more decisions, spread across 7 years in total.
12 of the 15 agencies here assessed darolutamide more than once, PBAC (Australia) most often at 5 entries — repeat review is the norm for this molecule rather than the exception.
darolutamide has been through 15 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for darolutamide reads 16 recommended, 7 not recommended, 7 restricted and 2 deferred to NICE, with 6 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| HAS (France) | 10 Jun 2026 | Indication extension | SMR insufficient | source |
| SMC (Scotland) | 8 Jun 2026 | Treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy. | not recommended | source |
| AOTMIT (Poland) | 23 Apr 2026 | programu lekowego B.56 „Leczenie chorych na raka gruczołu krokowego (ICD-10: C61) | recommended | source |
| HIRA (South Korea) | 5 Mar 2026 | 1. 고위험 비전이성 거세저항성 전립선암 (nmCRPC) 환자의 치료 (2.3. 호르몬 반응성 전이성 전립선암 (mHSPC)) | reimbursable only at the evaluated price | source |
| G-BA (Germany) | 19 Feb 2026 | Nubeqa — benefit assessment §35a | added benefit: not proven | source |
33 further decisions for darolutamide, across 14 agencies, are not shown here. They include the most recent record on file, 17 Jul 2026 from ZIN (Netherlands); its outcome is in the subscriber dataset. They link to 27 further source documents.
Related molecules
- enzalutamide — same ATC class L02B — Endocrine therapy
- apalutamide — same ATC class L02B — Endocrine therapy
- abiraterone — same ATC class L02B — Endocrine therapy
- fulvestrant — same ATC class L02B — Endocrine therapy
- relugolix — same ATC class L02B — Endocrine therapy
- elacestrant — same ATC class L02B — Endocrine therapy
Coverage: 38 decisions for darolutamide from 15 agencies, 2020 to 2026. Data to 7 Sep 2026. ATC class L02B — Endocrine therapy. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.