Apalutamide: 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
G-BA (Germany), HAS (France) and HIRA (South Korea), among others, recommended or restricted apalutamide, while AOTMIT (Poland) did not recommend it.
Assessment has run over 8 years, from 2018 at PBAC (Australia) to 2026 at PBAC (Australia).
PBAC (Australia) changed its position: not recommended in 2018, recommended by 2026, after a resubmission.
No assessment is on file from CIPM (Spain), which is among the eight highest-volume agencies here.
The file is active: 6 of 28 records date from 2023 or later.
The programme is broad: 9 distinct indication wordings are recorded for apalutamide by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
7 of these 28 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
PBAC (Australia) was first to assess apalutamide, in 2018; HIRA (South Korea) did not open a file until 8 Dec 2022 — a wide spread of 4.4 years between the earliest and latest system to look at it.
The record arrives in waves: 6 separate years each carry two or more decisions, spread across 9 years in total.
10 of the 12 agencies here assessed apalutamide more than once, PBAC (Australia) most often at 7 entries — repeat review is the norm for this molecule rather than the exception.
apalutamide has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for apalutamide reads 17 recommended, 4 not recommended, 3 restricted and 1 deferred to NICE, with 3 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| HIRA (South Korea) | 2 Oct 2025 | 고위험 비전이성 거세저항성 전립선암 (nmCRPC) 환자의 치료 | extension of coverage appropriate (risk-share extension) | source |
| PHARMAC (New Zealand) | 15 Aug 2024 | For the treatment of men with: metastatic hormone-sensitive prostate cancer (mHSPC) / metastatic castrate-sensitive pros… | PTAC advice: High | source |
| HAS (France) | 25 Oct 2023 | Listing (Transparency Committee) | SMR substantial · ASMR V | source |
| SMC (Scotland) | 10 Jul 2023 | In adult men for the treatment of non‑metastatic castration‑resistant prostate cancer (NM‑nmCRPC) who are at high risk of developing metastatic disease | accepted | source |
| PBAC (Australia) | 2021 | Prostate cancer | Not Recommended | source |
23 further decisions for apalutamide, across 12 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 16 further source documents.
Related molecules
- enzalutamide — same ATC class L02B — Endocrine therapy
- darolutamide — 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: 28 decisions for apalutamide from 12 agencies, 2018 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.