Daratumumab: 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
AIFA (Italy), G-BA (Germany) and HAS (France), among others, recommended or restricted daratumumab, while AWMSG (Wales) and TLV (Sweden) did not recommend it.
DMC (Denmark) has been harder on daratumumab than on its own caseload: it refused 4 of 5 decisive submissions here (80%), against a base rate of 27% across everything it has assessed.
Assessment has run over 10 years, from 30 Sep 2016 at AWMSG (Wales) to 30 Sep 2026 at NICE (England).
ZIN (Netherlands) changed its position: not recommended on 28 Nov 2017, restricted by 5 Aug 2026, after a resubmission.
Every one of the eight highest-volume agencies in this archive has a record for daratumumab.
Not every gap is a refusal: for daratumumab, 2 submissions were never made and 4 were withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
The file is active: 46 of 115 records date from 2023 or later.
The programme is broad: 27 distinct indication wordings are recorded for daratumumab by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
10 of these 115 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 daratumumab, on 30 Sep 2016; HIRA (South Korea) did not open a file until 10 Oct 2024 — an unusually long tail of 8.1 years between the earliest and latest system to look at it.
The record arrives in waves: 10 separate years each carry two or more decisions, spread across 11 years in total.
14 of the 15 agencies here assessed daratumumab more than once, HAS (France) most often at 13 entries — repeat review is the norm for this molecule rather than the exception.
daratumumab has been through 15 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for daratumumab reads 50 recommended, 23 not recommended, 14 restricted and 6 other, with 22 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| AWMSG (Wales) | 3 Sep 2026 | in combination with bortezomib, lenalidomide and dexamethasone for untreated multiple myeloma when an autologous stem ce… | excluded, NICE appraised | source |
| ZIN (Netherlands) | 5 Aug 2026 | Advies - alleen vergoeden na prijsdaling daratumumab (Darzalex®) voor de behandeling van een vorm van amyloïdose (herbeo… | reimburse only after price negotiation (sluis) | source |
| PBAC (Australia) | 2026 | Newly diagnosed systemic light chain amyloidosis | Untreated multiple myeloma | Relapsed and/or refractory multiple myeloma | Not applicable | source |
| NICE (England) | 24 Jun 2026 | NICE TA1170 | published appraisal | source |
| DMC (Denmark) | 29 Apr 2026 | Nydiagnosticerede voksne patienter med knoglemarvskræft, som ikke er egnede til HDT | Direkte indplacering, ikke anbefalet | source |
110 further decisions for daratumumab, across 15 agencies, are not shown here. They include the most recent record on file, 30 Sep 2026 from NICE (England); its outcome is in the subscriber dataset. They link to 87 further source documents.
Related molecules
- pembrolizumab — same ATC class L01F — Antineoplastics
- nivolumab — same ATC class L01F — Antineoplastics
- rituximab — same ATC class L01F — Antineoplastics
- bevacizumab — same ATC class L01F — Antineoplastics
- blinatumomab — same ATC class L01F — Antineoplastics
- trastuzumab deruxtecan — same ATC class L01F — Antineoplastics
Coverage: 115 decisions for daratumumab from 15 agencies, 2016 to 2026. Data to 7 Sep 2026. ATC class L01F — Antineoplastics. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.