Isatuximab: 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 NICE (England), among others, recommended or restricted isatuximab, while AOTMIT (Poland) did not recommend it.
Assessment has run over 6.4 years, from 29 Apr 2020 at AWMSG (Wales) to 24 Sep 2026 at NICE (England).
DMC (Denmark) changed its position: not recommended on 18 Nov 2020, recommended by 2 Jul 2026, after a resubmission.
No assessment is on file from PBAC (Australia), PHARMAC (New Zealand) and TLV (Sweden), each among the eight highest-volume agencies here.
Not every gap is a refusal: for isatuximab, 2 submissions were never made and 1 was withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
The file is active: 19 of 38 records date from 2023 or later.
The programme is broad: 9 distinct indication wordings are recorded for isatuximab by the agencies that label one in English (AWMSG, NICE and SMC).
AWMSG (Wales) was first to assess isatuximab, on 29 Apr 2020; CHUIKYO (Japan) did not open a file until 5 Aug 2026 — a wide spread of 6.3 years between the earliest and latest system to look at it.
The record arrives in waves: 5 separate years each carry two or more decisions, spread across 6 years in total.
11 of the 12 agencies here assessed isatuximab more than once, NICE (England) most often at 4 entries — repeat review is the norm for this molecule rather than the exception.
isatuximab has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for isatuximab reads 17 recommended, 6 not recommended, 4 no benefit and 3 deferred to NICE, with 8 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| NYE METODER (Norway) | 23 Aug 2026 | Til bruk for innførte indikasjoner for den intravenøse formuleringen | introduced | source |
| CHUIKYO (Japan) | 5 Aug 2026 | サークリサ: cost-effectiveness evaluation (new product, high price or high sales) | evaluation under way | source |
| HAS (France) | 1 Apr 2026 | Indication extension | SMR substantial · ASMR IV | source |
| DMC (Denmark) | 20 Apr 2022 | 2. linjebehandling af knoglemarvskræft | Ikke anbefalet | source |
| ZIN (Netherlands) | 25 May 2021 | Pakketadvies sluisgeneesmiddel isatuximab (Sarclisa®) | reimbursed with conditions (sluis) | source |
33 further decisions for isatuximab, across 11 agencies, are not shown here. They include the most recent record on file, 24 Sep 2026 from NICE (England); its outcome is in the subscriber dataset. They link to 30 further source documents.
Related molecules
- atezolizumab — same ATC class L01X — Antineoplastics
- olaparib — same ATC class L01X — Antineoplastics
- durvalumab — same ATC class L01X — Antineoplastics
- aflibercept — same ATC class L01X — Antineoplastics
- osimertinib — same ATC class L01X — Antineoplastics
- venetoclax — same ATC class L01X — Antineoplastics
Coverage: 38 decisions for isatuximab from 12 agencies, 2020 to 2026. Data to 7 Sep 2026. ATC class L01X — Antineoplastics. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.