Midostaurin: 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), DMC (Denmark) and HAS (France), among others, recommended or restricted midostaurin, while AWMSG (Wales) did not recommend it.
On the same population the two systems disagree outright: NICE (England) recorded restricted in TA523, while PBAC (Australia) recorded not recommended for “Acute myeloid leukaemia”.
Assessment has run over 8 years, from 2017 at PBAC (Australia) to 2025 at PBAC (Australia).
PBAC (Australia) changed its position: not recommended in 2017, recommended by 2025, after a resubmission.
No assessment is on file from CIPM (Spain), which is among the eight highest-volume agencies here.
Not every gap is a refusal: for midostaurin, 1 submission was never made — an outcome set by the company rather than the assessor.
The file is active: 3 of 22 records date from 2023 or later.
7 distinct indication wordings are recorded for midostaurin by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
4 of these 22 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 midostaurin, in 2017; G-BA (Germany) did not open a file until 2 May 2024 — a wide spread of 6.8 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 12 of 22 dated records fall in 2018 alone.
6 of the 11 agencies here assessed midostaurin more than once, PBAC (Australia) most often at 4 entries — repeat review is the norm for this molecule rather than the exception.
11 of the 18 agencies in this archive hold a record for midostaurin.
The full ledger for midostaurin reads 12 recommended, 3 no benefit, 3 not recommended and 2 restricted, with 2 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| PBAC (Australia) | 2025 | Advanced systemic mastocytosis | Recommended | source |
| G-BA (Germany) | 2 May 2024 | Rydapt — benefit assessment §35a | added benefit: not proven | source |
| NICE (England) | 22 Sep 2021 | NICE TA728 | recommended (optimised) | source |
| HAS (France) | 17 Feb 2021 | Re-assessment following post-listing study results | SMR low · ASMR V | source |
| PHARMAC (New Zealand) | 29 Sep 2020 | Acute myeloid leukaemia (AML), FLT3-mutation positive | PTAC advice: High · decision reached | source |
17 further decisions for midostaurin, across 10 agencies, are not shown here. They link to 10 further source documents.
Related molecules
- gemtuzumab ozogamicin — divergent outcome (recommended vs not recommended) on a shared indication
- 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
Coverage: 22 decisions for midostaurin from 11 agencies, 2017 to 2025. Data to 7 Sep 2026. ATC class L01X — Antineoplastics. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.