Gilteritinib: 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 G-BA (Germany), among others, recommended or restricted gilteritinib, while AOTMIT (Poland) and CIPM (Spain) did not recommend it.
Assessment has run over 5.1 years, from 10 Oct 2019 at AWMSG (Wales) to 17 Nov 2024 at NYE METODER (Norway).
PBAC (Australia) changed its position: not recommended in 2021, recommended by 2022, after a resubmission.
No assessment is on file from PHARMAC (New Zealand), which is among the eight highest-volume agencies here.
The file is active: 2 of 18 records date from 2023 or later.
4 distinct indication wordings are recorded for gilteritinib by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
2 of these 18 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 gilteritinib, on 10 Oct 2019; NYE METODER (Norway) did not open a file until 17 Nov 2024 — a wide spread of 5.1 years between the earliest and latest system to look at it.
The record arrives in waves: 3 separate years each carry two or more decisions, spread across 6 years in total.
3 of the 13 agencies here assessed gilteritinib more than once, CIPM (Spain) most often at 4 entries — repeat review is the norm for this molecule rather than the exception.
gilteritinib has been through 13 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for gilteritinib reads 7 recommended, 6 not recommended, 4 restricted and 1 deferred to NICE.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| NYE METODER (Norway) | 17 Nov 2024 | Behandling av voksne med residiverende eller refraktær akutt myelogen leukemi (AML) med FLT3-mutasjon | introduced | source |
| CIPM (Spain) | 2 Feb 2023 | SECRETARIA DE ESTADO DE SANIDAD 31 MINISTERIO DE SANIDAD MINISTERIO DE SANIDAD Indicación terapéutica autorizada : Xospa… | not financed by the SNS · art. 92 d | source |
| PBAC (Australia) | 2022 | Acute myeloid leukaemia | Recommended | source |
| DMC (Denmark) | 18 May 2022 | Akut myeloid leukæmi (AML) med FLT3m R/R | Delvist anbefalet | source |
| HIRA (South Korea) | 3 Sep 2021 | FLT3 변이 양성인 재발 또는 불응성 급성 골수성 백혈병 성인 환자의 치료 약제급여평가위원회 제시 조건 수용 시 | reimbursement appropriate | source |
13 further decisions for gilteritinib, across 10 agencies, are not shown here. They link to 11 further source documents.
Related molecules
- gemtuzumab ozogamicin — divergent outcome (recommended vs not recommended) on a shared indication
- ibrutinib — same ATC class L01E — Antineoplastics
- zanubrutinib — same ATC class L01E — Antineoplastics
- cabozantinib — same ATC class L01E — Antineoplastics
- selpercatinib — same ATC class L01E — Antineoplastics
- acalabrutinib — same ATC class L01E — Antineoplastics
Coverage: 18 decisions for gilteritinib from 13 agencies, 2019 to 2024. Data to 7 Sep 2026. ATC class L01E — Antineoplastics. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.