Canakinumab: 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), HAS (France) and HIRA (South Korea), among others, recommended or restricted canakinumab, while AOTMIT (Poland), AWMSG (Wales) and CONITEC (Brazil), among others, did not recommend it.
On the same population the two systems disagree outright: PBAC (Australia) recorded recommended for “Cryopyrin associated periodic syndromes (CAPS)”, while AWMSG (Wales) recorded not recommended for “Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in children aged 2 to < 4 years”.
The file has been open for more than a decade: 16.5 years separate the first record, 25 Jan 2010 at AWMSG (Wales), from the most recent, 2026 at PBAC (Australia).
AIFA (Italy) changed its position: recommended on 25 Sep 2018, restricted by 25 Sep 2018.
No assessment is on file from PHARMAC (New Zealand), TLV (Sweden), CIPM (Spain) and G-BA (Germany), each among the eight highest-volume agencies here.
Not every gap is a refusal: for canakinumab, 5 submissions were never made and 2 were withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
The file is active: 8 of 31 records date from 2023 or later.
Against its own class, canakinumab is an outlier: 57% of its decisive outcomes were positive, where molecules sharing ATC class L04A average 78%.
The programme is broad: 12 distinct indication wordings are recorded for canakinumab by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
4 of these 31 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 canakinumab, on 25 Jan 2010; HIRA (South Korea) did not open a file until 1 Feb 2024 — an unusually long tail of 14.1 years between the earliest and latest system to look at it.
The record arrives in waves: 7 separate years each carry two or more decisions, spread across 12 years in total.
9 of the 10 agencies here assessed canakinumab more than once, HAS (France) most often at 5 entries — repeat review is the norm for this molecule rather than the exception.
10 of the 18 agencies in this archive hold a record for canakinumab.
The full ledger for canakinumab reads 11 recommended, 9 not recommended, 5 non-submission and 2 other, with 4 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| HAS (France) | 1 Apr 2026 | Re-assessment following post-listing study results | SMR substantial · ASMR IV | source |
| NYE METODER (Norway) | 27 Apr 2025 | Behandling av Stills sykdom og systemisk juvenil idiopatisk artritt (sJIA) etter behandlingssvikt eller intoleranse for … | decision recorded | source |
| AOTMIT (Poland) | 23 Jun 2024 | programu lekowego „Leczenie chorych z aktywną postacią reumatoidalnego zapalenia stawów i młodzieńczego idiopatycznego z… | not recommended | source |
| HIRA (South Korea) | 4 Apr 2024 | 1. 크리오피린 관련 주기적 증후군 (CAPS) 2. 종양괴사인자 수용체 관련 주기적 증후군 (TRAPS) 3. 고면역글로불린 D 증후군 / 메발론산 키나아제 결핍증 (HIDS/MKD) 4. 가족성 지중해 열 (FM… | reimbursement appropriate | source |
| CONITEC (Brazil) | 13 Nov 2021 | Tratamento da Artrite Idiopática Juvenil Sistêmica | not incorporated | source |
26 further decisions for canakinumab, across 10 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 19 further source documents.
Related molecules
- adalimumab — same ATC class L04A — Immunosuppressants
- upadacitinib — same ATC class L04A — Immunosuppressants
- secukinumab — same ATC class L04A — Immunosuppressants
- tocilizumab — same ATC class L04A — Immunosuppressants
- ustekinumab — same ATC class L04A — Immunosuppressants
- infliximab — same ATC class L04A — Immunosuppressants
Coverage: 31 decisions for canakinumab from 10 agencies, 2010 to 2026. Data to 7 Sep 2026. ATC class L04A — Immunosuppressants. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.