Belimumab: 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), HIRA (South Korea) and NICE (England), among others, recommended or restricted belimumab, while CIPM (Spain), CONITEC (Brazil) and PBAC (Australia) did not recommend it.
The file has been open for more than a decade: 14.8 years separate the first record, 16 Jun 2011 at AWMSG (Wales), from the most recent, 15 Mar 2026 at NYE METODER (Norway).
G-BA (Germany) changed its position: recommended on 2 Aug 2012, restricted by 14 May 2020.
Every one of the eight highest-volume agencies in this archive has a record for belimumab.
Not every gap is a refusal: for belimumab, 1 submission was never made and 1 was withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.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: 6 of 28 records date from 2023 or later.
The programme is broad: 11 distinct indication wordings are recorded for belimumab by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
2 of these 28 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 belimumab, on 16 Jun 2011; HIRA (South Korea) did not open a file until 6 Mar 2025 — an unusually long tail of 13.8 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 13 years in total.
8 of the 12 agencies here assessed belimumab more than once, HAS (France) most often at 7 entries — repeat review is the norm for this molecule rather than the exception.
belimumab has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for belimumab reads 13 recommended, 5 not recommended, 3 restricted and 2 deferred to NICE, with 5 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| HAS (France) | 14 Jan 2026 | Indication extension | SMR substantial · ASMR IV | source |
| HIRA (South Korea) | 6 Mar 2025 | 스미스 클라인 성인 활동성 전신홍반루푸스 | extension of coverage appropriate (risk-share extension) | source |
| PHARMAC (New Zealand) | 17 Nov 2023 | Lupus nephritis in adult patients as an add-on therapy to standard of care | PTAC advice: High | source |
| CONITEC (Brazil) | 30 Jun 2023 | Tratamento adjuvante de pacientes com 18 anos ou mais, com LES e que apresentem alto grau de atividade da doença apesar … | not incorporated | source |
| SMC (Scotland) | 7 Nov 2022 | As add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDN… | accepted (restricted) | source |
23 further decisions for belimumab, across 10 agencies, are not shown here. They include the most recent record on file, 15 Mar 2026 from NYE METODER (Norway); its outcome is in the subscriber dataset. They link to 16 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: 28 decisions for belimumab from 12 agencies, 2011 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.