Denosumab: 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

AWMSG (Wales), NICE (England) and NYE METODER (Norway), among others, recommended or restricted denosumab, while CONITEC (Brazil) did not recommend it.

Where denosumab met resistance it was usually narrowed rather than refused: 18 of 50 decisive outcomes were recommendations with restrictions, against 9 outright refusals.

The file has been open for more than a decade: 16.6 years separate the first record, 10 Feb 2010 at AWMSG (Wales), from the most recent, 20 Sep 2026 at NYE METODER (Norway).

HAS (France) changed its position: recommended on 11 Apr 2012, not recommended by 15 May 2024.

No assessment is on file from G-BA (Germany), which is among the eight highest-volume agencies here.

Not every gap is a refusal: for denosumab, 6 submissions were never made and 2 were withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.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: 26 of 67 records date from 2023 or later.

The programme is broad: 19 distinct indication wordings are recorded for denosumab by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).

10 of these 67 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 denosumab, on 10 Feb 2010; CIPM (Spain) did not open a file until 18 Dec 2024 — an unusually long tail of 14.8 years between the earliest and latest system to look at it.

The record arrives in waves: 13 separate years each carry two or more decisions, spread across 14 years in total.

Restriction is doing real work here: 18 of 50 decisive outcomes narrowed denosumab to a subgroup rather than accepting or refusing it outright, at AOTMIT (Poland), NICE (England) and PHARMAC (New Zealand) among others.

11 of the 11 agencies here assessed denosumab more than once, TLV (Sweden) most often at 20 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 denosumab.

The full ledger for denosumab reads 23 recommended, 18 restricted, 9 not recommended and 6 non-submission, with 11 in other categories.

Decisions on file

AgencyDateIndication as recorded OutcomeSource
AOTMIT (Poland)3 Jul 2026Izamby reimbursement recommendationnot recommendedsource
AWMSG (Wales)10 Jun 2026Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to b…outside AWMSG criteriasource
TLV (Sweden)28 Apr 2026Evfraxy ingår i högkostnadsskyddet med begränsningrestricted subsidysource
CIPM (Spain)18 Dec 2024SECRETARIA DE ESTADO DE SANIDAD 8 MINISTERIO DE SANIDAD MINISTERIO DE SANIDAD Indicaciones terapéuticas autorizadas: Tra…financed by the SNS · art. 92 a, d, esource
PBAC (Australia)2021Bisphosphonate-refractory hypercalcaemia of malignancy (HCM)Recommendation was rescinded by the PBAC with the support from the sponsor.source

62 further decisions for denosumab, across 11 agencies, are not shown here. They include the most recent record on file, 20 Sep 2026 from NYE METODER (Norway); its outcome is in the subscriber dataset. They link to 48 further source documents.

Related molecules

Coverage: 67 decisions for denosumab from 11 agencies, 2010 to 2026. Data to 7 Sep 2026. ATC class M05B — Bone diseases. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.

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