Idebenone: 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

NICE (England), SMC (Scotland) and TLV (Sweden), among others, recommended or restricted idebenone, while AOTMIT (Poland), CIPM (Spain) and DMC (Denmark) did not recommend it.

AOTMIT (Poland) has been harder on idebenone than on its own caseload: it refused 5 of 5 decisive submissions here (100%), against a base rate of 41% across everything it has assessed.

Assessment has run over 9.4 years, from 16 Mar 2016 at HAS (France) to 28 Aug 2025 at NICE (England).

HAS (France) changed its position: not recommended on 16 Mar 2016, recommended by 19 Jan 2022, after a resubmission.

No assessment is on file from PBAC (Australia), PHARMAC (New Zealand) and G-BA (Germany), each among the eight highest-volume agencies here.

The file is active: 4 of 16 records date from 2023 or later.

Against its own class, idebenone is an outlier: 33% of its decisive outcomes were positive, where molecules sharing ATC class N06B average 65%.

HAS (France) was first to assess idebenone, on 16 Mar 2016; NICE (England) did not open a file until 28 Aug 2025 — an unusually long tail of 9.4 years between the earliest and latest system to look at it.

The record arrives in waves: 5 separate years each carry two or more decisions, spread across 7 years in total.

Restriction is doing real work here: 4 of 15 decisive outcomes narrowed idebenone to a subgroup rather than accepting or refusing it outright, at NICE (England), SMC (Scotland) and TLV (Sweden) among others.

3 of the 9 agencies here assessed idebenone more than once, AOTMIT (Poland) most often at 5 entries — repeat review is the norm for this molecule rather than the exception.

9 of the 18 agencies in this archive hold a record for idebenone.

The full ledger for idebenone reads 10 not recommended, 4 restricted, 1 recommended and 1 superseded.

Decisions on file

AgencyDateIndication as recorded OutcomeSource
NICE (England)28 Aug 2025NICE TA1093recommended (optimised)source
AOTMIT (Poland)22 May 2025Raxone reimbursement recommendationnot recommendedsource
CIPM (Spain)29 Jan 2024Indicaciones terapéuticas autorizadas: Raxone está indicado para el tratamiento de la alteración visual en adolescentes …not financed by the SNS · art. 92 dsource
HAS (France)19 Jan 2022Re-assessment of SMR and ASMRSMR moderate · ASMR IVsource
DMC (Denmark)28 Apr 2021Lebers hereditære opticus-neuropati (LHON)Ikke anbefaletsource

11 further decisions for idebenone, across 7 agencies, are not shown here. They link to 10 further source documents.

Related molecules

Coverage: 16 decisions for idebenone from 9 agencies, 2016 to 2025. Data to 7 Sep 2026. ATC class N06B — Psychoanaleptics. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.

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