Roflumilast: 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) and TLV (Sweden) recommended or restricted roflumilast, while SMC (Scotland) and ZIN (Netherlands) did not recommend it.
Assessment has run over 8 years, from 28 Jul 2010 at AWMSG (Wales) to 31 Jul 2018 at ZIN (Netherlands).
TLV (Sweden) changed its position: restricted on 4 Jan 2011, recommended by 25 Sep 2015.
Coverage is thin among the largest agencies: 5 of the eight highest-volume bodies — HAS (France), PBAC (Australia) and PHARMAC (New Zealand) among them — hold no record for roflumilast at all.
Nothing has been added since 2018; on this evidence the file is dormant.
Against its own class, roflumilast is an outlier: 50% of its decisive outcomes were positive, where molecules sharing ATC class R03D average 86%.
3 distinct indication wordings are recorded for roflumilast by the agencies that label one in English (AWMSG, NICE and SMC).
AWMSG (Wales) was first to assess roflumilast, on 28 Jul 2010; SMC (Scotland) did not open a file until 11 Sep 2017 — a wide spread of 7.2 years between the earliest and latest system to look at it.
Restriction is doing real work here: 2 of 6 decisive outcomes narrowed roflumilast to a subgroup rather than accepting or refusing it outright, at NICE (England) and TLV (Sweden).
2 of the 5 agencies here assessed roflumilast more than once, ZIN (Netherlands) most often at 2 entries — repeat review is the norm for this molecule rather than the exception.
Coverage is narrow: only 5 of the 18 agencies here have assessed roflumilast.
The full ledger for roflumilast reads 3 not recommended, 2 restricted, 1 recommended and 1 deferred to NICE.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| ZIN (Netherlands) | 31 Jul 2018 | GVS-advies roflumilast (Daxas®) als aanvullende onderhoudsbehandeling van ernstig COPD geassocieerd met chronische bronc… | not reimbursed (GVS) | source |
| SMC (Scotland) | 11 Sep 2017 | For maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (forced expiratory volume in one second [FEV1]) post-bronchodilator less than 50% predict… | not recommended | source |
| NICE (England) | 26 Jul 2017 | NICE TA461 | recommended (optimised) | source |
| TLV (Sweden) | 25 Sep 2015 | Daxas ingår i högkostnadsskyddet med generell subvention | general subsidy | source |
| AWMSG (Wales) | 28 Jul 2010 | Maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 postbronchodilator less than 50% pred… | excluded, NICE appraised | source |
2 further decisions for roflumilast, across 2 agencies, are not shown here. They link to 2 further source documents.
Related molecules
- tiotropium — divergent outcome (not recommended vs recommended) on a shared indication
- budesonide / formoterol — divergent outcome (not recommended vs recommended) on a shared indication
- olodaterol / tiotropium — divergent outcome (not recommended vs recommended) on a shared indication
- umeclidinium — divergent outcome (not recommended vs recommended) on a shared indication
- budesonide / formoterol / glycopyrronium — divergent outcome (not recommended vs recommended) on a shared indication
- beclometasone — divergent outcome (not recommended vs recommended) on a shared indication
Coverage: 7 decisions for roflumilast from 5 agencies, 2010 to 2018. Data to 7 Sep 2026. ATC class R03D — Obstructive airway diseases. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.