Buprenorphine / Naloxone: 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), HAS (France) and PHARMAC (New Zealand), among others, recommended or restricted buprenorphine / naloxone, while PBAC (Australia) did not recommend it.
Where buprenorphine / naloxone met resistance it was usually narrowed rather than refused: 5 of 12 decisive outcomes were recommendations with restrictions, against 1 outright refusal.
The file has been open for more than a decade: 16 years separate the first record, 20 Nov 2006 at TLV (Sweden), from the most recent, 7 Nov 2022 at SMC (Scotland).
No assessment is on file from CIPM (Spain) and G-BA (Germany), each among the eight highest-volume agencies here.
Not every gap is a refusal: for buprenorphine / naloxone, 1 was withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
5 distinct indication wordings are recorded for buprenorphine / naloxone by the agencies that label one in English (AWMSG, PBAC and SMC).
2 of these 16 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
TLV (Sweden) was first to assess buprenorphine / naloxone, on 20 Nov 2006; PBAC (Australia) did not open a file until 2019 — an unusually long tail of 12.7 years between the earliest and latest system to look at it.
The record arrives in waves: 3 separate years each carry two or more decisions, spread across 9 years in total.
Restriction is doing real work here: 5 of 12 decisive outcomes narrowed buprenorphine / naloxone to a subgroup rather than accepting or refusing it outright, at AWMSG (Wales), PHARMAC (New Zealand) and SMC (Scotland).
5 of the 6 agencies here assessed buprenorphine / naloxone more than once, HAS (France) most often at 4 entries — repeat review is the norm for this molecule rather than the exception.
6 of the 18 agencies in this archive hold a record for buprenorphine / naloxone.
The full ledger for buprenorphine / naloxone reads 6 recommended, 5 restricted, 2 other and 1 not assessed, with 2 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| SMC (Scotland) | 7 Nov 2022 | Substitution treatment for opioid drug dependence. | accepted (restricted) | source |
| AWMSG (Wales) | 9 Dec 2021 | Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. Th… | outside AWMSG criteria | source |
| HAS (France) | 30 Jun 2021 | Listing (Transparency Committee) | SMR substantial · ASMR V | source |
| TLV (Sweden) | 8 Feb 2021 | Suboxone sublingual film ingår i högkostnadsskyddet | general subsidy | source |
| PBAC (Australia) | 2020 | Buprenorphine + naloxone is indicated for the treatment of opioid dependence, within a framework of medical, social and psychological treatment. | Resubmission to request a Section 100 (Opiate Dependence Treatment Program) Restricted Ben… | source |
11 further decisions for buprenorphine / naloxone, across 6 agencies, are not shown here. They link to 8 further source documents.
Related molecules
- nicotine — same ATC class N07B — Other nervous system
- buprenorphine — same ATC class N07B — Other nervous system
- varenicline — same ATC class N07B — Other nervous system
- nalmefene — same ATC class N07B — Other nervous system
- naltrexone — same ATC class N07B — Other nervous system
- venetoclax — also decided by SMC in 2022Q4
Coverage: 16 decisions for buprenorphine / naloxone from 6 agencies, 2006 to 2022. Data to 7 Sep 2026. ATC class N07B — Other nervous system. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.