BuprenorphineB-Patch
Maintenance and initiation treatment of opioid use disorder/dependence, with or without prior stabilisation on sublingual buprenorphine or buprenorphine/naloxone (weekly formulation), or maintenance treatment following stabilisation on weekly prolonged release buprenorphine or sublingual buprenorphine or buprenorphine/naloxone (monthly formulation).
Decisions on record
The committee reached more than one outcome for this medicine at its most recent sitting — different indications were decided differently. The header reflects the least favourable of them; all are listed below.
- Meeting Nov 2021 Recommended Opioid dependence
- Meeting Nov 2021 Not recommended Opioid dependence
- Meeting Mar 2020 Not recommended Buprenorphine + naloxone is indicated for the treatment of opioid dependence, within a framework of medical, social and psychological treatment.
- Meeting Nov 2019 Recommended Opiate use disorder (OUD)
- Meeting Nov 2019 Not recommended Opiate dependence
- Meeting Mar 2019 Recommended Opiate dependence
- Meeting Mar 2019 Deferred Opiate dependence
- Meeting Nov 2018 Not recommended Opiate dependence
6 earlier decisions
- Jul 2016 Recommended Chronic severe disabling pain
- Nov 2015 Recommended Pain
- Nov 2015 Not recommended Chronic pain
- Jul 2015 Deferred Pain
- Mar 2015 Deferred Pain
- Nov 2014 Recommended 4mg/1mg film: sublingual, 12mg/3mg film: sublingual, Suboxone® sublingual film, Reckitt Benckiser Pty Ltd. New listing (Minor submission) Opiate dependence Section 100 (Opiate Dependence Treatment Program) listing of two new strengths of buprenorphine + naloxone sublingual film.
Access path
- TGA registered · B-Patch
TGA label equal than the PBS population
- Jul 2005Recommended · restricted
vs oxycodone controlled release (CR)
- Mar 2015Deferred
Evidence: RCT → Cost-minimisation
- Nov 2015Recommended
Evidence: Cost-minimisation → Other
- Nov 2015Not recommended
current restriction level remains appropriate to meet patient needs, unclear pain treatment algorithm, risk of…
- ↻ resubmittedJul 2016Recommended · restricted
- Nov 2018Not recommended
Evidence: Cost-minimisation → RCT
- ↻ resubmittedMar 2019Recommended
- Mar 2019Deferred
- Nov 2019Recommended
Comparator changed: buprenorphine/naloxone sublingual film (Suboxone) →…
- Nov 2021Recommended · restricted
Comparator changed: buprenorphine/naloxone sublingual film (Suboxone®) and buprenorphine…
- PBS listing · Restricted
From the public summary
The PBAC recommended the listing of the new form, 160 mg monthly prolonged release buprenorphine, for the treatment of opiate dependence on the basis that it should be available only under special arrangements under Section 100 for opiate dependence with restricted benefit.PSD · Nov 2021
The listing of the 160 mg monthly injection form was recommended on a cost- minimisation basis to the other currently listed monthly forms of buprenorphine injection.PSD · Nov 2021
The submission presented a cost minimisation analysis of prolonged release buprenorphine based on the previously accepted claim of non-inferior efficacy and safety compared to sublingual buprenorphine/naloxone (para 7.8, Buprenorphine PSD, November 2018 PBAC meeting; para 7.4, Buprenorphine PSD, March 2019 PBAC meeting).PSD · Nov 2021
At the March 2019 meeting the PBAC recommended prolonged release buprenorphine on a cost minimisation basis versus sublingual buprenorphine/ naloxone, and noted that cost effectiveness was acceptable based on drug costs alone, flat priced on a per day basis across dose strengths, at an equi-effective dose of 18.34 mg/day of sublingual buprenorphine/naloxone, with a '''''% price premium (para 7.1 and 7.5, Buprenorphine PSD, March 2019 PBAC meeting).PSD · Nov 2021
No formal clinical claim was made in the submission. The PBAC previously accepted a claim of non-inferiority of prolonged release buprenorphine to sublingual buprenorphine/naloxone (para 7.8, Buprenorphine PSD, November 2018 PBAC meeting; para 7.4, Buprenorphine PSD, March 2019 PBAC meeting).PSD · Nov 2021
The data presented in the submission to support the proposed changes to the restriction (adding the 160 mg monthly dose; allowing direct initiation) were based on the evidence submitted to the TGA to support the recently approved changes to the prolonged release buprenorphine restriction and product information.PSD · Nov 2021
A comment from Better Access Australia advocated for an end to ‘the charging of uncapped fees that do not count towards a patient’s Safety Net’. The organisation proposed that making ODT medicines dual Section 85/100 listed would ‘end the discriminatory practice of current s100 uncapped fees’.PSD · Nov 2021
6.69. The submission noted that, if appropriate, the sponsor is willing to enter a Risk Share Arrangement to mitigate the risk to government due to an unforeseen increase in patients accessing Sublocade. The sponsor did not provide any further details. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Mar 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission was recommended on a cost-minimisation basis versus sublingual buprenorphine/naloxone.
The PBAC recommended the Section 100 (Opiate Dependence Treatment Program) listing for buprenorphine prolonged release subcutaneous injection (Buvidal®) for the treatment of opioid dependence based on a cost minimisation basis with sublingual buprenorphine/naloxone. PBAC · 2019
Decision context
PopulationAdults with opioid use disorder/dependence; weekly formulation can be initiated with or without prior stabilisation on sublingual buprenorphine or buprenorphine/naloxone; monthly formulation requires prior stabilisation on weekly prolonged release buprenorphine, sublingual buprenorphine, or buprenorphine/naloxone.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2021 | Recommended · restricted | sublingual buprenorphine/naloxone | — | RCT · Non-inferiority in efficacy and safety |
| Nov 2019 | Recommended | buprenorphine/naloxone sublingual film (Suboxone®) and buprenorphine modified release injection (Buvidal®) | — | Other · Other |
| Mar 2019 | Recommended | sublingual buprenorphine/naloxone | — | RCT · Illicit opioid use (cumulative distribution function), treatment retention, safety |
| Mar 2019 | Deferred | buprenorphine/naloxone sublingual film (Suboxone) | — | RCT · Surrogate |
| Nov 2018 | Not recommended | sublingual buprenorphine/naloxone | — | RCT · Urine_drug_screen |
| Jul 2016 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Recommended | — | — | Other |
| Nov 2015 | Not recommended | — | — | Cost-minimisation |
| Mar 2015 | Deferred | — | — | Cost-minimisation · Cost-minimisation |
| Jul 2005 | Recommended · restricted | oxycodone controlled release (CR) | — | RCT · Pain intensity reduction |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT02357901 | Ph 3 | 665 | Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opi… | completed |
Consumer voice
Better Access Australia advocated for ending uncapped fees on ODT medicines and proposed dual Section 85/100 listing to eliminate discriminatory practice, while expressing concern that delays based on Post-market Review would be unfair to patients.
end the charging of uncapped fees that do not count towards a patient's Safety Net Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA and PBAC indications cover initiation/maintenance of opioid dependence with identical stabilisation requirements for weekly and monthly formulations.