Buprenorphine/NaloxoneSuboxone Film
Recommended PainRestricted
Treatment of opioid dependence within a framework of medical, social and psychological treatment, for opioid substitution therapy in patients entering treatment or in maintenance treatment including detoxification.
1
Submissions
2019–19
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2011 Recommended Opiate Dependence no PSD
Access path
- TGA registered · Suboxone Film
TGA label equal than the PBS population
- Nov 2019Not recommended
vs buprenorphine/naloxone sublingual film (Suboxone film)
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC did not recommend the listing of buprenorphine with naloxone sublingual tablets (Zubsolv®) for the treatment of patients with opioid dependence on the basis that the clinical need for Zubsolv was unclear, non-inferior clinical effectiveness of 17PSD · Nov 2019
7.2 The PBAC considered that the clinical need for Zubsolv was low given the availability of other strengths of buprenorphine with naloxone on the PBS, and the recent PBS listing of buprenorphine modified release injection, which a proportion of patients are likely to transition to following stabilisation on daily buprenorphine with naloxone.PSD · Nov 2019
Economic analysis
6.35 The submission presented a cost-minimisation analysis, however this is only reasonable if the PBAC were to accept the claim that Zubsolv has non-inferior effectiveness and safety compared with Suboxone film. 13PSD · Nov 2019
6.36 The submission estimated that the equi-effective doses were Zubsolv 5.7 mg buprenorphine is equal to 8 mg buprenorphine in Suboxone film (administered sublingually), with the cost-minimisation analysis including drug costs only. As discussed above, this dose relativity was not considered to be supported by the bioavailability data presented and the claim relied on the results from Trial OX219- 006.PSD · Nov 2019
Clinical claim
VAS = visual analogue scale; AE = adverse event Source: Table 1.4, p9 of the submission.PSD · Nov 2019
6.30 The submission described Zubsolv as non-inferior in terms of effectiveness and non- inferior in terms of safety compared with Suboxone film in the treatment of opiate dependence.PSD · Nov 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design
Decision context
PopulationPatients with opioid dependence entering opioid substitution treatment or in maintenance treatment, including those undergoing detoxification.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2019 | Not recommended | buprenorphine/naloxone sublingual film (Suboxone film) | — | RCT · Retention in treatment |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT02038790 | Ph 4 | 33 | Overall Intervention Preference As Assessed by Participants | completed |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify opioid dependence treatment within medical/social/psychological framework, with PBAC clarifying treatment stages (entry, maintenance, detoxification) already implicit in TGA label.