Buprenorphine With NaloxoneSuboxone Film
Treatment of patients with opioid dependence, within a framework of medical, social and psychological treatment.
Decision on record
- Meeting Mar 2011 Recommended Opiate Dependence no PSD
Access path
- TGA registered · Suboxone Film
TGA label equal than the PBS population
- Mar 2020Not recommended
clinical need for Zubsolv was unclear, non-inferior clinical effectiveness to Suboxone film was not demonstrated…
From the public summary
The PBAC did not recommend the listing of buprenorphine with naloxone sublingual tablets (Zubsolv®) for the treatment of patients with opioid dependence. The PBAC considered that no further evidence was provided in the resubmission to address the previous concerns raised regarding the uncertain equi-effective dose to Suboxone, unclear clinical need and significant quality use of medicines issues.PSD · Mar 2020
The PBAC noted the single arm extension study (OX219-008) that reported urine drug screen results up to 24 weeks, however considered that the updated data did not provide more certainty of non-inferiority beyond 15 days. Therefore, the PBAC maintained that the data presented did not adequately establish non-inferiority between Zubsolv and Suboxone film.PSD · Mar 2020
The minor resubmission presented a cost-minimisation analysis of Zubsolv compared with Suboxone Film. The proposed equi-effective dose remained unchanged from the major submission: 5.7mg buprenorphine in Zubsolv is equi-effective to 8 mg buprenorphine in Suboxone.PSD · Mar 2020
At its November 2019 meeting, the PBAC considered the proposed equi-effective doses to be uncertain based on the available bioavailability data to Suboxone tablet, a lack of direct bioavailability evidence between Zubsolv and Suboxone film, and issues with dosing methodology used in the key study.PSD · Mar 2020
The resubmission presented urine drug screen (UDS) data from studies OX219-006 and OX219-008 to attempt to provide an objective outcome measure of decreased drug use. The resubmission considered that, as the number of patients with opiate- positive UDS was similar between Zubsolv and Suboxone and was maintained in the 24 week extension study OX219-008, the comparative efficacy between the products was supported. 6PSD · Mar 2020
Cost-effectiveness
Cost-minimisation analysis presented; no ICER calculated as this is a cost-minimisation submission comparing drug costs only.
Decision context
PopulationAdults with opioid dependence requiring treatment within a framework of medical, social and psychological treatment.
Why it was knocked back
- clinical need for Zubsolv was unclear, non-inferior clinical effectiveness to Suboxone film was not demonstrated, equi-effective doses were uncertain, significant quality use of medicines concerns relating to dose titration issues and prescriber confusion regarding strengths leading to incorrect dosing of patients
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2020 | Not recommended | buprenorphine/naloxone sublingual film (Suboxone) | — | RCT · Treatment retention |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT02038790 | Ph 4 | 33 | Overall Intervention Preference As Assessed by Participants | completed |
Consumer voice
Health care professionals and organisations supported increasing the range of medications available for patients, highlighting potential palatability improvements and reduced risk of diversion due to faster dissolution.
The comments outlined the benefits of increasing the range of medications available for patients, including potential palatability improvements. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify opioid dependence treatment within medical, social and psychological framework; PBAC specifies adults but TGA label includes this population.