OpicaponeONGENTYS
Adjunctive therapy to levodopa-decarboxylase inhibitor combination in adult patients with Parkinson disease experiencing end-of-dose motor fluctuations.
Decision on record
- Meeting Jul 2021 Recommended Parkinson disease
Access path
- TGA registered · ONGENTYS
TGA label equal than the PBS population
- Jul 2021Recommended · restricted
vs entacapone
- PBS listing · Restricted
From the public summary
The PBAC recommended listing opicapone as a General Schedule Restricted Benefit for Parkinson disease, with the same circumstances of use as entacapone, on a cost- minimisation basis with entacapone.PSD · Jul 2021
The PBAC advised the equi-effective doses are opicapone 49.2 mg once daily = entacapone 856 mg daily (given as divided doses with each L-dopa dose).PSD · Jul 2021
The submission appropriately presented a cost-minimisation analysis compared to entacapone.PSD · Jul 2021
The equi-effective doses were estimated as opicapone 50mg daily and entacapone 1,000mg per day in 5 divided doses. This equivalence was based on rounding up the mean dose of entacapone from the trial (906 or 913 mg/day) to the 1,000mg/day DDD.PSD · Jul 2021
The submission described opicapone as non-inferior in terms of effectiveness compared to entacapone. The ESC and PBAC considered the claim was adequately supported.PSD · Jul 2021
The submission described opicapone as non-inferior in terms of safety compared to entacapone. The ESC and PBAC considered this claim was adequately supported.PSD · Jul 2021
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC considered the revised equi-effective doses were reasonable. PBAC · 2021
Decision context
PopulationAdult patients with Parkinson disease on stable levodopa-decarboxylase inhibitor therapy experiencing motor fluctuations due to end-of-dose effects.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2021 | Recommended · restricted | entacapone | — | RCT · Absolute OFF-time |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| BIPARK II (BIA-91067-302) | Ph 3 | 427 | Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With … | completed |
Consumer voice
Parkinson's Australia provided input noting the convenience and possible adherence benefits of a once-daily COMT inhibitor option for patients managing end-of-dose motor function symptoms associated with L-dopa treatment.
the convenience and possible adherence benefits of a once-daily COMT inhibitor option for patients to help control end-of-dose motor function symptoms associated with treatment with L-dopa Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify adjunctive levodopa-decarboxylase inhibitor therapy for Parkinson disease with end-of-dose motor fluctuations in adults.