Foslevodopa With FoscarbidopaVyalev
Treatment of advanced Parkinson's disease with severe disabling motor fluctuations not adequately controlled by oral therapy.
Decisions on record
- Meeting Nov 2024 Recommended Advanced Parkinson disease with severe disabling motor fluctuations
- Meeting May 2024 Not recommended Advanced Parkinson's disease with severe disabling motor fluctuations not adequately controlled by oral therapy
- Meeting Jul 2023 Noted Advanced Parkinson's Disease no PSD
Access path
- TGA registered · Vyalev
TGA label narrower than the PBS population
- May 2024Not recommended
vs levodopa/carbidopa intestinal gel (LCIG)
- ↻ resubmittedNov 2024Recommended
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the S100 HSD and General Schedule listing of foslevodopa with foscarbidopa (FosLD/FosCD) for the treatment of advanced Parkinson’s disease (PD) with severe disabling motor fluctuations not adequately controlled by oral 15PSD · Nov 2024
6.2 The PBAC considered the equi-effective doses to be 1.32 vials of FosLD/FosCD and 1.10 cassettes of LCIG per day.PSD · Nov 2024
5.15 The re-submission presented a revised cost-minimisation approach (CMA) that explored the five main issues the PBAC identified as needing to be addressed, including: • The initiation cost of FosLD/FosCD being underestimated;PSD · Nov 2024
• The cost of surgical insertion of PEG-J tubes for LCIG likely being overestimated; • The duration of the CMA being too short;PSD · Nov 2024
were required to address concerns regarding the effectiveness to LCIG, including sensitivity impact of discontinuations in the pivotal analyses accounting for treatment FosLD/FosCD trial (M15-736) on both the Yes. discontinuation and missing data. estimated efficacy for FosLD/FosCD and the indirect comparison with LCIG (paras 7.1, 7.8, The re-submission also presented additional 7.9, 7.15).PSD · Nov 2024
Based on the CMA presented in the submission, the PBAC considered the cost of FosLD/FosCD per patient was likely to be higher than that of The revised CMA in the re-submission LCIG, due to: (a) the initiation cost of explored issues a-e (noted left) raised by the FosLD/FosCD being underestimated; (b) the cost PBAC, and stated that accounting for these for the surgical insertion of PEG-J tubes for LCIG results in an effective price of $ per 7- Yes.PSD · Nov 2024
5.2 The PBAC noted and welcomed the input from individuals (3) and organisations (Parkinson’s Australia and National Parkinson’s Alliance) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with FosLD/FosCD including the possibility for out of hospital administration, and improved quality of life. The PBAC noted that this advice was supportive of the evidence provided in the submission.PSD · Nov 2024
5.29 The re-submission proposed a revised risk sharing arrangement (RSA) that included both an increased rebate level for FosLD/FosCD of % (compared to % for LCIG) and an adjustment for the revised financial estimates.PSD · Nov 2024
Cost-effectiveness
Cost-minimisation analysis (CMA) conducted; no ICER calculated. The submission was based on a claim of non-inferior comparative effectiveness and cost-minimisation (not cost-effectiveness).
The results of the CMA are presented in Table 10. PSD · 2024
Decision context
PopulationPatients with advanced Parkinson's disease with severe disabling motor fluctuations not adequately controlled by oral therapy.
Risk sharingRisk Sharing Arrangement (RSA) structure proposed where FosLD/FosCD would join the existing RSA for LCIG (and potentially LECIG), with increased caps to account for additional use and a proposed rebate level.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended | levodopa/carbidopa intestinal gel (LCIG) | — | RCT · Other |
| May 2024 | Not recommended | levodopa/carbidopa intestinal gel (LCIG) | — | RCT · Other |
Consumer voice
Three individuals and two organisations (Parkinson's Australia and National Parkinson's Alliance) provided input describing benefits of FosLD/FosCD treatment, including out-of-hospital administration and improved quality of life.
The comments described a range of benefits of treatment with FosLD/FosCD including the possibility for out of hospital administration, and improved quality of life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to those 'not adequately controlled by oral therapy', adding treatment-failure criterion absent from TGA label.