Levodopa With Carbidopa MonohydrateAPO-LEVODOPA/CARBIDOPA
Advanced Parkinson's disease with severe disabling motor fluctuations not adequately controlled by oral therapy.
Decision on record
- Meeting Mar 2009 Not recommended Treatment of advanced idiopathic Parkinson's disease with severe motor fluctuations despite optimized oral treatment. A positive clinical response to Duodopa administered via a temporary nasoduodenal tube should be confirmed before a permanent percutaneous endoscopic gastronomy (PEG) tube is inserte
Access path
- TGA registered · APO-LEVODOPA/CARBIDOPA
TGA label narrower than the PBS population
- Nov 2019Recommended · restricted
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended to amend the current listings for levodopa with carbidopa monohydrate intestinal gel (Duodopa®) for the treatment of advanced Parkinson’s disease with a maximum quantity of 8 packs to restrict access to patients requiring more than 1 cassette per day.PSD · Nov 2019
6.2 The PBAC noted there are potential QUM issues with the current listings, where some patients may be using the product beyond the registered shelf-life. It considered the new listings and changes to current listings to be appropriate measures to mitigate the risk of patients inadvertently self-administering out-of-date medicine, whilst also ensuring access for patients requiring a dose of more than 1 cassette per day regardless of if they do, or do …PSD · Nov 2019
Cost-effectiveness
Not modelled — this is a minor submission (reformulation/maximum quantity adjustment) with no new economic evaluation.
Decision context
PopulationPatients with advanced Parkinson's disease who have severe disabling motor fluctuations not adequately controlled by oral therapy, commenced on treatment in a hospital-based movement disorder clinic, with adequate cognitive function to manage administration with a portable continuous infusion pump.
Risk sharingDuodopa is subject to a Deed of Agreement which encompasses a Special Pricing Arrangement (SPA) rebate and a Risk Sharing Arrangement (RSA) with subsidisation caps.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2019 | Recommended · restricted | — | — | Other |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with adequate cognition, hospital-initiated treatment, and oral therapy failure; TGA label lacks these clinical and administrative criteria.