Levodopa With CarbidopaAPO-LEVODOPA/CARBIDOPA
Advanced Parkinson's disease with severe disabling motor fluctuations not adequately controlled by oral therapy.
Decisions on record
- Meeting Nov 2010 Recommended Parkinson disease
- Meeting Mar 2008 Not recommended Parkinson’s disease
Access path
- TGA registered · APO-LEVODOPA/CARBIDOPA
TGA label narrower than the PBS population
- Mar 2008Not recommended
unacceptably high and uncertain incremental cost effectiveness ratio, small trial populations with treatment…
- ↻ resubmittedNov 2010Recommended · restricted
Comparator changed: standard medical management (mix of suboptimal oral medication…
- Nov 2016Recommended
Evidence: RCT → Other
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the removal of the current wording ‘a positive clinical response to Duodopa® administered via a temporary nasoduodenal tube should be confirmed before a permanent percutaneous endoscopic gastrostomy (PEG) tube is inserted’ from the Note section under the restriction of levodopa with carbidopa on the basis that this is a clinical practice decision.PSD · Nov 2016
6.2 The PBAC noted the update to the PI for Duodopa® and considered that the nasojejunal test phase may be exempted under the discretion of a physician. In this situation, it is appropriate to initiate the treatment directly with placement of the PEG-J.PSD · Nov 2016
Cost-effectiveness
Minor submission with no economic comparison.
The PBAC therefore rejected the submission on the basis of the unacceptably high and uncertain incremental cost effectiveness ratio for levodopa with carbidopa gel compared to standard medical management. PBAC · 2008
Decision context
PopulationPatients with advanced Parkinson's disease with 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended | — | — | Other |
| Nov 2010 | Recommended · restricted | oral therapy, apomorphine and deep brain stimulation | $45k–75k | RCT |
| Mar 2008 | Not recommended | standard medical management (mix of suboptimal oral medication including oral levodopa and carbidopa, and continuous sub | $45k–75k | RCT · Other |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to hospital-initiated therapy, adequate cognition, and portable pump management; TGA label has no such requirements.