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Levodopa With Carbidopa Monohydrate And Entacapone

Recommended · restricted NeurologyAuthority RequiredLater-line line 💬 consumer voice

Advanced idiopathic Parkinson's disease with severe motor fluctuations despite optimised alternative pharmacological treatment.

1
Submissions
1 resub
2024–24
On the record
ICER range
Cost-min
Cost basis
risk sharing

Access path

1 submission · public record
  1. Jul 2024
    Recommended · restricted

    vs levodopa with carbidopa monohydrate intestinal gel (LCIG)

  2. PBS listing · Authority Required
RecommendedDeferredNot recommended

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated by design.

The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because LECIG is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over LCIG, or not expected to address a high and urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2022 for Pricing Pathway A were not met. PBAC · 2024

Decision context

PopulationAdults with advanced idiopathic Parkinson's disease with severe motor fluctuations despite optimised oral alternative pharmacological treatment.

Risk sharingLECIG to be included in the same Risk Sharing Arrangement as LCIG with no increase in the financial caps.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Jul 2024 Recommended · restricted levodopa with carbidopa monohydrate intestinal gel (LCIG) RCT

Consumer voice

Jul 2024

Two individuals provided consumer input via the PBS website. Their comments focused on the impact of advanced Parkinson's Disease and highlighted the benefits of dose administration across an extended period over oral therapy requiring regular dosing.

the input focused on a treatment other than LECIG, but was useful in emphasising the impact of advanced Parkinson's Disease on people with the condition Consumer comments · PSD
treatment burdenunmet needquality of lifedisease impact