Levodopa With Carbidopa Monohydrate And Entacapone

5.1 The PBAC recommended the S100 HSD and general schedule listing of levodopa with entacapone and carbidopa intestinal gel (LECIG) for the treatment of advanced idiopathic Parkinson disease with severe motor fluctuations despite optimised alternative pharmacological treatment.PSD · Jul 2024

5.2 With respect to the restriction, the PBAC recommended the PBS indication should be consistent with the LCIG PBS listing and state ‘Advanced Parkinson disease.’ In addition, the PBAC considered that it was appropriate for the clinical criteria to state ‘Patient must have severe disabling motor fluctuations not adequately controlled by at least one of: (i) oral therapy; (ii) intestinal gel formulation containing levodopa’.PSD · Jul 2024

4.9 In March 2024, the PBAC noted the cost-minimisation approach (CMA) proposed by the submission was based on steady state dose-adjusted plasma levodopa concentrations observed in the LSM-003 study and assumed one cartridge of LECIG per day was equivalent to one cassette of LCIG per day (i.e. 1:1).PSD · Jul 2024

The mean dose does not Mean levodopa dose per March 2024 accurately account for all patients day from the LSM-003, Submission’s 1.00 cartridge 1.00 cassette requiring at least one cartridge of ELEGANCE, GLORIA, base case LECIG and a proportion requiring DUOGLOBE studies. a partial second cartridge per day.a This appropriately represented the Assuming 50% of patients proportion of patients using only used one LECIG cartridge one cartridge.PSD · Jul 2024

4.8 In March 2024, the PBAC considered the clinical evidence that was presented in the submission (to support the clinical claim of non-inferior effectiveness of LECIG relative to LCIG) to have significant limitations, but on balance agreed with ESC and concluded that the clinical claim was likely reasonable (paragraph 7.7, levodopa with carbidopa and entacapone PSD, March 2024 PBAC Meeting).PSD · Jul 2024

4.7 The PBAC noted that in Study LSM-003 patients received LECIG morning doses corresponding to 80% (n = 5) or 90% (n = 6) of their individual morning dose of LCIG, 80% of the LCIG maintenance dose, and 80% of extra doses (Senek 2017).PSD · Jul 2024

4.17 The resubmission noted that LCIG is currently under a Risk Sharing Arrangement with annual financial caps. The resubmission anticipated that LECIG would be included in the same Risk Sharing Arrangement as LCIG with no increase in the financial caps required.PSD · Jul 2024

For more detail on PBAC’s view, see section 5 PBAC outcome. 12PSD · Jul 2024