Approval of reimbursement for the treatment of advanced levodopa-responsive Parkinson's disease with motor fluctuations and hyperkinesia or severe dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of SCYOVA (foslevodopa/foscarbidopa) 240 mg/mL + 12 mg/mL solution for infusion is substantial in the MA indication.
Clinical Added Value
no clinical added value
Considering:
demonstration of the superiority only versus oral levodopa/carbidopa after 12 weeks of treatment on:
change in average daily normalised “on” time without troublesome dyskinesia (primary endpoint): 2.72 hours versus97 hours, i.e. a mean difference of 1.75 hours (p = 0.0083),
change in average normalised “off” time (key secondary endpoint): -2.75 hours versus -0.96 hours, i.e. a mean difference of -1.79 hours (p = 0.0054),
the absence of comparison versus the available second-line treatments for Parkinson’s disease, in particular apomorphine as continuous subcutaneous infusion, despite this being possible,
the lack of quality of life evidence, in the absence of robust data,
the safety profile of foslevodopa/foscarbidopa, marked by specific cutaneous adverse reactions,
the Committee deems that SCYOVA (foslevodopa/foscarbidopa) 240 mg/mL + 12 mg/mL solution for infusion provides no clinical added value (CAV V) in the care pathway in the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.
Listen
