Abstract:OBJECTIVES: To estimate the cost-effectiveness of foslevodopa/foscarbidopa, a 24-hour continuous subcutaneous infusion of levodopa-based therapy, compared to levodopa/carbidopa intestinal gel (LCIG), the most utilized device-aided therapy for the treatment of advanced Parkinson’s disease (PD) with severe motor fluctuations and hyperkinesia or dyskinesia in Greece.

METHODS: A state-transition Markov model, with 17-health states and one absorbing state (death), was locally adapted from a Greek payer perspective over a lifetime horizon. The model defines health states for each treatment according to ‘OFF’ time, ranging from 0 to 16 hours, in one-hour increments. The clinical efficacy inputs for foslevodopa/foscarbidopa were derived from the pivotal randomized control M15-736 trial (NCT04380142), whereas efficacy for LCIG was modelled using inputs derived from a network meta-analysis, expressed as a risk ratio relative to foslevodopa-foscarbidopa. Safety and utility data were extracted from the foslevodopa/foscarbidopa clinical trial and literature. Direct costs pertaining to drug acquisition, administration, monitoring, disease management, and adverse events were considered in the analysis. All cost inputs were indexed to 2024 euros. Quality-adjusted life years (QALYs), total costs and incremental cost-effectiveness ratios (ICERs) are reported. Costs and QALYs were discounted at 3.5% per annum. Sensitivity and scenario analyses were conducted.

RESULTS: Foslevodopa/foscarbidopa was found to be a dominant treatment strategy compared to LCIG, being more effective (producing QALY gains of 0.11; 5.85 versus 5.74) while being less expensive (€49,034 in cost-savings; €494,890 versus €543,923, respectively). One-way sensitivity and scenario analyses confirmed the cost-effectiveness of foslevodopa/foscarbidopa. At the defined cost-effectiveness threshold of €44,000/QALY gained (twice the Greek per capita income), foslevodopa/foscarbidopa had a 100% probability of being cost-effective relative to LCIG.

CONCLUSIONS: Foslevodopa/foscarbidopa was found to be a cost-effective treatment option versus LCIG for patients with advanced PD with severe motor fluctuations and hyperkinesia or dyskinesia in Greece.