OBJECTIVES: Perampanel (PER) has been included in Chinese National Reimbursement Drug List in 2020, one year after its approval. This study aims at evaluating cost-effectiveness and budget impact of PER+ antiepileptic drugs (AEDs) versus lacosamide (LCM)+AEDs (one year ahead of PER in drug approval and listing, respectively) for patients with partial-onset seizures in China.

METHODS: The study perspective is Chinese health system. A Markov model with four states (yearly seizure frequency of ≥53, 13-52, 1-12 and seizure free) was developed. Efficacy data were derived from trials (NCT01618695, NCT01710657). Utilities and mortality were derived from literature. Quality-adjusted life year (QALY) was estimated for health outcomes. Life-time direct costs were included. All outcomes were discounted using 5% discounting rate. Deterministic and probabilistic sensitivity analysis were performed. This study also estimated budget impact to Chinses payers for the first three years (2021-2023) after listing.

RESULTS: In the base case analysis, PER (8mg/d)+AEDs per patient was associated with a gain of 0.054 QALYs and $2390 cost saving compared to LCM (400mg/d)+AEDs. PER (4mg/d)+AEDs per patient was associated with a gain of 0.010 QALYs and $860 cost saving compared to LCM (200mg/d)+AEDs. Utilities and extreme discounting rate were the most sensitive parameters. The base-case results were robust after 10,000 iterations. For budget impact, the incremental expenditure of PER listing would be 1.28, 2.83 and 4.56 million USD from 2021 to 2023, respectively, but covering more eligible epileptic patients in the same time (1918, 4287 and 8983, respectively). Market share, prevalence and proportion of PER clinical dose used by patients were the most sensitive parameters.

CONCLUSIONS: This study indicates that PER as adjunctive treatment brings value to patients with partial-onset seizures in China. The cost-effectiveness of PER is dominant to its peer and the incremental budget is within affordability of Chinese payers.