| [Purpose] The purpose of this study is to evaluate the long-term cost-effectiveness of Rotigotine transdermal patch by comparing it with Pramipexole（immediate release / extended release）in the treatment of Parkinson’s Disease.The result will provide a reference in the process of the drug insurance catalogue adjustment.[Methods] This study is based on the healthcare system perspective and the Markov Model was constructed by using MS Excel 2016.Patients with Parkinson’s Disease were divided into six states including H＆Y stages 1-5 and death.Cost including disease diagnosis,rehabilitation,drugs,medical services of Parkinson’s Disease has been collected through expert consultation and questionnaires.Other parameters such as transition probability between Markov states and the quality of life of rotigotine and Pramipexole in each stage are collected through literature research.Using Markov cohort simulations to calculate the cost and utility values of Pramipexole and Rotigotine during a lifetime simulation.Deterministic sensitivity analysis,probability sensitivity analysis and scenario analysis are used to report the uncertainty of models and parameters.[Results] 1.The annual medical burden of Parkinson’s Disease patients in the early stage（Hoehn-Yahr 1 ＆ 2）,3,4,and 5 are 6748.29 yuan,27,982.01 yuan,37,324.54 yuan and 42,326.63 yuan,respectively.The cost of drugs accounts for a relatively large amount in each period.2.The ICERs of Rotigotine vs immediate-release Pramipexole and extended-release Pramipexole are 1,119,159.49 yuan and 305,568.71 yuan respectively,which are higher than the threshold（three times per capita GDP in 2018）.3.Through deterministic sensitivity analysis,we found factors that have a greater impact on results include the UPDRS scores in clinical trials and prices of Rotigotine and Pramipexole.From the probabilistic sensitivity analysis,the average of the 1,000 Monte Carlo simulations results is highly consistent with the baseline cost-utility analysis results,which proves the stability of the research.Also,according to the threshold analysis,adjusting drug prices can effectively reduce the incremental cost-utility value,which can provide a reference for the formulation of Rotigotine’s compensation pricing strategy.[Conclusions] Drug cost is the main source of the current economic burden of Parkinson’s Disease in China.Although judging from the current results,Rotigotine is not economical compared to Pramipexole（regular release/ extended release）,the advantages of this drug in providing steady blood levels and improving patient compliance can’t be ignored.Policymakers must consider multiple dimensions of drug comprehensively in the process of adjusting the medical insurance catalogue,such as effectiveness,economics,safety,innovation,fairness,and suitability to make scientific decisions.Besides,it is also necessary to explore the application of pharmacoeconomics in the drug pricing compensation mechanism by combining the price adjustment results of this study and international experience in various ways such as price-for-quantity exchange,international price comparison,direct price reduction,or drug donation programs.Exploring reasonable compensation and pricing of drugs can protect the health rights of patients with Parkinson’s Disease effectively. |
