Budget impact analysis of pembrolizumab in the treatment for EGFR gene mutation-negative and anaplastic lymphoma kinase-negative locally advanced or metastatic non-small cell lung cancer
OBJECTIVE To predict the possible impact of pembrolizumab(PEM)as a first-line drug after being included in the national medical insurance system in the treatment of advanced or metastatic non-small cell lung cancer based on real-world data from the perspective of the national medical insurance payer,to provide a basis for the decision-making of the medical insurance department.METHODS A budget impact analysis model was constructed to compare the impact of pembrolizumab not included in medical insurance and included in medical insurance on medical insurance fund expenditure in the next five years(2024-2028)with 2023 as the baseline year.The target population was the patients with EGFR gene mutation-negative and anaplastic lymphoma kinase(ALK)-negative locally advanced or metastatic non-small cell lung cancer;estimated cost mainly included the cost of drugs,the cost of adverse reaction treatment,the cost of examination,the cost of admission and monitoring,etc;equipment ratio of PEM in 183 hospitals of Guangdong province from 2020 to 2022 was used as the market share.Univariate sensitivity analysis was used to test the robustness of the basic analysis results.RESULTS When PEM was not included in the medical insurance,the medical insurance reimbursement amount of the target population from 2024 to 2028 was 4 933 623.5 thousand yuan-5 151 198.3 thousand yuan,respectively.If PEM was included in the medical insurance,the above data were 11 871 972.2 thousand yuan-14 540 571.0 thousand yuan,respectively;the increase in medical insurance reimbursement under the two scenarios was 6 720 773.9 thousand yuan-9 606 947.5 thousand yuan,respectively.The proportion of medical insurance reimbursement to the medical insurance expenditure of the year after PEM was included in medical insurance was 0.298 0%,0.262 1%,0.228 8%,0.208 2%,and 0.185 7%,respectively.The increase in medical insurance reimbursement accounted for 1.084 0%,0.995 7%,0.888 6%,0.886 3%,and 0.861 6%of the increase in the expenditure of the medical insurance fund in the current year,all of which showed a decreasing trend year by year.CONCLUSIONS If PEM is included in medical insurance,due to its high unit price,the medical expenditure will increase accordingly,which will have a great impact on the medical insurance fund expenditure.However,when the drug is used in patients with EGFR mutation-negative and ALK-negative locally advanced or metastatic non-small cell lung cancer,the proportion of the medical insurance reimbursement amount in the current year's medical insurance fund expenditure and the proportion of the increase in medical insurance reimbursement in the current year's increase in medical insurance fund expenditure are decreasing year by year.