PHP74 Submission of New Drug Reimbursement and Pricing Applications to National Health Insurance (NHI) of Taiwan, Meeting Outcomes of the Drug Benefit Committee

Abstract

OBJECTIVES: The Drug Benefit Committee (DBC) appraises the value of new drug and categorises it as class 1 (substantial improvement), 2A (moderate improvement) or 2B (similar) according to relative treatment effect of new drug compared with the exiting treatment(s), and pricing method link to the category is decided. When DBC considers more information is required the application will be further discussed in extension meeting, and appeal could be entered if the license holder did not agree upon the result. We analyzed the features of new drug applications and corresponding DBC meeting outcomes in 2007 and 2008. METHODS: Data were abstracted from the applications and DBC meeting minute. RESULTS: There were 82 applications during the study period, 51 were submitted by the multinational companies and 31 by domestic companies; 6 applied for class 1; and 70 were singlecompound. By end of 2008, 63 (77%) were reimbursed; for the unreimbursed, 7 were withdrawn by the applicants and 12 were denied by the DBC. 20 new drugs received unconditional recommendation, 43 with conditional coverage. 31 (38%) submissions entered appeals, 22 for price and 9 for reimbursement decision. Appealed successfully in 22 (71%), but double the duration to reach final result. The final reimbursed prices were 81% to 91% of the applied price in class 1, and 55% to 73% in class 2. The feature of company (foreign or domestic) and the ratio of applied to the first DBC decided price had influence on the decision of company to enter an appeal. CONCLUSIONS: The reimbursement and price process is evolving continuously. How to justify the value of treatment to the community, scientific sound methods for assessment and appraisal, and transparency of the process and outcomes are the important considerations. The cumulative experience is valuable for future improvement.