Gau-Tzu Chen1, Shu-Chen Chang2, Chee-Jen Chang3. 1. Center for Advancement of Pharmacy Education, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan. 2. Research Services Center for Health Information, Chang Gung University, Taoyuan City, Taiwan; Taiwan Society for Pharmacoeconomics and Outcomes Research, Taipei, Taiwan. 3. Research Services Center for Health Information, Chang Gung University, Taoyuan City, Taiwan; Taiwan Society for Pharmacoeconomics and Outcomes Research, Taipei, Taiwan; Graduate Institute of Clinical Medical Sciences, Chang Gung University, Taoyuan City, Taiwan; Clinical Informatics and Medical Statistics Research Center, Chang Gung University, Taoyuan City, Taiwan; Department of Cardiology, Chang Gung Memorial Hospital, Linkou, Taiwan. Electronic address: cjchang@mail.cgu.edu.tw.
Abstract
BACKGROUND: Taiwan has implemented a national health insurance system for more than 20 years now. The benefits of pharmaceutical products and new drug reimbursement scheme are determined by the Expert Advisory Meeting and the Pharmaceutical Benefit and Reimbursement Scheme (PBRS) Joint Committee in Taiwan. OBJECTIVES: To depict the pharmaceutical benefits and reimbursement scheme for new drugs and the role of health technology assessment (HTA) in drug policy in Taiwan. METHODS: All data were collected from the Expert Advisory Meeting and the PBRS meeting minutes; new drug applications with HTA reports were derived from the National Health Insurance Administration Web site. Descriptive statistics were used to analyze the timeline of a new drug from application submission to reimbursement effective, the distribution of approved price, and the approval rate for a new drug with/without local pharmacoeconomic study. RESULTS: After the second-generation national health insurance system, the timeline for a new drug from submission to reimbursement effective averages at 436 days, and that for an oncology drug reaches an average of 742 days. New drug approval rate is 67% and the effective rate (through the approval of the PBRS Joint Committee and the acceptance of the manufacturer) is 53%. The final approved price is 53.6% of the international median price and 70% of the proposed price by the manufacturer. Out of 95 HTA reports released during the period January 2011 to February 2017, 28 applications (30%) conducted an HTA with a local pharmacoeconomic study, and all (100%) received reimbursement approval. For the remaining 67 applications (70%) for which HTA was conducted without a local pharmacoeconomic analysis, 54 cases (81%) were reimbursed. CONCLUSIONS: New drug applications with local pharmacoeconomic studies are more likely to get reimbursement.
BACKGROUND: Taiwan has implemented a national health insurance system for more than 20 years now. The benefits of pharmaceutical products and new drug reimbursement scheme are determined by the Expert Advisory Meeting and the Pharmaceutical Benefit and Reimbursement Scheme (PBRS) Joint Committee in Taiwan. OBJECTIVES: To depict the pharmaceutical benefits and reimbursement scheme for new drugs and the role of health technology assessment (HTA) in drug policy in Taiwan. METHODS: All data were collected from the Expert Advisory Meeting and the PBRS meeting minutes; new drug applications with HTA reports were derived from the National Health Insurance Administration Web site. Descriptive statistics were used to analyze the timeline of a new drug from application submission to reimbursement effective, the distribution of approved price, and the approval rate for a new drug with/without local pharmacoeconomic study. RESULTS: After the second-generation national health insurance system, the timeline for a new drug from submission to reimbursement effective averages at 436 days, and that for an oncology drug reaches an average of 742 days. New drug approval rate is 67% and the effective rate (through the approval of the PBRS Joint Committee and the acceptance of the manufacturer) is 53%. The final approved price is 53.6% of the international median price and 70% of the proposed price by the manufacturer. Out of 95 HTA reports released during the period January 2011 to February 2017, 28 applications (30%) conducted an HTA with a local pharmacoeconomic study, and all (100%) received reimbursement approval. For the remaining 67 applications (70%) for which HTA was conducted without a local pharmacoeconomic analysis, 54 cases (81%) were reimbursed. CONCLUSIONS: New drug applications with local pharmacoeconomic studies are more likely to get reimbursement.
Keywords:
National Health Insurance Administration; Pharmaceutical Benefit and Reimbursement Scheme; health technology assessment; new drug pricing policy; reimbursement