FROM REGULATORY APPROVAL TO SUBSIDISED PATIENT ACCESS IN THE ASIA-PACIFIC REGION- A COMPARISON OF SYSTEMS ACROSS AUSTRALIA, CHINA, JAPAN, KOREA, NEW ZEALAND, TAIWAN AND THAILAND

Author(s)

Kim H1, Jung H2, Chou P3, Kunihara T4, Tosanguan J5, Tang Z6, Brydon S1, Cook G1
1Bristol-Myers Squibb, Melbourne, Australia, 2Bristol-Myers Squibb, Seoul, South Korea, 3Bristol-Myers Squibb, Taipei, Taiwan, 4Bristol-Myers Squibb, Tokyo, Japan, 5Bristol-Myers Squibb, Bangkok, Thailand, 6Bristol-Myers Squibb, Shanghai, China

OBJECTIVES: Pharmaceuticals can be marketed when regulatory approval has been obtained. However other barriers may need to be cleared before patients can gain access to subsidised medicines. In the Asia-Pacific region these subsidised systems are often government programmes and range from national tax funded schemes (Australian Pharmaceutical Benefits Schedule) through to coverage of a specific population (Thailand Social Security Scheme for office workers). Navigating these systems can be as simple as submitting a pricing application or as complex as a full scale societal health technology assessments. The aim of this study is to compare the processes and timings between regulatory approval and subsidised access to medicines across the Asia-Pacific region. METHODS: Reimbursement guidelines from seven different jurisdictions in the Asia-Pacific region were reviewed. Differences in processes and time from regulatory approval to subsidised access were captured between Australia, China, Japan, Korea, New Zealand, Taiwan and Thailand.   RESULTS: Only Australia and Thailand allows evaluation of reimbursement in parallel with regulatory evaluation. Parallel processing has been discussed in Korea and Taiwan but has not been implemented. The time between regulatory approval and subsidised access differs across jurisdictions. In general additional processes such as health economic evaluation, pricing negotiation, budget approval and administration prolong time to subsidised access well beyond 6 months post regulatory approval. Japan is unique as a reimbursement price should be published within 60 days after regulatory approval. CONCLUSIONS: While most jurisdictions in the Asia-Pacific region differ in terms of regulatory and access approval processes all but one of the jurisdictions included in this study require a regulatory approval letter before reimbursement can be sought. Parallel processing can shorten time for patients to access new medicines however other factors such as health economic evaluation, pricing negotiation, budget approval and administration are also important.

Conference/Value in Health Info

2014-09, ISPOR Asia Pacific 2014, Beijing, China

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PHP58

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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