ANALYSIS OF PRICING & REIMBURSEMENT APPROVAL PROCESS FOR NEW DRUGS IN KOREA UNDER NEWLY-INTRODUCED HTA ENVIRONMENT (2007-2010)

Author(s)

Kim HJ, Park JH, Shin HH, Ko SKPfizer Pharmaceuticals Korea Limited, Seoul, South Korea

OBJECTIVES: Since 2007, HTA environment has been introduced to evaluate new drug’s pricing & reimbursement in Korea, and PE submission became one of mandatory requirements in HIRA (Health Insurance Review Agency). The objective of this study is to understand the overall process and result under the current environment, and to identify factors in the process which might cause a patient access issue. METHODS: We reviewed DREC (Drug Reimbursement Evaluation Committee)’s result reports (n=97) of new products from August 2007 to November 2010, which is open to the public. RESULTS: Among total 97 cases, the number of reimbursement decision was 58 (59.8%) at HIRA. The majority of reason for reimbursement decision was lower treatment cost (67.2%). DREC accepted only 12 cases’ ICER value for reimbursement decision, 85 decisions were made without PE result data. Although clinical usefulness was improved in 33 cases, non-reimbursement decision was made in 6 cases because cost-effectiveness or PE data was uncertain. Among 39 cases of non-reimbursement decisions, 10 cases accepted WAP (Weighted Average Price) that HIRA suggested. Success rate of price negotiation at NHIC was 68.0%, and took 3.7 months including administrative process from DREC decision to MOHW (Ministry of Health and Welfare)’s final announcement. Average duration for final reimbursement decision was 16.9 months.  Approximately 7 more months were necessary for applicant with PE data rather than without PE data (22.0 months vs. 15.0 months). CONCLUSIONS: The aim for introducing HTA is to list drugs which prove clinical usefulness and cost effectiveness but this analysis shows that it is difficult to expedite patient access to medicine through a HTA environment in Korea. Alternatives beyond PE evidence are needed for timely patients’ access to innovative drugs.

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

PHP118

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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