A Proposal for a Parallel Submission Process for New Drug Applications and Health Technology Assessment in Taiwan: A Win
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A Proposal for a Parallel Submission Process for New Drug Applications and Health Technology Assessment in Taiwan: A Win-Win Solution Yen-Hrei Tarn, HS, PhD Director, Division of Health TechnologyAssessment, Centerfor Drug Evaluation, Taipei, Taiwan Herng-Der Chern, MD, PhD Executive Director, Center for Drug Evaluation. Taipei, Taiwan
Key Words New drug application; Health technology assessment; Reimbursement; Parallel submission process; Phannacoeconomics Correspondence Address Yen-Huei Tarn. MS. PhD. Division of Health Technology Assessment, Center for Drug Evaluation, IF, No. 15-1.Sec. I , Hangjou S. Road, Taipei 100, Taiwan (email: [email protected]).
The purpose of this article is to raise a possible sdution for both reimbursement body and pharmaceutical manufacturer in situations where the price of a new drug was set too low and there is not enough incentive for the manufacturer to conduct a phannacoeconomic (PE) or outcomes stucj. in the local environment. For breakthrough or substantially improved products, parallel submission may re-
INTRODUCTION The Center for Drug Evaluation (CDE) was commissioned by the Department of Health (DOH) of Taiwan on July l3,1998, as a nongovernmental, nonprofit organization. Under the delegation and commission of DOH, CDE evaluates new drugs and new medical devices for regulatory requirements and offers consultation services to related parties before approval is granted by the Bureau of Pharmaceutical Affairs (BPA). Main tasks of CDE include: review of new drug applications (NDAs), evaluation of premarketing approvals and clinical trial protocols for medical devices, review of clinical trial protocols for new drugs, bridging study evaluations, Taiwan's Critical Path program (of biomedical product development), and consultation. Through these, CDE plays a pivotal role to enhance the quality and efficiency of drug evaluation for appropriate and timely access to innovative medicine, thus promoting the health and welfare of the public. In February 2007, the minister of health made the decision to establish a new division of Health Technology Assessment (HTA) in CDE to provide evidence of the value of new health care technologies for decision makers in the Bureau of National Health Insurance (BNHI). BNHI is the reimbursement body that now covers 99%
duce the time lag between marketing approval and reimbursement decision. Prm'ding a median price of 10 rejkrence countries could give an incentive for a manufacturer to invest in a local PE study, provide local outcomes data, and receive a price adjustment accordingly at the fourth year. This is a concept and real implementation may need more input from all stakehdders.
of the population and contracts with 91.5% of health care providers in Taiwan. Starting in June 2007, a proposed structure, working model, and responsibilities of the HTA division in relation to BNHI were suggested and communicated with the officers in DOH, BNHI, scholars in related academia, and people in pharmaceutical industries. Before that time, p
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