A Proposal for a Parallel Submission Process for New Drug Applications and Health Technology Assessment in Taiwan: A Win-Win Solution

Abstract

The purpose of this article is to raise a possible solution 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 pharmacoeconomic (PE) or outcomes study in the local environment. For breakthrough or substantially improved products, parallel submission may reduce the time lag between marketing approval and reimbursement decision. Providing a median price of 10 reference 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 stakeholders.