• Last updated：2024-08-27
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        For the sake of the new drug NHI coverage price approving process, NHIA introduced the following two items under categories of cases requiring HTA in its “Operation Manual for Proposing Addition of New Drugs to NHI Coverage ”

1.   New drugs: New drugs for treating critical injuries or illnesses or involving a new mechanism of action, with costs in any single year over the 5-year period of estimated adoption for coverage exceeding NT$ 100 million.

2.   Expansion of coverage for existing drugs: Drugs for treating critical injuries or illnesses, with costs in any single year over the 5-year period of estimated expansion in the scope of coverage exceeding NT$ 50 thousand.

Besides above-mentioned criteria, NHIA will define other cases requiring HTA reflective of its policies, too.

       For new drugs whose application as Class 1 new drug is to be submitted, the proposer needs to follow the “Instructions for Completing the Proposal for Adoption of Drugs in NHI Coverage - Drugs Only (A1)” by providing empirical data comparing with the best and most common drugs or treatments available at the moment to support the breakthrough innovative nature of the specific new drug in terms of obviously improved clinical efficacy. The clinical efficacy hereunder includes reduced danger and side effects, too.
       CDE HTA completed the HTA of 36 breakthrough innovative new drugs, 126 ordinary drugs, and 16 special devices in total throughout 2022. Among them, the 36 breakthrough innovative new drugs, by their category, are divided into: new composition x 25, new formulation x 2, and new administration route x 1, and financial assessment x 8 and the 126 ordinary new drugs into new composition, financial assessment, relative efficacy assessment, existing or new compounds, clinical efficacy assessment, new administration route, new formulation, re-assessment and expanded scope of application/scope of coverage/expanded or revised scope of coverage, etc.
       In addition, in terms of related analyses, assessments, and studies applied for the utilization of NHI resources, the scope covers healthcare services, drugs and special devices. Throughout 2022, a total of 8 topics were completely reported. As far as the provision of applicable analytical research reports for National Health Insurance Fee Schedule and Reference List for Medical Services is concerned, 4 cases were completed in 2022. In terms of “advancing the routine health technology re-assessment system of the NHIA and re-assessing items that are already covered,” a total of 10 topics were completed and reported in 2022.

      The HTA helps NHIA with the HTA of ordinary new drugs, breakthrough innovative new drugs and special devices proposed for coverage, which will serve as reference during the National Health Insurance Pharmaceutical Benefit and Reimbursement Scheme Joint Preparation Meeting. Multiple cases for including new drugs in NHI coverage and expanding the scope of coverage for existing drugs have been approved one after another through the Joint Preparation Meeting under the joint efforts of the NHIA, experts, the medical community, consumer representatives and patient groups, with beneficiary populations including children, cancer patients and patients with rare disease, among others. Applicable benefits of drugs that are covered include possible additional treatment options, improved accessibility of medications, reduced side effects, extended overall survival, enhanced quality of life and connection with international treatment guidelines, etc. By optimizing applicable research findings in NHI coverage, it also helps the NHIA advance in its NHI payment mechanism. With HTA, the Division continues to help the NHIA make the most cost-effective distribution applying limited healthcare resources so that the valuable NHI resources may render the maximum efficacy.