The National Health Insurance Administration (NHIA) has been proactively addressing the stability and resilience of the supply of NHI-covered medications in Taiwan. Following the easing of the COVID-19 pandemic, the NHIA has undertaken a comprehensive review of the current drug pricing and adjustment principles. Since the beginning of 2023, multiple consultation meetings have been held to gather recommendations from experts, scholars, and stakeholders. Based on these inputs, the NHIA has been actively planning reforms to the NHI pharmaceutical pricing policy.

These reforms include revisions to the NHI Drug Fee Schedule and certain provisions of the Regulations for Adjusting NHI Drug Prices (Drug Price Adjustment Regulations). In accordance with the Administrative Procedure Act, the proposed amendments have been publicly announced for a 60-day public comment period to solicit feedback.

The NHIA stated that the draft amendments to the NHI Drug Fee Schedule and certain provisions of the Drug Price Adjustment Regulations aim to foster the future development of the pharmaceutical industry and accelerate the inclusion of new drugs in NHI coverage, offering significant benefits. To this end, the NHIA has expanded incentives for domestic pharmaceutical manufacturers to produce innovative drugs. Drugs launched on the international market within two years, or those approved for over five years in the top 10 advanced countries but classified as new ingredients in Taiwan, will be eligible for preferential pricing, comparable to newly launched drugs in Taiwan.

Meanwhile, the NHIA encourages the timely introduction of generic drugs and biosimilars into the market to expand prescription drug options. For domestically manufactured generic drugs or biosimilars developed to enter the market after the expiration of a brand-name drug's patent, the first two to obtain drug licenses within five years of the patent's expiry will be eligible for pricing equivalent to, at most, that of the original brand-name drug.

Thirdly, domestically manufactured drugs will receive preferential pricing to ensure a stable drug supply. This includes drugs made with locally produced active pharmaceutical ingredients, drugs supported by safety clinical trials conducted domestically and published in international academic journals (with updates included in their package inserts), and generic drugs that are the first to file a Paragraph IV patent declaration with the authorities and receive approval for a drug license. If any of these three conditions are met, the NHI pricing will ontain a 10% premium.

Finally, to ensure a stable supply and reasonable pricing of pharmaceuticals, products may be exempt from annual pricing adjustments if all three of the following criteria are met: the product is listed as an essential drug by the competent authority, domestically manufactured alternatives exist within the same category, and no more than three items exist in the same classification within that category. To improve pharmaceutical accessibility for the Taiwanese population and accelerate the inclusion of new drugs in the NHI package, the NHIA is implementing a parallel review procedure and an active inclusion mechanism, while also easing relevant regulations regarding written application documents.

For any comments or suggestions on the draft amendment, please submit your feedback or contact the NHIA during the preview period, which concludes on January 20, 2025.