In the Bio Taiwan Committee meeting held during August 28-30, 2023, the Director General of the National Health Insurance Administration (NHIA) mentioned several new plans related to the pricing of new drugs and generics under National Health Insurance (NHI) to accelerate drug launches in Taiwan.

New Drugs

There are two pilot programs. The first one is parallel processing of drug regulatory registration at the Taiwan Food and Drug Administration and drug pricing at the NHIA. Eligible candidates for parallel processing include new drugs for unmet medical needs, breakthrough new drugs (like gene therapy or cell therapy) and substitute new drugs for financial considerations. The second program is conditional listing. For new drugs that are promising but have uncertain cost benefits, the drugs can be included in the NHI system for two years and will be assessed at the same time.

In addition, according to the current pricing scheme, if a new drug’s first worldwide launch is in Taiwan, it may be deemed as a “first launched new drug” and enjoy beneficial pricing. The NHIA plans to extend the “first launched new drug” pricing to include those that are manufactured in Taiwan and first launched in a foreign country if the regulatory registration in Taiwan is requested within two years.

Generics

The NHIA aims to unify the prices for generics with the same ingredients and quality, and the first few generics may enjoy a higher price to encourage swift launching of generics once new drug patents expire. Additionally, the NHIA will encourage hospitals to choose generics or biosimilars by subsidizing hospitals with the funds from the cost savings realized from the reduced expenses of generic drugs.

The NHIA has scheduled to propose draft amendments to relevant regulations by the end of this year.

(Summarized from the introductory speech of the NHIA Director General in the second session of the Bio Taiwan Committee 2023.)

* Section Chief of International Patent Division at Tai E International Patent & Law Office