The Ministry of Health and Welfare of Taiwan Issued the Operational Principles for the Temporary Payment of New Cancer Drugs

I. Introduction

In light of the high cost of cancer drugs, the National Health Insurance Administration (hereinafter referred to as “NHIA”) under the Ministry of Health and Welfare of Taiwan has proposed a mechanism to provide temporary funding for new cancer drugs to enhance accessibility for cancer patients. This approach aims to accelerate the inclusion of new cancer drugs in the national health insurance benefits. On February 25, 2025, the NHIA issued the Operational Principles for Temporary Payment of New Cancer Drugs (hereinafter referred to as "the Principles"). The Principles further regulate the scope of cancer drugs eligible for temporary payment, the review process for temporary payment, and the circumstances under which temporary payment will be discontinued.  They also ensure the consideration of patient advocacy groups' opinions and patients' rights to medication. The key points of the Principles are summarized as follows:

II. Eligible Drugs

Drugs applicable to the Principles must hold a drug permit license issued by the central health authority and meet one of the following conditions (Article 2 of the Principles): 

1. New cancer drugs or new indications that have completed Phase III clinical trials, with clear clinical efficacy evidence, but have not been included in the national health insurance benefits due to budget constraints.

2. Other drugs deemed necessary by the NHIA.

 III. Registration and Data Submission by New Cancer Drug Companies

1. Companies holding a drug permit license must complete registration on the NHIA's system by the end of November each year. They must provide data on the drugs they propose for temporary payment over the next two years, along with financial impact assessments (Article 3 of the Principles).

2. When submitting proposals for drug inclusion in the national health insurance benefits based on the National Health Insurance Drug Payment Items and Standards, companies must also submit a reassessment plan for temporary payment drugs (hereinafter referred to as "the Plan") if they choose to apply the temporary payment scheme (Article 5 of the Principles).

3. If the estimated annual drug costs exceed NT$500 million within five years after the start of temporary payment, companies must also submit a pharmacoeconomic evaluation report (Article 6 of the Principles). 

IV. Temporary Payment Review Process

1. After the expert consultation meeting (hereinafter referred to as "Initial Review") accepts a company's proposal or recommends the inclusion of a drug under temporary payment, the NHIA must notify the company and complete the Plan review within a specified period. The decision to include the drug under temporary payment must be made, and the company must be notified to respond whether it agrees to the temporary payment (Articles 7 and 8 of the Principles).

2. For drugs included in temporary payment through the joint formulation meeting for the National Health Insurance Drug Payment Items and Standards, the Plan must be approved by the NHIA within six months after the announcement of the drug's inclusion in temporary payment takes effect. If the Plan is not approved or submitted on time, the temporary payment for the drug will be canceled, and the company must refund the drug costs paid during the temporary payment period (Article 10 of the Principles).

3. If a company agrees to temporary payment, it must sign a drug payment agreement (hereinafter referred to as "the Agreement"), incorporating the Plan into the Agreement. The Agreement's validity period must not exceed five years (Article 11 of the Principles).

4. Companies must submit a reevaluation report (hereinafter referred to as "the Report") to the NHIA six months before the Agreement expires.  Failure to submit the Report on time will result in the termination of temporary payment (Article 12 of the Principles).

5. The NHIA must provide the company with the review results within two months of receiving the Report (Article 14 of the Principles).

 V. Termination of Temporary Payment, Free Provision of Drugs, and Solicitation of Patient Group Opinions

1. During the effective period of the Agreement, temporary payment will be terminated if any of the following conditions occur (Article 13 of the Principles):
a. The drug permit license is revoked or canceled by the competent authority.
b. The company requests termination in writing with a clear reason and obtains approval from the NHIA.
c. Other special circumstances agreed upon by both parties.

2. Before the Agreement expires, if any of the following conditions occur, the company must provide the drug free of charge during the transition period:
a. The company fails to submit the Report within the specified timeframe, resulting in the termination of temporary payment (Article 12 of the Principles).
b. The joint formulation meeting determines a new payment method, but patients do not meet the new payment conditions, or if the NHIA does not provide benefits for patients who have already used the drug (Article 15 of the Principles).

3. The NHIA must publicly solicit opinions from patient groups before holding the Initial Review and during the review of the Plan (Article 19 of the Principles).