• Last updated：2024-08-19
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With the rapid development of medical technologies and the increasing demand from the public and medical community for new medical technologies, medical services, and drugs, the NHIA has introduced several pharmaceutical policy reforms in recent years. These measures aim to expedite the coverage of drugs based on scientific evidence and value considerations, with the goal of maximizing patient benefits, reducing the public's burden, and achieving fairness in healthcare. The relevant measures are as follows.

 1. Diversified Negotiation and Price Discussion Mechanism under National Health Insurance
To expedite the adoption of new drugs into National Health Insurance reimbursement, MoHW recently announced new regulations regarding Managed Entry Agreements (MEA). Under these regulations, NHIA will be able to utilize various negotiation mechanisms to reach agreements with pharmaceutical companies, accelerating the introduction of effective new drugs and ensuring that patients receive more timely treatment and care. 
       In recent years, with the rapid advancement of drug development technologies, various new drugs, such as those for cancer, have been introduced to the market, raising high expectations among many patients. However, these new drugs are often expensive, and their clinical efficacy still requires further validation post-market. To address the financial impact of new drugs on health insurance systems and the uncertainty regarding their efficacy, countries such as the United Kingdom, Italy, Canada, and South Korea have adopted MEA mechanisms. 
       To align the use of new drugs in Taiwan with international standards, the Ministry of Health and Welfare announced on September 19, 2018, an amendment to certain provisions of the National Health Insurance - Pharmaceutical Benefit and Reimbursement Scheme. The amendment introduces reimbursement agreements based on efficacy or financial outcomes, offering various risk-sharing models. These include, after price negotiations, having manufacturers refund a certain percentage of the drug cost based on patients' overall survival, disease-free survival, and clinical efficacy responses, as well as providing fixed discounts, subsidies for part of the drug cost in combination with other drugs, and other diverse methods. This approach allows the NHIA to employ these mechanisms during price negotiations with pharmaceutical companies to expedite the introduction of effective new drugs.

2.Continued Advancement in NHI Coverage Review Procedure
       NHIA indicates that actions taken to advance in expedited adoption of drugs for coverage are as follows:
(1)    Implementation of Conditional Listing: For drugs that have not completed Phase III clinical trials but are clinically urgent, the system will apply, starting in 2023, to drugs that have received accelerated approval from the Food and Drug Administration. This system, designed for urgent clinical needs, allows for temporary coverage to improve drug accessibility for the public. Currently, 4 new drugs and 2 expanded indications have been included under this system, totaling 6 items, including treatments for lung cancer, bile duct cancer, neuroblastoma, leukemia, NTRK gene fusion tumors, and the latest CAR T cell therapy products.
(2)    Establishment a Center for Health Policy and Technology Assessment (CHPTA): On January 1, 2024, the “Center for Health Policy and Technology Assessment ” was created to take charge of conducting HTAs, to help expedite the review of new drugs to be covered by the NHI, and to facilitate exchange and collaboration with specialized international organizations such as NICE, connect with the international society in terms of clinical guidelines, and advance HTA capabilities in our country. The future goal is to establish an Incorporated Administrative Agency. 
(3)    Promotion of new measures for parallel review: Starting in January 2024, new measures for parallel review would be introduced. When manufacturers apply for new drug registration, they can simultaneously apply for reimbursement recommendations from the NHIA. This aims to shorten the waiting time for both lisence review and reimbursement approval. It is estimated that the reimbursement for the drug can be announced as effective within 6 months after obtaining the licens. The planned applicable drugs are as follows:
I.    Drugs treating pediatric or rare serious illnesses or breakthrough therapies for which prioritized review and expedited approval are determined through the registration review by the Food and Drug Administration. 
II.    For drugs that are not yet marketed internationally when applying to be authorized to register in our country.
III.    New drugs manufactured in Taiwan within 2 years after they are commercialized internationally while their registration is being applied for in our country.
IV.    New-composition new drugs that have been commercialized for 5 years in Top 10 medicinally advanced countries yet are researched, developed, and manufactured in Taiwan while their registration is being applied for in our country.
V.    Drugs applying new technologies with relatively better efficacy than existing items covered by the NHI and lower in price. 
VI.    Expanded budget for new drugs: NHIA has managed to increase the budget planned for new drugs, new technologies (including new drugs, new special devices, newly added diagnosis and treatment items - NGS) and Conditional Listing as part of its 2024 NHI global budget, that is, NT$7.093 billion in total, a growth of 116% as compared to the increase of NT$3.819 billion in the 2023 new health technology budget. 
(4)    Planned establishment of the new (cancer) drug fund: NHIA will refer to the use condition of the 2024 NHI fund in the future in order to secure additional budget and to plan the establishment of a new (cancer) drug fund independent of the NHI global budget.