Pharmaceutical News
HPA, NHIA and TFDA work together to care for patients with rare conditions
2020/12/27

The Health Promotion Administration (HPA), the National Health Insurance Administration (NHIA) and the Taiwan Food and Drug Administration (TFDA) have been working together to provide the care for patients with rare diseases.   Currently, the NHI spends about NT$6-7 billion a year on 115 NHI-reimbursed drugs for 42 rare conditions.  The health authorities also provide special nutrients, emergency drugs and medical devices for patients, as well as set up logistics centers in charge of the procurement, storage and supply of products and offer supports for carers.

Dr Lee Po-Chang, the Director-General of the NHIA, pointed out that the NHI aims to provide services for every patient in need with the patient’s best interest at heart.  For example, from July 1st, the NHI started providing the SMA drug which is the most expensive NHI-listed drug so far, costing NT$9 million per patient a year.   There are about 40 patients qualified for this treatment; and the total drug fees will be NT$400 million a year.

Dr Lee Po-Chang pointed out that it takes about 9.7 months for a new drug to be listed in the NHI Benefit Scheme; but it takes less time for the drugs for rare diseases.  However, for drugs for rare diseases, the biggest challenge is that they are usually expensive, and the price negotiation with drug companies is very time consuming.

Wang Ying-Wei, the Director-General of the HPA, explained that the HPA’s tasks are to fill the gap left by the NHI.  Most patients with rare conditions require home care; therefore, the access to equipment and devices for home care is very important.  The Rare Disease and Orphan Drug Act was revised to provide subsidies on 4 types of home care equipment and devices (respirator, oxygen generator, blood oxygen monitor and expectoration machine) with a view to improve patients’ quality of life and to reduce their financial burden.

Wu Hsiu-Mei, the Director-General of the TFDA, pointed out that the 10-year market exclusivity rights is provided as an incentive to encourage drug companies to apply for the marketing authorization of drugs for rare diseases.  Regulatory guidance is also available to help drug companies file the drug license application. 

The TFDA’s target is to increase the number of licensed drugs for rare diseases, instead of providing the drugs via the route of special importation.  From 2011 to 2018, the number of drug items via special importation fell from 35 to 21 items; and the number of licensed drugs increased from 39 to 89. 

The implementation of the Rare Disease and Orphan Drug Act has further strengthened the care for the vulnerable; however, the increasing price of drugs for rare diseases is a threat to the national healthcare system.  Also, as the technology advances, some conditions will be disqualified for rare diseases; and the government will have to establish an exit mechanism.  This will have impact on patients, too.

【2020-12-22 / United Daily News】