“There are plenty approved new drugs; but the problem is that it takes 3 to 5 years for them to be listed in the NHI Benefit Scheme. And during the waiting time, new drugs are simply too expensive for patients,” said Prof Yang Chih-Liang, the superintendent of the NTU Cancer Center.
As the NHI is short of resources to catch up with the growing number of new cancer drugs, the NHIA set strict criteria for the NHI listing and delayed the listing process. This has affected patients’ access to new drugs, as well as the recruitment of subjects for new drug clinical trials.
Prof Yang pointed out that, according to the Declaration of Helsinki, drug companies have the obligation to continue providing the treatments for the subjects who have participated in the clinical trials after the launch of the drug products in that country. Therefore, international drug companies will firstly consider the possibility for the investigational new drugs of being covered by the national health insurance scheme before deciding where to carry out the clinical trials.
The quality of clinical trials in Taiwan has always been the first-class in the Asia-Pacific region. Taking the 3rd generation of target therapies for lung cancer for example, Taiwan recruited more subjects than other countries in 2013. However, patients’ access to the drug has been seriously delayed. The drug was launched in Taiwan in 2017; and not until 2020, the drug was reimbursed by the NHI, said Prof Yang.
Also, the NHI reimbursement conditions are not in line with international treatment guidelines. For example, it is a common international treatment standard to use immunotherapies in combination with chemotherapies as the first line treatment for stage 4 patients. However, Taiwan just started reimbursing immunotherapies as stand-alone therapies last year.
The discrepancy between the NHI reimbursement conditions and international treatment guidelines hugely reduces the number of patients qualified for the treatments, hence affects the recruitment of clinical trial subjects.
【2020-10-30 / United Daily 】
