The long wait for new drugs to be included in the NHI Benefit Scheme has always been severely criticized.  The waiting time is even longer for new cancer drugs, almost twice as long as average.  In 2022, the waiting time for a new cancer drug to be listed by the NHIA reached 787 days.  In order to accelerate the process, the NHIA collaborated with the TFDA and the CDE to launch the parallel review mechanism.  Under this mechanism, applicants can apply for the new drug license and the NHI listing at the same time.  The process will be shortened from 16 months to 12 months.  The NHIA plans to launch this mechanism next January.

All new drugs must firstly pass the drug review and approval process before they can apply for NHI listing.  The drug review and approval process takes more than 200 days.  Tsai Shu-Ling, the Deputy Director-General of the NHIA, said that the parallel review mechanism will expedite the process.  Once the drug license is issued, the NHIA will immediately hold the “NHI Drug Dispensing Items and Fee Schedule Joint Establishment Meeting” to process the application of NHI listing. 

 “This mechanism is designed with patient’s best interest in mind,” said Tsai.  In order to address the criticism of the lengthy NHI listing process, the NHIA has been looking at various measures for improvement, including setting up the Cancer Drug Fund and the aforementioned parallel review mechanism. 

Lin Ya-Hui, Executive Director of the Taiwan Healthcare Reform Foundation, expressed that the new mechanism only aims to accelerate the initial review process; however, it does not address the issues of a growing cancer population, expensive new drugs, NHI drug pricing policies, NHI’s financial burden, crowding out effects, etc.  Lin suggested that the NHIA should increase its funding sources to fix the problem from the root.

Tsai Shu-Ling mentioned that under the parallel review mechanism, drug companies will be required to prepare some documents in advance, for example the HTA dossier.  The NHIA will further explain to drug companies the mechanism and its requirements in the second half of this year.  It is up to drug companies to decide whether to apply for a parallel review or not.  TFDA officials said that drug review and approval is conducted according to the Pharmaceutical Affairs Law; and they respect the relevant policies promoted by the NHIA.

Ma Yi-Jin, the CEO of the Taiwan Cancer Foundation, said that despite the fact that cancer patients have to wait 787 days for a new cancer drug to be listed by the NHI, the reimbursement conditions are usually very strict and about 70% of the cancer patients are not eligible for them.

Patient groups hope that the access to new drugs and their reimbursements could be brought into line with international practices.  This means to accelerate the provision of genetic tests, new drugs and combination therapies which are proven to be able to improve patients’ conditions and quality of life.

【2023-07-04 / United Daily】