[Reporter's View] Approval-to-reimbursement takes only 6 mth

Expanded scope of the GIFT may be necessary

The Ministry of Food and Drug Safety (MFDS) has been operating the 'Global Innovative products on Fast Track (GIFT)' since 2022.

 

GIFT is a 'Program Supporting the Expedited Review of Global Innovative Products' launched by the MFDS, aiming to quickly launch medicines for life-threatening diseases, such as cancer, and rare diseases, as well as those demonstrating innovativeness.

 

It is intended to deliver these medicines to patients quickly.

 

According to the MFDS, 55 items have been designated as GIFT over the past three years.

 

Significant achievements have been made; for example, 39 items among these were approved.

 

Notably, GIFT-designated products, which are treatments for severe and rare diseases, are a good fit for the 'concurrent approval-evaluation-negotiation pilot program' led by the Ministry of Health and Welfare since 2023 and are generating synergistic effects.

 

The 'concurrent approval-evaluation-negotiation pilot program' is a system that supports expedited National Health Insurance listing by conducting MFDS product approval, Health Insurance Review & Assessment Service (HIRA) reimbursement evaluation, and National Health Insurance Service (NHIS) drug price negotiation in parallel.

 

Previously, the process from approval to reimbursement took over 300 days: 120 days for MFDS approval, 150 days for HIRA evaluation, and 60 days for NHIS negotiation.

 

This pilot program has shown that such procedure was cut by about half.

 

Candidates for the pilot program must meet specific criteria, such as treatments for cancer or rare diseases with a life expectancy of less than one year, a small patient population, the absence of alternative treatments, and demonstrated superior efficacy with over two years of survival.

 

As such, GIFT-designated products are the optimal candidates.

 

All five products selected for the pilot program so far have been GIFT products: Recordati Korea's Qarziba (dinutuximab beta), Ipsen Korea's Bylvay (Odevixibat), Curocell's LimKato (anbasel), UCB's Fintepla (fenfluramine), and MSD's Winrevair (sotatercept).

 

Currently, Qarziba, Bylvay, and Winrevair have received expedited approval.

 

Qarziba, in particular, was reimbursed from December 1, 2024, completing the process from approval to drug pricing in just six months.

 

In terms of results, both the GIFT program and the 'concurrent approval-evaluation-negotiation pilot program' are welcome developments for the industry and for improving patient access.

 

However, even though the systems have been in operation for two to three years, their scope remains limited, and there are concerns for broader implementation.

 

While the GIFT program has established a preferential drug pricing regulation for new drugs developed by innovative pharmaceutical companies, only five products (2.6%) that received expedited review under GIFT have been approved.

 

The selection criteria for the 'concurrent approval-evaluation-negotiation pilot program' are also so stringent that it is difficult to select more products, even from the GIFT list.

 

Although the government is aware of the need for expanded operation based on the systems' records, there is a perception that many issues still need to be resolved regarding staffing and inter-ministerial communication.

 

As the necessity of these systems is proven by their results, there may be a need to focus on expanding the expedited review and 'concurrent approval-evaluation-negotiation pilot program.'