Debate over fast-track listing of new drugs continues

Patient groups say “Listing period should be shortened through stronger post-evaluation”

Following the press conference by CCEJ, further criticism is expected from the Korean Pharmacists for Democratic Society

Debate continues over the proposed reform of the drug pricing system aimed at shortening the reimbursement listing period for new drugs. On one side are calls to strengthen treatment access, while on the other are concerns that the reform could sharply increase the burden on Korea’s national health insurance budget.

While working bodies like HIRA are preparing to strengthen post-listing control, concerns persist about the effectiveness and potential side effects of expedited listing.

The Korean Pharmacists for Democratic Society, which previously called for reconsideration of the fast-track listing initiative together with the Citizens' Coalition for Economic Justice (CCEJ) last month, plans to hold a briefing session next week to point out issues in the proposed new drug pricing reform.

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On the 10th, the Korea Alliance of Patient Organizations urged the government to promptly implement the fast-track listing and post-listing evaluation system, arguing that delays in national health insurance reimbursement after regulatory approval for anticancer drugs and rare disease treatments are reducing treatment accessibility.

The government recently announced that starting in 2026, it will launch a pilot program for a “fast-track listing–post-evaluation system,” which would shorten the reimbursement listing period for rare disease treatments from the current maximum of 240 days to within 100 days. The alliance called for the swift implementation of the measures.

KAPO emphasized, “Rather than blocking entry at the early stage, it is important to establish a sophisticated post-listing evaluation and management system based on treatment performance.”

Until recently, attention surrounding the drug pricing reform had focused largely on price cuts for already-listed drugs, while the direction of the fast-track listing reform for new drugs received relatively less attention. The pharmaceutical industry, which has little reason to oppose faster market entry, had been cautiously waiting for details of the implementation plan.

However, the issue gained prominence in February when groups including CCEJ, the Korean Association for Serious Diseases, and the Korean Pharmacists for Democratic Society urged reexamination of the fast-track listing policy. They also called for a public hearing on issues including raising the ICER threshold and introducing flexible drug pricing agreements.

Criticism calling for broader social discussion is expected to continue this month. The Korean Pharmacists for Democratic Society is expected to hold a briefing on March 18 on the proposed new drug pricing reform and express opposition to the fast-track listing policy.

An official from the organization said, “Although there are measures to evaluate outcomes and provide refunds if necessary, there are no clear post-management mechanisms, such as price reductions or market withdrawal, after post-evaluation. As the financial burden on the National Health Insurance is expected to surge, preparing countermeasures must be prioritized.”

The official continued, “There are also doubts about whether strengthened post-listing management measures are appropriate for Korea. The briefing will address the impact of the overall new drug pricing reform, including fast-track listing.”

Critics also argue that the reform of the new drug pricing system, like the proposed price cuts for generics, lacked sufficient prior discussion.

A pharmaceutical industry official said, “As with the generic drug pricing reform, this situation arose because sufficient discussion was not conducted before the reform plan was announced. If there had been even a process to coordinate the implementation measures, the current backlash would not have occurred.”