Concerns mount over push for 100-day listing of rare disease drugs

Concerns mount over push for 100-day listing of rare disease drugs

Korean Pharmacists' Association for Healthy Society, “Post-listing evaluation plan must come first...concerns over government’s forced implementation in February”

“Drug pricing system reform that excludes citizens and patient groups is an issue...a consultative body needs to be formed”

Concerns are mounting over the government’s plan to list rare disease therapies within 100 days, with critics warning that the absence of concrete post-marketing evaluation measures could ultimately undermine the national health insurance system.

Some point to the lack of sufficient social consensus in the drug pricing reform as the fundamental issue, arguing that a formal discussion body involving civil society groups, patient advocacy groups, and experts should be established before it is too late.

On the 9th, the Citizens’ Coalition for Economic Justice (CCEJ), the Korean Pharmaceutical Association for a Healthy Society, and the Korea Severe Disease Association held a joint press conference to express their opposition to the fast-track listing of rare disease treatments.

Even after the event, Dong-geun Lee, Vice President of the Korean Pharmacists' Association for Healthy Society, repeatedly stressed the problems inherent in pursuing fast-track listing without post-marketing evaluation measures.

Lee emphasized, “It makes no sense to push ahead with the fast-track listing without a post-marketing evaluation plan in place. We have already conveyed our concerns, but the Ministry of Health and Welfare appears intent on proceeding according to a predetermined schedule.” He emphasized that post-marketing evaluation measures must be established first before any fast-track listing is pursued.

The Korean Pharmacists' Association for a Healthy Society maintains that even if the timing of the drug pricing system reform plan, including expedited listing, is delayed, the potential side effects of the policy must be thoroughly examined.

Lee said, “The February Health Insurance Policy Deliberation Committee (HIPDC) decision timeline was also arbitrarily set by the Ministry. Even if the schedule is pushed back, sufficient discussion is necessary. If there is even a draft plan for post-marketing evaluation, it should be disclosed so that meaningful dialogue can take place.”

Lee also warned, “To make listing within 100 days possible, verification would have to be bypassed and prices approved as requested. That kind of timeline is only feasible for drugs exempt from negotiation or for generics. But based on what has been announced so far, rare disease therapies would effectively be eligible for listing without any additional hurdles.”

Given that rare disease treatments often cost tens to hundreds of millions of won, critics argue that if a large number of previously unlisted products are approved, the additional financial burden could exceed one trillion won. Despite this, they say, the government has yet to present any clear plan for securing the necessary funding.

The groups also insist that the results of performance-based evaluations for high-priced drugs should be transparently disclosed to patients. Some rare disease therapies already listed have failed to deliver the expected outcomes, and groups argue that this information must be transparently provided to patients.

Lee said, “Although the ministry has met with patient groups, it appears to be merely notifying them of decisions already made and pushing the policy through. More discussion is needed with citizens, patient groups, and experts. Above all, the government must disclose its basic plans for post-marketing evaluation and funding.”

The Korean Pharmacists' Association for Healthy Society, CCEJ, and patient groups are also continuing discussions on the effectiveness and potential problems surrounding the reform of the generic drug pricing system, suggesting that criticism of the broader drug pricing overhaul is likely to intensify further.