MoHW and NHIS agree on need to expand expedited listing

need to discuss priorities

At the National Assembly forum, “Improvements should be made to expedite listing in line with the government agenda”

Yoo-kyung Yoon, Director-General of Pharmaceutical Management, “We need to set a roadmap for efficient fiscal use”

Yeon-sook Kim, Director-General of Pharmaceutical Benefit,” Drug pricing system must reflect innovative value of new medicines”

The Ministry of Health and Welfare (MoHW) expressed consensus on the need to expand fast-track reimbursement to improve access to treatments for rare and severe diseases.

 

As the government agenda already includes system improvements to reflect the innovative value of new drugs, the ministry stated its intent to support these reforms.

 

On the 26th, at a forum on improving the operation of the National Health Insurance finance hosted by Representatives Mi-hwa Seo and Jong-tae Jang, the government, industry, and academia all voiced the need to expand fast-track reimbursement for rare disease treatments.

 

Yeon-sook Kim, Director-General of the Pharmaceutical Management Division at MOHW

Yeon-sook Kim, Director-General of the Pharmaceutical Management Division at MOHW, said, “Rare and severe diseases are difficult to diagnose, and the small patient population leads to insufficient data.

 

We do regret how the listing process takes a long time, and communication regarding system improvements has been slow.

 

We will gather opinions to develop the system rationally.” Kim added, “This is also included in the government's national agenda.

 

We have decided that the drug pricing system will support the creation of an ecosystem for innovative new drug development by reflecting the innovative value of new drugs.

 

This also includes alleviating the burden of rare and intractable diseases.” "Our goal is to ensure that more necessary drugs are covered quickly through expedited listing and to broaden coverage.

 

Currently, we are also attempting to accelerate the process by concurrently handling approval and listing.

 

The national agenda also comprehensively includes improvements to the drug pricing system.

 

However, as it requires significant social consensus and careful consideration, we will need time to discuss improvement measures." The National Health Insurance Service (NHIS) emphasized the need for a roadmap to prioritize reimbursement and use resources more efficiently.

 

Yoo-kyung Yoon, Director of Pharmaceutical Management at NHIS

Yoo-kyung Yoon, Director of Pharmaceutical Management at NHIS, said, “There are limitations in terms of budget and review manpower, but I agree expansion is necessary.

 

We recognize the importance of prioritization.

 

We need to review reimbursed drugs, set reimbursement priorities, and establish a roadmap for efficient fiscal use.” “We must determine how to select drugs eligible for fast-track, identify issues as the system is implemented, and continuously improve it to ensure prompt reimbursement can be achieved.

 

Adjusting the reimbursement scope requires social consensus, so we will thoroughly gather opinions from stakeholders.” Yoon also emphasized, “Improvements to the generic drug pricing system must also be considered alongside measures to foster a virtuous cycle in the industry.

 

Rapid listing of rare and intractable disease drugs is included in national policy tasks, and we will strive to develop solutions.” The industry expressed that establishing a virtuous cycle structure is urgently needed to enable the development of innovative new drugs for rare and severe diseases.

 

Jae-won Heo, Executive Director at Gilead Sciences Korea

Jae-won Heo, Executive Director at Gilead Sciences Korea, noted, “Hepatitis C, which can progress to liver cancer, already has curative treatments.

 

If patients are treated early, it can actually reduce the financial burden on the NHIS.

 

Data also shows that 20% of cancer patients give up economic activity, devoting much of their time to caregiving.

 

Supporting their return to society carries significant value.” Heo explained, “The number of patients is small, but development is extremely difficult, and companies inevitably face heavy burdens.

 

Even after more than 10 years of research, it is not uncommon to see results showing no clinical effect.

 

Despite failures, companies continue to develop treatments because patients exist.

 

A virtuous cycle must be established so development is feasible,” urging expansion of new drug access.

 

Professor Yong-jin Kwon of Seoul National University Hospital

Criticism also emerged that the government should not show a passive attitude toward coverage for rare and severe diseases, and that Aative review of the generic drug pricing system is also necessary.

 

Professor Yong-jin Kwon of Seoul National University Hospital's Public Healthcare Center pointed out, "New drugs are approved, but they aren't even used as non-reimbursed treatments, so they don't show up in the statistics.

 

The coverage rate appears high, but that's because no treatment exists.

 

In reality, the coverage rate for rare diseases isn't high.

 

Furthermore, care costs are not factored in.“ Kwon further criticized, “NHIS does not examine how much value has been generated (so far) from the high prices paid for generics and the development of innovative R&D treatments.

 

How much have domestic pharmaceutical companies advanced over the past 25 years?

 

We need to evaluate the outcomes and discuss the development of the pharmaceutical industry.” stressing the need to reform the generic pricing system.