“Cut prices of generic drugs across the board”

Revoke approval of drugs that did not demonstrate bioequivalence

Prof. Yong-jin Kim of the Seoul National University Hospital stressed the reprioritization of reimbursement

“76.9% of the public agree on maintaining current insurance premiums while differentiating coverage for mild vs. severe diseases”

Calls for expanded fast-track reimbursement, coverage, and post-marketing management… urges flexible decisions

A proposal has been made to establish reimbursement priority for treatments targeting rare/serious diseases versus mild conditions, thereby expanding access to new drugs.

 

There were also calls to reform the distorted pharmaceutical budget structure by cutting generic prices across the board and canceling approvals for products lacking bioequivalence data.

 

At a National Assembly forum on improving the operation of health insurance finances for rare and severe diseases, hosted on the 26th by lawmakers Mi-hwa Seo and Jong-tae Jang, participants stressed the need to allocate limited insurance resources more effectively to improve access to new drugs.

 

Prof.

 

Yong-jin Kwon of Seoul National University Hospital’s Public Healthcare Center

Professor Yong-jin Kwon of Seoul National University Hospital’s Public Healthcare Center said, “The National Health Insurance system has reached a structural contradiction.

 

While pharmaceutical spending exceeds the OECD average, access to innovative drugs remains restricted, depriving patients of treatment opportunities.

 

Coverage for rare and severe diseases should have expanded, but instead, it has regressed.” Professor Kwon called for ▲Reestablishing reimbursement priorities, ▲reforming the drug management system , and ▲expanding access to new drugs.

 

He explained that a survey conducted last July of 1,000 citizens showed significant public agreement on prioritizing coverage for patients with rare and severe diseases.

 

According to the results, 46.7% agreed with prioritizing severe disease patients, and 52.7% supported prioritizing rare disease patients.

 

However, 76.9% responded that while premiums should be maintained at the current level, coverage should be differentiated.

 

Prof.

 

Kwon said, “This suggests there is sufficient basis to regard reprioritization as being highly feasible.” Professor Kwon proposed the following improvement measures ▲establishing a National Health Insurance Priority Committee with public participation ▲implementing blanket price reductions for generic drugs and fostering competition, and ▲introducing a fast-track system for rapid listing and flexible benefit determination.

 

Prof.

 

Kwon said, “The share of pharmaceutical expenditures is already high, but the portion spent on new drugs is low.

 

The generic market is driving distortion.

 

We should consider whether this is due to high prescription volumes or high generic prices,” stressing the need to shift reimbursement priorities from mild to severe conditions.

 

He added, “Prioritization should consider disease severity and social costs, as well as risks of treatment delays and potential market failures.” He also argued that generic drug prices should be cut across the board, and generics lacking bioequivalence testing should have their approvals revoked.

 

He stated, “It is unworthy of our national standing that drugs without bioequivalence certification are still circulating.

 

Bioequivalence test results should be made public.

 

Citizens must be convinced that the efficacy and composition are identical.” Furthermore, he called for expanding fast-track reimbursement and flexible decision-making for rare disease drugs.

 

Suggestions included accelerating reviews, granting conditional approvals, and enhancing post-marketing management through fast-track pathways.

 

He concluded, “We must streamline the health technology assessment process and implement conditional approvals.

 

If MFDS approval represents the product, insurance reimbursement represents the technology.

 

Even if not yet officially authorized, reimbursement should be possible based on technological appropriateness.

 

For rare diseases, conditional approval and reimbursement must be adopted, and real-world evidence (RWE) should be leveraged for more sophisticated post-market management.” He added, “Flexible reimbursement frameworks must be expanded.

 

Risk-sharing agreements (RSA) should be applied diversely, such as on a performance-based basis.

 

Patients should also understand that the limited coverage can be gradually expanded over time.”