Improvement to the post-marketing management for pharma

will be discussed comprehensively by the end of this year

Unified mechanism research results will be reflected…the actual transaction price survey will proceed as before

If the confirmation of the re-evaluation targets is delayed, it may be difficult to proceed next year

A comprehensive discussion regarding the post-marketing management program of pharmaceuticals, including actual transaction price-based drug price reduction and re-evaluation of pharmaceutical reimbursement, is anticipated once research results become available at the end of this year.

 

Improvement plans to the actual transaction price-based drug price reduction and re-evaluation of pharmaceutical reimbursement programs have already been discussed with the pharmaceutical industry.

 

However, with the release of the 'Research on a Unified Mechanism for Post-marketing Drug Price Management,' commissioned by the Ministry of Health and Welfare, scheduled for the end of this year, the policy is to conduct a comprehensive discussion based on results.

 

On September 9, the Ministry of Health and Welfare officially announced the detailed operational guidelines for adjusting the ceiling price based on its actual transaction price survey, which is conducted once every two years.

 

The survey will target 19,588 drugs and inspect 104,275 medical institutions from July 1 of last year to June 30 of this year.

 

However, as before, public and national hospitals will be excluded from the survey.

 

Additionally, low-priced drugs, discontinuation-prevention drugs, narcotics, orphan drugs, radiopharmaceuticals, artificial perfusion solutions, and oxygen·nitrous oxide are excluded.

 

Oxygen and nitrous oxide were added to the list of excluded items this time.

 

Discussions on improving the actual transaction price reduction program began late last year.

 

Based on the 'Research on Improving the Actual Transaction Price-Based Drug Price Reduction System' (led by Professor Kim Jinhyun of Seoul National University), which was commissioned by the Health Insurance Review & Assessment Service, a consultative body was formed with the pharmaceutical industry to gather opinions until the first half of this year.

 

The consultative body discussed issues such as abolishing the 10% price reduction cap and including public and national hospitals in the survey.

 

The proposal to include public and national hospitals in the survey is a matter that the pharmaceutical industry strongly opposes, as drug dumping is a structural problem in public hospital bidding, where drugs are often awarded for as low as KRW 1.

 

Although the process of gathering opinions from the pharmaceutical industry has been completed, the actual transaction price survey will proceed as before, excluding public and national hospitals.

 

Only oxygen and nitrous oxide were included in the list of excluded items.

 

An industry official said, "We understand that the improvement plan for the actual transaction price-based drug price reduction program will be discussed as part of a discussion with other post-marketing management programs after the unified post-market mechanism research is released at the end of the year." He added, "At that time, the issue of including public and national hospitals may be re-discussed." The improvement plan for the re-evaluation of drug reimbursement appropriateness is also scheduled for re-discussion after the unified post-market management research.

 

The plan was discussed at a subcommittee meeting of the Health Insurance Policy Deliberation Committee last month, but it was not included on the review agenda for the main session.

 

The details of the re-evaluation improvement plan are to change the selection criteria from the existing average claim amount of 0.1% or more over three years (approx.

 

KRW 20 billion) to KRW 10 billion or more, and to expand the condition for not being listed in other countries from fewer than two A8 countries to fewer than three countries.

 

Notably, seven ingredients, including ginkgo leaf extract, were selected for next year, which is the first year of the second re-evaluation phase under the comprehensive health insurance plan.

 

However, with the discussion delayed, the progress of the re-evaluation next year itself is now uncertain.

 

An industry official said, "If the confirmation of the re-evaluation targets is delayed, it may be difficult to proceed next year, considering the time needed to prepare materials like textbooks," and added, "It will be necessary to wait and see how the discussion proceeds after the post-marketing unified mechanism research is released at the end of the year."