Announcement of dual pricing system

for domestically produced new drugs

Policy to strengthen reimbursement management for expensive new drugs, including refund system and prior approval system

The Ministry of Health and Welfare is expected to include the application of a refund-type risk-sharing system for innovative new drugs in the plan to provide appropriate information on the innovative value of new drugs to be announced soon.

 

In order to improve accessibility to rare disease treatments, the company announced its position to carefully review the plan to expand the scope of drugs from children to adults by omitting the submission of economic evaluation data.

 

In the case of reimbursement management for expensive new drugs, we plan to implement policies to minimize uncertainty in financial impact by applying a patient-based performance-based reimbursement system, implementing a prior approval system, and setting standards for discontinuation of medication.

 

On the 19th, the Ministry of Health and Welfare responded as follows to a written inquiry from People Power Party lawmaker Lee Jong-seong on the government audit.

 

◆Application of the dual pricing system = Regarding the expansion of the refund-type risk-sharing system to prevent Korea from passing and promote the overseas expansion of domestically developed new drugs, the Ministry of Health and Welfare said, "We are reviewing a plan to improve the drug price system to appropriately compensate for the innovative value of new drugs." We also agreed on the need to ensure profitability and support the overseas export of R&D-invested new drugs, such as conducting domestic clinical trials.

 

In particular, they announced that they will prepare appropriate measures, including the application of a risk-sharing system (dual pricing system), to the extent that they do not conflict with WTO trade issues in order to promote the overseas expansion of domestically produced new drugs and strengthen price competitiveness.

 

◆ Expansion of drugs subject to PE data = In order to strengthen patient accessibility to new drugs for serious diseases such as cancer and rare diseases, the Ministry of Health and Welfare has revised related regulations since January of this year to allow for rapid listing of new drugs with a small number of patients and clinically proven to improve quality of life.

 

He explained that he is operating it by adding it as a PE omission target.

 

Crysvita, a new drug for the treatment of hypophosphataemic rickets in children, was administered on May 1, an example of rapid reimbursement due to a revised regulation.

 

At the same time, the Ministry of Health and Welfare expressed its position that social discussion is needed regarding the expansion of drugs subject to PE omission to adults and that it should be pursued with caution.

 

It should be taken into account that the PE omission system is an exceptional operation in which the cost-effectiveness evaluation is determined based on the listed price of the excluded country.

 

◆Improvement of the orphan drug coverage rate = In relation to the improvement of the orphan drug coverage rate, the Ministry of Health and Welfare aims to strengthen coverage of treatments for expensive severe diseases and has launched two items to treat rare pediatric diseases with a life expectancy of less than one year, no alternative drugs, and sufficient improvement effect.

 

They announced that they are conducting a pilot project to simultaneously conduct the Ministry of Food and Drug Safety approval evaluation, HIRA reimbursement evaluation, and NHIS drug price negotiation in the second half of this year.

 

It was announced that reimbursement management would be strengthened by applying a patient-based performance-based reimbursement system for high-priced new drugs, implementing a prior approval system, and setting standards for discontinuation of medication to minimize uncertainty about financial impact.