‘RSA may be applied to non-rare innovative new drugs'

If they demonstrate effect and innovativeness

Director Chang-Hyun Oh “Part of measure to ensure appropriate compensation for drug price of innovative drugs… the scope of innovativeness under discussion”

Will disclose plans for systemic improvement within the year

Chang-Hyun Oh, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare

The Ministry of Health and Welfare announced it will improve its policy to allow innovative new drugs to be listed for reimbursement through the risk-sharing assessment (RSA) track even if they are not anticancer or rare disease treatments if they demonstrate a clinical effect.

 

If allowed, it is expected that the scope of drugs that are applied RSA will increase, and more drugs that are not designated as rare disease may be promptly listed for reimbursement as long as they have a good effect.

 

Chang-Hyun Oh, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare, said so at the ‘Discussions for the national measure to manage life-threatening rare diseases’ that was held at the National Assembly on the 6th.

 

Director Oh said, “Only anticancer drugs and rare disease drugs are currently applied RSA, however, we plan to pave the way to take the innovativeness of drugs into account and apply RSA to those drugs.

 

We are discussing how to apply RSA to drugs that clinically demonstrate an improvement in quality of life by determining the scope of recognizing innovation for drugs.” Director Oh reiterated the need to set an appropriate drug price compensation policy for innovative new drugs that the ministry had announced as an improvement task this year.

 

Although the ministry had been flexible in applying the reimbursement listing system to life-threatening diseases until now, Director Oh said that the ministry will introduce a system that can improve patient access to drugs that were not designated as rare disease drugs in the future.

 

Director Oh said, “We will discuss measures to allow the application of RSA to treatments that are not designated as rare diseases to allow compensation of their appropriate drug price as long as the treatments have verified their efficacy.

 

For example, diseases such as generalized pustular psoriasis and short bowel syndrome have not been designated as rare diseases, but we will set a standard that can recognize the innovativeness of these treatments as well.” He added, “Although pharmaceutical companies would need to share a part of the burden, we will contemplate ways to open up opportunities for new reimbursement listings this year.

 

We haven’t decided on to what extent we will be recognizing the innovativeness, but will make more efforts under the policy goal of expanding access to new drugs.”