NHIS may cover high-priced new drugs with refund-type RSA

Preferential treatment for innovative PVA drugs under discussion

Director Hae Min Jung of the Department of Drug Management at NHIS “Plans to achieve both accelerated listing and financial soundness at the same time"

The National Health Insurance Service is planning to improve the Risk Sharing Agreement (RSA) Scheme and is also discussing measures to improve the Price-Volume Agreement (PVA) system to reflect rewards for the innovative value of new drugs.

 

The Department of Drug Management at NHIS said so at a press conference with correspondents on the 29th.

 

Hae Min Jung, Director of the Department of Drug Management at NHIS, said “We are reflecting the results of the research service that was conducted to improve the RSA system, and advancing the system to achieve both the rapid listing of high-priced drugs and financial soundness of NHI finances.

 

The demand for expansion of RSA subjects has been increasing, so we are planning to expand the drugs eligible to apply for performance-based refund-type RSA from one-shot treatments to high-priced drugs.

 

We are also considering improving related systems, such as by new types of financial sharing plans.” Jung also added that discussions are underway with relevant organizations and the industry to come up with measures to reduce the administrative burden.

 

Also, additional projects will be carried out for the post-marketing control of drugs that waived the submission of pharmacoeconomic evaluation data, which HIRA is seeking to improve.

 

Jung said, “One of the results of the research service suggested the need for post-marketing management and system improvement for drugs were exempted from the submission of pharmacoeconomic evaluation data.

 

Therefore, we plan to refer to the results of the research service on ‘Preparing measures to improve the PE exemption system’ that has been carried out by HIRA this year and come up with additional improvement tasks.” Since December 2013, when RSA was first implemented, to August 1, 2023, 68 drugs and 123 items have received reimbursement in Korea through the RSA system, and the RSA contract for 18 drugs and 26 items has been terminated.

 

The amount refunded by pharmaceutical companies under the RSA system amounted to KRW 328.1 billion in 2022, and the refund amount has been increasing in line with the rise in the number of RSA contracts signed over the past five years.

 

Hae Min Jung, Director of the Department of Drug Management at NHIS, is answering questions at a press conference held on the 29th

The NHIS is seeking to improve the RSA system to manage high-priced drugs.

 

As of 2022, 14 high-priced drugs costing more than KRW 300 million per person a year had filed claims of KRW 179.3 billion, which is around KRW 420 million per patient.

 

This accounts for around 0.8% of total drug expenditures (KRW 22.9 trillion) spent by the NHIS.

 

37 drugs cost more than KRW 100 million per person a year, and the claims amount of the drugs amounts to KRW 348 billion.

 

Due to these high-priced drugs, drug expenditures in health insurance finances have been increasing by more than KRW 1 trillion every year and reached KRW 22.9 trillion in 2022.

 

This is why NHIS is seeking ways to share the financial risks through the RSA system when listing high-priced drugs, and to minimize the increase in drug costs by reducing prices of drugs that showed a rapid increase in usage through PVA negotiations.

 

The government is also discussing measures for applying preferential treatment to innovative new drugs when applying PVA.

 

This part is being carried out as part of the 'Measures to Improve the Insurance Drug Price System for Appropriate Compensation for the Innovative Value of New Drugs' that is being carried out by the Ministry of Health and Welfare.

 

Jung said, “Improvement plans, such as appropriate compensation for the innovative value of new drugs, may be announced through the Health Insurance Policy Deliberation Committee meeting at the end of September at the earliest.

 

The plan also includes the PVA part, which includes the pharmaceutical companies’ request that new drugs that meet the innovativeness requirements should be exempt from negotiations when they are subject to PVA 3 times in a row.

 

Whether the requests were accepted will be clear when the final plan is disclosed at the end of September.”