Improve the reimb system to accommodate high-priced drugs

Including the RSA and pharmacoeconomic evaluation exemption systems

HIRA holds forum on improving reimbursement management… MOHW “setting priorities in insurance coverage is important”

The government expressed its will to reform the reimbursement management system with the emergence of super-expensive new drugs.

 

At the ‘Forum for the reimbursement management of high-priced pharmaceuticals,’ Yoon Seok Yang, Director of Ministry of Health and Welfare’s Division of Pharmaceutical Benefits, said, “Concern is what I first feel when a deputy director in charge reports that a new high-priced drug was released.

 

This is why we have no choice but to agree at least in direction that we need to improve the reimbursement system, such as the risk-sharing system and the pharmacoeconomic evaluation exemption system to ensure access for the patients.” With Novartis Korea's ‘Kymriah inj (tisagenlecleucel)’ that passed deliberation by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service marking the start, the imminent entry of ultra-high-priced one-shot treatments that cost 500 million to 2 billion won per shot including ‘Zolgensma (onasemnogene abeparvovec)’ are increasing government’s concerns.

 

The government’s basic plan is to use the current systems in place, including the RSA and PE exemption system, to improve access to such ultra-high-priced new drugs.

 

Yang said, “We are assessing what factors to prioritize when evaluating the cost-effectiveness of such drugs.

 

In other words, a well-established post-management system would be most important in terms of policy.” Yang added, “As it would cost hundreds of millions of won per administration, the pharmaceutical companies would first need to present reasonable grounds for the use of such drugs, and from the perspective of managing reimbursement, we have no choice but to focus on post-management.

 

HIRA and NHIS would have to establish a reimbursement management system.”

Viewers show interest in the reimbursement listing of ultra-high-priced drugs and its post-managemen at the live YouTube forum on high-priced new drugs

Ae-Ryun Kim, NHIS’s Deputy Minister of the Pharmaceutical Management Division, said “High-priced new drugs have been granted reimbursement using various systems, including the approval-reimbursement linkage system or RSA.

 

In particular, the cost-effectiveness of high-priced drugs that were applied the PE exemption system is difficult to determine, and this is why the need for a post-management system has been continuously raised.” Kim added, “When establishing a post-management system, we need to consider the subjects, method and use and collection of data in its design.

 

For example, HIRA believes that tighter management would be needed in the future for Kymirah, as the measure to refund a certain amount of the cost when patients do not see an effect as well as an expenditure cap was set for the use of the drug.” DREC Chair Jung Shin Lee.

 

Emeritus Professor of Oncology at Asan Medical Center, said “Times have changed.

 

In the past, it was all about the quality of the drug, but now discussions are focused on patient results, and end with its cost.” “Spinraza marked the start of this discussion, and more expensive drugs will continue to be introduced.

 

As Phase III data isn’t sufficient, the only way for us to cover the drugs is by using post-management.” At the forum, criticism also arose regarding introducing ultra-high-priced drugs through the PE exemption system.

 

Eun-Young Bae, Professor of Pharmacy at Gyeongsang National University, said “In terms of value assessment, rather than PE exemptions, work should be done to evaluate insufficient information, identify which parts are important, and collect relevant data.

 

Also, reevaluations should be conducted for PE exemption drugs.” Patient groups on the other hand expressed that the approved drugs should be promptly listed rather than be managed for reimbursement, even if they are ultra-high-priced.

 

Eun-Young Lee, Director of the International Alliance of Patients Organizations, said, “Safety measures and patient protection needs to be discussed thoroughly, and I know HIRA and NHIS are contemplating on how to manage reimbursement of such high-priced drugs.

 

For high-priced drugs, prompt access to the drugs is of utmost importance, even more so than patient accessibility in general.

 

If the patients do not get access to the drugs in time, it wouldn’t be effective.

 

Promptness is most important.”