When will Keytruda’s reimb be reviewed by DREC?

Estimated claims amount is currently under evaluation

In the process of evaluating the possibility of preliminary price cuts for a drug that expanded its scope of use

DREC review unlikely before September; reimbursement expansion within the year uncertain

Attention is focused on when Keytruda, for which reimbursement standards were set for 11 indications in February, will be submitted to the Drug Reimbursement Evaluation Committee (DREC) for review.

 

This is because, although the reimbursement standards were established by the Health Insurance Review and Assessment Service's Cancer Review Committee, the barrier of DREC remains.

 

According to industry sources on the 15th, HIRA is currently evaluating the estimated additional claims for Keytruda.

 

This process is conducted to decide whether to apply the preliminary drug price reduction system for drugs with an expanded scope of use.

 

The preliminary drug price reduction system for drugs with expanded scope of use is a system designed to quickly increase patient access to treatment by omitting cost-effectiveness evaluations.

 

It applies a pre-determined reduction rate to reduce the insurance price ceiling for drugs by up to 5% in consideration of the estimated additional claims resulting from the expansion of reimbursement criteria.

 

However, this system is applied only when the expected claims amount is between KRW 1.5 billion and KRW 10 billion.

 

If the expected claim amount exceeds KRW 10 billion, the drug price is adjusted through negotiations between the National Health Insurance Service regarding the expansion of the drug's approved indications.

 

In February, the National Health Insurance Service set reimbursement criteria for 11 additional indications for Keytruda.

 

MSD requested reimbursement expansion in 2023, and after 5 attempts, the expansion was finally approved by the National Health Insurance Service on the company’s 6th attempt.

 

At that time, the reimbursement criteria were set for stomach cancer, esophageal cancer, endometrial cancer, colorectal cancer, squamous cell carcinoma, cervical cancer, breast cancer, small intestine cancer, and bile duct cancer.

 

After setting the reimbursement criteria, HIRA reported it to the MOHW.

 

After review, MOHW requested HIRA to review the preliminary drug price reduction for drugs with an expanded scope of use.

 

It is expected to take some time before the application can be submitted for DREC review, as the relevant work must be completed first.

 

Some predict that it will be difficult for the matter to be submitted to the DREC even in August.

 

This is because the analysis of the expected claims amount will take a long time due to the large number of indications, and the pharmaceutical companies must also go through the process of accepting the preliminary drug price reduction.

 

Even if it passes DREC review, negotiations with the National Health Insurance Service remain, and it is uncertain whether its reimbursement will be granted and listed within the year.

 

Due to the complicated reimbursement process, some in the industry believe that the introduction of indication-specific pricing should be considered.

 

However, health authorities remain cautious about introducing such a system.

 

Whichever the cause, the patients are likely to face a long wait.

 

However, it is a positive sign that HIRA recently added 12 indications for Keytruda to the partial reimbursement list as part of anticancer combination therapies, reducing the financial burden on patients.

 

With the partial reimbursement, the other therapies included in the combination, excluding Keytruda, are covered by health insurance.