Applying for reimbursement extensions to 13 indications at the same time is an unprecedented move. This move was made by MSD Korea for its immuno-oncology drug Keytruda (pembrolizumab), and the case has been marked as a ‘historical first’ ever since the introduction of the positive-listing system in Korea.

Applying for the reimbursement of 13 indications is not an easy task. Since Keytruda is a risk-sharing agreement (RSA) drug, each indication must undergo an evaluation process similar to that of a new drug to be eligible for reimbursement.

Indications approved through Phase III trials must go through a pharmacoeconomic evaluation review to prove cost-effectiveness, while those approv