The industry watches whether Keytruda (pembrolizumab), which demonstrated treatment benefits in early triple-negative breast cancer, will pass the reimbursement hurdle.

As the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) convenes in October, whether Keytruda will set a ground to expand 17 indications will be watched.

According to the pharmaceutical industry, the HIRA will convene the 7th Cancer Disease Review Committee (CDRC) meeting on October 2nd.

Currently, Imfinzi (durvalumab) and Jemperli (dostarlimab) are applying for reimbursement expansion. The review of Keytruda, which has applied for reimbursement of 17 indications, is garnering attention.

In April, the CDRC review postponed setting the criteria for Keytruda, saying, 'We will reconsider setting the reimbursement criteria when the company submits a supplement for financial contribution.'

While many indications seek reimbursement listing, tiple-negative breast cancer outcome is gaining attention.

MSD presented the KEYNOTE-522 study, which confirmed the overall survival (OS) data for Keytruda in high-risk early triple-negative breast cancer, during the recent European Society for Medical Oncology (ESMO) Congress 2024.

The KEYNOTE-522 study is a Phase 3 clinical trial evaluating Keytruda in combination with cancer chemotherapy as a perioperative adjuvant therapy.

During the median 75.1 months follow-up, Keytruda perioperative adjuvant therapy in patients with high-risk early triple-negative breast cancer significantly improved the OS compared to the placebo group.

Sohn, Joo Hyuk, Professor of the Division of Oncology at Yonsei Cancer Hospital, said, "In early cancer treatment aiming for complete recovery, it is not easy to demonstrate improvement in the OS rate. Improving the OS rate is a meaningful result in that it indicates saving lives of patients with early triple-negative breast cancer."

The experts suggest that since the study results demonstrate clinical data to be considered for reimbursement evaluation, it may be sufficient to prove its effectiveness.

Park Yeon Hee, Professor of the Department of Hematology-Oncology at Samsung Medical Center, said, "With data demonstrating improvement in OS rate, it must be considered for reimbursement review," adding, "Because patients with triple-negative breast cancer are young and economically active, the drug's societal value must be considered as well."

Park added, "For patients, a diagnosis of triple-negative breast cancer diagnosis may have felt like a disaster. Keytruda offers hope to these patients. It is meaningful that early intervention may eliminate the need for follow-up treatment."

The problem will likely be the cost. Because the CDRC review in April stated, 'We will reconsider setting the reimbursement criteria when the company submits a supplement for a financial contribution,' the company may need to make more financial contribution.

However, the experts suggest that reimbursement for the drug may be possible for use in combination with perioperative chemotherapy, where the volume of use at 8 cycles is predictable, when considering its impact on the National Insurance finance.

As the company applies for reimbursement of Keytruda's 17 indications, approval outcome by individual indication is not easily determined. Whether Keytruda's triple-negative breast cancer indication will pass the reimbursement hurdle is not clear.

An industry personnel said, "Keytruda's reimbursement application, including the individual indication with few patients, has drawn attention, but the company is discussing other strategies after not passing the CDRC review," adding, "The company will likely think over the strategy after the upcoming CDRC review now that it has more indications than the initial 13."