More than seven months have passed since MSD Korea’s application for expanding coverage for 13 indications of Keytruda (pembrolizumab) was stuck in the Cancer Disease Review Committee (CDRC), prompting anxious patients to request the review of individual indications.

Contrary to MSD Korea's intention to ensure that no indication is marginalized due to the company's priorities, the government's review period could be stretched indefinitely and become a "wrong move" for patients in urgent need, turning the industry's concern into reality, industry insiders said.

The Health Insurance Review and Assessment Service (HIRA) recently released the results of its first cancer review meeting of the year, which included a "reconsideration" decision on expanding Keytruda's coverage.

The latest review dealt with Keytruda’s remaining six indications, including early-stage triple-negative breast cancer. As the panel previously made the “rediscussion” decision for the other seven indications on two previous occasions, it shelved discussions on all 13 indications.

However, HIRA said it would first review each indication's medical feasibility and necessity for Keytruda. Afterward, it will analyze the impact by submitting a financial sharing plan from the pharmaceutical company for the total finances of the proven indications and discuss whether to set a reimbursement standard, according to HIRA officials.

According to some sources, MSD Korea has not received a financial sharing plan from HIRA. So, whether the cancer review committee will even recognize all or part 13 of Keytruda's indications as valid is unknown.

This indefinite delay in the review process for Keytruda's coverage expansion has led to growing frustration among cancer patients who find it difficult to wait further.

For example, a group of triple-negative breast cancer patients recently asked MSD to reapply for coverage of Keytruda's indication.

The organization emphasized that coverage of Keytruda for triple-negative breast cancer is urgent and necessary due to the young age of patients, the rapid rate of deterioration, and the lack of alternative treatment options.

"Over time, we have accumulated data showing the effectiveness of Keytruda's pre and postoperative adjuvant therapy in early-stage triple-negative breast cancer, and doctors who were hesitant to recommend it in the past due to its non-reimbursement are now actively recommending it," said Lee Du-ri who represents triple-negative breast cancer patients’ group.

Lee explained that some patients receiving Keytruda without coverage who have achieved complete remission with Keytruda upfront are taking self-help measures by skipping postoperative adjuvant therapy due to financial burden, adding that patients in poorer financial situations may feel marginalized because they have no choice.

Lee also called attention to the desperate situation of patients with metastatic triple-negative breast cancer.

"Patients with triple-negative breast cancer are often young, so their children are still young. Their families try to persuade them to undergo treatment by selling their homes or borrowing money, but they don't want to strain their families by undergoing treatment that won't cure them," Lee said. "If they can afford it, they'll take it, but right now, patients and their families are facing a double whammy of conflicts over Keytruda treatment.”

Lee went on to say, "Recently, we strongly requested MSD Korea to consider the triple-negative breast cancer indication separately, but the company seems to be sticking to its stance of applying for all 13 indications at once. We hope the government will recognize patients' financial burden and the urgent need for treatment."