The implications of Keytruda’s reimb expansion

Lung cancer–focused coverage expands to broad reimbursement across 13 cancer types, including women’s cancers and gastric cancer

A notable case of expanding coverage through risk-sharing agreements without indication-specific pricing

MSD Korea’s immune checkpoint inhibitor Keytruda (pembrolizumab) is expected to complete the process of expanding its reimbursed indications at the Health Insurance Policy Deliberation Committee (HIPDC) meeting scheduled for today (the 23rd).

Following approval by the committee, Keytruda’s reimbursement will be significantly expanded from January next year, increasing from the current 7 indications across 4 cancer types to 18 indications spanning 13 cancer types.

This marks the culmination of a process that began with the reimbursement application in 2023—nearly three years in the making. Beyond the numerical addition of reimbursement for 9 additional cancer types and 11 new indications at once, the decision signifies enhanced treatment accessibility for previously underserved cancer types.

It also stands as a significant precedent, having found a breakthrough for expanding reimbursement indications under the existing RSA framework before the government’s formal introduction of its indication-specific drug pricing system.

According to industry sources on the 23rd, the National Health Insurance Service's Health Insurance Review and Assessment Service (HIRA) will vote on expanding Keytruda's reimbursement indications at its meeting today at 2 PM.

Starting next January, Keytruda will be reimbursed for gastric cancer, esophageal cancer, endometrial cancer, colorectal cancer, squamous cell carcinoma, cervical cancer, breast cancer, small cell lung cancer, and bile duct cancer. Previously, reimbursement was applied to 7 indications across 4 cancer types: non-small cell lung cancer, Hodgkin lymphoma, melanoma, and urothelial carcinoma.

While coverage was previously concentrated on non-small cell lung cancer, the expansion will now allow insurance coverage for a broader range of patients, including those with women’s cancers such as endometrial, breast, and cervical cancer.

Furthermore, for several cancer types, including endometrial cancer, small cell lung cancer, and bile duct cancer, reimbursement will be extended to patients with MSI-H (microsatellite instability-high) tumors, significantly improving access for patient groups that had previously been excluded from treatment options.

A milestone in multi-indication coverage ahead of indication-based pricing

Keytruda, which received a multi-indication approval, has long been at the center of discussions surrounding the potential introduction of an indication-based pricing (IBP) system in Korea.

While the government recently announced plans to introduce IBP through a drug pricing system reform, concrete measures have yet to be finalized. In this context, Keytruda's case can be seen as an example where the Health Insurance Review and Assessment Service (HIRA), the National Health Insurance Service (NHIS), and the pharmaceutical company found a broad solution for expanding coverage within the current Reimbursement Strategy Agreement (RSA) framework.

With several other multi-indication therapies awaiting reimbursement review, this case is expected to serve as a reference model for future reimbursement decisions, regardless of whether IBP is formally adopted.

Keytruda currently holds approvals for 18 cancer types and 35 indications, so further attempts to expand reimbursement coverage are anticipated going forward.

Of course, this expansion of Keytruda's indications does not eliminate the need for IBP. How the government's drug pricing system will accommodate blockbuster drugs with multiple indications remains an unresolved policy challenge.

However, the significance of Keytruda's recent coverage expansion lies in its active use of RSA to achieve results effectively approaching an indication-based pricing system. The case is meaningful not only for enhancing patient access to treatment but also for clarifying the extent to which existing reimbursement mechanisms can be leveraged to address complex multi-indication therapies.