[Reporter's Notebook] For cancer patients, time is life

Ten years have passed since the immuno-oncology drug Keytruda (pembrolizumab) was approved in Korea in March 2015.

Numerous clinical studies and real-world treatments have already proven the innovative therapeutic effects of immune checkpoint inhibitors, and the medical community has emphasized their potential for use beyond cancer for years.

However, the government's approval process for its expanded coverage has been slow. In June 2023, Keytruda submitted its application to cover 13 cancers with high unmet medical needs. After additional submissions, 17 indications are awaiting review. Despite repeated discussions, the government has not presented a clear position for nearly two years.

That reminds me of the four-year delay in expanded coverage for the first-line treatment of non-small cell lung cancer (NSCLC) from 2017.

While the need for treatment was clear, the government delayed the decision, citing the financial burden and equity with existing treatments. This left many patients without access to the global standard of care. Coverage for lung cancer was not expanded until 2022, and Keytruda is now facing the same delays.

The key issue in the Keytruda reimbursement review is the “financial sharing plan.” The government is asking pharmaceutical companies to share the financial burden, and there have been repeated discussions. However, the fact that the reimbursement discussion for a globally recognized standard of care has been stalled for a second year reveals little more than policymaking limitations.

Immunotherapies are now recognized for their ability to treat a wide range of cancers beyond traditional boundaries. Keytruda has shown efficacy in many cancers harboring MSI-H or dMMR mutations and has become the standard of care for many solid tumors.

In major countries, including the U.S., Europe, and Japan, Keytruda's indication expansion has been rapid, and insurance coverage has been more flexible. In Korea, however, the government has been slow to decide, citing financial burdens, which means that patients who need the drug are not receiving it at the right time.

More than a decade after the treatment paradigm shifted, the government has failed to respond while sticking to the old screening method.

Since their inception, immuno-oncology drugs have undergone hundreds of global clinical trials, suggesting that they will be used to treat a wide range of cancers, not just specific cancers. The government should have considered how to cover these multiple-cancer drugs in the health system by, for instance, commissioning a study.

However, the government has kept the existing screening methodology in place rather than devising a new payment model. This is an administrative expediency that ignores the changing times and adheres to existing practices.

Furthermore, it is a dereliction of duty to continue asking pharmaceutical companies to pay their share while rejecting new policy approaches proposed by the industry, such as the “indication-specific drug pricing system.”

For cancer patients, time is life. Without a policy decision to improve treatment access, the endless debates over financial burden effectively deprive patients of a cure.

The government can no longer postpone its responsibility. It is the state's responsibility to implement a reimbursement policy that fits the new treatment paradigm.

To avoid a repeat of the four-year lung cancer reimbursement nightmare, it must start real discussion and decision now.