Changes will be brought to the health system as a patient's existing co-payment amount will remain the same for ongoing chemotherapy when a reimbursed cancer drug combined with a newly developed, non-reimbursed new drug.

Previously, insurance coverage for combination therapy comprising two drugs was unavailable, placing a financial burden on patients. The recent changes to this policy are viewed positively. However, as more combination therapies with new drug-new drug combinations are being approved, there are discussions about the need to establish procedures.

The Ministry of Health and Welfare (MOHW) has recently issued an administrative notice proposing partial revision to the 'Detailed Criteria and Methods for Applying Reimbursement (Drugs),' which included details on combination cancer therapy.

Previously, if a non‑reimbursed drug was added to a regimen already covered by reimbursement, even the previously reimbursed drugs would lose their coverage, increasing patients' out‑of‑pocket costs.

After the announcement, patient organizations and academics have proposed suggestions. In response, the Health Insurance Review and Assessment Service (HIRA) convened a Cancer Drug Review Committee (CDRC) meeting in October 2024 to establish a review policy for determining the reimbursement status of major combination therapies.

Under the revisions, adding a non‑reimbursed anticancer drug to an existing reimbursed regimen will not affect the co-payment rate for the reimbursed drugs.

In detail, a new clause states, 'When combining a reimbursed chemotherapy regimen with another anticancer drug, the existing co-payment for the previously initiated chemotherapy shall continue to apply to that regimen.'

A pharmaceutical industry employee remarked, "The combination anticancer therapy included in this notice are first-line treatments that account for a relatively small share of the National Health Insurance expenditure, so there have been calls for improvement," and added, "We were expecting changes after the April 30 CDRC meeting, but it's good news to see the draft notification issued so quickly. From a pharmaceutical company perspective, this change is truly significant."

The partial revision notice announced by the MOHW exemplifies the case of AstraZeneca’s immuno‑oncology drug Imfinzi (durvalumab), which was under discussion for biliary tract cancer reimbursement last year.

At that time, the CDRC maintained Imfinzi as non‑reimbursed for first‑line treatment of biliary tract cancer while recognizing reimbursement only for the other combination therapy drugs, gemcitabine and cisplatin chemotherapy (GemCis).

New drug+new drug combination therapy gains attention, demands for improving the reimbursement process↑

As issues for combination therapy comprising an existing first‑line chemotherapy agent with a new drug are likely to be resolved, interest is growing in whether a reimbursement process for "new drug + new drug" combinations can be established.

In fact, with more multinational companies having applied for reimbursement of combination therapies that include innovative anticancer agents, requests for a formalized process have continued.

According to discussions at the March 'Policy forum on improving cancer patient access to combination therapies,' 54 anticancer combination therapies have been approved in South Korea over the past five years. Of these, 28 cases add a new drug to an existing therapy, and 26 are combinations of two new drugs.

In other words, roughly half of the recently approved combination therapies involve two novel agents.

There are suggestions for institutional policies to ensure that reimbursement can be reviewed quickly and rationally when a combination therapy includes drugs from different companies. The Korea Research-based Pharmaceutical Industry Association (KRPIA) has formed a working group to devise solutions.


The government acknowledges the need to improve the system…limitations exist to mandating private companies

A closer look reveals the challenges. When two new drugs from different companies are used for combination therapy, each company's circumstances, such as volume‑based pricing or price-volume agreement, make simultaneous reimbursement applications difficult.

Currently, there is no basis for the two companies to coordinate their reimbursement status. If only one company applies, proving cost‑effectiveness can be problematic, and the therapy may remain split between reimbursed and non‑reimbursed drugs, contrary to the system's intent to reduce patient burden.

While the government acknowledges the need for reforms, it also recognizes that it cannot mandate private pharmaceutical companies to comply.

At the forum, Hee‑Yeon Park of the MOHW explained, "When combining new drugs+new drugs, we need additional measures. We are reviewing various approaches for reimbursement mediation, but there are aspects we cannot mandate due to each company's circumstances."

Several ideas have been proposed similar to official notifications regarding generic drug pricing application cases.

According to pharmaceutical industry sources, generics that enter the market after a delay instead of immediately after the patent expiry file for drug pricing review, HIRA will notify the original manufacturer, allowing the company to decide its response strategy.

There is also a proposal to have HIRA notify other manufacturers when one company applies for an anticancer combination therapy reimbursement. Because companies do not publicly disclose their reimbursement applications, having HIRA coordinate and guide the review could aid in setting the directions.

Additionally, experts have suggested applying a more flexible ICER threshold for combination therapies, recognizing that such regimens typically involve longer treatment durations than monotherapies. Therefore, proven innovative combinations should warrant a relaxed ICER criterion.

A KRPIA official commented, "Several companies have agreed on the need to establish a clear process for combination therapy. We are gathering exemplary cases from abroad and will propose recommendations once we agree on the necessary steps."