With the government announcing a major overhaul of its reimbursement policy for the use of anticancer drug combination therapies, there are various predictions on what specific methodology would be adopted.

Curiosity is also growing about the scope of reimbursement that will be granted among the numerous combination therapies available, as well as when it will be applied.

#In particular, as the MOHW has only announced the overhaul without providing any specific details, pharmaceutical companies, healthcare professionals, and patients are paying close attention and offering various predictions.

According to industry sources on the 28th, the Ministry of Health and Welfare recently announced a partial amendment to the “Detailed Standards for the Application of Medical Care Benefits” with the main focus on improving the reimbursement policy for combination therapies. If confirmed as is, the amendment will be applied starting next month.

The key point of the amendment is to completely change the reimbursement method for combination therapies, which has recently emerged as a major option in cancer treatment.

Over the past five years, a total of 54 combination therapies using anticancer drugs have been approved in Korea. Among these, 28 involved adding new drugs to existing ones, while 26 involved combining two new drugs.

However, if a new drug that is not covered by insurance is added to a drug that is already covered, it is considered a new therapy, and the existing drug is also no longer covered, placing a significant burden on patients. Furthermore, as combination therapy has become a trend in new drug development not only in Korea but also in the global market, controversy has repeatedly arisen whenever a new combination is approved in Korea.

Amidst this controversy, the MOHW decided to add the following content to the revised notice: “In cases where anticancer therapy already granted reimbursement is used in combination with other anticancer drugs, the existing coinsurance rate shall apply to the existing anticancer therapy.”

The MOHW added, ”In accordance with the HIRA announcement that the drug administration standards for anticancer therapy will be changed, the cost burden regulations will also be revised accordingly.” For reference, the MOHW also provided HIRA's contact information instead of its own in the administrative notice.

Following the administrative notice, patient groups and related organizations such as the KRPIA unanimously welcomed the MOHW's policy.

However, as no further details have been provided, questions surrounding the specific methodology are growing.

Based on the announcement alone, it is unclear whether all anticancer drugs that are currently reimbursed regardless of indication will immediately be granted the same coverage when used in combination with other anticancer drugs starting in May.

Even if individual treatments are currently covered by reimbursement, if they are approved for new indications when used in combination and are not covered by reimbursement, there is uncertainty as to which of the treatments will be covered by reimbursement after the administrative notice is finalized. This naturally leads to the question of whether the more expensive or less expensive one of the two drugs will be reimbursed.

In addition, there are questions about whether combination therapies that have been approved by the MFDS based only on progression-free survival (PFS) data without overall survival (OS) data will be reimbursed under the MOHW's new policy.

Accordingly, the industry, especially the multinational pharmaceutical companies, is paying close attention to the HIRA Cancer Disease Deliberation Committee meeting scheduled for the 30th. If the MOHW administrative notice is finalized at the end of this month, the industry expects the additional details to be announced at the CDDC meeting held at the end of April.

At a CDDC meeting in October last year, HIRA established deliberation principles for discussing whether to approve reimbursement for major combination therapies and has been gathering opinions from relevant academic societies.

A CDDC member, who is a university hospital professor, said, “In previous discussions, HIRA did not allow the use of drug A with reimbursement and drug B with 100% coinsurance just because their combined use was approved by the MFDS. Instead, we decided to discuss it if a request was made through the collection of opinions from academic societies.” He added, ”Even if it is approved by the MFDS if reimbursement is granted as is, it will cause problems with insurance finances, so this would require the Cancer Drug Review Committee’s control.”

He added, “We were originally scheduled to discuss the opinions on combination therapy reimbursement proposed by each academic society at the end of this month. We will focus on the recommendations made in the guidelines for anticancer drugs, but it is questionable whether it is possible to switch all the recommended therapies to reimbursement at once given the current situation.”

This is why there are concerns in the frontline about what will happen if the MOHW's announcement is implemented in May.

Some are fearing possible reimbursement cuts.

With the MOHW's policy on combination therapy announced, a series of inquiries have already been pouring in from patients during outpatient visits.

A professor of hematology and oncology at a tertiary hospital, who requested anonymity, said, “HIRA has gathered opinions on the reimbursement of combination therapy through academic societies, but it is still questionable whether everything can be applied in May. I am concerned that there will be cuts when we file the claims.”

He added, ”In the case of multiple myeloma, combination therapy is always used for each stage of treatment. Moreover, the number of high-priced treatments has been increasing recently,” he said, expressing his concern, ”If reimbursement cuts are made, hospitals will suffer considerable damage. We must prepare for all possibilities.”

As a result, if the MOHW's policy is applied as is to clinical practice, the sequencing itself, including the number of treatment sequences, will differ for each type of cancer.

A pharmaceutical industry official explained, “Although this policy is being promoted specifically for anticancer drugs, issues of equity with other diseases are bound to arise in the future. If this policy is limited to anticancer drugs, the entire sequencing in clinical practice will change. If some drugs are used in the first line because they are reimbursed, there may be cancer types for which there are no treatment options that can be used with reimbursement in the second line.”

The insider concluded, “Considering all these factors if the May notice is finalized, it could cause significant confusion in practice and the pharmaceutical industry. While patients may welcome this development, it is an issue that requires more systematic discussion.”