'Discussion on changing pathological examination medical fee needs to happen faster'

Customized treatment for cancer patients has become possible with the development of immunotherapies.

However, Korea’s outdated reimbursement for pathology tests, a prerequisite for using immunotherapy, has become a stumbling block for faster anticancer treatment, pathologists and oncologists said at a news conference, held by Ono Pharmaceutical and BMS on Thursday.

“There has recently been a number of cases where pathology tests are set as the reimbursement standard for new anticancer drugs,” Professor Kim Tae-jung of the Department of Hospital Pathology at St. Mary’s Seoul Hospital said. “Therefore, not only drugs but also pathology tests have a significant influence on the establishment of treatment strategies.”

According to Kim, Korean hospitals conduct pathology tests, such as companion and complementary diagnosis, to check the presence and rate of programmed death-ligand 1 (PD-L1) expression before using immunotherapies.

The difference between companion and complementary diagnoses is the medical fee.

“While companion and complementary diagnosis require the same manpower, resources, and data, they are classified as either Level I or II according to the purpose of use,” Kim said. “If the drug indication is limited to patients who meet certain conditions, and screening through a pathology test is necessary, it is approved as a companion diagnosis and receives Level II fee.”

If the drug obtained indications for all patients without any additional conditions, the pathology test is performed for the purpose of predicting treatment response rather than selecting patients, and it is classified as a complementary diagnosis and receives a Level I fee, which is lower than Level II, Kim added.

As the schedule for revising the fee for pathology examination from Level I to Level II is always late compared to the reimbursement of a certain drug, patients may miss the timely treatment time, Kim said.

Even if the regulator starts discussing changing complementary diagnosis to companion diagnosis, it is impossible to predict when it will be implemented as there are no regulations that set a deadline for such discussions, he added.

During the media session, Professor Rha Sun-young of the Department of Oncology at Yonsei Cancer Center gave a real-world example.

“In September 2021, the reimbursement of Opdivo (ingredient: nivolumab) was expanded to cover PD-L1-positive head and neck cancer patients, but the revision of companion diagnostics fee related to the expanded indication was delayed by one month from when the drug reimbursement was applied,” Rha said. “As a result, it delayed the drug’s prescription in the hospital by two to three months.”

As a way to solve the problem, Rha stressed that it is necessary to advance the review period for pathological examination changes at least one month before the start date of drug reimbursement.