Hematology society urges retention of insurance coverage for expensive CAR-T treatments

Internal medicine specialists treating blood cancers are expressing concerns about the mental distress caused by reduced insurance benefits for expensive CAR-T treatments, urging that vague reimbursement standards be clarified and expanded to align with global standards.

Last Friday, the Korean Society of Hematology held an academic meeting and press conference to discuss policy issues related to blood diseases and provide policy recommendations.

Since its foundation in 1958, the society has led the development of hematology for more than 60 years. It is a typical multidisciplinary society with specialists in internal medicine, pediatrics, and diagnostic laboratory medicine. Through 12 specialized research groups, the society leads in-depth research and clinical development in each blood disease area.

At the press conference, the society complained that even though innovative new drugs for blood cancer have been developed recently, patients' access to new drugs is limited due to delays in reimbursement despite high drug prices, forcing medical professionals to suffer from mental distress due to unreasonable benefit cuts after reimbursement.

The society cited Kymriah (tisagenlecleucel) as an example. This CAR-T (chimeric antigen receptor T-cell) drug was introduced in Korea in March 2021 and received reimbursement in April 2022.

Kymriah is approved for “the third or subsequent treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory after two or more prior systemic therapies” and “the second or subsequent treatment of relapsed or refractory B-cell acute lymphocytic leukemia (ALL) after relapse or second relapse following transplantation in children and young adults up to 25 years of age.”

The “failure” criteria for previous treatments are crucial, as the number of treatments determines coverage. However, the current reimbursement criteria do not specifically address this, leaving room for interpretation.

For instance, if a patient fails to respond to a second-line drug, the doctor may consider it a failure and move on to the next treatment. However, according to the participants, the government may decide to cut the benefits for not treating the patient until there is a sufficient response.

“Even from the perspective of experts, there is room for disagreement on the interpretation of the Kymriah reimbursement criteria,” said Dr. Kim Hye-ry (Department of Pediatrics, Asan Medical Center), the hematology society’s PR director. “Our society has submitted to the government opinions from overseas scholars on the issues of Kymriah cuts that have already occurred, but the authorities have not accepted it.”

She noted that four to five cases of benefit cuts have occurred since Kymriah’s reimbursement. Despite the high cost of the treatment—over 400 million won ($285,000)—if cuts are made to Kymriah’s reimbursement, which is not subject to pre-screening due to its critical timing, the hospital and its medical staff will bear the full financial responsibility.

“From a doctor's point of view, it is a situation where a patient needs a certain treatment and cannot miss this time, but it may not necessarily meet the insurance standards,” said Dr. Kim Seok-jin (Department of Hematology-Oncology, Samsung Medical Center), the president of the hematology society. “In this case, if the drug is used, the entire treatment cost is not reimbursed, which puts a great burden on the hospital and puts the medical staff in a difficult situation.”

“These cuts are mentally stressful for the medical staff as they are already under a lot of pressure to treat patients,” Kim said. “Even when the patient has recovered and returned to their normal routine, the doctor cannot escape the remaining reimbursement issues.”

The hematology society called for revising the vague reimbursement criteria for CAR-T therapy, claiming that the criteria should be more specific and that coverage should be expanded to meet global standards.

The society reiterated its call to establish a dedicated Hematologic Diseases Review Committee, separate from the Cancer Disease Review Committee (CDRC), to allow for specialized evaluation of treatments for hematologic conditions.