Starting Feb. 1, Janssen Korea's anti-CD38 antibody Darzalex (daratumumab) will be covered as a first-line treatment for multiple myeloma.

The Ministry of Health and Welfare held this year’s first Health Insurance Policy Review Committee meeting on Thursday and decided to expand the scope of multiple myeloma treatment and adjust the upper limit of the drug price.

Multiple myeloma is one of the three primary blood cancers, along with leukemia and malignant lymphoma, and is a rare and incurable disease difficult to cure.

Until now, Darzalex has been reimbursed only for patients who have relapsed after receiving three treatments or who have not responded to treatment.

From now on, however, it will be available in combination with bortezomib/thalidomide/dexamethasone in the first-line treatment of multiple myeloma as a DVTd four-drug regimen.

It comes six years after Darzalex received benefits as a monotherapy for relapsed or refractory relapsed multiple myeloma.

The DVTd 4-drug regimen demonstrated clinical utility in the global phase 3 CASSIOPEIA study in newly diagnosed multiple myeloma patients eligible for hematopoietic stem cell transplantation. Compared to conventional induction regimens (VTd and VRd 3-drug regimens), it significantly improved progression-free survival and overall survival.

Based on this result, the U.S. National Comprehensive Cancer Network (NCCN) guidelines and the European Society for Medical Oncology (ESMO) clinical practice guidelines now recommend DVTd for newly diagnosed multiple myeloma patients who are candidates for stem cell transplantation.

The expanded coverage will also significantly reduce patient burden.

The reimbursement price of Darzalex will be lowered by 5 percent from the current price to 364,703 won ($255) for 100mg and 1,458,813 won ($1,020) for 400mg after being applied with risk-sharing (total limit type and refunding type) system.

Accordingly, patients prescribed Darzalex for multiple myeloma will have to pay about 45 million won per person per year but will now pay only 2.27 million won per year with a 5 percent co-payment.