Will the MM drug Tecvayli finally be reimbursed in Korea?

Clears DREC review 3 years after approval…raising hopes for the introduction of an additional treatment option

Other bispecific antibodies, including Elrexfio and Talvey, remain nonreimbursed

Tecvayli, a novel treatment for multiple myeloma, has completed the Health Insurance Review and Assessment Service stage of the reimbursement process nearly 3 years after receiving marketing authorization in Korea.

According to industry sources, Janssen Korea’s bispecific antibody Tecvayli (teclistamab) recently passed HIRA’s Drug Reimbursement Evaluation Committee.

The decision follows the drug’s Korean approval in July 2023 and its passage through the Cancer Drug Deliberation Committee in May. Tecvayli’s progress is being welcomed in the field, as reimbursement of new therapies has been particularly slow in multiple myeloma.

Multiple myeloma remains an incurable disease, but in the past, survival rates were very low due to limited treatment options.

In recent years, however, innovative treatments such as monoclonal antibodies, CAR-T therapies, and bispecific antibodies have expanded treatment options and improved survival.

In fact, over the past 20 years, the five-year survival rate for multiple myeloma patients has increased from 29.8% in 2001-2005 to about 50.1% in 2017-2021. However, this remains below the 60% survival rate in developed countries such as the United States, and limited access to care is widely regarded as a major contributing factor.

In Korea, only 13 (52%) of the 22 drugs recommended in the NCCN guidelines for multiple myeloma are covered by reimbursement (based on the NCCN guidelines 2024 v2).

For example, Darzalex (daratumumab) was approved in 2019 as a first-line combination therapy for multiple myeloma, but was only granted reimbursement as a fourth-line monotherapy in Korea.

It was not until October last year, roughly five years later, that the DREC recognized the appropriateness of expanding the reimbursed use of Darzalex under its risk-sharing agreement. Also, Xpovio (selinexor) was granted reimbursement in July 2024, after 4 reimbursement attempts since its approval in 2021.

Bispecific antibody therapies for multiple myeloma simultaneously bind a target antigen on myeloma cells and CD3 on T cells. While some BCMA×CD3 bispecific antibodies are IgG2 kappa antibodies derived from two monoclonal antibodies, Tecvayli is a full-size IgG4-PAA bispecific antibody that redirects T cells to BCMA-expressing myeloma cells, offering a novel therapeutic approach.

Despite their high clinical utility, Tecvayli and other bispecific antibodies, including Elrexfio (elranatamab) and Talvey (talquetamab), all remain unreimbursed in Korea. Therefore, attention is now focused on whether Tecvayli can clear price negotiations with the National Health Insurance Service and complete the final stretch of its reimbursement journey.

Tecvayli was approved based on results from the Phase 1/2 MajesTEC-1 study. In the trial, which evaluated the efficacy and safety of the drug in a total of 165 patients, Tecvayli achieved an overall response rate (ORR) of 63% in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more therapies, including triple-class exposure to a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Also, 32.7% of the patients achieved a stringent complete response (sCR).

Also, 6.7% and 19.4% of patients showed complete response (CR) and very good partial response (VGPR), respectively. The median time to first response was 1.2 months, and the duration of response (DOR) was analyzed to be 18.4 months (14.9-not estimable).