Pfizer’s Elrexfio fails to pass CDDC's reimb review in KOR

Company expresses will to reattempt reimbursement listing

Series of bispecific antibody treatment options fail to receive reimbursement one after another

New treatment options in the field of multiple myeloma are having difficulty receiving reimbursement listing in Korea.

 

Following the rejection of Janssen Korea’s ‘Tecvayli (teclistamab)' in November last year, Pfizer Korea's ‘Elrexfio (elranatamab)' also failed to pass the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee in February.

 

As the Ministry of Food and Drug Safety designated the drug as a Global Innovative Product on Fast Track (GIFT) and approved it through the fast track, the news was received with a great deal of disappointment in the field.

 

However, the pharmaceutical company's will does not seem to be dampened.

 

A Pfizer representative said on the 19th, “We will again attempt reimbursement to increase treatment access for patients.

 

We will do our best to reduce our patients’ burden.” Multiple myeloma occurs in the plasma cells of the bone marrow.

 

As a blood cancer that mainly occurs in the elderly, its continued treatment can prolong life for the patients.

 

Among the various new drugs being developed in this field, monoclonal antibodies and bispecific antibodies are being used in the medical field.

 

In particular, bispecific antibodies are considered a safe and effective treatment option for relapsed or refractory multiple myeloma, where resistance increases with each treatment cycle, resulting in shorter remission periods and fewer available treatment options upon each line of treatment.

 

The approved bispecific antibody treatment options in Korea, include Elrexfio, Tecvayli, and Talvey (talquetamab).

 

However, all of them are not reimbursed in Korea.

 

Amid the failed discussions over coverage of a series of bispecific antibody drugs in the early stages, whether any drug will be granted reimbursement and improve patient access is gaining attention.

 

Meanwhile, Elrexfio was designated by the Ministry of Food and Drug Safety as a GIFT item and was approved as a monotherapy for adult patients who have received more than three lines of treatment, including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies, in May last year.

 

The US FDA has also designated it as an innovative drug and granted accelerated approval for the drug.

 

Elrexfio’s efficacy was demonstrated through the Phase II MagnetisMM-3 trial, an open-label, multicenter, non-randomized study that was conducted on 123 who had not received prior BCMA-directed therapy (i.e., BCMA-naïve patients).

 

Results of Cohort A showed that the drug recorded an objective response rate (ORR) of 61.0% and a complete response (CR) of 37.4%.

 

The progression-free survival (PFS) period was 17.2 months, and the overall survival (OS) period was 24.6 months, demonstrating an unprecedented long-term treatment effect.

 

The data proved that long-term survival benefits and slowing disease progression can improve the quality of life of patients who have no other treatment options.