Reimbursement talks on first CMV prophylaxis soon to begin

DREC to deliberate MSD Prevymis as Economic Evaluation Committee passed it last month

Clinical study confirmed the medicine inhibiting reactivation of CMV

The reimbursement approval talk is about to get started for Prevymis, a medicine to prevent cytomegalovirus (CMV) infection in stem cell transplant recipient.

 

Korean pharmaceutical industry sources reported MSD’s Prevymis (letemovir) that was passed by Economic Evaluation Subcommittee last month would be deliberated by Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) on May 7.

 

Reactivation of CMV in patients, who have undergone a stem cell transplant, could cause diseases like pneumonia, hepatitis, myocarditis, gastroenteritis and encephalitis.

 

Despite a low level of CMV viral load in blood, it could increase the risk of mortality.

 

A study found that in early hospitalization stage of CMV-positive patients who had stem cell transplant, the risk in overall mortality could be 3.5 times higher than in non-infected patients, whereas the mortality rate in patients with CMV viremia have 2.6 times greater risk of overall mortality than patients with no viremia up to 60 days after the transplant.

 

However, the current CMV treatment in allogenic hematopoietic stem cell transplantation (HSCT) recipients mostly relies on pre-emptive therapy, which injects antiviral medication when the viral load exceeds a certain level.

 

In 2018, Korean Ministry of Food and Drug Safety (MFDS) has approved of Prevymis to be used to help prevent CMV infection and disease in adults who have received an allogenic HSCT.

 

The treatment has both injection and tablet formulation options and it can be administered once-daily from the day of or within 28 days of HSCT for up to 100 days after the transplant The U.S.

 

Food and Drug Administration (FDA) has approved the use of Prevymis in 2017 and also designated it as a Breakthrough Therapy, Priority Review Drug and Fast Track Drug.

 

President Yoon Sung-soo of Korean Society of Hematology (Department of Internal Medicine at Seoul National University School of Medicine) explained, “The limitation of the existing pre-emptive therapy is clear as it initiates treatment only when the CMV viral load reaches the threshold level.

 

The medical demand on Prevymis is surging as it is a crucial treatment option for the survival of high-risk patients.” Clinical studies have confirmed Prevymis hindering the reactivation of CMV and lowering the risk of mortality.

 

The studies reported no observation of adverse reactions like myelosuppression or renal toxicity.

 

In the 2019 guidelines published by the National Comprehensive Cancer Network (NCCN) and European Conference on Infections on Leukemia (ECIL), Prevymis has been recommended as a prophylaxis in CMV-seropositive allogeneic HSCT recipient.