Novartis’s Jakavi makes a step towards reimb for GvHD

as a treatment for Graft-versus-Host Disease

Passes Drug Reimbursement Evaluation Standard Subcommittee review... coordinating the date for its review by the Drug Reimbursement Evaluation Committee

Jakavi offers a new treatment option in a field that lacks appropriate treatment options

‘Jakavi’ is now one step closer to extending reimbursement to Graft versus Host Disease (GvHD) in Korea.

 

According to industry sources, Novartis Kroea’s Jakavi (ruxolitinib) recently passed deliberation by the Drug Reimbursement Evaluation Standard Subcommittee.

 

The next step is for the drug to be reviewed by the Drug Reimbursement Evaluation Committee.

 

Novartis Korea submitted an application to extend reimbursement for Jakavi (ruxolitinib) to Graft-versus-Host Disease (GvHD), immediately after receiving approval for the indication in May 2022.

 

The application passed review after being pending at this stage for 8 months.

 

GvHD is a potentially serious complication that may occur after allogeneic stem cell transplantation.

 

When the donor’s T cells (the graft) view the patient’s healthy cells (the host) as foreign and attack and damages them, affecting various organs including the skin, the gastrointestinal tract, the liver, and the lungs.

 

As symptoms can appear throughout the body, GvHD poses another challenge to patients who have survived allogeneic hematopoietic stem cell transplantations by affecting the patient’s quality of life.

 

Steroids are used as standard first-line therapy, but unmet needs exist as no standard-line therapy exists in the second-line for the 50% of patients that fail treatment in the first-line.

 

In this area, Jakavi arose as an option that can be used to treat patients aged 12 years and older with acute or chronic GvHD who have an inadequate response to corticosteroids or other systemic therapies.

 

Hee-Jae Kim, the Chief Chair of the Korean Society of Blood and Marrow Transplantation (Professor of Hematology at the Catholic University of Korea), said, “Jakavi demonstrated superior effect in treating acute and chronic GvHD patients in clinical studies and has shown similar results in the field, and opened up new possibilities for patients suffering from the lack of an appropriate treatment option” Meanwhile, Jakavi has demonstrated its efficacy in the Phase III REACH2 trial.

 

Results showed that the overall response rate with Jakavi at Day 28 was 62% (96/154), compared to the 39% that was achieved with the best available therapy (61/155) Also, the durable overall response was found to be twice higher in the Jakavi group at Day 56 at 22% (34/155) compared with 40% (61/154) in the control group.