Discussions on expanding benefit for Jakavi's GVHD are slow

Difficulties in expanding coverage of new treatment options for GvHD

Discussions on expanding insurance coverage for Jakavi's Graft-versus-Host Disease (GvHD) indication have been sluggish.

 

According to the industry, Novartis Korea Jakavi passed the harmaceutical Reimbursement Criteria Subcommittee of the Health Insurance Review and Assessment Service last February, but it has not been submitted to the Financial Impact Assessment Subcommittee, which is a step before the Pharmaceutical Reimbursement Evaluation Committee.

 

In May 2022, after obtaining indications for graft-versus-host disease in Korea, the drug submitted an application for an extension of coverage.

 

However, after being put on hold for more than 8 months, discussions on salary have begun.

 

GvHD is a serious complication that can occur after an allogeneic hematopoietic stem cell transplant (allo-SCT).

 

The transplanted donor's T cells recognize the patient's normal cells as foreign substances and attack them, affecting various organs such as the skin, gastrointestinal tract, liver, and lungs.

 

As symptoms can appear throughout the body, GvHD poses another challenge to patients who have survived allogeneic hematopoietic stem cell transplantation and affects their quality of life.

 

Steroids are used as the first-line therapy, but about 50% of them fail, and in these cases, standard treatment has not yet been established, so there is an unmet demand for effective treatment options.

 

Jakavi is an option for the treatment of patients with acute or chronic graft-versus-host disease aged 12 years or older who do not respond adequately to prior corticosteroid therapy in these circumstances.

 

Kim Hee-jae, chairman of the Korean Society for Hematopoietic Stem Cell Transplantation (Professor of Hematology at Seoul St.

 

Mary’s Hospital), said, “Jakavi has shown good effects through clinical studies in the treatment of acute and chronic patients, and similar results have been shown in actual practice.

 

“It opens up new possibilities for many patients,” he said.

 

Jakavi has proven its efficacy in GvHD through the phase 3 REACH2 study.

 

As a result, the overall response (OR) on day 28 of the Jakavi-administered group was 62% (96/154), which was higher than that of the control group, Best Available Therapy (BAT)-administered group, 39% (61/155).

 

On the 56th day, the durable overall response was confirmed to be 40% (61/154), about twice as high as 22% (34/155) of the control group.

 

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