'Rezurock' for cGVHD enters NHIS drug price negotiation

An alternative for patients who failed first and second-line treatments…attention has been gathered to whether it will become reimbursed within this year

Selective inhibitor of ROCK2…confirmed to have a 75% ORR through clinical trials

Product photo of Rezurock

'Rezurock,' a treatment for the treatment of chronic graft-versus-host disease (cGVHD), has entered the last stage for insurance reimbursement listing.

 

Sanofi Korea and the National Health Insurance Service (NHIS) are currently under negotiations for the drug pricing of the ROCK2 inhibitor 'Rezurock (belumosudil).

 

Rezurock is a pharmaceutical that received Fast Track designation from the U.S.

 

Food and Drug Administration (FDA).

 

It was approved in Korea in August of last year and launched as a non-reimbursed drug in November.

 

Rezurock is notable for selectively inhibiting ROCK2, a signaling pathway modulating chronic graft-versus-host disease (cGVHD)'s inflammatory response and fibrotic process.

 

cGVHD is a complication that occurs in half of patients who received autologous stem cell transplantation.

 

Patients with cGVHD may be few due to the disease's nature, but the disease occurs in half of the patients who receive the transfer.

 

It is a severe and life-threatening disease that requires treatment.

 

cGVHD is a major factor that accounts for 37.8% of the deaths of blood cancer patients, excluding recurrence.

 

Notably, the treatment of chronic cGVHD is becoming more important as the cases of hematopoietic stem cell transplant are increasing every year in Korea (a total of 1,794 cases as of 2023).

 

42% of the transplant patients experience chronic cGVHD on average within 3 years, and 66% of the patients already experience acute cGVHD.

 

However, there is a gap in the treatment strategy.

 

Steroids, recommended as a first-line treatment in both Korean and overseas treatment guidelines, are difficult for long-term use.

 

When used for an extended period, it may cause osteoporosis, joint damage, organ failure, hypertension, upset stomach, and growth suppression.

 

Ninety-six percent of patients with chronic cGVHD use steroids as their first-line treatment.

 

70% of patients receive second-line treatment, and about 50% pursue third-line treatment.

 

Currently, there are no effective third-line treatment options available when second-line treatments fail, forcing patients to rely on combinations of steroids and immunomodulator drugs.

 

Furthermore, 97% of patients with cGVHD who receive steroid treatment experience one or more side effects, and the most frequent side effect is infection (79.5%).

 

Infections in multiple organs significantly lower a patient's quality of life.

 

A host immune response in the lung or liver is fatal.

 

It is to be watched whether Rezurock will become a solid new treatment option with the reimbursement coverage.

 

Meanwhile, Rezurock's clinical trial involved patients who failed to respond to two or more lines of systemic therapy.

 

Patients treated with Rezurock recorded an overall response rate (ORR) of 75%, demonstrating superior effects compared to conventional treatment.

 

Notably, in areas where improvement is difficult with conventional therapy, such as joints, liver, and lung, it also showed ORR of 71%, 39%, and 26%, respectively.

 

Professor Hee-Je Kim in the Department of Hematology at Seoul St.

 

Mary's Hospital (Hematology Hospital's Director) said, "42% of patients with cGVHD have symptoms across the whole body, leading to significant worsening of quality of life.

 

Since the host response that occurs in lung and liver can critically affect patients with blood cancer, treatments that would effectively manage such response have been in need."