Janssen Korea said that the Ministry of Health and Welfare granted coverage for Sylvant (siltuximab), a treatment for multicentric Castleman disease (MCD), starting Thursday.
"We are pleased to provide a new treatment option for patients with MCD, and Janssen Korea remains committed to improving the quality of life and extending survival for patients suffering from rare diseases,” said Yoo Jae-hyeon, director of Janssen’s specialty business unit.
The reimbursement will bring the cost of the injection to 449,500 ($412) for a 100 mg vial and 1,798,000 ($1,648) for a 400 mg vial for MCD patients who do not have human immunodeficiency virus (HIV) and a human herpesvirus-8 (HHV-8) infection, according to the Korea Pharmaceutical Information Center. The ministry initially approved the drug in December 2015.
MCD is a form of Castleman disease that affects multiple, as opposed to a singular, sets of lymph nodes and other tissues. The symptoms of the disease are often general and include fever, enlarged lymph nodes, night sweats, and weakness and fatigue.
Although the disorder has a high mortality rate, no cure currently exists. Around 35 percent of patients die within five years of diagnosis, Janssen Korea said.
“MCD is a proliferative disease that acts very much like lymphoma. Accurate diagnosis at hemato-oncology department is a priority for proper treatment,” said Professor Yoon Sung-soo of Seoul National University Hospital.
Sylvant is the only FDA-approved treatment for multicentric Castleman’s disease patients who are HIV and HHV-8 negative. The anti-interleukin-6 (IL-6) chimeric monoclonal antibody drug is also the first and only MCD treatment to be reimbursed in Korea, the company said.
The drug’s efficacy and safety were demonstrated in a randomized, double-blind, multi-national, placebo-controlled study MCD 2001, the company said.
<© Korea Biomedical Review, All rights reserved.>