Bayer Korea’s targeted liver cancer therapy Stivarga (ingredient: regorafenib) won approval for expanded coverage as a second-line treatment starting in May, the company said Wednesday.

The recent expansion covers patients who have hepatocellular carcinoma in addition to the existing coverage for patients with gastrointestinal stromal tumors (GISTs), it said.

Stivarga

Through the expanded coverage, liver cancer patients who have been treated with another Bayer drug called Nexavar (ingredient: sorafenib) in first-line treatment will pay 5 percent of drug costs when being treated with Stivarga.

“Hepatocellular carcinoma (HCC) is one of the major carcinomas that occur in Koreans, and many patients in need of anticancer therapies have not had new therapies in the past 10 years except for Nexavar,” said Korean Liver Cancer Association Chairman Park Jong-won. “It is fortunate that [these patients] have hope for new treatment with Stivarga’s reimbursement as a second-line chemotherapy drug.”

The coverage is expected to increase the treatment accessibility and reduce the financial burdens of patients who have liver cancer, which is the second leading cause of cancer deaths in Korea, Bayer Korea said.

Stivarga is a once-daily, oral prescription multi-kinase inhibitor that works by blocking certain proteins on certain normal and cancer cells.

According to Bayer Korea, Stivarga has proved to improve the overall survival rate of patients statistically. The expanded reimbursement is based on safety, and efficacy data of Stivarga from a multinational, multicenter, randomized, double-blind, placebo-controlled RESOURCE 3 trial on liver cancer patients whose disease progressed despite first-line treatment with Nexavar.

The drug is approved to treat metastatic colorectal cancer, gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma in Korea. It first gained the Ministry of Health and Welfare’s approval as a second-line treatment for liver cancer in July last year.

Related : Bayer gets domestic approval for liver cancer drug

Bayer Korea noted that Stivarga gained reimbursement through a risk-sharing agreement with the health authorities for patients who have been previously treated with Nexavar.

An RSA is a system wherein pharmaceutical companies share the financial burden of a drug due to the uncertainty of the therapy’s efficacy and effectiveness. Most medicines that gain coverage through RSAs do not have substitutes or treatments that have a similar therapeutic effect.

yjc@docdocdoc.co.kr

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