Belimumab, the First and Only Biologic for Systemic Lupus Erythematosus, Included in China's 2020 National Reimbursement Drug List

Today, GlaxoSmithKline (GSK) announced that belimumab (brand name: Benlysta), the first and only biologic agent approved globally for the treatment of systemic lupus erythematosus (SLE), has been included in the 2020 National Reimbursement Drug List (covering basic medical insurance, work-related injury insurance, and maternity insurance). This marks the inclusion of belimumab in the national reimbursement list within its second year on the market.

Systemic Lupus Erythematosus (SLE) is a complex chronic autoimmune disease characterized primarily by multi-organ involvement, with a predilection for women of childbearing age aged 15–45 years. Data indicate that under conventional treatment, nearly two-thirds of patients experience at least one episode of disease activity (chronic disease activity or relapsing-remitting pattern) during a 7-year follow-up period, and 50% of patients develop permanent organ damage within 5 years of disease onset.

According to Professor Zeng Xiaofeng, Director of the Department of Rheumatology and Immunology at Peking Union Medical College Hospital, there are currently nearly one million patients with systemic lupus erythematosus (SLE) in China, predominantly women of childbearing age. For a long time, the management of SLE in China has been characterized by insufficient medical resources and limited drug availability. Therefore, urgent challenges in current SLE treatment include better control of disease activity, delaying organ damage, reducing adverse drug reactions, and improving quality of life. “Clinical studies have shown that after 52 weeks of belimumab treatment, 50% of patients achieved an improved disease response rate and symptom relief. Long-term, standardized therapy yields significant clinical benefits for patients. However, for the majority of patients, the financial burden prevents them from adhering to long-term, standardized treatment.”

Since its approval in China in July 2019 for the treatment of adult systemic lupus erythematosus (SLE), belimumab was further approved in December this year for pediatric SLE indications (for patients aged 5 years and older). It is recommended by the "2020 Chinese Guidelines for Diagnosis and Treatment of Systemic Lupus Erythematosus" for SLE patients who have inadequate response, intolerance, or relapse after treatment with corticosteroids and/or immunosuppressants. Through this national medical insurance negotiation, belimumab has been included in the 2020 National Reimbursement Drug List. With medical insurance reimbursement, the actual out-of-pocket treatment costs for patients will be significantly reduced.

Wang Xinguang, Vice President and Head of Corporate Affairs, Market Access, and Commercial Operations at GSK, stated that belimumab, as a breakthrough innovative therapy in GSK’s lupus treatment portfolio, has witnessed the government’s emphasis on reducing the burden of chronic diseases—including lupus—and its support for innovative medicines, from its introduction into China last year to its recent inclusion in the National Reimbursement Drug List.

(Editor:Wang Xing）

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