Belimumab for Adult Lupus Nephritis Included in China's 2023 National Reimbursement Drug List

ShanghaiDecember 13, 2023PR Newswire -- December 13, 2023, GSK China announced that its biologic Benlysta (generic name: Belimumab for Injection) for the treatment of adult lupus nephritis (LN) has been included in the National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug List (2023) (hereinafter referred to as the National Medical Insurance List). As the world's first biologic to cover both adult and pediatric systemic lupus erythematosus (SLE) and adult lupus nephritis indications, the inclusion of its adult lupus nephritis indication in the National Medical Insurance List will significantly improve the accessibility of this innovative biologic, helping adult lupus nephritis patients manage their disease with long-term standard care, aiming to achieve organ protection and improved prognosis.

Belimumab is the only biologic agent recommended by the Chinese guidelines, EULAR (European Alliance of Associations for Rheumatology) guidelines, and KDIGO (Kidney Disease: Improving Global Outcomes) guidelines, and has been approved by the National Medical Products Administration of China for the treatment of systemic lupus erythematosus. Currently, its approved indications in China for adult and pediatric systemic lupus erythematosus and adult lupus nephritis have been included in the National Reimbursement Drug List*.

Systemic Lupus Erythematosus (SLE) is an autoimmune disease that affects multiple systems throughout the body. Among its complications, lupus nephritis is one of the most severe. Approximately 40%-60% of SLE patients present with lupus nephritis at the onset of the disease, with a recurrence rate as high as 33%-40%. Each recurrence may lead to further organ damage. About 20% of patients with lupus nephritis progress to end-stage renal disease (ESRD) within 10 years of diagnosis.ⁱ, the need for kidney dialysis or kidney transplantation is an important cause of death in SLE patients.ⁱⁱ

Professor Chen Wei, Vice Chairman of the Nephrology Society of the Chinese Medical Association and a professor at the First Affiliated Hospital of Sun Yat-sen University, stated: "Currently, the treatment for lupus nephritis is mainly based on a regimen combining steroids with immunosuppressants. However, nearly 60% of patients still experience persistent disease activity or repeated relapses. Additionally, follow-up studies in China show that more than half of SLE patients suffer from organ damage. Existing treatment options have issues such as low renal remission rates, high recurrence rates, and significant toxic side effects from long-term medication. The recent inclusion of belimumab for lupus nephritis in the National Reimbursement Drug List (NRDL) has greatly improved patient access to this drug. After medical insurance reimbursement, the actual treatment costs paid by patients have significantly decreased, offering more possibilities for the long-term standardized management of the disease to reduce relapses and achieve organ protection."

The "2019 Chinese Guidelines for the Diagnosis and Treatment of Lupus Nephritis" propose: The ultimate goal of treating lupus nephritis is to improve the long-term survival rates of patients and their kidneys, as well as enhance their quality of life.ⁱⁱ. The treatment of lupus nephritis requires continuous long-term therapy from induction to maintenance. Induction therapy should be individualized, and the duration of maintenance therapy after achieving complete remission should last at least 3 years.ⁱⁱLong-term maintenance of hormones should ideally be reduced to within 7.5 mg/d, and if possible, discontinued.ⁱⁱThe 2023 European Alliance of Associations for Rheumatology Systemic Lupus Erythematosus Management Guidelines (i.e., EULAR Guidelines) indicate: For all patients with active proliferative lupus nephritis, consider belimumab at the start of treatment (induction phase).1b/A] or calcineurin inhibitors (CNIs) combined with MMF/CYC [1a/A] and hormones.ⁱⁱⁱ

BLISS-LN Study is the largest and longest Phase 3 clinical trial globally for active lupus nephritis, enrolling 448 patients over a period of two years. This study aims to evaluate the efficacy and safety of belimumab in adult patients with active lupus nephritis. The research data were published in the September 2020 issue of the New England Journal of Medicine. Compared with standard therapy, the combination of belimumab during the induction phase demonstrated statistically significant differences across all four primary endpoints. These include the renal response rate (PERR) at 104 weeks of treatment, complete renal response (CRR), time to renal-related events or death, and overall renal response (ORR).

Vice President and General Manager of GSK China, Qi Xin, stated: "GSK is committed to enhancing the accessibility and affordability of innovative medical solutions for patients in China. Thanks to the national new drug evaluation policies and medical insurance inclusion, GSK's breakthrough biologic Belimumab has been approved in China for adult lupus nephritis, as well as systemic lupus erythematosus in both adults and children, and has been included in the National Medical Insurance Catalog. This not only provides doctors with more treatment options but also significantly reduces the financial burden on lupus patients. Moving forward, we will continue to collaborate with the government, clinicians, and all sectors of society to ensure that more patients benefit from innovative treatment solutions."

*Limited payment scope of Benlysta (Belimumab for Injection) in China's National Medical Insurance Catalog: 1. In combination with standard therapy, for patients aged 5 years and above with active, autoantibody-positive systemic lupus erythematosus (SLE) who remain highly disease active (e.g., positive anti-ds-DNA antibodies and low complement, SELENA-SLEDAI score ≥8) despite standard therapy; 2. In combination with standard therapy for adult patients with active lupus nephritis.