Sanofi's Renvela (Sevelamer Carbonate) for Non-Dialysis Hyperphosphatemia Newly Included in China's National Reimbursement Drug List

On January 18, 2023, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security officially announced the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2022)." The non-dialysis hyperphosphatemia indication for Renvela (Sevelamer Carbonate Tablets) has been newly included in this medical insurance catalog, bringing a new treatment option for patients with chronic kidney disease (CKD) in China. This marks another milestone for Sanofi in further expanding the accessibility of its medications. This indication was officially approved in China in July 2021.
As is known to all, the kidney is the main organ for phosphorus excretion. After the occurrence of chronic kidney disease, renal function is impaired, and the ability to excrete phosphorus can be observed to weaken in stage 2 of chronic kidney disease, leading to phosphorus accumulation in the body and causing elevated serum phosphorus levels. When serum phosphorus levels exceed 4.5 mg/dL (1.45 mmol/L), hyperphosphatemia occurs.
Hyperphosphatemia can directly accelerate the progression of renal failure and mortality. For every increase of approximately 0.3 mmol/L in blood phosphorus: the risk of renal failure increases by 36%, and the risk of cardiovascular death increases by 50%. Therefore, guidelines both in China and internationally recommend initiating phosphate management in the early stages of chronic kidney disease: starting phosphate-lowering treatment when there is progressive or persistent elevation in phosphate levels; the goal of phosphate control is to reduce blood phosphate to as close to the normal range as possible (2-).
Multiple studies have proven that sevelamer significantly improves the long-term prognosis of non-dialysis chronic kidney disease patients with hyperphosphatemia, including delaying the initiation of renal replacement therapy, reducing all-cause mortality, and decreasing cardiovascular event risks. The REVEAL real-world study showed that, compared to calcium-containing phosphate binders, sevelamer significantly reduced the risk of non-dialysis chronic kidney disease patients initiating renal replacement therapy by 16% over three years of follow-up. It also significantly decreased the risk of MACE+ (including non-fatal myocardial infarction, stroke, all-cause mortality, unstable angina, and heart failure) by 12%.
Data shows that with the aggravation of China's aging population and the increasing incidence of diseases such as diabetes and hypertension year by year, the incidence of chronic kidney disease is also on a constant rise. The incidence rate of chronic kidney disease among Chinese adults is as high as 10.8%, and it is expected to become the fifth leading cause of death globally by 2040. After the non-dialysis hyperphosphatemia indication for calcium carbonate sevelamer tablets was included in medical insurance, the cost for patients has significantly decreased. This will greatly reduce the medical payment burden for chronic kidney disease patients in China, bring new hope to frontline treatment, help patients prolong their lives, and improve their quality of life.
Professor Li Wenge, Director of the Department of Nephrology at China-Japan Friendship Hospital, stated: "As a non-calcium phosphate binder for the comprehensive management of hyperphosphatemia in chronic kidney disease, Renvela effectively reduces phosphorus levels while significantly slowing vascular calcification and renal failure progression in non-dialysis patients, thereby reducing mortality risk. The recent inclusion of this indication in the national medical insurance fully covers both dialysis and non-dialysis hyperphosphatemia populations, further improving patient compliance and reducing treatment costs."