地诺单抗是否纳入医保？

(Denosumab) is a RANK ligand (RANKL) inhibitor with a different mechanism of action than currently approved drugs that reduce skeletal complications of tumors. It is a fully humanized monoclonal antibody (IgG2 monoclonal antibody) that specifically targets receptor activator of nuclear factor-κB ligand (RANKL). It prevents RANKL from binding to its receptor substances, inhibits osteoclast activation and development, reduces bone resorption, and increases bone density. On November 18, 2010, denosumab was approved to prevent bone-related events caused by cancer that has spread to the bone. On June 13, 2013, denosumab (denosumab) was approved to treat adults and adolescents with giant cell tumor of bone (GCTB), a rare and usually noncancerous tumor. So is Denosumab (Denosumab) included in medical insurance?

On October 26, 2018, Amgen Pharmaceuticals submitted a marketing application in China. Denosumab (Denosumab) was approved by the National Medical Products Administration in May 2019 for the treatment of giant cell tumor of bone that is unresectable or where surgical resection may cause severe functional disability, including adults and adolescent patients with skeletally mature disease (defined as at least 1 mature long bone and body weight >45 kg). The price of 120 mg of denosumab produced by Amgen in the United States is about $3,000, and it is currently not included in medical insurance.

A one-year, double-blind, randomized controlled phase III clinical trial, DECIDE, compared the effectiveness and safety of denosumab and alendronate. A total of 1,189 postmenopausal women were enrolled. The average baseline T-score of the lumbar vertebrae of the enrolled patients was -2.6, and the average age was 64 years old. Patients were randomly divided into: treatment group (60 mg subcutaneous injection of this product, once every 6 months, n = 594), control group (oral alendronate sodium 70 mg, once every 6 months, n = 595). All subjects were supplemented with 500 mg of calcium per day, and the dose of vitamin D was adjusted based on plasma 25-hydroxyvitamin D levels. After 12 months, it can be observed that the BMD of both groups increased at all detection sites (hip, spine, femoral neck, trochanter, and distal 1/3 of the radius), but the increase in the treatment group was more significant than that of the control group (the primary endpoint of total hip BMD increased by 3.5 and 2.6, respectively, P <0. 000 1). The incidence of adverse reactions was similar between the two groups. A patient survey showed that the majority of patients (77%) preferred to receive twice-yearly subcutaneous injections of denosumab.

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