地诺单抗纳入医保没呢？

(denosumab, also known as AMG-162, trade name Prolia) is a bone resorption inhibitor with a unique mechanism of action. It specifically targets receptor activator of nuclear factor kappa B (RANK) ligand, inhibits the activation and development of osteoclasts, reduces bone resorption, and increases bone density.

A randomized, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of this product in the treatment of osteoporosis in postmenopausal women. Patients were randomly divided into 7 denosumab treatment groups [41 to 54 subjects in each group, receiving subcutaneous injection of denosumab 6, 14, 30 mg (all once every 3 months), 14, 60, 100 or 210 mg (all once every 6 months)], an active control group (oral alendronate sodium 70 mg, once a week) and a placebo group. The main evaluation index is the change of the patient's spinal bone mineral density (BMD) from the baseline level after treatment. The results showed that after 12 months, compared with the baseline level, the spinal BMD of patients in the treatment group increased by 3.0% to 6.7%, that in the control group increased by 4.6%, and that in the placebo group decreased by 0.8% (P < 0.001). After 24 months, the spinal BMD of patients in the treatment group increased by 4.13% to 8.89%, while that in the placebo group decreased by 1.18%. The BMD of the hip and distal 1/3 of the radius in the treatment group was also significantly increased compared with the placebo. During this period, there were no significant differences in patient tolerability, BTM levels, and adverse reaction rates between groups. Among the 7 treatment groups, the 60 mg (once every 6 months) group has an ideal balance point in terms of safety and efficacy, and will continue to be used in phase III clinical trials at this dose in the future.

A 3-year randomized, double-blind, placebo-controlled phase III clinical trial FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) evaluated the effectiveness and safety of denosumab in the treatment of osteoporosis in postmenopausal women. Patients were randomly assigned to: treatment (denosumab 60 mg subcutaneously every 6 months, n = 3902) or placebo (n = 3906). The primary outcome measure was the incidence of new vertebral fractures over the 3-year period, and secondary outcomes included the incidence of hip and nonvertebral fractures and the time to first fracture during the observation period. The subjects were aged between 60 and 90 years old, with an average age of 72.3 years. The basic value of spine or total hip T-score was between -4.0 and -2.5 (the average was -2.8). About 23% of the subjects had a history of at least one fracture before entering this trial. All patients also received daily supplements of 1,000 mg of vegetarian calcium and 400 to 800 IU of vitamin D. The results showed that compared with the placebo group, the incidence of new vertebral fractures in the treatment group was reduced by 68% (2.3% in the treatment group, 7.2% in the placebo group, P < 0.0001), the incidence of hip fractures was relatively reduced by 40% (0.7% in the treatment group, 1.2% in the placebo group, P = 0.036), and the incidence of non-vertebral fractures was relatively reduced by 20% (2.3% in the treatment group, 1.2% in the placebo group, P = 0.036). 6.5%, 8.0% in the placebo group, P =0.011).

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 was approved to treat adults and adolescents with giant cell tumor of bone (GCTB), a rare and usually noncancerous tumor.

So is denosumab included in medical insurance?

Unfortunately, denosumab has not entered the domestic market. The price of denosumab 120mg produced by Amgen in the United States is about $3,000. Therefore, the issue of medical insurance still needs to wait. If the patient needs to purchase it, he or she can purchase it through the regular overseas medical service company Medical Companion Travel.