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Zoledronic Acid- Reclast and Zometa AHM

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Zoledronic Acid- Reclast and Zometa AHM Zoledronic acid- Reclast and Zometa AHM Clinical Indications • Zoledronic acid (Zometa, Reclast) are considered medically necessary for 1 or more of the following indications • Bone metastases or bone pain presumed due to bone metastases from breast cancer, lung cancer, neuroendocrine tumors, prostate cancer, thyroid cancer, and other solid tumor types . Consistent with Zometa’s FDA-approved labeling, zoledronic acid is considered medically necessary for bone metastases from prostate cancer if cancer has progressed after treatment with at least one hormonal therapy • Hypercalcemia of malignancy • Multiple myeloma, including smoldering multiple myeloma and solitary plasmacytomas • Osteogenesis imperfecta in persons who have failed or are intolerant of pamidronate • Paget disease of bone • Prevention of osteoporosis in post-menopausal women with osteopenia who meet 1 [A] or more of the following . Unable to tolerate two oral bisphosphonates (e.g., alendronate (Fosamax), risedronate (Actonel)) . Unable to tolerate one oral bisphosphonate plus one selecitve estrogen receptor modulator (SERM) (e.g., raloxifene (Evista)) . Oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time) [B] • Prevention of osteoporosis in persons receiving aromatase inhibitors (e.g., anastrozole (Arimidex), letrozole (Femara), exemestane (Aromasin)) who meet 1 or more of the following . Unable to tolerate two oral bisphosphonates (e.g., alendronate (Fosamax), risedronate (Actonel)) . Oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time) AC-AEREC112011 Page 1 of 24 Copyright 2016 No part of this document may be reproduced without permission ActiveHealth Management Medical Management Guidelines [C] • Prophylaxis of drug-induced osteopenia secondary to androgen deprivation therapy in prostate cancer [D] • Treatment of osteoporosis in men who meet 1 or more of the following . Unable to tolerate two oral bisphosphonates (e.g., alendronate (Fosamax), risedronate (Actonel)) . Oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time) [E] • Treatment of postmenopausal osteoporosis in women who meet 1 or more of the following . Unable to tolerate two oral bisphosphonates (e.g., alendronate (Fosamax), risedronate (Actonel)) . Unable to tolerate one oral bisphosphonate plus one selective estrogen receptor modulator (SERM) (e.g., raloxifene (Evista)) . Oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time [F] • Prevention and treatment of glucocorticoid-induced osteoporosis in persons meet ALL of the following . Who are receiving 5 mg of prednisone daily (or equivalent) . Are expected to be on oral or parental glucocorticoids for 12 months or more . Member has 1 or more of the following : • Unable to tolerate 2 oral bisphosphonates e.g., alendronate (Fosamax), risedronate (Actonel)) • Oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time) • Zoledronic acid is considered investigational for the following because it has not been shown to be safe and effective for these indications (not an all inclusive list): • Aseptic necrosis (osteonecrosis) • Breast cancer (adjuvant/neoadjuvant therapy) • Charcot neuroarthropathy • Mazabraud syndrome • McCune-Albright syndrome • Non-small cell lung cancer (adjuvant/neoadjuvant therapy) • Osteopenia (not meeting the above coverage requirements) • Osteoporosis associated with hyperparathyroidism • Otosclerosis AC-AEREC112011 Page 2 of 24 Copyright 2016 No part of this document may be reproduced without permission ActiveHealth Management Medical Management Guidelines • Prevention of colorectal cancer in post-menopausal women • Psoriatic arthritis • SAPHO (synovitis, acne, pustulosis, hyperostosis, and osteitis) syndrome • The World Health Organization defines osteoporosis as a BMD value at the spine, hip, or forearm of 2.5 or more SD (standard deviations) below the young adult mean (T-score less than or equal to 2.5), with or without the presence of a fragility fracture. Osteopenia is any bone density below the young adult mean • Reclast is contraindicated in persons with creatinine clearance less than 35 ml/min or in persons with evidence of acute renal impairment. Indications considered Not Medically Necessary • Zoledronic acid is considered investigational for the following because it has not been shown to be safe and effective for these indications (not an all inclusive list): • Aseptic necrosis (osteonecrosis) • Breast cancer (adjuvant/neoadjuvant therapy) • Mazabraud syndrome • McCune-Albright syndrome • Non-small cell lung cancer (adjuvant/neoadjuvant therapy) • Osteopenia (not meeting the above coverage requirements) • Osteoporosis associated with hyperparathyroidism • Otosclerosis • Prevention of colorectal cancer in post-menopausal women • Psoriatic arthritis • SAPHO (synovitis, acne, pustulosis, hyperostosis, and osteitis) syndrome • Reclast is contraindicated in persons with creatinine clearance less than 35 ml/min or in persons with evidence of acute renal impairment. Evidence Summary Background • Zoledronic acid (Zometa) is an intravenously administered bisphosphonate that has been approved by the Food and Drug Administration (FDA) for the treatment of hypercalcemia of malignancy. The clinical studies that were presented to the FDA for approval directly compared zoledronic acid to the intravenous bisphosphonate pamidronate (Aredia). The advantages of zoledronic acid over pamidronate, from clinical studies, include a more rapid rate of infusion (a 15-minute infusion time for zoledronic AC-AEREC112011 Page 3 of 24 Copyright 2016 No part of this document may be reproduced without permission ActiveHealth Management Medical Management Guidelines acid versus a 2-hour infusion time for pamidronate) and a significantly higher response rate with zoledronic acid. • Pooled data from the two multi-center trials involving 275 patients with hypercalcemia of malignancy compared patients receiving a single dose of either 4 mg or 8 mg zoledronic acid infused over five minutes, to patients receiving a single 90 mg dose of pamidronate infused over two hours. By day 10 of treatment, corrected serum calcium concentrations were normalized in 88.4 percent of patients treated with 4 mg zoledronic acid, and 86.7 percent treated with 8 mg zoledronic acid. In comparison, 69.7 percent of patients treated with pamidronate achieved normalized serum calcium concentrations. The median duration of complete response (maintaining normalized calcium levels) was higher in patients treated with zoledronic acid than pamidronate (32 and 43 days for zoledronic acid 4 and 8 mg, and 18 days for pamidronate). • Zoledronic acid has been compared to pamidronate in a 13-month Phase III study of 1,648 patients with advanced Stage III multiple myeloma or advanced breast cancer with bone metastases. The study showed that zoledronic acid and pamidronate are approximately equal in effectiveness with respect to the primary efficacy endpoint, the proportion of patients experiencing at least one skeletal-related event. The skeletal morbidity rate was slightly lower in patients treated with zoledronic acid than in those treated with pamidronate, and zoledronic acid significantly decreased the incidence and event rate for radiation therapy to bone. Pain scores decreased in all treatment groups, and zoledronic acid and pamidronate were equally well tolerated. • According to National Comprehensive Cancer Network guidelines (NCCN, 2010), zoledronic acid may be indicated in multiple myeloma, including smoldering multiple myeloma and solitary plasmacytomas, in combination with induction chemotherapy for persons with bone disease, including osteopenia. • In two placebo-controlled clinical studies in patients with bone metastases from prostate cancer (n = 643) or from other solid tumors (n= 773), both the percentage of patients with skeletal events (e.g., pathologic fracture, radiation therapy to bone, surgery to bone, or spinal cord compression) and the time to first skeletal event were decreased relative to placebo. In randomized controlled studies submitted to FDA for approval, there were 11 percent fewer skeletal events in zoledronic acid-treated patients with metastatic prostate cancer and 7 percent fewer skeletal events in treated patients with other metastatic solid tumors compared to placebo-treated patients. • The FDA approved labeling for zolerdronic acid (Zometa) injections in patients with multiple myeloma and metastatic bone lesions from solid tumors for patients with a creatinine clearance of greater than 60 mL/min is 4 mg infused over 15 minutes every 3 - 4 weeks. The optimal duration of therapy is unknown. Upon initial treatment, the recommended zolerdronic acid (Zometa) doses for patients with reduced renal function (mild and moderate renal impairment) are listed in the Table below. These doses are AC-AEREC112011 Page 4 of 24 Copyright 2016
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