RECLAST (zoledronic acid) INJECTION
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1 RECLAST (zoledronic acid) INJECTION Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. Description: Reclast is a bisphosphonate that inhibits osteoclast-mediated bone resorption. It may be used in postmenopausal women for the prevention and treatment of osteoporosis, in men with osteoporosis to increase bone mass, for prevention and treatment of glucocorticoid-induced osteoporosis in non-pregnant women and men starting or continuing systemic glucocorticoids and for treatment of Paget s disease in non-pregnant women and men. O581.4.docx Page 1 of 6
2 Criteria: Osteoporosis: Reclast injection is considered medically necessary for the treatment of osteoporosis in postmenopausal women with osteoporosis with documentation of ALL of the following: 1. T-score of -2.5 or worse (e.g., -3.0, -3.5) 3. Dosage of Reclast is not greater than 5 mg given by intravenous injection once per year Reclast injection is considered medically necessary for the prevention of osteoporosis in postmenopausal women with documentation of ALL of the following: 1. Postmenopausal women with osteopenia defined as T-score of -1 to -2.5 (i.e., -1.0, -1.5, -2.0, -2.5) 3. Dosage of Reclast is not greater than 5 mg given by intravenous injection once every 2 years Reclast injection is considered medically necessary to increase bone mass in men with osteoporosis or osteoporosis secondary to hypogonadism with documentation of ALL of the following: 1. Documentation of ONE of the following: T-score of -2.5 or worse (e.g., -3.0, -3.5) T-score of -1 or worse (e.g., -1.5, -2.0) at the femoral neck and at least 1 prevalent vertebral deformity History of osteoporotic clinical fracture of clavicle or long bone after age Dosage of Reclast is not greater than 5 mg given by intravenous injection once per year O581.4.docx Page 2 of 6
3 Criteria: (cont.) Osteoporosis: (cont.) Reclast injection is considered medically necessary for the treatment and prevention of glucocorticoid-induced osteoporosis in non-pregnant women and men with documentation of ALL of the following: 1. Individual is initiating or continuing systemic glucocorticoids 2. Daily dose is equal to or greater than 7.5 mg of prednisone 3. Individual is expected to remain on glucocorticoids for at least 12 months 4. Individual is receiving supplemental calcium and vitamin D 5. Dosage of Reclast is not greater than 5 mg given by intravenous injection once per year 6. Creatinine clearance is equal to or greater than 35 ml/min Paget s Disease: Initial Course of Treatment: Reclast injection is considered medically necessary for non-pregnant women and men with Paget s disease of the bone with documentation of ALL of the following: 1. Documentation of ONE of the following: Elevation in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range Individual is symptomatic Individual is at risk for complication from the disease 3. Dosage of Reclast is not greater than 5 mg given by intravenous injection O581.4.docx Page 3 of 6
4 Criteria: (cont.) Paget s Disease: (cont.) Repeat Courses of Treatment: Repeat courses of Reclast injection are considered medically necessary for non-pregnant women and men with Paget s disease with documentation of ALL of the following: Other: 1. Documentation of ONE of the following: Individual has relapsed documented by an increase in serum alkaline phosphatase Individual s serum alkaline phosphatase has failed to normalize Individual is symptomatic 3. Dosage of Reclast is not greater than 5 mg given by intravenous injection Reclast injection for all other indications not previously listed is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome. O581.4.docx Page 4 of 6
5 Resources: 1. American College of Physicians, Qaseem, A, et al. Screening for Osteoporosis in Men: A Clinical Practice Guideline from the American College of Physicians. 2008;148: California Technology Assessment Forum. Vitamin D for the Prevention of Osteoporotic Fractures. Blue Shield of California Foundation. 2/16/ International Society for Clinical Densitometry Official Positions Liu, H, Paige, N, et, al. Screening for Osteoporosis in Men: A Systematic Review for an American College of Physicians Guideline. Ann Intern Med. 2008;148(9). 5. MacLean, C, Newberry, S, et, al. Systematic Review: Comparative Effectiveness of Treatments to Prevent Fractures in Men and Women with Low Bone Density or Osteoporosis. Ann Intern Med National Institutes of Health Osteoporosis and Related Bone Diseases National Resource Center. Osteoporosis in Men Novartis. Reclast Package Insert O581.4.docx Page 5 of 6
6 Resources: (cont.) FDA Product Approval Information for Reclast Injection: (cont.) - FDA- approved dosage: The recommended dose of Reclast for treatment of osteoporosis in postmenopausal women is 5 mg intravenously once per year. The recommended dose of Reclast for prevention of osteoporosis in postmenopausal women is 5 mg intravenously once every 2 years. The recommended dose of Reclast for treatment of osteoporosis in men is 5 mg intravenously once per year. The recommended dose of Reclast for treatment and prevention of glucocorticoid-induced osteoporosis is 5 mg intravenously once per year. The recommended dose of Reclast for Paget s disease is 5 mg intravenously. After a single treatment with Reclast in Paget s disease an extended remission period is observed. Specific re-treatment data are not available. However, re-treatment with Reclast may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice. Reclast is contraindicated in patients with a creatinine clearance of < 35 ml/min. Acute renal impairment, including renal failure, has been observed following the administration of Reclast, especially in patients with pre-existing renal compromise, advanced age, concomitant nephrotoxic medications, concomitant diuretic therapy, or severe dehydration. Rare reports of hospitalization and/or dialysis or fatal outcome have occurred. Optimal duration of use has not been determined. Patients should have the need for continued therapy re-evaluated on a periodic basis. O581.4.docx Page 6 of 6
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RECLAST safely and effectively. See full prescribing information for RECLAST. Reclast (zoledronic
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