This Coverage Policy applies to Individual Health Insurance Marketplace benefit plans only.

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1 This Coverage Policy applies to Individual Health Insurance Marketplace benefit plans only. INJECTABLE OSTEOPOSIS AGENTS SUBJECT Pharmacologic Agents: Bisphosphonates: Boniva IV (ibandronate) Reclast (zoledronic acid) Monoclonal Antibody: Prolia (denosumab) Parathyroid Agent: Forteo (teriparatide [rdna origin]) COVERAGE POLICY Coventry Health Care covers for osteoporosis treatment when the following criteria is met: BONIVA IV A. Treatment of osteoporosis (T score -2.5 SD at the femoral neck, hip or spine per WHO definition or a prior fragility fracture) B. EITHER i. The patient fails to have an adequate response to treatment with at least ONE oral ii. The patient is intolerant to at least TWO bisphosphonate or has a contraindication to the use, including one IV bisphosphonate. (Table 1) RECLAST A. Treatment of Paget s disease of bone i. Diagnosis of Paget s disease with serum alkaline phosphatase > 2x upper limit of normal (ULN) of age-specific normal reference range ii. Diagnosis of Paget s disease who are symptomatic, or those at risk for complications from their disease B. Treatment of osteoporosis i. Treatment of osteoporosis (T score -2.5 SD at the femoral neck, hip or spine per WHO definition or a prior fragility fracture) ii. EITHER a. The patient fails to have an adequate response to treatment with at least ONE oral b. The patient is intolerant to at least TWO oral bisphosphonate or has a contraindication to the use (Table 1) C. Prevention of osteoporosis Coventry Health Care, Inc. Page 1 COVERAGE POLICY

2 i. Low bone mass with documented bone mineral density (BMD) of T-score between -1.0 and -2.5 at the femoral neck, total hip or spine ii. EITHER a. The patient fails to have an adequate response to treatment with at least ONE oral b. The patient is intolerant to at least TWO oral bisphosphonate or has a contraindication to the use (Table 1) D. Prevention or treatment of glucocorticoid-induced osteoporosis (GIO): i. Documentation of long-term therapy (previous use and/or anticipated use) with systemic glucocorticoids at a daily dose equivalent to at least 7.5 mg of prednisone (Table 2) for at least 12 months ii. EITHER a. The patient fails to have an adequate response to treatment with at least ONE oral b. The patient is intolerant to at least TWO oral bisphosphonate or has a contraindication to the use (Table 1) PROLIA A. For the treatment of i. Postmenopausal women with osteoporosis who are at high risk for fracture; or who have failed or are intolerant of previous osteoporosis therapy, based on physician assessment ii. Increasing bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer iii. Increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer iv. Increasing bone mass in men with osteoporosis at high risk for fracture B. EITHER i. The patient fails to have an adequate response to treatment with at least ONE oral ii. The patient is intolerant to at least TWO bisphosphonate or has a contraindication to the use, including one IV bisphosphonate. (Table 1) FTEO (Covered Under the Pharmacy Benefit) A. For the treatment of postmenopausal women with osteoporosis or for the treatment of men with primary or hypogonadal osteoporosis who are at high risk (Table 4) for fracture may be considered medically necessary when: i. The patient fails to have an adequate response to treatment with at least ONE bisphosphonate Prolia (denosumab), ii. The patient is intolerant to or has a contraindication to the use of at least TWO bisphosphonate Prolia (denosumab) B. For the treatment of osteoporosis with a previous fragility fracture, defined as fracture that occurs as a result of minimal trauma such as from a fall from the seated or standing position or due to heavy lifting, may be considered medically necessary when: i. The patient fails to have an adequate response to treatment with at least ONE bisphosphonate of adequate treatment duration ( 2 years) (Table 1), Coventry Health Care, Inc. Page 2

3 ii. The patient is intolerant to at least TWO bisphosphonate or has a contraindication to the use, including one IV bisphosphonate. (Table 1) C. For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture when: i. Documentation of long-term therapy (previous use and/or anticipated use) with systemic glucocorticoids at a daily dose equivalent to at least 7.5 mg of prednisone (Table 2) for at least 12 months ii. EITHER a. The patient fails to have an adequate response to treatment with at least ONE b. The patient is intolerant to at least TWO bisphosphonate or has a contraindication to the use, including one IV bisphosphonate. (Table 1) AUTHIZATION PERIOD LIMITATIONS Please refer back to the Coverage Policy section on the appropriate authorization period. BONIVA IV Initial Approval: 1 year (injections no more frequently than every 3 months) Extended Approval: Annual review based on: a) Improvement or stabilization of BMD at the lumbar spine compared to baseline (pre-treatment) b) Compliance with therapy c) Continued inability to take oral therapy d) Unknown optimal duration of therapy RECLAST Paget s disease: Initial Approval: 1 injection Extended Approval: Specific re-treatment data are not available. However, re-treatment with Reclast may be considered in: a) Patients who have relapsed, based on increases in serum alkaline phosphatase, b) Patients who failed to achieve normalization of their serum alkaline phosphatase, c) Patients with documented symptoms such as bone pain, bone deformity, neurological complication caused by compression of neural tissue and hypervascularity causing excessive warmth. Osteoporosis in men or women: Initial Approval: 1 year, 1 injection per year Extended Approval: 2 years, 1 injection per year Review based on therapeutic response as follows: a) Improvement or stabilization of BMD at the lumbar spine compared to baseline (pretreatment), and b) Compliance with therapy, and c) Continued inability to take oral therapy Glucocorticoid-induced osteoporosis: Initial Approval: 1 year, 1 injection per 1 year Extended Approval: Annual review based on: a) Continued corticosteroid use, and b) Continued inability to take oral therapy Coventry Health Care, Inc. Page 3

4 Prevention of osteoporosis in postmenopausal women: Initial Approval: 1 time, 1 injection every 2 years Extended Approval: Biennial (every 2 years) review based on therapeutic response as follows: a) Improvement or stabilization of BMD compared to baseline (pre-treatment), and b) Compliance with therapy, and c) Continued inability to take oral therapy PROLIA Initial Approval: 1 year (injections no more frequently than every 6 months) Extended Approval: Annual review based on: a) Improvement or stabilization of BMD at the lumbar spine compared to baseline (pre-treatment) b) Compliance with therapy FTEO Initial Approval: 1 year Extended Approval: Review and extended authorization: 1 year, Max lifetime duration 2 years PROCUREMENT J code: Reclast (J3488), Prolia (J0897), Boniva (J1740) **Forteo is covered under the pharmacy benefit Specialty pharmacy source: Aetna Specialty Pharmacy (ASRx) Contact: ASRx toll free number: (866) ASRx toll free fax number: (866) ASRx address: NON-COVERAGE 1. Use not approved by the FDA 2. The use is unapproved and not supported by the literature or evidence as an accepted off-label use. (see Off-Label Use Policy for determining accepted use ) 3. Concomitant use with other injectable bisphosphonate agents (Boniva IV (ibandronate), Reclast (zoledronic acid)), Forteo (Teriparatide [rdna origin]), or Prolia (denosumab) 4. In addition, for specific agents: a. Boniva IV i. For treatment of osteoporosis secondary to glucocorticoid therapy ii. For the treatment of osteogenesis imperfecta b. Forteo i. For use in gonadotropin-releasing hormone analog-induced estrogen deficiency ii. Members who have received the maximum length of therapy with Forteo (i.e. 2 years) iii. Increasing bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer iv. Increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer c. Prolia i. Patients with hypocalcemia ii. Patients with osteopenia d. Reclast i. Women who are pregnant/ lactating ii. Patients with hypocalcemia iii. Patients with decreased renal function (i.e. CrCl < 35 ml/min) iv. Patients previously on Zometa therapy v. Use in combination with Zometa Coventry Health Care, Inc. Page 4

5 Table 1. Oral Bisphosphonate Options for Osteoporosis Fosamax (Alendronate) Actonel (Risedronate) Atelvia (Risedronate) Boniva (Ibandronate) Fosamax + D (Alendronate + Cholecalciferol) Table 2. Corticosteroid Dosage Equivalents Drug Name Daily steroid dose equivalent to Prednisone 7.5 mg Cortisone 37.5 mg Hydrocortisone 30 mg Prednisone 7.5 mg Prednisolone 7.5 mg Methylprednisolone 6 mg Triamcinolone 6 mg Betamethasone 0.9 mg Dexamethasone 1.12 mg Table 4. High Risk Factors for a Subsequent Fragility Fracture Patient must have TWO of the following risk factors: 1. Low BMD* (T-score less than or equal to -2.5 at the spine or hip or both), 2. Prior fragility fracture (occurs as a result of minimal trauma such as from a fall from the seated or standing position or due to heavy lifting), 3. Advanced Age ( 65 years ), 4. Family History of Osteoporosis (1st degree relative) * Dual-energy x-ray absorptiometry (DEXA) is the considered the gold standard to measure BMD. Fractures of the spine and hip are the most clinically important low-trauma fractures resulting from osteoporosis. Coventry Health Care, Inc. Page 5

6 BACKGROUND From the AACE Guideline: A clinical diagnosis of osteoporosis and decision to initiate pharmacologic therapy can be made without BMD testing in postmenopausal women who have fragility fractures of the hip or spine. Nevertheless, BMD measurement is useful in these patients to quantify fracture risk and to establish a baseline for monitoring the response to treatment. For women without prior fractures (in the absence of major trauma), BMD is the single predictor of future fracture risk (for every 1-SD decrease in age-adjusted BMD, the relative risk of fracture increases 1.6-fold to 2.6-fold). The relationship between bone density and fracture risk, however, is a continuum, without a clear fracture threshold. WHO has defined T-score criteria for classification of osteoporosis and low bone mass (osteopenia) on the basis of DXA measurements. These criteria are useful for classification and risk stratification in individual patients, epidemiologic studies, and therapeutic trial design, but they are not intended as treatment thresholds. Although there is good evidence that the risk for fractures is sufficiently high in most postmenopausal women with osteoporosis (T-scores -2.5) to merit pharmacologic intervention, cost-effective management of women with osteopenia (T-scores between and -2.5) is less clear-cut. Although their overall rate of fractures is lower than that of patients with osteoporosis, more than 50% of fragility fractures occur in these patients with low bone mass. In order to identify those patients who are most likely to sustain a fracture, BMD results must be used in combination with other clinical risk factors for osteoporosis-related fractures for accurate assessment of fracture risk and appropriate treatment decisions. The FRAX tool integrates the contribution of BMD and other clinical risk factors and calculates an individual patient s absolute probability of fracture during a period of 10 years. It is now recommended that treatment decision include consideration of fracture probability. REFERENCES 1. National Guideline Clearinghouse (NGC). Guideline synthesis: Screening and risk assessment for osteoporosis in postmenopausal women. In: National Guideline Clearinghouse (NGC) [Web site]. Rockville (MD): 2008 Apr (revised 2012 Nov) Available: 2. American Association of Clinical Endocrinologists: Medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2010 edition The Paget Foundation for Paget s Disease of Bone and related disorders. Questions and Answers about Paget s Disease of Bone Forteo package insert. Lilly, Indianapolis, IN. September Saag, KG, Shane, E., et al. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. NEJM. 2007; 357: Disclaimer: Coventry Health Care, Inc. (CHC) medical policies, technology assessments, and medical reviews (collectively CHC Policies ) are developed by CHC to provide guidance in administering plan benefits and constitute neither offers of coverage nor medical advice. Access to CHC Policies is provided for general reference purposes only and does not infer guaranteed coverage. CHC does not provide health care services or supplies. Providers are expected to exercise their independent medical judgment in rendering the most appropriate care. State and federal law, as well as benefit plan terms and conditions and CHC Policies in effect on the date that any service is rendered, including but not limited to definitions and specific inclusions/exclusions, take precedence over clinical policy and must be considered first in determining eligibility for coverage. The terms of the member's benefit plan shall determine coverage. Some benefit plans exclude coverage for services or supplies that Coventry may consider medically necessary. If there is a discrepancy between this policy and a member's benefit plan, the benefits shall govern. Coverage may also differ for CHC Medicare and/or Medicaid members based on any applicable Centers for Medicare & Medicaid Services (CMS) coverage statements including National Coverage Determination (NCD), Local Medical Review Policies (LMRP), and/or Local Coverage Determinations (LCD). As clinical technology is continually updated, CHC policies are subject to periodic updates. Do not rely on printed versions of CHC policies as they may be outdated. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or means without the written consent of CHC. Coventry Health Care, Inc. Page 6

7 Appendix A: Injectable Treatment Algorithm for Osteoporosis Failure of 1 oral bisphosphonate for 2 years Intolerance of 2 bisphosphonates including 1 IV bisphosphonate for Prolia and Boniva Reclast Covered under medical benefit Prolia Covered under medical benefit Boniva Covered under medical benefit Forteo Covered under pharmacy benefit See Appendix B if have documented fragility facture Coventry Health Care, Inc. Page 7

8 Appendix B: High Risk Injectable Treatment Algorithm for Osteoporosis Failure of 1 bisphosphonate for 2 years Intolerance of 2 bisphosphonates, including 1 IV bisphosphonate Previous fragility fracture Yes No Forteo Covered under pharmacy benefit Prolia Covered under medical benefit Forteo Covered under pharmacy benefit Coventry Health Care, Inc. Page 8

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