Zoledronic Acid (Reclast®)

We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

I. INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications

A. Treatment and prevention of osteoporosis in postmenopausal women

B. Treatment to increase bone mass in men with osteoporosis

C. Treatment and prevention of glucocorticoid-induced osteoporosis in patients expected to be on glucocorticoids for at least 12 months

D. Treatment of Paget’s disease of bone in men and women

Limitations of Use: Optimal duration of use has not been determined. For patients of low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.

All other indications are considered experimental/investigational and not medically necessary.

II. DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review: Supporting chart notes or medical record indicating a history of fractures, T-score, and FRAX fracture probability as applicable to Section III.

III. CRITERIA FOR INITIAL APPROVAL

A. Postmenopausal osteoporosis, treatment and prevention

Authorization of 12 months may be granted to postmenopausal members for treatment or prevention of osteoporosis when ANY of the following criteria are met:

1. Member has a history of fragility fractures

2. Member has a pre-treatment T-score less than or equal to -2.5

3. Member has osteopenia (i.e., pre-treatment T-score greater than -2.5 and less than -1)

B. Osteoporosis in men

Authorization of 12 months may be granted to male members with osteoporosis when ANY of the following criteria are met:

1. Member has a history of an osteoporotic vertebral or hip fracture

2. Member has a pre-treatment T-score less than or equal to -2.5

3. Member has osteopenia (i.e., pre-treatment T-score greater than -2.5 and less than -1) with a high pre-treatment FRAX fracture probability (See Appendix)

C. Glucocorticoid-induced osteoporosis

Authorization of 12 months may be granted for members with glucocorticoid-induced osteoporosis when BOTH of the following criteria are met:

1. Member is currently receiving or will be initiating glucocorticoid therapy at an equivalent prednisone dose of greater than or equal to 2.5 mg/day for at least 3 months

2. Member meets ANY of the following criteria:

i. Member has a history of a fragility fracture

ii. Member has a pre-treatment T-score of less than or equal to -2.5

iii. Member has osteopenia (i.e., pre-treatment T-score greater than -2.5 and less than -1) with a high pre-treatment FRAX fracture probability (See Appendix)

D. Paget’s disease of bone

Authorization of 1 month (one dose [5 mg]) may be granted for treatment of Paget’s disease of bone.

IV. CONTINUATION OF THERAPY

A. Paget’s disease of bone

All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.

B. All other indications

Authorization of 12 months may be granted for all members (including new members) who are currently receiving the requested medication through a previously authorized pharmacy or medical benefit, who meet either of the following:

1. Member has received less than 24 months of therapy and has not experienced clinically significant adverse events during therapy

2. Member has received 24 months of therapy or more and meets both of the following:

i. Member has experienced clinical benefit (i.e., improvement or stabilization in T-score since the previous bone mass measurement)

ii. Member has not experienced any adverse effects

V. APPENDIX

FRAX Fracture Risk Assessment Tool

· High FRAX fracture probability: 10-year major osteoporotic fracture risk ≥ 20% or hip fracture risk ≥ 3%

· 10-year probability; calculation tool available at: https://www.sheffield.ac.uk/FRAX/

· The estimated risk score generated with FRAX should be multiplied by 1.15 for major osteoporotic fracture (including fractures of the spine [clinical], hip, wrist, or humerus) and 1.2 for hip fracture if glucocorticoid treatment is greater than 7.5 mg (prednisone equivalent) per day.

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

1. Reclast [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; April 2020.

2. Zoledronic acid injection [package insert]. Princeton, NJ: Fosun Pharma USA Inc.; June 2023.

3. LeBoff MS, Greenspan SL, Insogna KL, et al. The clinician’s guide to prevention and treatment of osteoporosis. Osteoporos Int. 2022;33(10):2049-2102.

4. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis 2020. Endocr Pract. 2020;26 (Suppl 1):1-46.

5. Watts NB, Adler RA, Bilezikian JP, et al. Osteoporosis in men : an Endocrine Society clinical practice guideline. J Clin Endocr Metab. 2012;97(6):1802-1822.

6. Fink HA, Gordon G, Buckley L, et al. 2017 American College of Rheumatology Guidelines for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis. Arthritis Care Res. 2017;69:1521-1537.

7. Singer FR, Bone HG, Hosking DJ, et al. Paget’s Disease of Bone: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2014; 99(12): 4408-22.

8. FRAX® Fracture Risk Assessment Tool. © Centre for Metabolic Bone Diseases, University of Sheffield, UK. Available at: https://www.shef.ac.uk/FRAX. Accessed October 12,2023.

ORIGINAL EFFECTIVE DATE: 6/9/2007

MOST RECENT REVIEW DATE: 7/31/2024

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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