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 Indication

Evenity is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered.

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 fragility fractures, T-score, and FRAX fracture probability as applicable to section III.

III. CRITERIA FOR INITIAL APPROVAL

Postmenopausal osteoporosis treatment

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

A. Member has a history of fragility fractures

B. Member has a pre-treatment T-score less than or equal to -2.5OR 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 B) and meets ANY of the following criteria:

1. Member has indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores [less than or equal to -3], or increased fall risk)

2. Member has failed prior treatment with or is intolerant to previous injectable osteoporosis therapy (e.g., zoledronic acid [Reclast], teriparatide [Forteo, Bonsity], denosumab [Prolia], abaloparatide [Tymlos])

3. Member has had an oral bisphosphonate trial of at least 1-year duration or there is a clinical reason to avoid treatment with an oral bisphosphonate (See Appendix A)

IV. CONTINUATION OF THERAPY

All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria AND have received less than 12 monthly doses of Evenity.

V. APPENDICES

Appendix A. Clinical reasons to avoid oral bisphosphonate therapy

Presence of anatomic or functional esophageal abnormalities that might delay transit of the tablet (e.g., achalasia, stricture, or dysmotility
Active upper gastrointestinal problem (e.g., dysphagia, gastritis, duodenitis, erosive esophagitis, ulcers)
Presence of documented or potential gastrointestinal malabsorption (e.g., gastric bypass procedures, celiac disease, Crohn’s disease, infiltrative disorders, etc.)
Inability to stand or sit upright for at least 30 to 60 minutes
Inability to take oral bisphosphonate at least 30 to 60 minutes before first food, drink, or medication of the day
Renal insufficiency (creatinine clearance <35 mL/min)
History of intolerance to an oral bisphosphonate

Appendix B. WHO 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.shef.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. Evenity [package insert]. Thousand Oaks, CA: Amgen; April 2020.

2. 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.

3. 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.

4. Eastell R, Rosen CJ, Black DM, et al. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2019;104:1595-1622.

5. Carey, John. What is failure of bisphosphonate therapy for osteoporosis. Cleve Clinic J Med. 2005; 72:1033-1039.

6. FRAX® Fracture Risk Assessment Tool. © Centre for Metabolic Bone Diseases, University of Sheffield, UK. Available at: https://www.sheffield.ac.uk/FRAX/. Accessed October 5, 2023.

7. Ensrud KE, Crandall CJ. Osteoporosis. Ann Intern Med 2017;167(03):ITC17–ITC32.

ORIGINAL EFFECTIVE DATE: 9/30/2019

MOST RECENT REVIEW DATE: 5/14/2024

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.

This document has been classified as public information.