Evenity (romosozumab) — Coverage Criteria for Postmenopausal Osteoporosis
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Covers prior authorization, coverage criteria, and limitations for Evenity (romosozumab) for treatment of osteoporosis in postmenopausal women at high risk for fracture for Blue Cross Blue Shield of Tennessee members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Evenity (romosozumab)
Initial therapy coverage criteria
Covered when ALL of the following are met for postmenopausal osteoporosis (authorization of up to 12 months):
See FRAX appendix for definition and glucocorticoid adjustments
Examples listed in policy
Specific agents listed in policy
Continuation Therapy
Continuation of therapy
Applies to all members including new members requesting continuation
Limitations
Limitations of use
All other indications are considered experimental/investigational and not medically necessary
All indications other than the FDA-approved indication for treatment of postmenopausal osteoporosis and listed compendial uses are considered experimental/investigational and are not medically necessary.
Use of Evenity (romosozumab) beyond 12 monthly doses is not medically necessary. Requests for unlisted indications are also not medically necessary.
Clinical Thresholds and Coding-related Definitions
Definitions
Authorization, Documentation, and Provider Requirements
Prior Authorization Required
Prior authorization is required. Authorization of up to 12 months (12 monthly doses) may be granted when the coverage criteria are met. Use beyond 12 monthly doses is not covered and will be denied.
- Authorization limit: up to 12 months (12 monthly doses)
- Requests exceeding 12 monthly doses will be denied
Prior Therapy Requirement
Policy requires documentation of prior therapy attempts unless member meets high-risk criteria. Members must have had an inadequate response or intolerance to prior osteoporosis therapies as specified, or meet other high-risk indications specified in the coverage criteria.
- Prior trial of, or inadequate response/intolerance to, injectable osteoporosis therapy (e.g., zoledronic acid [Reclast], teriparatide [Forteo], a denosumab product [Prolia and biosimilars], abaloparatide [Tymlos]) OR
- Prior trial of, or inadequate response/intolerance to, oral bisphosphonate therapy
- Exceptions: members with very high fracture risk (advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3, increased fall risk) or with fragility fractures or qualifying FRAX probability may meet criteria without prior therapy as described in the coverage criteria
Documentation Required for Prior Authorization
Submit chart notes, medical record documentation, or claims history supporting prior medications tried and the member's response or intolerance. Also submit documentation of fragility fracture history, pre-treatment T-score, and FRAX fracture probability as applicable to the coverage criteria.
- Chart notes or medical record documentation of prior osteoporosis therapies and response/intolerance
- Documentation of fragility fractures (if applicable)
- Pre-treatment T-score and FRAX fracture probability (if applicable)
Background
Evenity (romosozumab) is approved for treatment of osteoporosis in postmenopausal women at high risk for fracture. Therapy duration is limited to 12 monthly doses; if osteoporosis therapy remains warranted after that period, continued treatment should be pursued with an anti‑resorptive agent.
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