CurrentBlue Cross Blue Shield - TennesseePolicy N/A

Evenity (romosozumab) — Coverage Criteria for Postmenopausal Osteoporosis

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.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyEvenity (romosozumab) — Coverage Criteria for Postmenopausal Osteoporosis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 31, 202649d

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation of T-score, FRAX or fragility fracture and prior therapy history; authorization may be granted for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12maximum duration of therapy covered

T≤-2.5osteoporosis threshold

FRAX ≥20%/≥3%high FRAX definition

PostmenopausalFDA indication included

Coverage Criteria for Evenity (romosozumab)

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyEvenity (romosozumab) — Coverage Criteria for Postmenopausal Osteoporosis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 31, 202649d

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation of T-score, FRAX or fragility fracture and prior therapy history; authorization may be granted for up to 12 months.

SourceLink

On This Page

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Initial therapy coverage criteria

Covered when ALL of the following are met for postmenopausal osteoporosis (authorization of up to 12 months):

Diagnostic threshold: Member has a pre-treatment T-score ≤ -2.5 OR member has osteopenia (pre-treatment T-score between -1 and -2.5) with a high pre-treatment FRAX probabilityT-score ≤ -2.5 OR FRAX major ≥20% or hip ≥3%

See FRAX appendix for definition and glucocorticoid adjustments

High-risk clinical features: Member has a history of fragility fractures OR indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3, increased fall risk)

Examples listed in policy

Prior therapy failure/intolerance: Member has had an inadequate response or intolerance to previous injectable osteoporosis therapy (e.g., zoledronic acid, teriparatide, denosumab, abaloparatide) OR inadequate response/intolerance to previous oral bisphosphonate therapy

Specific agents listed in policy

Continuation Therapy

Continuation of therapy

Continuation: Member must meet all requirements in the coverage criteria and have received fewer than 12 monthly doses of Evenity< 12 doses

Applies to all members including new members requesting continuation

Limitations

Limitations of use

Duration limit: Limit duration of use to 12 monthly doses; if osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered12 monthly doses

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

T-score and FRAX thresholds

Osteoporosis T-score thresholdPre-treatment T-score ≤ -2.5

Osteopenia with high FRAXPre-treatment T-score between -1 and -2.5 PLUS high pre-treatment FRAX (see FRAX thresholds)

High FRAX numeric thresholdsFRAX major osteoporotic fracture ≥ 20% OR hip fracture probability ≥ 3%

Definitions

High FRAX probability

High FRAX probability definition10-year major osteoporotic fracture probability ≥ 20% OR hip fracture probability ≥ 3%

Glucocorticoid dose adjustmentIf glucocorticoid dose > 7.5 mg prednisone equivalent/day, multiply FRAX major risk by 1.15 and hip fracture risk by 1.2

FRAX tool referenceUse FRAX (https://fraxplus.org) to calculate 10-year fracture probabilities

Fragility fracture

Definition of fragility fractureLow trauma fracture from force similar to a fall from standing position

Example contextCounted as a qualifying high-risk feature for authorization when present with T-score or FRAX criteria

Usage noteDocument fracture history in prior authorization submission as supporting evidence

Authorization, Documentation, and Provider Requirements

Prior Authorization

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

Step Therapy

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

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.