CurrentBlue Cross Blue Shield - IowaPolicy 05.02.78

Romosozumab (Evenity) for Postmenopausal Osteoporosis — Coverage Criteria

Covers criteria, documentation, and prior authorization requirements for romosozumab (Evenity) in postmenopausal women at high risk for fracture for Wellmark Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyRomosozumab (Evenity) for Postmenopausal Osteoporosis — Coverage Criteria

Policy CodePolicy 05.02.78

Change TypeNo material change

Effective DateJun 3, 2026

Next Review DateApr 1, 2026

Key ActionObtain prior authorization and submit chart notes documenting fragility fractures, pre-treatment T-score or FRAX probability, and prior osteoporosis therapy history.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12maximum duration of therapy covered

2 syr/28dquantity limit

J3111HCPCS code

FRAX ≥20%/≥3%high fracture risk threshold

Coverage Criteria for Romosozumab (Evenity)

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Initial Therapy

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

Initial Approval Criteria: 1) Member has a history of fragility fractures (e.g., low trauma fracture from standing height).

fragility fracture definition provided in-line

Initial Approval Criteria - T-score/FRAX branch

a: Member has indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3, or increased fall risk).
Examples listed in policy
b: Member has had an inadequate response or intolerance to previous injectable osteoporosis therapy (e.g., zoledronic acid, teriparatide, denosumab products, abaloparatide).
Examples listed in policy
c: Member has had an inadequate response or intolerance to previous oral bisphosphonate therapy.
See Appendix A for clinical reasons to avoid oral bisphosphonates

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval may be granted for up to 12 months when criteria for postmenopausal osteoporosis are met.

Prior authorization required for initiation and continuation of therapy.
Initial approvals: up to 12 months when criteria for postmenopausal osteoporosis are met.

Step Therapy

Therapy Sequencing / Trials

Policy requires trials of or documentation of intolerance/inadequate response to other osteoporosis therapies in certain situations before approval.

Documentation of prior trial and inadequate response or intolerance to oral bisphosphonates when applicable.
Documentation of prior trial and inadequate response or intolerance to injectable osteoporosis therapies (e.g., zoledronic acid [Reclast], teriparatide [Forteo, Bonsity], denosumab products [Prolia, Jubbonti], abaloparatide [Tymlos]) when applicable.
Appendix A lists clinical reasons to avoid oral bisphosphonates (these may justify skipping an oral bisphosphonate trial): achalasia, strictures/dysmotility, active upper GI disease, malabsorption, inability to remain upright 30–60 minutes, inability to take before first food/drink/medication, renal insufficiency (CrCl <35 mL/min), history of intolerance to oral bisphosphonate).

Documentation Required

Required Documentation for Prior Authorization

Submit chart notes or medical record documentation to support the authorization request.

History of fragility fractures, if present (e.g., low-trauma fracture from standing height).
Pre-treatment T-score (DXA) and, when applicable, FRAX fracture probability.
Chart notes, medical record documentation, or claims history supporting prior osteoporosis medications tried and response/intolerance.
If oral bisphosphonate trial is not documented, include clinical rationale (see Appendix A reasons to avoid oral bisphosphonates).

Denial Risk

Documentation Triggers for Denial

Failure to submit requested documentation may result in denial of the authorization request.

Missing chart notes or medical record documentation of fragility fracture history may trigger denial.
Absence of pre-treatment T-score or FRAX probability (when applicable) may trigger denial.
Lack of documentation of prior medication history or inadequate response/intolerance may trigger denial when such trials are required by the criteria.

Definitions and Risk Thresholds

High risk for fracture — definition and implications

DefinitionHigh risk for fracture: history of osteoporotic (fragility) fracture or multiple clinical risk factors for fracture.

Policy implicationMembers meeting high fracture risk criteria may be eligible for romosozumab (Evenity) under the policy when other coverage criteria are met.

Duration limitTherapy is limited to 12 monthly doses; if continued osteoporosis treatment is needed, transition to an anti-resorptive agent should be considered.

High FRAX probability — numeric definition and adjustment

High FRAX probability10-year major osteoporotic fracture risk ≥20% OR hip fracture risk ≥3%.

Glucocorticoid adjustmentIf patient is on glucocorticoids >7.5 mg/day (prednisone equivalent), multiply FRAX major fracture probability by 1.15 and hip fracture probability by 1.2.

Use of toolFRAX 10-year probability is calculated using the FRAX web tool (https://www.shef.ac.uk/FRAX/).