CurrentUnitedHealthcarePolicy CS2026D0080R

Evenity (Romosozumab-Aqqg) — Medical Benefit Drug Policy (Outpatient)

Medical benefit drug policy governing outpatient coverage criteria and prior authorization for Evenity (romosozumab-aqqg) in postmenopausal patients at high risk for fracture under UnitedHealthcare Community Plan.

Policy Summary

PayerUnitedHealthcare

PolicyEvenity (Romosozumab-Aqqg) — Medical Benefit Drug Policy

Policy CodePolicy CS2026D0080R

Key ActionObtain prior authorization confirming diagnosis, supporting BMD/FRAX or fracture history, prior bisphosphonate therapy history, and plan to limit romosozumab to ≤12 monthly doses with transition to antiresorptive therapy.

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

T-score ≤ -2.5osteoporosis threshold

≥20% / ≥3%FRAX trigger

12 monthsmax authorization

J3111HCPCS

~150+ICD-10 examples

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Coverage Criteria for Evenity (romosozumab-aqqg)

Initial Therapy

Covered when ALL of the following are met:

Initial coverage criteria: 1) Diagnosis of osteoporosis.

Diagnostic evidence (ONE of)

A: BMD T-score ≤ -2.5 based on BMD measurements from lumbar spine (≥2 vertebral bodies), hip (femoral neck or total hip), or radius (one-third site).
B: History of a minimal-trauma fracture of one of the following: vertebral compression fracture, hip fracture, distal radius fracture, pelvic fracture, or proximal humerus fracture.
C
- C.1: BMD T-score between -1.0 and -2.5 based on lumbar spine (≥2 vertebral bodies), hip (femoral neck or total hip), or radius (one-third site).
- C.2: FRAX 10-year fracture probability meeting at least one threshold: major osteoporotic fracture ≥ 20% OR hip fracture ≥ 3%.

Prior therapy / suitability (ONE of)

1: Both of the following: history of intolerance to oral bisphosphonate therapy AND history of failure, contraindication, or intolerance to intravenous bisphosphonate therapy (e.g., pamidronate, zoledronic acid).
2: History of failure or contraindication to oral bisphosphonate therapy.
3: History of failure, contraindication, or intolerance to intravenous bisphosphonate therapy.

Concomitant therapy exclusion: Patient is not receiving Evenity in combination with parathyroid hormone analogs (e.g., teriparatide [Forteo], abaloparatide [Tymlos]) or RANK ligand inhibitors (e.g., denosumab [Prolia], denosumab for oncology [Xgeva]).

Dosing and duration: Evenity dosing must be in accordance with the FDA-approved labeling; authorization is limited to no more than 12 months.<= 12 months

Reauthorization/Continuation Therapy

Reauthorization / Continuation

Continuation: Continued use beyond 12 months is unproven and not medically necessary; clinical benefit has not been demonstrated beyond 12 months in phase 3 trials.12 months

Initial romosozumab coverage criteria

Covered when ALL of the following are met:

Indication and risk: Patient is a postmenopausal woman at high risk for fracture (e.g., history of osteoporotic fracture or multiple validated risk factors) or has failed or is intolerant to other available osteoporosis therapy, consistent with the FDA indication and guideline recommendations.

Duration limit: Planned romosozumab therapy does not exceed 12 monthly doses.<= 12 months

Documentation: Clinical documentation supports high fracture risk (for example: recent fracture, multiple fractures, very low T-score, or elevated FRAX) and includes a plan for subsequent antiresorptive therapy after completion of romosozumab, as recommended by guidelines.

Concurrent administration of Evenity (romosozumab-aqqg) with other bone-active anabolic or antiresorptive biologic agents is prohibited. Specifically, patients must not receive Evenity in combination with parathyroid hormone analogs (e.g., Forteo, Tymlos) or RANK ligand inhibitors (e.g., Prolia, Xgeva) as a condition of coverage.

Romosozumab therapy should be planned with a clear maximum duration and follow-up strategy. The policy limits Evenity use to a maximum of 12 monthly doses. Use beyond 12 monthly doses may be considered only when there is documented clinical justification and a contemporaneous plan to transition to or initiate an appropriate antiresorptive therapy after completing Evenity.

Continued treatment with Evenity beyond 12 months is unproven based on phase 3 clinical trial data and is therefore considered not medically necessary for routine authorization.

Requests for romosozumab exceeding 12 monthly doses will be subject to additional review and may be denied if there is no documented plan for subsequent antiresorptive therapy or if the request does not align with the FDA-defined indication (postmenopausal women at high risk for fracture or patients who have failed or are intolerant to other osteoporosis therapies).

Billing and Diagnosis Codes

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be granted only when all coverage criteria are met, including documentation of diagnosis, fracture/BMD/FRAX thresholds, prior bisphosphonate history, and concordance with FDA dosing and duration limits.

Authorization limited to no more than 12 months (12 monthly doses).
Evenity (romosozumab) must be dosed per FDA-approved labeling.

Denial Risk

Denial Triggers and Use Limits

Requests lacking required clinical documentation or not meeting the diagnostic or prior-therapy criteria are subject to denial.

Missing BMD T-scores, absent fragility fracture history, or no FRAX calculation when indicated may trigger denial.
Requests that do not demonstrate prior failure/intolerance/contraindication to oral (and when required, IV) bisphosphonates as described in criteria may be denied.

Background on Romosozumab and Indication

Evenity (romosozumab-aqqg) is a human monoclonal antibody that inhibits sclerostin and is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture — defined by a history of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance to other available osteoporosis therapies. The drug has an anabolic effect on bone that wanes after 12 monthly doses; for this reason, use is limited to 12 monthly doses and, when ongoing osteoporosis treatment is required, should be followed by an appropriate antiresorptive agent. The clinical benefit beyond 12 months has not been demonstrated in phase 3 trials, and concurrent use with parathyroid hormone analogs or RANK ligand inhibitors is not permitted.

High risk for fracture — policy definition

High risk definition — T-scoreBMD T-score ≤ -2.5 at lumbar spine, femoral neck/total hip, or one-third radius

High risk definition — fragility fractureHistory of qualifying low‑trauma fracture (vertebral, hip, distal radius, pelvis, proximal humerus)

High risk definition — T-score with FRAXT-score between -1 and -2.5 plus FRAX major ≥20% or hip ≥3%

Definitions and Diagnostic Thresholds

T-score — definition and thresholds

T-score definitionStandard deviation difference between patient's BMD and young adult reference measured by DXA

Osteoporosis thresholdT-score ≤ -2.5 SD

Osteopenia rangeT-score between -1.0 and -2.5 SD

FRAX — description and use

FRAX descriptionFracture Risk Assessment Tool to predict 10‑year probability of hip and major osteoporotic fracture

InputsCan be used with or without femoral neck BMD

Clinical use

Policy Revision History

04/01/2026Policy effective date / template updateLatest

Policy effective date set to April 1, 2026; revision noted as a template update.

Policy Summary

PayerUnitedHealthcare

PolicyEvenity (Romosozumab-Aqqg) — Medical Benefit Drug Policy

Policy CodePolicy CS2026D0080R

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

On This Page

Use beyond 12 monthly doses is considered unproven and not medically necessary and may be denied.

Use of Evenity in combination with parathyroid hormone analogs or RANK ligand inhibitors is not permitted and may result in denial.

Billing Rule

Coding and Billing Risk

Claims using diagnosis codes other than the covered osteoporosis codes listed in the policy (e.g., M80*, M81*, M82* or Z78.310) may be reviewed or denied for coding mismatch.

Ensure claim diagnosis codes correspond to approved codes for osteoporosis (age-related or other osteoporosis with or without current pathological fracture) or personal history of healed osteoporotic fracture (Z78.310).
Using nonspecified or unrelated ICD-10 codes increases risk of claim denial.

Documentation Required

Clinical Documentation Required

Document the clinical pathway used to establish a diagnosis of postmenopausal osteoporosis and high fracture risk. Include supporting data for the diagnostic criteria met (one of the accepted diagnostic pathways).

Fragility fracture documentation (e.g., vertebral compression, hip, distal radius, pelvis, proximal humerus) with dates and trauma description.
BMD T-scores from DXA scans with site(s) measured (lumbar spine, femoral neck, total hip, or one‑third radius).
FRAX 10‑year probabilities when applicable (major osteoporotic fracture ≥20% or hip ≥3%) and whether femoral neck BMD was included.

Documentation Required

Postmenopausal Osteoporosis and High Fracture Risk Documentation

Document postmenopausal status and provide evidence that the patient is at high or very high fracture risk per guideline definitions when indicated.

Evidence of recent fracture (e.g., within past 12 months), multiple fractures, or fractures while on approved osteoporosis therapy.
Very low BMD (e.g., T-score < -3.0), high risk for falls, or very high FRAX probability as defined by guideline thresholds.
If romosozumab is used for >12 months (not recommended), documentation must include rationale and an antiresorptive plan to follow — note that continued use beyond 12 months is unproven.

Documentation Required

Prior Therapy Requirements

Prior therapy requirements must be documented per the policy before approval unless the patient meets exceptions stated in the FDA indication or guideline-based placement.

History of intolerance to oral bisphosphonates and either failure, contraindication, or intolerance to intravenous bisphosphonates when the policy requires both.
Alternatively, history of failure or contraindication to oral bisphosphonate therapy alone, or failure/contraindication/intolerance to IV bisphosphonates, as applicable per the criteria.
If the request cites "failed or intolerant to other available osteoporosis therapy" as per the FDA label, provide clinical details supporting that statement.

Note

Guideline-Based Placement and Co-Therapy Considerations

Guideline-based placement: romosozumab is recommended for patients at very high fracture risk or when oral therapy is unsuitable; document alignment with guideline criteria and post-romosozumab maintenance plans.

Per AACE/Endocrine Society guidelines, consider romosozumab for patients with recent fractures, multiple fractures, fractures on therapy, very low T-score (e.g., < -3.0), or very high FRAX probability.
Romosozumab treatment duration should be limited to up to 12 months; after completion, document an antiresorptive therapy plan to maintain BMD gains.
Romosozumab must not be given in combination with parathyroid hormone analogs or RANK ligand inhibitors — document current and prior osteoporosis medications to confirm no prohibited combinations.

Romosozumab mechanism

Mechanism of actionBinds and inhibits sclerostin, preventing its inhibition of Wnt signaling

Therapeutic effectsIncreases bone formation and decreases bone resorption

TargetSclerostin (secreted by osteocytes) — negative regulator of bone formation

Assists clinicians in long‑term fracture risk assessment to inform diagnosis and treatment decisions

FRAX thresholds summary — U.S. clinical diagnosis

US major osteoporotic fracture threshold (10-year)≥ 20%

US hip fracture threshold (10-year)≥ 3%

Role in diagnosisMeeting either threshold may support a clinical diagnosis of osteoporosis in the United States