UnitedHealthcare Evenity Coverage Update

Coverage Criteria for Evenity (romosozumab-aqqg)

Initial Therapy

Covered when ALL of the following are met

Diagnosis of osteoporosis.

High risk evidence: One of: BMD T-score ≤ -2.5 based on DXA of lumbar spine (≥2 vertebral bodies), hip (femoral neck or total hip), or one-third radius; OR history of minimal-trauma fracture (vertebral compression, hip, distal radius, pelvis, or proximal humerus); OR both: BMD T-score between -1.0 and -2.5 and FRAX 10-year probability meeting US thresholds (major osteoporotic fracture ≥20% or hip fracture ≥3%).see DXA and FRAX thresholds

Prior therapy requirement: One of: (1) History of intolerance to oral bisphosphonate therapy AND history of failure, contraindication, or intolerance to intravenous bisphosphonate therapy (e.g., pamidronate, zoledronic acid); OR (2) History of failure or contraindication to oral bisphosphonate therapy; OR (3) History of failure, contraindication, or intolerance to oral or IV bisphosphonate therapy (policy lists equivalent phrasings).

Policy includes multiple equivalent statements regarding prior bisphosphonate therapy.

Concomitant therapy: Patient is not receiving Evenity in combination with parathyroid hormone analogs (e.g., Forteo, Tymlos) or RANK ligand inhibitors (e.g., Prolia, Xgeva).

Dosing/authorization duration: Dosing in accordance with FDA-approved labeling; authorization limited to no more than 12 months.12 months

Covered clinical indications (general)

Evidence-supported indications from trials and diagnostic definitions

Diagnosis basis: Osteoporosis diagnosed by one of: (1) fragility (minimal-trauma) fracture; (2) DXA T-score ≤ -2.5 at lumbar spine (≥2 vertebral bodies), femoral neck, total hip, or one-third radius; or (3) T-score between -1.0 and -2.5 with elevated FRAX meeting US thresholds (major osteoporotic fracture ≥20% or hip fracture ≥3%).see DXA and FRAX thresholds

Trial evidence: Romosozumab demonstrated reduced vertebral and clinical fracture risk in FRAME (12 months: 73% reduction in new vertebral fractures) and sustained benefit when followed by denosumab; ARCH showed romosozumab-to-alendronate reduced new vertebral fractures versus alendronate (48% at 24 months) though increased serious cardiovascular events were observed during year 1 with romosozumab versus alendronate.

References FRAME and ARCH trial results.

Coverage criteria — romosozumab

Covered when ALL of the following are met

Population: Postmenopausal women with osteoporosis at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors, very low T‑score, recent fracture, or very high FRAX probability).

Aligned with FDA indication and specialty guideline definitions.

Treatment duration: Planned romosozumab use limited to 12 monthly doses.<=12 months

Anabolic effect wanes after 12 doses; continuation beyond 12 months not supported.

Follow-up therapy: Documented plan to initiate or continue antiresorptive therapy after completion of romosozumab to maintain BMD gains.

Recommended by guidelines.

Do not administer Evenity (romosozumab-aqqg) in combination with parathyroid hormone analogs (e.g., Forteo, Tymlos) or RANK ligand inhibitors (e.g., Prolia, Xgeva). This prohibition is required by the coverage criteria and must be documented in the prior authorization request.

Use caution or consider exclusion for patients with recent serious cardiovascular events. In the ARCH trial, serious cardiovascular adverse events during year 1 occurred more often with romosozumab (2.5%) than with alendronate (1.9%), and this observed safety signal should inform risk–benefit assessment prior to authorization.

The policy limits therapy to a maximum planned duration of 12 monthly doses. The FDA notes that the anabolic effect of romosozumab wanes after 12 monthly doses; therefore, use beyond this duration is not supported by the labeling and is outside the covered authorization period.

Patients with increased cardiovascular risk should be considered carefully because the ARCH trial reported a higher incidence of serious cardiovascular adverse events with romosozumab during year 1 compared with alendronate. Evaluate individual cardiovascular history when assessing medical necessity.

Continued use of Evenity beyond 12 months is unproven and considered not medically necessary. Phase 3 trial data did not demonstrate clinical benefit beyond 12 months, and requests for continuation past this period are expected to be denied.

This policy was retired for Louisiana membership effective April 1, 2026. Retirement of the policy for the Louisiana plan may render prior coverage determinations inapplicable to members affected by the disenrollment date; verify current coverage rules for impacted members.

Coding — HCPCS and Diagnosis Codes

HCPCS CodesHCPCS

J3111

Injection, romosozumab-aqqg, 1 mg

ICD-10 Codes — Age-related osteoporosis with current pathological fractureICD-10

M80.00XA	Age-related osteoporosis with current pathological fracture, unspecified site, initial encounter for fracture
M80.00XD	Age-related osteoporosis with current pathological fracture, unspecified site, subsequent encounter for fracture with routine healing
M80.00XG	Age-related osteoporosis with current pathological fracture, unspecified site, subsequent encounter for fracture with delayed healing
M80.00XK	Age-related osteoporosis with current pathological fracture, unspecified site, subsequent encounter for fracture with nonunion
M80.00XP	Age-related osteoporosis with current pathological fracture, unspecified site, subsequent encounter for fracture with malunion
M80.00XS	Age-related osteoporosis with current pathological fracture, unspecified site, sequela
M80.011A	Age-related osteoporosis with current pathological fracture, right shoulder, initial encounter for fracture
M80.011D	Age-related osteoporosis with current pathological fracture, right shoulder, subsequent encounter for fracture with routine healing
M80.011G	Age-related osteoporosis with current pathological fracture, right shoulder, subsequent encounter for fracture with delayed healing
M80.011K	Age-related osteoporosis with current pathological fracture, right shoulder, subsequent encounter for fracture with nonunion

1–10 of 12

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ICD-10 Codes — Other osteoporosis with current pathological fracture (selected)ICD-10

M80.811A	Other osteoporosis with current pathological fracture, right shoulder, initial encounter for fracture
M80.812A	Other osteoporosis with current pathological fracture, left shoulder, initial encounter for fracture
M80.819A	Other osteoporosis with current pathological fracture, unspecified shoulder, initial encounter for fracture
M80.821A	Other osteoporosis with current pathological fracture, right humerus, initial encounter for fracture
M80.822A	Other osteoporosis with current pathological fracture, left humerus, initial encounter for fracture
M80.829A	Other osteoporosis with current pathological fracture, unspecified humerus, initial encounter for fracture
M80.831A	Other osteoporosis with current pathological fracture, right forearm, initial encounter for fracture
M80.832A	Other osteoporosis with current pathological fracture, left forearm, initial encounter for fracture
M80.839A	Other osteoporosis with current pathological fracture, unspecified forearm, initial encounter for fracture

ICD-10 Codes — Other osteoporosis with current pathological fracture, lower leg/ankle/vertebra/other (required additions)ICD-10

M80.862A	Other osteoporosis with current pathological fracture, left lower leg, initial encounter for fracture
M80.869A	Other osteoporosis with current pathological fracture, unspecified lower leg, initial encounter for fracture
M80.871A	Other osteoporosis with current pathological fracture, right ankle and foot, initial encounter for fracture
M80.872A	Other osteoporosis with current pathological fracture, left ankle and foot, initial encounter for fracture
M80.879A	Other osteoporosis with current pathological fracture, unspecified ankle and foot, initial encounter for fracture
M80.88XA	Other osteoporosis with current pathological fracture, vertebra(e), initial encounter for fracture
M80.8AXA	Other osteoporosis with current pathological fracture, other site, initial encounter for fracture

ICD-10 Codes — Additional examplesICD-10

M81.0	Age-related osteoporosis without current pathological fracture
M81.8	Other osteoporosis without current pathological fracture
Z78.310	Personal history of (healed) osteoporosis fracture

Clinical thresholdsmixed

FRAX	10-year major osteoporotic fracture ≥ 20% OR hip fracture ≥ 3%
BMD T-score	Osteoporosis: T-score ≤ -2.5; Osteopenia: T-score between -1 and -2.5 (with FRAX thresholds for treatment consideration)
Duration	Maximum duration of Evenity: 12 monthly doses

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Documentation must demonstrate that the patient meets the coverage criteria for romosozumab (Evenity) including diagnosis, qualifying BMD or fracture history/FRAX, and prior bisphosphonate treatment history when applicable. Authorization is limited to a maximum of 12 months (12 monthly doses).

Affected drug: romosozumab (Evenity) — HCPCS J3111
Authorization limit: <= 12 months (12 monthly doses)
Policy applies to postmenopausal women at high risk for fracture

Documentation Required

Prior Authorization Documentation Requirements

Provide documentation of diagnosis consistent with WHO/DXA or FRAX criteria, or presence of a qualifying fragility fracture. Include supporting BMD T-scores (lumbar spine, femoral neck/total hip, or one-third radius), FRAX 10-year probabilities when applicable, and a history of prior osteoporosis treatments or reasons they are not appropriate.

Background and Indication

Romosozumab (Evenity) is a sclerostin inhibitor indicated for treatment of osteoporosis in postmenopausal women at high risk for fracture. The policy defines high risk for fracture by a history of osteoporotic (minimal-trauma) fracture, very low BMD T-scores (e.g., ≤ -2.5 at approved sites), or a combination of osteopenia and elevated FRAX 10‑year probabilities (U.S. thresholds: major osteoporotic fracture ≥ 20% or hip fracture ≥ 3%). The indication and diagnostic thresholds guide prior authorization documentation and the requirement for a plan to follow romosozumab with antiresorptive therapy after up to 12 monthly doses.

Definitions and Diagnostic Thresholds

High risk for fracture — inv-31

BMD-defined high riskBMD T-score ≤ -2.5 at lumbar spine, hip, or one-third radius

Fragility fracture historyHistory of minimal-trauma vertebral compression fracture, hip, distal radius, pelvis, or proximal humerus

Combined criterionT-score between -1 and -2.5 plus qualifying FRAX (major ≥20% or hip ≥3%) also defines high risk

DXA T-score thresholds — inv-32

Osteoporosis thresholdT-score ≤ -2.5 = osteoporosis

Osteopenia thresholdT-score between -1.0 and -2.5 = osteopenia

Revision History and Policy Changes

2026-04-01retiredLatest

Policy retired for Louisiana membership; Louisiana plan membership disenrolled effective April 1, 2026.

2025-12-01references_updated

Supporting information and References section updated; previous policy version archived as CSLA2024D0080J.

duration_guidance

Clarified clinical guidance that the anabolic effect of romosozumab wanes after 12 monthly doses and use should be limited to 12 monthly doses with consideration of subsequent antiresorptive therapy.

OpenPayer

Evenity (Romosozumab-Aqqg) (for Louisiana Only) — Retired April 1, 2026