UnitedHealthcare Evenity coverage update; Prior Auth

Coverage Criteria for Evenity (romosozumab-aqqg)

Initial Therapy

Covered when ALL of the following are met

Initial approval requirements: Patient is a postmenopausal individual with a diagnosis of osteoporosis; AND meets ONE of the following: (a) BMD T-score < -2.5 based on measurements from lumbar spine (at least two vertebral bodies), hip (femoral neck or total hip), or one-third radius; OR (b) vertebral compression fracture; OR (c) history of fracture from minimal trauma (hip, pelvis, distal radius, or proximal humerus); OR (d) BMD T-score between -1.0 and -2.5 PLUS FRAX 10-year major osteoporotic fracture probability ≥20% AND hip fracture probability ≥3%.see BMD and FRAX thresholds

From Coverage Rationale and Instructions for Use

Prior Bisphosphonate Failure/Intolerance

AND patient has one of the following prior therapy statuses

Prior therapy requirements: Either: (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 intravenous bisphosphonate therapy.document prior therapy or intolerance

Policy lists multiple acceptable prior therapy pathways

Concomitant Therapy and Duration

Other coverage conditions: Patient is not receiving Evenity in combination with RANK ligand inhibitors (e.g., Prolia, Xgeva) or parathyroid hormone analogs (e.g., Forteo, Tymlos); dosing must follow FDA labeling; authorization is limited to no more than 12 months; continued use beyond 12 months is considered unproven and not medically necessary.12 months maximum

Concomitant therapy prohibited and reauthorization guidance

Initial therapy coverage

Covered when ALL of the following are met

FDA indication and treatment duration: Patient is a postmenopausal woman at high risk for fracture (history of osteoporotic fracture or multiple risk factors for fracture, or failed/intolerant to other available osteoporosis therapy) AND planned romosozumab treatment will be limited to 12 monthly doses with consideration of subsequent antiresorptive therapy to maintain BMD gains.12 months

Reflects FDA indication and guideline-aligned follow-up

Concurrent use of Evenity (romosozumab-aqqg) with other anabolic or antiresorptive biologic agents is not permitted for coverage. Specifically, patients must not receive Evenity in combination with RANK ligand inhibitors (e.g., Prolia, Xgeva) or parathyroid hormone analogs (e.g., Forteo, Tymlos). This prohibition is a requirement for authorization and must be documented in the prior authorization request.

Romosozumab dosing and duration must follow the FDA-approved labeling. Authorization is limited to a maximum of 12 monthly doses; requests for dosing or cumulative duration beyond this labeled course are not consistent with the FDA-directed regimen and require justification aligned with policy criteria.

The policy states that clinical benefit of Evenity beyond 12 months has not been demonstrated in phase 3 trials. As a result, continued use beyond 12 months is considered unproven and not medically necessary and may be denied upon reauthorization review.

Continuation of romosozumab beyond the 12 monthly dose course is not supported unless there is a documented plan to transition the patient to an antiresorptive agent; the anabolic effect wanes after 12 months and the FDA labeling advises consideration of antiresorptive therapy thereafter.

Coding — HCPCS and ICD-10

Covered HCPCS CodesHCPCSCovered

J3111

Injection, romosozumab-aqqg; mg

Applicable ICD-10 Diagnosis Codes (partial list)ICD-10

M80.0B2A	Age-related osteoporosis with current pathological fracture, left pelvis, initial encounter for fracture
M80.0B2D	Age-related osteoporosis with current pathological fracture, left pelvis, subsequent encounter for fracture with routine healing
M80.0B2G	Age-related osteoporosis with current pathological fracture, left pelvis, subsequent encounter for fracture with delayed healing
M80.0B2K	Age-related osteoporosis with current pathological fracture, left pelvis, subsequent encounter for fracture with nonunion
M80.0B2P	Age-related osteoporosis with current pathological fracture, left pelvis, subsequent encounter for fracture with malunion
M80.0B2S	Age-related osteoporosis with current pathological fracture, left pelvis, sequela

Applicable ICD-10 Codes (Osteoporosis with/without fracture)ICD-10Covered

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

Relevant ICD Codes from documentICD-10

M80.8B2A	Other osteoporosis with current pathological fracture, left pelvis, initial encounter for fracture
M80.8B2D	Other osteoporosis with current pathological fracture, left pelvis, subsequent encounter for fracture with routine healing
M80.8B2G	Other osteoporosis with current pathological fracture, left pelvis, subsequent encounter for fracture with delayed healing
M80.8B2K	Other osteoporosis with current pathological fracture, left pelvis, subsequent encounter for fracture with nonunion
M80.8B2P	Other osteoporosis with current pathological fracture, left pelvis, subsequent encounter for fracture with malunion
M80.8B2S	Other osteoporosis with current pathological fracture, left pelvis, sequela

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Romosozumab (Evenity) is covered only when the patient meets all listed high‑risk criteria and required documentation is provided. Requests that do not include the clinical criteria below or required diagnosis codes may be denied.

Authorization limited to a maximum of 12 monthly doses (FDA‑labeled duration).
Do not concomitantly administer romosozumab with RANK‑ligand inhibitors or parathyroid hormone analogs.

Billing Rule

Use Listed ICD‑10 Codes on Requests

Use the listed osteoporosis ICD‑10 diagnosis codes on prior authorization and claim submissions. Claims may be denied if submitted diagnosis codes do not match the applicable osteoporosis codes.

Initial Authorization Requirements

Initial Therapy Requirements

Initial authorization requirements

Initial: See Coverage criteria: diagnosis of osteoporosis plus meeting BMD OR vertebral compression fracture OR qualifying fragility fracture OR FRAX thresholds; documentation must include supporting DXA T-score or FRAX results and history of qualifying fracture when applicable; dosing per FDA labeling; authorization limited to a maximum of 12 months.

Consolidated from Coverage Rationale and Instructions for Use

Efficacy-supported initial regimen

Evidence supporting efficacy and typical dosing from trials

Typical trial regimen: Romosozumab 210 mg subcutaneously once monthly for up to 12 months demonstrated reductions in vertebral and clinical fractures in randomized trials (FRAME, ARCH, phase 2 studies) and produced the largest BMD gains at 210 mg monthly; benefits were observed when followed by antiresorptive therapy.210 mg monthly; 12 months

Continuation / Reauthorization Criteria

Continuation Therapy

Reauthorization/Continuation

Continuation beyond 12 months is considered unproven and not medically necessary; authorization should not be provided beyond 12 months absent compelling evidence and a plan for transition to antiresorptive therapy.

Policy states lack of demonstrated benefit beyond 12 months in phase 3 trials

Antiresorptive follow-up

Guidance on post-romosozumab therapy to maintain BMD gains

Post-treatment recommendation: Following up to 12 months of romosozumab, patients who remain at risk for fracture should receive antiresorptive therapy (e.g., bisphosphonate or denosumab) to maintain increases in bone mineral density and reduce fracture risk.

Supported by FDA labeling and Endocrine Society/AACE guidelines

Step Therapy and Prior Treatment Requirements

Step	Requirement
1	Prior failure, contraindication, or intolerance to oral bisphosphonate therapy (e.g., history of intolerance to oral bisphosphonates).
2	If oral bisphosphonate intolerance present, history of failure, contraindication, or intolerance to intravenous bisphosphonate therapy (e.g., pamidronate, zoledronic acid) must be documented.
3	Alternative pathway: documented history of failure or contraindication to oral bisphosphonate therapy alone may meet prior therapy requirement where specified.

Requirement	Details / Documentation
Clinical justification of high fracture risk may be required	Providers should document evidence of very high fracture risk per guideline definitions (recent fracture within past 12 months, fractures while on therapy, multiple fractures, injurious falls, or very high FRAX probability); guideline thresholds and examples provided by AACE/ACE and Endocrine Society support romosozumab use in these patients.
Documentation of intolerance or failure of other therapy may be required	When applicable, document prior intolerance, contraindication, or failure of other osteoporosis therapies (for example inability to use oral therapy) to justify romosozumab initiation as recommended for patients unable to use oral agents.

Quantity Limits

romosozumab (Evenity) — maximum authorization

Maximum authorization duration12 monthly doses (12 months)

Dosing contextAnabolic effect wanes after 12 monthly doses; follow with antiresorptive therapy if continued treatment is indicated

Coverage implicationAuthorization limited to 12 months per FDA guidance

Site of Care

Note

No site‑of‑care restrictions specified

No site‑of‑care restrictions are specified in this policy section for administration of romosozumab.

Administration site (e.g., infusion/administration center) is not restricted by this policy section

Key Definitions

High risk for fracture — definition

Definition of high risk for fracture (BMD)BMD T-score ≤ -2.5 at lumbar spine, hip (femoral neck or total hip), or one-third radius

Other high-risk findingsVertebral compression fracture or history of fracture from minimal trauma (hip, pelvis, distal radius, proximal humerus)

FRAX-based high riskFRAX 10-year major osteoporotic probability ≥ 20% or hip probability ≥ 3% (used with T-score between -1 and -2.5)

DXA T-score — definition

DXA T-score definitionNumber of standard deviations a patient's BMD differs from young adult reference (T-score)

Osteoporosis thresholdT-score ≤ -2.5 defines osteoporosis

Background

Evenity (romosozumab-aqqg) is a sclerostin inhibitor indicated for treatment of osteoporosis in postmenopausal women at high risk for fracture — defined by history of osteoporotic fracture, multiple fracture risk factors, or failure/intolerance to other osteoporosis therapies. The FDA-labeled regimen supports up to 12 monthly doses, after which the anabolic effect declines and follow-up with an antiresorptive agent should be considered. The policy uses these indications and the 12-month duration limit to define prior authorization requirements and coverage decisions.

OpenPayer

Evenity (romosozumab-aqqg) — Medical Benefit Drug Policy (coverage criteria)