ModifiedUnitedHealthcarePolicy IEXD0080.11

Evenity (Romosozumab-Aqqg) Medical Benefit Drug Policy

Governs coverage and medical-necessity criteria for Evenity (romosozumab-aqqg) under UnitedHealthcare Individual Exchange medical benefit plans (excludes MA, NV, NY). Applies to providers requesting authorization for treatment of postmenopausal osteoporosis at high risk for fracture.

Policy Summary

PayerUnitedHealthcare

PolicyEvenity (Romosozumab-Aqqg) Medical Benefit Drug Policy

Policy CodePolicy IEXD0080.11

Change TypeRevised coverage rationale languageupdated references

Effective DateDec 1, 2025

Next Review Date

Key ActionSubmit prior authorization for Evenity confirming postmenopausal osteoporosis at high fracture risk and request authorization for no more than 12 months with dosing per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Replaced language indicating 'continued use of Evenity beyond 12 months is unproven and not medically necessary' with 'continued use of Evenity beyond 12 months is unproven'.

Updated References section to reflect the most current information.

12 monthsmaximum authorization duration

J3111HCPCS code

Most states (excl. MA,NV,NY)geographic applicability

Postmenopausal osteoporosisindication

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7,180FRAME trial subjects

73%vertebral fracture RRR (12 mo)

Coverage Criteria for Evenity (romosozumab-aqqg)

inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Therapy for Evenity: Diagnosis of postmenopausal osteoporosis; patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple fracture risk factors, or failure/intolerance to other available osteoporosis therapy); dosing consistent with FDA-approved labeling; authorization requested for no more than 12 months.

inv-02: Reauthorization/Continuation of Care — Reauthorization considerations

Reauthorization considerations

Continuation/Reauthorization: The clinical benefit of Evenity has not been demonstrated beyond 12 months in phase 3 clinical trials; continued use beyond 12 months is unproven.

Requests for durations >12 months lack supporting phase 3 evidence and may be reviewed accordingly.

inv-03: Evidence-based rationale — Clinical evidence supporting use

Clinical evidence supporting use

FRAME trial population and outcomes: FRAME (7,180 postmenopausal women age 55–90) randomized to romosozumab monthly for 12 months vs placebo showed a 73% lower risk of new vertebral fractures at 12 months and persistent fracture-risk reduction when followed by denosumab; FRAME extension through 36 months demonstrated sustained BMD gains and reduced fracture incidence after transition to denosumab.

Summarizes FRAME and extension outcomes; romosozumab mechanism increases bone formation and decreases resorption via sclerostin inhibition.

inv-04: Initial Therapy (alternate/location-specific language) — Covered when ALL of the following are met

Covered when ALL of the following are met

Eligibility: Patient is a postmenopausal woman with osteoporosis at high risk for fracture (history of osteoporotic fracture or multiple risk factors) or has failed/intolerant to other osteoporosis therapy.

Aligned with FDA indication and guideline context

Treatment duration: Planned romosozumab use is limited to 12 monthly doses (1 year).<=12 months

Anabolic effect wanes after 12 monthly doses; follow-on antiresorptive therapy should be considered

High risk features (examples): Recent fracture (eg within 12 months), fractures while on therapy, multiple vertebral fractures, very low T-score (eg < -3.0), very high FRAX probability (eg major osteoporotic fracture >30% or hip >4.5%).see examples

inv-05: Continuation / Transition Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Post-course antiresorptive therapy: If osteoporosis therapy remains warranted after completion of up to 12 monthly doses of romosozumab, continued therapy with an antiresorptive agent (eg denosumab or a bisphosphonate) is recommended to maintain BMD gains and reduce fracture risk.

Recommendation consistent with FDA informational guidance and Endocrine Society guidance

This policy applies to UnitedHealthcare Individual Exchange medical benefit plans in all states except for Massachusetts, Nevada, and New York. Consult the member-specific benefit plan document for plan-level applicability and any state-specific requirements.

Coverage of experimental, investigational, or otherwise unproven treatments may be excluded by the member certificate of coverage. Some Certificates of Coverage or state mandates, however, may allow coverage for investigational or off‑label uses under specific conditions; when applicable, those provisions supersede this policy. Always consult the member-specific benefit document and applicable state mandates before authorizing coverage for treatments described as experimental or unproven.

Clinical trials have not demonstrated benefit of Evenity beyond one year of treatment; therefore, continued use beyond 12 months is described as unproven. The FDA notes the anabolic effect wanes after 12 monthly doses and recommends limiting duration to 12 monthly doses, with transition to an antiresorptive agent thereafter if ongoing therapy is needed. Policy history: prior wording that characterized continued use beyond 12 months as “not medically necessary” has been revised to the current language stating it is “unproven.”

The clinical benefit of Evenity has not been demonstrated beyond 12 months in phase 3 clinical trials. Accordingly, the policy describes that the continued use of Evenity beyond 12 months is unproven, and the drug’s anabolic effect is reported to wane after 12 monthly doses, supporting a limit of up to 12 monthly doses per treatment course.

Revision note: the policy language was updated to remove the phrase that continued use of Evenity beyond 12 months was “not medically necessary.” The current wording describes continued use beyond 12 months as unproven rather than explicitly not medically necessary.

Coding and Diagnosis Codes

Applicable HCPCS CodesHCPCSCovered

J3111

Injection, romosozumab-aqqg, 1 mg

Applicable ICD-10 Diagnosis Codes (examples)ICD-10Covered

M80.*	Age-related osteoporosis with current pathological fracture (multiple specific subcodes listed in policy)
M80.811A	Other osteoporosis with current pathological fracture, right shoulder, initial encounter for fracture

Applicable ICD-10 CodesICD-10Covered

M80.0AXD	Age-related osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with routine healing
M80.0AXG	Age-related osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with delayed healing
M80.0AXK	Age-related osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with nonunion
M80.0AXP	Age-related osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with malunion
M80.0AXS	Age-related osteoporosis with current pathological fracture, other site, sequela
M80.0B1A	Age-related osteoporosis with current pathological fracture, right pelvis, initial encounter for fracture
M80.0B1D	Age-related osteoporosis with current pathological fracture, right pelvis, subsequent encounter for fracture with routine healing
M80.0B1G	Age-related osteoporosis with current pathological fracture, right pelvis, subsequent encounter for fracture with delayed healing
M80.0B1K	Age-related osteoporosis with current pathological fracture, right pelvis, subsequent encounter for fracture with nonunion
M80.0B1P	Age-related osteoporosis with current pathological fracture, right pelvis, subsequent encounter for fracture with malunion

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DXA T-score threshold

DXA T-score thresholdT-score ≤ -2.5

DXA sites referencedLumbar spine, femoral neck, total hip, or one-third radius

WHO definition contextT-score ≤ -2.5 defines osteoporosis when other causes ruled out

FRAX thresholds (US)

FRAX (US) major osteoporotic fracture threshold10-year probability ≥ 20%

FRAX (US) hip fracture threshold10-year probability ≥ 3%

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required for Evenity (romosozumab) when used for treatment of postmenopausal osteoporosis in patients at high risk for fracture. Requests must document the indication and meet criteria in the policy. Authorization is limited to a maximum of 12 months (12 monthly doses) in accordance with FDA labeling.

Prior authorization required
Limit authorization to ≤ 12 months (12 monthly doses)

Prior Authorization

Benefit-Specific Prior Authorization

Benefit coverage is dependent on the member-specific benefit plan document. Refer to the member’s Certificate of Coverage or plan document for information on PA requirements, coverage of off‑label uses, and any state-mandated exceptions. Where state mandates apply, they supersede this policy.

Check member-specific benefit plan document for PA and off-label coverage
State mandates may supersede policy or benefit document

Background and Rationale

Background: Evenity (romosozumab‑aqqg) is a sclerostin‑inhibiting monoclonal antibody indicated for treatment of osteoporosis in postmenopausal women at high risk for fracture — defined by a history of osteoporotic fracture, multiple fracture risk factors, or failure/intolerance to other osteoporosis therapy. Clinical trials used romosozumab administered monthly for up to 12 months, after which benefits plateau and follow‑on antiresorptive therapy is recommended to maintain gains in bone mineral density.

Definitions and Clinical Thresholds

Definition of high risk for fracture

Prior osteoporotic fractureHistory of osteoporotic (fragility) fracture

Multiple fracture risk factors or recent fractureMultiple risk factors for fracture or recent fracture (eg within 12 months)

Failed or intolerant to other therapyPatients who have failed or are intolerant to other available osteoporosis therapy

Other examplesFractures while on therapy, very low T-score, or very high FRAX probability may also denote high risk

Osteoporosis (DXA/FRAX criteria)

DXA diagnostic criterionT-score ≤ -2.5 at lumbar spine, femoral neck, total hip, or one-third radius

Initial Authorization Criteria

inv-35: Initial Therapy — Initial authorization criteria

Initial authorization criteria

Initial Authorization: Diagnosis of postmenopausal osteoporosis; patient at high risk for fracture (history of osteoporotic fracture, multiple risk factors, or failure/intolerance to other osteoporosis therapy); dosing per FDA labeling; authorization for up to 12 months.

inv-36: Initial therapy — Clinical trial initial regimen

Clinical trial initial regimen

Initial romosozumab regimen used in evidence: Romosozumab administered subcutaneously once monthly for 12 months as used in the FRAME trial.12 months

Trial regimen; policy adopts 12-month course as the authorized duration where indicated

Continuation and Sequencing Criteria

inv-38: Continuation Therapy — Continuation therapy guidance

Continuation therapy guidance

Continuation: Clinical benefit beyond 12 months not demonstrated; continued use beyond 12 months is unproven.

Requests exceeding 12 months lack supporting phase 3 evidence and may be subject to denial or special review.

inv-39: Continuation / sequencing — Trial regimen and follow-up therapy noted in clinical studies

Trial regimen and follow-up therapy noted in clinical studies

Post-romosozumab sequencing: In clinical trials, patients received romosozumab monthly for 12 months then transitioned to denosumab 60 mg every 6 months for at least 12–24 months; ongoing antiresorptive therapy maintained BMD gains.

May inform policy requirements for subsequent therapy

Step Therapy and Sequencing Considerations

Step consideration	Notes / policy implication
Assess prior osteoporosis therapies (failure or intolerance) when determining that a patient is ‘high risk for fracture’
Policy may require documentation of prior therapies or reasons for intolerance as part of establishing high-risk status for Evenity authorization

Step consideration	Notes / policy implication
Use of romosozumab for 12 months followed by transition to denosumab is supported by clinical trial evidence
Policy sequencing can mirror trials: authorize romosozumab for up to 12 months with recommendation/expectation of transition to an antiresorptive (eg, denosumab) to maintain BMD gains

Step consideration	Notes / policy implication
Allow romosozumab as an initial therapy option for patients at very high fracture risk or when oral therapy is not feasible
Policy may permit initial use without prior oral therapy when clinician documents very high-risk features (recent fracture, multiple fractures, very low T‑score, high FRAX) or inability to use oral agents per AACE/Endocrine Society guidance

Policy Revision History

2025-12-01revisionLatest

Revised coverage rationale: replaced language stating continued use of Evenity beyond 12 months was 'unproven and not medically necessary' with language that continued use beyond 12 months is 'unproven'; updated References and archived previous policy version IEXD0080.10.

Policy Summary

PayerUnitedHealthcare

PolicyEvenity (Romosozumab-Aqqg) Medical Benefit Drug Policy

Policy CodePolicy IEXD0080.11

Change TypeRevised coverage rationale languageupdated references

Effective DateDec 1, 2025

Next Review Date

Key ActionSubmit prior authorization for Evenity confirming postmenopausal osteoporosis at high fracture risk and request authorization for no more than 12 months with dosing per FDA labeling.

SourceLink

On This Page

Per AACE/Endocrine Society definitions

Estimates 10-year probability of hip and major osteoporotic fractures (with or without femoral neck BMD)

FRAX thresholds for very high fracture risk

FRAX threshold for very high fracture risk — major fracture10-year probability > 30%

FRAX threshold for very high fracture risk — hip fracture10-year probability > 4.5%

Use in guideline contextClassified as 'very high fracture probability' per AACE/ACE guidance

Prior Authorization

PA: Indication and Duration

Requests must confirm the patient is a postmenopausal woman at high risk for fracture and specify the planned duration of therapy. High risk includes history of osteoporotic fracture, multiple fracture risk factors, very low T-score, recent fracture, fractures while on approved therapy, or other guideline-defined high/very-high risk.

Patient is postmenopausal woman at high risk for fracture
Planned therapy duration must be provided (authorization limited to ≤ 12 months)

Denial Risk

Duration and Dosing

Duration and dosing must follow FDA-approved labeling. The anabolic effect of romosozumab wanes after 12 monthly doses; use beyond 12 months is not supported by the label and may be denied. If ongoing osteoporosis treatment is indicated after 12 months, transition to an antiresorptive agent (for example, denosumab) should be considered per prescribing information and guidelines.

Dosing must adhere to FDA labeling
Requests exceeding 12 months likely to be denied
Consider antiresorptive therapy after 12 months (e.g., denosumab)

Denial Risk

Duration-Based Denial Risk

Use beyond 12 monthly doses is not supported by the FDA label and represents a duration-based denial risk. Requests for continuation past 12 months must provide compelling rationale and will be reviewed in the context of benefit provisions and available evidence.

Duration beyond 12 months is a denial risk
Provide clinical justification if requesting >12 months; approval is unlikely without exceptional rationale

Step Therapy

Therapy History Considered

Document prior therapy history. Preference is for patients who have failed or are intolerant to other available osteoporosis therapies or who meet guideline criteria for initial use (very high fracture risk). Include past osteoporosis treatments, reasons for discontinuation or intolerance, and evidence of failure where applicable.

Document failure or intolerance to prior osteoporosis therapies when applicable
Guideline‑recommended sequencing (romosozumab up to 12 months followed by antiresorptive) should be noted

Step Therapy

Guideline-Informed Step/Selection

Professional guidelines recognize romosozumab as an option for patients at high or very high fracture risk and recommend treatment up to 1 year with subsequent antiresorptive therapy to maintain gains. Cite applicable guideline recommendations when submitting requests.

AACE/ACE and Endocrine Society guidance support romosozumab for certain high/very-high risk patients
Guidelines recommend romosozumab duration ≤12 months with follow-on antiresorptive therapy

Billing Rule

Coding Support

Billing and coding information should be included with the request. Use HCPCS J3111 for romosozumab administration and include an appropriate osteoporosis diagnosis code (examples below).

Include HCPCS: J3111 (Injection, romosozumab-aqqg, 1 mg)
Include appropriate ICD-10 osteoporosis diagnosis code (e.g., M80.*, M81.0, M81.8, Z78.310)

Billing Rule

Required Diagnosis Coding

Applicable ICD‑10 diagnosis codes that support medical necessity should be documented on the PA request (examples provided for reference). Ensure the diagnosis code reflects postmenopausal osteoporosis and fracture status where relevant.

Use M80.* codes for osteoporosis with current pathological fracture where applicable
Use M81.0 or M81.8 for osteoporosis without current pathological fracture
Z78.310 for personal history of healed osteoporotic fracture

Documentation Required

Required Documentation (Informational)

Prescribers should provide: indication, detailed fracture history, BMD/T-score results if available, prior osteoporosis therapies and reasons for discontinuation or failure, planned duration of romosozumab, and treatment plan after completing up to 12 months (e.g., transition to antiresorptive therapy). This documentation supports medical necessity review.

Document indication and fracture history
Include BMD/T-score and prior therapy details (dates, responses, intolerances)
Specify planned post-romosozumab treatment (antiresorptive agent)

Fragility fracturePresence of a fragility (osteoporotic) fracture supports diagnosis regardless of T-score

T-score plus FRAXT-score between -1.0 and -2.5 with elevated FRAX meets diagnostic criteria

Mechanism of action — Romosozumab

Mechanism classHuman monoclonal antibody that binds and inhibits sclerostin

Pathway effectBlocks sclerostin inhibition of Wnt signaling, promoting osteoblast development and function

Physiologic resultIncreases bone formation and decreases bone resorption

Drug — Naming

Brand nameEvenity

Generic nameromosozumab-aqqg (romosozumab)

Drug classSclerostin inhibitor; monoclonal antibody; anabolic osteoporosis agent

Very high fracture risk — examples

Recent fractureFracture within the past 12 months is a marker of very high fracture risk

Fracture while on therapy or multiple fracturesFractures occurring while on therapy or multiple vertebral fractures indicate very high risk

Very low T-scoreVery low T-score (eg < -3.0) denotes very high fracture risk

High FRAX probabilityFRAX: major osteoporosis fracture > 30% or hip fracture > 4.5% corresponds to very high fracture risk

inv-37: Efficacy Evidence — Clinical trial evidence supporting benefit in high-risk postmenopausal women

Clinical trial evidence supporting benefit in high-risk postmenopausal women

Evidence of benefit: Romosozumab 210 mg monthly for 12 months reduced vertebral fractures (eg 73% reduction at 12 months in FRAME), reduced clinical and nonvertebral fractures in randomized trials, and showed persistent benefits when followed by denosumab or alendronate in extension and comparator studies.

FRAME, FRAME extension, ARCH and other trials summarized

inv-40: Antiresorptive follow-up — Recommendations for therapy after romosozumab course

Recommendations for therapy after romosozumab course

Follow-on therapy: If osteoporosis therapy remains warranted after 12 monthly doses of romosozumab, continued therapy with an antiresorptive agent should be considered to maintain BMD and reduce fracture risk.

Consistent with FDA informational guidance and Endocrine Society recommendations