Evenity (romosozumab-aqqg) for postmenopausal osteoporosis

Coverage Summary

Initial therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

ALL of the following

Diagnosis of postmenopausal osteoporosis.
Patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy).
Dosing is in accordance with the United States Food and Drug Administration approved labeling.
Authorization is for no more than 12 months.<= 12 months

Reauthorization / Continuation of Care Criteria

Reauthorization / Continuation of Care

ALL of the following

The clinical benefit of Evenity (romosozumab-aqqg) has not been demonstrated beyond 12 months in Phase 3 clinical trials.
The continued use of Evenity beyond 12 months is unproven.

Coverage Rationale — Revision Note

Coverage Rationale (revision history note)

ALL of the following

Policy wording updated to state explicitly that continued use of Evenity beyond 12 months is unproven and to align authorization limits with the evidence supporting up to 12 months of therapy.

Evenity (romosozumab-aqqg) is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Informational guidance: limit therapy to 12 monthly doses in accordance with FDA-approved labeling and consider initiating or following with an anti-resorptive agent if continued osteoporosis treatment is warranted after 12 months.

Provider Actions & Authorization Requirements

Prior Authorization

Authorization limit

Authorization is required for Evenity (romosozumab-aqqg). Requests are limited to a maximum duration of 12 months and dosing must align with current FDA-approved labeling.

Affected code: J3111

Documentation Required

Clinical justification required

Document the clinical indication and rationale for therapy. Clinical records must demonstrate a diagnosis of postmenopausal osteoporosis and that the patient is at high risk for fracture. High-risk evidence includes history of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance of other available osteoporosis therapy. Dosing must follow FDA labeling.

Applicable Codes

Drug HCPCS codeHCPCS

J3111

Injection, romosozumab-aqqg, 1 mg

Diagnosis codes (osteoporosis with current pathological fracture) — included for referenceICD-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

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Applicable ICD-10 Diagnosis Codes (osteoporosis with and without current fracture; personal history)ICD-10

M80.872K	Other osteoporosis with current pathological fracture, left ankle and foot, subsequent encounter for fracture with nonunion.
M80.872P	Other osteoporosis with current pathological fracture, left ankle and foot, subsequent encounter for fracture with malunion.
M80.872S	Other osteoporosis with current pathological fracture, left ankle and foot, sequela.
M80.879A	Other osteoporosis with current pathological fracture, unspecified ankle and foot, initial encounter for fracture.
M80.879D	Other osteoporosis with current pathological fracture, unspecified ankle and foot, subsequent encounter for fracture with routine healing.
M80.879G	Other osteoporosis with current pathological fracture, unspecified ankle and foot, subsequent encounter for fracture with delayed healing.
M80.879K	Other osteoporosis with current pathological fracture, unspecified ankle and foot, subsequent encounter for fracture with nonunion.
M80.879P	Other osteoporosis with current pathological fracture, unspecified ankle and foot, subsequent encounter for fracture with malunion.
M80.879S	Other osteoporosis with current pathological fracture, unspecified ankle and foot, sequela.
M80.88XA	Other osteoporosis with current pathological fracture, vertebra(e), initial encounter for fracture.

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Clinical Evidence and Safety

0.5%FRAME: new vertebral fractures at 12 months with romosozumab vs placebo (0.5% vs 1.8%; 73% RRR; p<0.001)

1.0%FRAME extension: new vertebral fracture incidence through 36 months (1.0% vs 2.8%; 66% RRR; p<0.001)

48%ARCH: lower risk of new vertebral fractures at 24 months (48% vs alendronate) — romosozumab-to-alendronate vs alendronate-to-alendronate

2.5%ARCH safety: serious cardiovascular adverse events in year 1 (romosozumab 2.5% vs alendronate 1.9%)

3.2%Phase 3 vs teriparatide: greater total hip BMD increase through 12 months (difference ~3.2% favoring romosozumab)

Phase 3 clinical evidence indicates the clinical benefit of Evenity has not been demonstrated beyond 12 months; the policy therefore states that continued use beyond 12 months is unproven. The ARCH trial versus alendronate demonstrated fracture risk reductions but also identified a safety signal: during year 1 serious cardiovascular adverse events occurred more often with romosozumab than alendronate (2.5% vs 1.9%). Other phase 3 studies (FRAME and its extension, and comparator trials) show vertebral and clinical fracture reductions with 12 months of romosozumab and persistent benefit when followed by antiresorptive therapy, but overall the trials have not established additional clinical benefit from treatment beyond 12 months. For these reasons the FDA and this policy recommend limiting romosozumab therapy to 12 monthly doses, and if further osteoporosis treatment is needed to follow with an anti-resorptive agent.

Background & Definitions

Background: Romosozumab is a human monoclonal antibody that inhibits sclerostin, producing both increased bone formation and decreased bone resorption. Evenity is indicated for postmenopausal osteoporosis in patients at high risk for fracture. The policy limits use to FDA-approved dosing and authorizes treatment for no more than 12 months because phase 3 clinical trials have not demonstrated benefit beyond 12 months. This document is a medical benefit drug policy defining coverage criteria, reauthorization guidance, and applicable procedure/diagnosis codes for Evenity (romosozumab-aqqg) for treatment of postmenopausal patients at high risk for fracture.

Revision History

2025-12-01revisionLatest

Replaced prior wording that stated 'continued use of Evenity beyond 12 months is unproven and not medically necessary' with revised wording 'continued use of Evenity beyond 12 months is unproven'.

2025-12-01clarificationLatest

Updated the References section to reflect the most current information, including Evenity prescribing information (October 2024); archived previous policy version 2024D0080K.