Evenity (romosozumab-aqqg)

Coverage Summary

Coverage stance: Covered with criteria for Evenity (romosozumab-aqqg) as a medical benefit for the treatment of osteoporosis in postmenopausal women at high risk for fracture. The policy (Policy Number: CS2024D0080P, Effective Date: November 1, 2024) requires meeting specified diagnostic thresholds (e.g., BMD T-score ≤ -2.5, qualifying fracture history, or BMD in the osteopenia range with FRAX meeting major fracture ≥ 20% or hip fracture ≥ 3%), and meets bisphosphonate prior therapy/intolerance criteria per the policy. Authorization is limited to no more than 12 months (treatment duration limited to 12 monthly doses).

Quick facts and thresholds

Maximum authorization duration≤ 12 months

Primary HCPCS codeJ3111

FRAX thresholds (major / hip)>= 20% / >= 3%

Target population (FDA)Postmenopausal women at high risk for fracture

Maximum recommended duration12 months (limit to 12 monthly doses)

Initial Therapy Criteria (Medically Necessary)

Continuation / Reauthorization Criteria

Unproven Uses and Exclusions

Policy-level exclusion: the policy states that clinical benefit of Evenity beyond 12 months has not been demonstrated and therefore continued use beyond 12 months is unproven and not medically necessary; the policy limits authorization to 12 months.

Applicable Codes

Drug HCPCSHCPCSCovered

J3111

Injection, romosozumab-aqqg, 1 mg

Applicable ICD-10 Diagnosis Codes (osteoporosis with pathologic fracture and other osteoporosis fracture codes)ICD-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 (listed in this part of the document)ICD-10

M80.869A	Other osteoporosis with current pathological fracture, unspecified lower leg, initial encounter for
M80.869D	Other osteoporosis with current pathological fracture, unspecified lower leg, subsequent encounter for fracture with routine healing
M80.869G	Other osteoporosis with current pathological fracture, unspecified lower leg, subsequent encounter for fracture with delayed healing
M80.869K	Other osteoporosis with current pathological fracture, unspecified lower leg, subsequent encounter for fracture with nonunion
M80.869P	Other osteoporosis with current pathological fracture, unspecified lower leg, subsequent encounter for fracture with malunion
M80.869S	Other osteoporosis with current pathological fracture, unspecified lower leg, sequela
M80.871A	Other osteoporosis with current pathological fracture, right ankle and foot, initial encounter for fracture
M80.871D	Other osteoporosis with current pathological fracture, right ankle and foot, subsequent encounter for fracture with routine healing
M80.871G	Other osteoporosis with current pathological fracture, right ankle and foot, subsequent encounter for fracture with delayed healing
M80.871K	Other osteoporosis with current pathological fracture, right ankle and foot, subsequent encounter for fracture with nonunion

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Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required with clinical criteria

Provider must obtain authorization demonstrating all coverage criteria are met (osteoporosis diagnosis, diagnostic risk criteria, bisphosphonate prior therapy/intolerance criteria as applicable, not on excluded combination therapies, dosing per FDA label) and limit authorization to no more than 12 months.

J3111

Documentation Required

Document BMD and/or fracture history and FRAX when applicable

Require documentation of BMD T-score results from lumbar spine (at least two vertebral bodies), hip (femoral neck, total hip), or radius (one-third radius site); specified minimal trauma fracture history (vertebral compression, hip, distal radius, pelvis, proximal humerus) when applicable; or FRAX 10-year probability meeting US thresholds (major osteoporotic fracture ≥ 20% or hip fracture ≥ 3%) when using a BMD T-score between -1 and -2.5.

Clinical Evidence Summary

2.5% v 1.9%ARCH: serious cardiovascular events year 1 (romosozumab vs alendronate)

Evidence context: Phase 3 trials supporting romosozumab include the FRAME trial (vertebral fracture reduction at 12 months and extension data through 36 months with subsequent denosumab), the ARCH trial showing fracture risk reductions with a romosozumab-to-alendronate sequence but a noted cardiovascular signal during year 1, the FRAME extension demonstrating persistent benefit through 36 months when followed by denosumab, and a bisphosphonate transition trial (Langdahl) showing superior total hip BMD increases versus teriparatide through 12 months. The policy emphasizes that benefit beyond 12 months is unproven.

Background & Definitions

Background: Evenity (romosozumab-aqqg) is FDA-indicated for treatment of osteoporosis in postmenopausal women at high risk for fracture (FDA defines high risk as history of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance to other available osteoporosis therapy). The FDA and the policy note that the anabolic effect wanes after 12 monthly doses, so treatment duration is limited to 12 months, and if continued osteoporosis therapy is warranted a transition to an antiresorptive agent (e.g., bisphosphonate or other antiresorptive) is recommended. Guideline context and diagnostic thresholds used in the policy include WHO DXA T-score definitions (osteoporosis T-score ≤ -2.5; osteopenia between -1 and -2.5) and US FRAX thresholds for clinical diagnosis (major fracture ≥ 20% or hip fracture ≥ 3%), with the policy specifying documentation of BMD, fracture history, or FRAX as applicable.

Term	Definition
High risk for fracture (FDA/Guidelines)
History of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance to other available osteoporosis therapy; guideline definitions add recent fracture, multiple fractures, very low T-score, or high FRAX probability.
FRAX
Fracture Risk Assessment Tool estimating 10-year probability of hip or major osteoporotic fracture, used with or without femoral neck BMD. In the United States, a clinical diagnosis may be made when FRAX 10-year probability of major osteoporotic fracture ≥ 20% or hip fracture ≥ 3%.

Revision History

2024-11-01policy_updateLatest

Updated Clinical Evidence and References sections to reflect the most current information.