Evenity (romosozumab-aqqg)

Coverage Summary

Evenity (romosozumab-aqqg) is covered with criteria for the treatment of osteoporosis in postmenopausal patients at high risk for fracture when the policy's coverage conditions are met. Authorization is limited to no more than 12 months (maximum of 12 monthly doses).

Initial Therapy / Medically Necessary

Evenity is proven for the treatment of osteoporosis in postmenopausal patients at high risk for fracture when ALL of the following criteria are met:

Diagnosis of postmenopausal osteoporosis
Patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture, 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

Reauthorization / Continuation of Care

Criteria for continued use

Reauthorization / Continuation of Care: Continued use of Evenity beyond 12 months is unproven and not medically necessary

The clinical benefit of Evenity has not been demonstrated beyond 12 months in phase 3 clinical trials.

Coverage criteria (context)

Covered when ALL of the following are met:

Patient is a postmenopausal woman with osteoporosis at high risk for fracture (FDA indicated population).
Treatment duration limited to 12 monthly doses (Evenity anabolic effect wanes after 12 doses).12 monthly doses
If ongoing osteoporosis therapy is warranted after 12 months, consider transition to antiresorptive therapy.
Clinical documentation supports history of osteoporotic fracture, multiple fracture risk factors, or failure/intolerance to other osteoporosis therapy as applicable per FDA label and guideline recommendations.

Applicable Codes

Drug HCPCSHCPCSCovered

J3111

Injection, romosozumab-aqqg, 1 mg

Applicable ICD-10 Diagnosis Codes (osteoporosis with current pathological fracture)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 (osteoporosis and pathological fractures)ICD-10Covered

M80.021A	Age-related osteoporosis with current pathological fracture, right humerus, initial encounter for fracture
M80.021D	Age-related osteoporosis with current pathological fracture, right humerus, subsequent encounter for fracture with routine healing
M80.021G	Age-related osteoporosis with current pathological fracture, right humerus, subsequent encounter for fracture with delayed healing
M80.021K	Age-related osteoporosis with current pathological fracture, right humerus, subsequent encounter for fracture with nonunion
M80.021P	Age-related osteoporosis with current pathological fracture, right humerus, subsequent encounter for fracture with malunion
M80.021S	Age-related osteoporosis with current pathological fracture, right humerus, sequela
M80.022A	Age-related osteoporosis with current pathological fracture, left humerus, initial encounter for fracture
M80.022D	Age-related osteoporosis with current pathological fracture, left humerus, subsequent encounter for fracture with routine healing
M80.022G	Age-related osteoporosis with current pathological fracture, left humerus, subsequent encounter for fracture with delayed healing
M80.022K	Age-related osteoporosis with current pathological fracture, left humerus, subsequent encounter for fracture with nonunion

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Provider Actions / Prior Authorization

Prior Authorization

Authorization required for Evenity

Authorization is required for Evenity (romosozumab-aqqg). Approvals are limited to a maximum of 12 months.

Affected code: J3111
Limit: Authorization for no more than 12 months

Denial Risk

Reauthorization denial beyond 12 months

Continued use of Evenity beyond 12 months is considered not medically necessary because phase 3 clinical trials did not demonstrate clinical benefit past 12 months.

Clinical Evidence Summary

0.5% vs 1.8%FRAME 12-month new vertebral fractures (73% RRR)

0.6% vs 2.5%FRAME 24-month vertebral fractures (75% RRR after transition to denosumab)

6.2% vs 11.9%ARCH 24-month new vertebral fractures (48% RRR vs alendronate)

Key evidence from randomized trials demonstrates fracture and BMD benefits with romosozumab in postmenopausal osteoporosis: FRAME (benefit at 12 months and through transition to denosumab), ARCH (benefit versus alendronate), Langdahl (benefit on hip BMD when transitioning from bisphosphonates), and the Phase 2 extension (McClung) that showed largest BMD gains in the first year. Phase 3 trials have not demonstrated clinical benefit of continued romosozumab beyond 12 months, and continued use beyond 12 months is considered unproven and not medically necessary.

Background & Definitions

Evenity is indicated for treatment of osteoporosis in postmenopausal women at high risk for fracture (history of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance to other available osteoporosis therapy). Phase 3 trials have not demonstrated benefit beyond 12 months, and the anabolic effect wanes after 12 monthly doses, so treatment duration should be limited to 12 monthly doses with consideration of transition to antiresorptive therapy if further osteoporosis treatment is needed.

Term	Definition
High risk for fracture (FDA label/guidelines)	History of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance to other available osteoporosis therapy; guidelines additionally define very high risk by recent fractures, multiple fractures, very low T-score, or high FRAX probability.
FRAX	Fracture Risk Assessment Tool estimating 10-year probability of hip and major osteoporotic fractures, used with or without femoral neck BMD. In the U.S., clinical diagnosis thresholds: 10-year probability ≥20% for major osteoporotic fracture or ≥3% for hip fracture.

Policy Thresholds (exact)

Maximum duration12 monthly doses

FRAX 10-year probability (US clinical diagnosis)>= 20% (major osteoporotic fracture) or >= 3% (hip fracture)

DXA T-score diagnostic threshold (WHO)Osteoporosis: <= -2.5 SD (osteopenia -1 to -2.5 SD)

Revision History

2024-11-01clarifiedLatest

Archived previous policy version IEXD0080.09; Updated Clinical Evidence and References sections to reflect the most current information.