CurrentColorado Rocky Mountain Health PlansPolicy IEXD0080.11

Evenity® (Romosozumab-Aqqg) – Individual Exchange Medical Benefit Drug Policy

Medical benefit drug policy for romosozumab-aqqg (Evenity) for Individual Exchange benefit plans (excludes MA, NV, NY). Defines coverage rationale, initial authorization limits, reauthorization stance, and applicable billing/diagnosis codes.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyEvenity® (Romosozumab-Aqqg) – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD0080.11

Change TypeRevised languagereferences updated

Effective DateDec 1, 2025

Next Review Date

Key ActionAuthorization requires documentation that all coverage criteria are met, including diagnosis of postmenopausal osteoporosis, high fracture risk, dosing per FDA labeling, and authorization limited to no more than 12 months.

SourceLink

POLICY UPDATE CHANGES

Revised continued-use language to remove explicit 'not medically necessary' determination; supporting information and references updated and prior version IEXD0080.10 archived.

Updated References section to reflect the most current information.

12 monthsMaximum authorization duration

MA/NV/NYState exclusions

postmenopausal womenIndicated population

high fracture risk

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Coverage Summary & Rationale

Scope: This policy applies to Evenity (romosozumab-aqqg) as a medical benefit drug for Individual Exchange plans (excludes MA, NV, NY) and defines coverage rationale, authorization limits, and applicable billing/diagnosis codes. Coverage stance: covered_with_criteria. Policy statement: Evenity is indicated for the treatment of osteoporosis in postmenopausal patients at high risk for fracture when diagnostic and clinical criteria are met (see coverage rationale). Authorization is limited to no more than 12 months of therapy.

Indication / Coverage Rationale

Covered when ALL of the following are met:

Postmenopausal osteoporosis: Patient is a postmenopausal woman with osteoporosis
High fracture risk: Patient is at high risk for fracture, defined as history of osteoporotic fracture, or multiple risk factors for fracture
Failure or intolerance to other therapy (informational): Patient has failed or is intolerant to other available osteoporosis therapy
This reflects FDA indication language included for informational purposes
Duration limit and transition: Duration of therapy limited to 12 monthly doses12 monthly doses
Anabolic effect wanes after 12 monthly doses; if continued therapy is warranted, follow with antiresorptive agent

Initial Authorization / Medically Necessary Criteria

Initial Authorization / 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
High fracture risk (examples): 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)
Includes examples used to define high fracture risk
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Authorization duration:

Reauthorization / Continuation Criteria

Reauthorization / Continuation of Care

Reauthorization criteria / evidence summary

Unproven beyond 12 months: The clinical benefit of Evenity has not been demonstrated beyond 12 months in phase 3 clinical trials. The continued use of Evenity beyond 12 months is unproven.
Policy does not support routine approval beyond 12 months

Continued Use / Beyond 12 Months (policy language change)

Policy statement on continued use: Continued use of Evenity beyond 12 months is considered unproven
Policy language replaced prior wording that explicitly stated continued use beyond 12 months was 'not medically necessary'; current language removes explicit 'not medically necessary' determination

Operational implication: The policy does not support routine approval of Evenity beyond 12 months because phase 3 clinical trials did not demonstrate benefit beyond that duration. If continued osteoporosis treatment is warranted after the 12-month Evenity course, the policy and FDA guidance recommend transitioning to an antiresorptive agent to maintain bone mineral density gains and reduce fracture risk.

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required with clinical criteria

Prior authorization is required. Documentation must show all coverage criteria are met: diagnosis of postmenopausal osteoporosis; patient at high fracture risk (e.g., history of osteoporotic fracture, multiple risk factors, or failed/intolerant to other osteoporosis therapy); dosing per FDA-approved labeling; and authorization limited to no more than 12 months.

J3111
Diagnosis: postmenopausal osteoporosis
High fracture risk (history of osteoporotic fracture, multiple risk factors, or failure/intolerance to other therapy)
Dosing consistent with FDA labeling
Authorization limited to 12 months

Documentation Required

Document failure or intolerance to other osteoporosis therapy

Document the reason other osteoporosis therapies were not appropriate. Include history of prior osteoporosis treatments and evidence of failure or intolerance (for example continued fractures on therapy, adverse reactions, or contraindications), or documentation of multiple fracture risk factors that justify use of Evenity.

Applicable Billing & Diagnosis Codes

Drug HCPCSHCPCSCovered

J3111

Injection, romosozumab-aqqg, 1 mg

Relevant ICD-10 Diagnosis Codes (osteoporosis with current pathological fracture and other osteoporosis 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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Relevant ICD-10 diagnosis codes (osteoporosis/fragility fracture history)ICD-10

M80.872G	Other osteoporosis with current pathological fracture, left ankle and foot, subsequent encounter for fracture with delayed healing
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

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Key Clinical Evidence & Trial Data

73%FRAME: vertebral fracture RRR at 12 months (0.5% vs 1.8%)

36%FRAME: clinical fracture lower risk at 12 months (1.6% vs 2.5%)

48%ARCH: vertebral fracture lower risk at 24 months (6.2% vs 11.9%)

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

Clinical trial duration limitation: Phase 3 trials did not demonstrate benefit beyond 12 months. FRAME and its extension show fracture reduction and maintained BMD when 12 months of romosozumab was followed by denosumab (FRAME extension: through 36 months new vertebral fracture incidence 1.0% romosozumab-to-denosumab vs 2.8% placebo-to-denosumab; 66% RRR). Phase 3 transition trials also document BMD benefits through 12 months (e.g., mean % change total hip through 12 months: +2.6% romosozumab vs -0.6% teriparatide in a transition trial).

Definitions & Background

Indication summary: Evenity is indicated for treatment of osteoporosis in postmenopausal patients at high risk for fracture. Treatment duration is limited to 12 months. Definitions: High risk for fracture—Defined in the FDA indication as history of osteoporotic fracture or multiple risk factors for fracture; guideline examples include recent fracture, multiple fractures, very low T-score, high FRAX probabilities, or fractures on therapy. FRAX—Fracture Risk Assessment Tool estimating 10-year probability of hip and major osteoporotic fractures; US thresholds cited: >= 3% for hip and >= 20% for major osteoporotic fracture.

Policy Revision History

12/01/2025policy_revisionLatest

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'; supporting information and references section updated; previous policy version IEXD0080.10 archived.

reference_updateLatest

Updated References section to reflect the most current information.