ModifiedCentenePolicy CP PHAR.428

Romosozumab-aqqg (Evenity) coverage

Policy governs medical necessity and prior authorization criteria for romosozumab-aqqg (Evenity) for treatment of postmenopausal osteoporosis and specifies limits, contraindications, and required documentation for Centene lines of business.

Policy Summary

PayerCentene

PolicyRomosozumab-aqqg (Evenity) coverage

Policy CodePolicy CP PHAR.428

Change TypeRevised criteria and durationsadded Appendix E

Effective Date05.21.19

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets initial approval criteria, including bisphosphonate trial history or exception and BMD results.

SourceLink

POLICY UPDATE CHANGES

Added criteria to ensure the member has not received ≥ 12 months cumulative Evenity therapy before approval per prescribing information.

Clarified preference for failure of generic alendronate as a bisphosphonate trial requirement.

Updated definition of very high risk for fracture per 2020 AACE/ACE PMO treatment guideline.

Added Appendix E to provide clarity on the interpretation of bone mineral density T-scores.

Revised initial approval duration to 12 months for Medicaid/HIM and added Commercial approval duration of 6 months or to the member's renewal date, whichever is longer.

Added criteria to ensure the member has not received 12 months cumulative Evenity therapy before approval per PI; clarified failure of generic alendronate is preferred; clarified dosage regimen in Appendix B per PI.

Updated definition of very high risk for fracture per 2020 AACE/ACE PMO treatment guideline.

Added coding implications section and HCPCS code J3111 (1 mg) referenced for informational purposes.

12 monthsmaximum cumulative Evenity therapy allowed

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Coverage Criteria

inv-01: Initial Approval Criteria

Covered when ALL of the following are met

Initial approval for PMO

a: Very high risk for fracture: Member is at very high risk for fracture as evidenced by one of: i) recent osteoporotic fracture within the past 12 months; ii) BMD T-score at the hip or spine < -3.0; iii) BMD T-score ≤ -2.5 PLUS a major osteoporotic fracture (spine, forearm, wrist, humerus).
Appendix E for T-score interpretation
b: Bisphosphonate trial or exceptions: Member has completed a 3-year trial of bisphosphonate therapy (generic alendronate preferred) at up to maximally indicated doses OR meets one of the exceptions: all bisphosphonates contraindicated; clinically significant adverse effects to both IV and PO formulations; loss of BMD while on bisphosphonate therapy; lack of BMD increase after ≥ 12 months of bisphosphonate therapy; or osteoporotic/fragility fracture while receiving bisphosphonate therapy.3 years
See Appendices B and D for details
Other requirements: Member is ≥ 18 years with closed epiphyses and has not received ≥ 12 months cumulative romosozumab (Evenity) therapy prior to approval; dosing 210 mg subcutaneously once monthly (2 prefilled syringes); dose must not exceed 210 mg/month or 2 prefilled syringes per month.210 mg/month; ≤ 12 months cumulative
Approval durations differ by line of business

inv-02: Continued Therapy

Re-authorization rules

Continued therapy: Re-authorization is not permitted. Members must meet the initial approval criteria to receive further therapy; approval duration is not applicable for re-authorization beyond allowed cumulative use.

See initial approval limits (cumulative 12 months) for duration guidance

inv-03: Approval criteria (summary)

Approval and continuation tied to duration limits, prior bisphosphonate use, and fracture risk definitions per guidelines.

Duration limits: Initial approval durations: Medicaid/HIM — 12 months; Commercial — 6 months or to the member's renewal date, whichever is longer.12 months; 6 months

Revised in 1Q 2025

Cumulative therapy limit: Member must not have received 12 months cumulative romosozumab (Evenity) therapy prior to approval; total duration of therapy is limited to 12 monthly doses per prescribing information.12 months cumulative

Per PI and policy clarification

Bisphosphonate trial bypass: A required bisphosphonate trial may be bypassed if the member experienced loss of BMD while on bisphosphonate therapy, lack of BMD increase after ≥ 12 months, or an osteoporotic/fragility fracture while receiving bisphosphonate therapy.

Non‑FDA approved indications that are not specifically addressed within this clinical policy are not authorized for coverage unless the request is supported by sufficient documentation of safety and efficacy consistent with applicable off‑label use policies (for example, CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, or CP PMN.53 for Medicaid) or by an applicable evidence of coverage document.

When there is a conflict between this clinical policy and state Medicaid coverage provisions, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any specific coverage rules that apply to Medicaid members.

Uses of romosozumab for non‑FDA approved indications that lack appropriate supporting documentation per the referenced off‑label use policies are considered not authorized and may be denied.

HCPCS and other billing codes listed in this policy are provided for informational purposes only. The inclusion of a code in this document does not guarantee coverage, and the absence of a code does not imply non‑coverage. Providers must follow current professional coding guidance when submitting claims; claims may be denied if coding or billing guidance is not followed.

Coding and Limits

HCPCS Codes referencedHCPCS

J3111

HCPCS CodesHCPCS

J3111

1 = mg

Maximum cumulative therapy

Maximum cumulative Evenity use≤ 12 months cumulative romosozumab-aqqg (Evenity) lifetime

Limit per prescribing informationLimit duration of use to 12 monthly doses; if therapy remains warranted, switch to an anti-resorptive agent

Approval requirementMember must not have received ≥ 12 months cumulative romosozumab therapy before approval

BMD T-score thresholds

Very high risk BMD thresholdBMD T-score at hip or spine < -3.0

Osteoporosis diagnostic thresholdBMD T-score ≤ -2.5 (diagnostic for osteoporosis; severe osteoporosis in presence of fragility fracture)

Provider Actions & Requirements

Prior Authorization

Prior Authorization & Documentation Requirements

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Requests for non–FDA approved indications that are not addressed in this policy will not be authorized unless sufficient documentation is provided per the applicable off‑label use policies (CP CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP PMN.53 for Medicaid) or evidence of coverage documents.

Submit office chart notes, lab results, imaging (BMD reports), and other clinical information to support criteria
Off‑label requests require additional documentation per payer off‑label use policies

Step Therapy

Bisphosphonate Trial Requirement / Bypass Conditions

Before initiating romosozumab (Evenity), the member must have completed a 3‑year trial of bisphosphonate therapy (generic alendronate preferred) at up to maximally indicated doses unless one of the bypass conditions below applies. A bisphosphonate trial may be bypassed when: all bisphosphonates are contraindicated; the member experienced clinically significant adverse effects to both IV and PO formulations; the member has experienced a loss of BMD while receiving bisphosphonate therapy; the member has experienced a lack of BMD increase after ≥ 12 months of bisphosphonate therapy; or the member experienced an osteoporotic/fragility fracture while receiving bisphosphonate therapy.

Background

Romosozumab‑aqqg (Evenity) is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women who are at high risk for fracture. Treatment duration is limited to a cumulative 12 months, and consideration should be given to subsequent anti‑resorptive therapy following completion of Evenity.

Definitions

High risk of fracture / Osteoporosis (PMO)

High risk definition (actionable)History of osteoporotic fracture OR multiple risk factors for fracture — qualifies as high risk of fracture for PMO

Osteoporosis diagnosisBMD T-score ≤ -2.5 (diagnostic threshold) or T-score ≤ -2.5 with fragility fracture

Treatment implicationEvenity indicated for PMO women at high risk for fracture; duration limited to 12 monthly doses

Very high risk for fracture

Very high risk (per guideline update)Includes recent osteoporotic fracture within 12 months, BMD T-score at hip or spine < -3.0, or T-score ≤ -2.5 with a major osteoporotic fracture

Guideline sourceUpdated per 2020 AACE/ACE PMO treatment guideline (see Appendix E)

Initial Therapy Criteria

inv-24: Initial Therapy

Initial therapy requirements and dosing

Initial therapy nodes: Diagnosis of PMO with either very high fracture risk OR completion of a 3-year bisphosphonate trial (or meeting an exception); member age ≥ 18 years with closed epiphyses; member has not received ≥ 12 months cumulative romosozumab; dosing 210 mg subcutaneously once monthly (2 prefilled syringes) for up to 12 months total.210 mg/month; ≤ 12 months cumulative

See Appendices B, D, and E for therapeutic alternatives, adverse effects, and T-score interpretation

inv-25: Initial therapy

Initial approval durations and prerequisites.

Initial approval duration - Medicaid/HIM: Initial approval for Medicaid/HIM: 12 months (limited to 12 months cumulative romosozumab use lifetime).12 months

Step Therapy Requirements

Step	Requirement	Notes / Exceptions
1	Completion of a 3-year trial of bisphosphonate therapy (generic alendronate preferred)	Trial must be at up to maximally indicated doses; member must not have received ≥ 12 months cumulative romosozumab prior to approval; age ≥ 18 years or documentation of closed epiphyses
1	Acceptable exceptions to the 3-year bisphosphonate requirement:	All bisphosphonates contraindicated; clinically significant adverse effects to both IV and PO formulations; loss of BMD while on therapy; lack of BMD increase after ≥ 12 months; or osteoporotic/fragility fracture while receiving bisphosphonate therapy (see Appendix B and D)

Condition allowing bypass	Required supporting evidence	Coverage impact
Loss of bone mineral density (BMD) while receiving bisphosphonate therapy	Documentation of serial BMD measurements demonstrating loss of BMD while on bisphosphonate therapy	Allows bypass of the 3-year bisphosphonate trial requirement
Lack of BMD increase after ≥ 12 months of bisphosphonate therapy	Documentation showing no BMD improvement after ≥ 12 months of appropriate bisphosphonate therapy	Allows bypass of the 3-year bisphosphonate trial requirement
Osteoporotic or fragility fracture while receiving bisphosphonate therapy	Clinical documentation of fracture event occurring during bisphosphonate therapy	Allows bypass of the 3-year bisphosphonate trial requirement
Contraindication to all bisphosphonates or clinically significant adverse effects to both IV and PO formulations	Clinical documentation of contraindication or adverse reactions to both IV and oral bisphosphonates (see Appendix D)	Allows bypass of the 3-year bisphosphonate trial requirement

Continuation Therapy Criteria

inv-26: Continuation Therapy

Re-authorization prohibition

Continuation: Re-authorization is not permitted. Members must meet the initial approval criteria and cumulative romosozumab use cannot exceed 12 months.≤ 12 months cumulative

Approval duration: Not applicable for re-authorization

inv-27: Continuation of therapy

Continuation of therapy requires the member to meet the initial approval criteria.

Continuation requirement: To continue therapy, the member must meet all initial approval criteria as specified in the policy.N/A

Requirement clarified in 1Q 2025 review

Quantity Limits

romosozumab-aqqg (Evenity) dosing

Recommended dose210 mg per month (2 prefilled syringes) — recommended regimen

Product strength210 mg total per monthly administration (2 prefilled syringes)

Quantity limit entryPolicy quantity limit: 210 mg per month

Site of Care

Note

No explicit site‑of‑care restriction stated

The policy does not state a site‑of‑care restriction for administration; no explicit infusion center restriction is specified in this section of the policy.

Documentation Required

Approval Duration & Coverage Governance

Approval durations vary by line of business and are subject to the member's coverage terms. Coverage decisions are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan policies and procedures.

Medicaid/HIM: Initial approval = 12 months (limited to 12 months cumulative romosozumab lifetime)
Commercial: Initial approval = 6 months or to the member's renewal date, whichever is longer (limited to 12 months cumulative romosozumab lifetime)
Continuation of therapy requires that the member continue to meet the initial approval criteria and cumulative romosozumab exposure limits