CurrentCommunity-CarePolicy N/A

Romosozumab (Evenity) — Coverage Criteria for Osteoporosis

Criteria for medical benefit coverage of romosozumab (Evenity) for treatment of osteoporosis in postmenopausal women, including eligibility, quantity limits, and authorization period; applies to the payer's covered population.

Policy Summary

PayerCommunity-Care

PolicyRomosozumab (Evenity) — Coverage Criteria for Osteoporosis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateSep 1, 2025

Key ActionObtain prior authorization with documentation of osteoporosis diagnosis, prior bisphosphonate trial status, fracture risk thresholds or fracture history, supplementation, and no concurrent use of listed agents.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

post-menopausal womenpopulation

T-score ≤ -3.0BMD threshold

FRAX ≥30% or hip ≥4.5%FRAX thresholds

up to 2/monthquantity limit

12lifetime fills

Coverage Criteria for Romosozumab (Evenity)

Initial Therapy

Covered when ALL of the following are met:

Population: Diagnosis of osteoporosis in post-menopausal women

Step therapy: Trial of bisphosphonate treatment was ineffective, contraindicated, or not tolerated

Risk criteria: Either very high-risk of fracture OR history of osteoporotic fractures

Very high-risk subcriteria: One of: BMD T-score ≤ -3.0 OR FRAX osteoporotic fracture score ≥ 30% OR FRAX hip fracture score ≥ 4.5%

Policy Summary

PayerCommunity-Care

PolicyRomosozumab (Evenity) — Coverage Criteria for Osteoporosis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateSep 1, 2025

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coding and Diagnostic Thresholds

Applicable HCPCS CodesHCPCSCovered

J3111

Injection, romosozumab-aqqg, 1 mg

inv-05: Bone Mineral Density (BMD) T-score — threshold used to define very-high-risk

BMD T-score thresholdBone Mineral Density (BMD) T-score ≤ -3.0

ContextUsed as one criterion for defining 'very high-risk of fracture' for romosozumab coverage

Source guidanceReferenced in coverage determination under 'Very high-risk of fracture'

inv-06: FRAX osteoporotic fracture score — threshold used to define very-high-risk

FRAX (osteoporotic fracture) thresholdFRAX osteoporotic fracture score ≥ 30%

ContextOne of the FRAX-based criteria to define 'very high-risk of fracture' for romosozumab coverage

UseMay be used as an alternative to a qualifying BMD T-score or history of osteoporotic fracture

inv-07: FRAX hip fracture score — threshold used to define very-high-risk

FRAX (hip) thresholdFRAX hip fracture score ≥ 4.5%

ContextFRAX hip score is an acceptable alternative FRAX metric to define 'very high-risk of fracture'

Coverage roleMeets the 'very high-risk' subcriterion for romosozumab authorization when threshold reached

Provider Requirements, Prior Authorization, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization required for romosozumab (HCPCS J3111). Documentation must demonstrate the member is a post‑menopausal woman with a diagnosis of osteoporosis, evidence regarding prior bisphosphonate therapy (trial was ineffective, contraindicated, or not tolerated), and supporting clinical test results or risk assessments. A trial of bisphosphonate therapy is required unless clearly documented as ineffective, contraindicated, or not tolerated. Romosozumab must not be used concomitantly with abaloparatide, teriparatide, or denosumab. If approved, authorizations are for up to 2 injections per month (2.34 mL / 210 mg per 30 days), for a coverage period up to 1 year and up to 12 fills per lifetime. Ensure calcium (1000 mg) and vitamin D (≥ 400 IU) supplementation is documented while on therapy.

Prior authorization required: romosozumab (HCPCS J3111).
Step therapy: trial of bisphosphonate required unless ineffective, contraindicated, or not tolerated.
Required documentation: diagnosis of osteoporosis in a post‑menopausal woman; documentation of bisphosphonate trial status; BMD T-score, FRAX scores, or history of osteoporotic fracture as applicable; calcium and vitamin D supplementation plan.
Quantity & duration: up to 2 injections/month (2.34 mL/210 mg per 30 days); authorization period up to 1 year; limit 12 fills per lifetime.
Concomitant therapy: not to be used with abaloparatide, teriparatide, or denosumab.

Denial Risk

Denial Triggers

Denial may be issued if required documentation is missing or criteria are not met. Common triggers for denial include absence of a documented bisphosphonate trial (or adequate documentation that it was ineffective, contraindicated, or not tolerated), lack of documentation that the member is a post‑menopausal woman with osteoporosis, failure to meet very‑high‑risk criteria (e.g., BMD T‑score ≤ -3.0, qualifying FRAX thresholds) or no history of osteoporotic fracture when applicable, missing evidence of calcium and vitamin D supplementation while on therapy, or requests for concomitant use with prohibited agents.

No documented bisphosphonate trial or no documentation that bisphosphonate was ineffective, contraindicated, or not tolerated.
Insufficient evidence of post‑menopausal osteoporosis (missing diagnosis).
Failure to meet very‑high‑risk criteria (BMD T‑score ≤ -3.0, FRAX osteoporotic fracture ≥ 30% or hip ≥ 4.5%) and no qualifying fracture history when required.
Missing documentation of calcium (1000 mg) and vitamin D (≥ 400 IU) supplementation plan.
Request for concomitant use with abaloparatide, teriparatide, or denosumab.

Documentation Required

Required Documentation

Document the diagnosis, prior treatment history (including details of bisphosphonate therapy and reasons for discontinuation if applicable), objective test results (BMD T‑score, FRAX scores), fracture history, supplementation plan for calcium and vitamin D, and proposed dosing/quantity. Include any contraindications or intolerance notes to support step‑therapy exceptions.

Include BMD T‑score and/or FRAX scores when claiming very‑high‑risk status.
Document bisphosphonate trial dates, agent(s), doses, and reason for failure/intolerance/contraindication.
Record prior osteoporotic fractures with dates and supporting imaging or clinical notes.
Document calcium (1000 mg) and vitamin D (≥ 400 IU) supplementation while on romosozumab.
Specify that romosozumab will not be given with abaloparatide, teriparatide, or denosumab.

Background

Romosozumab is an anabolic agent indicated for treatment of osteoporosis in postmenopausal women at high risk for fracture. The policy requires documentation of diagnosis, assessment of fracture risk by BMD T‑score or FRAX or a history of osteoporotic fracture, confirmation of a prior bisphosphonate trial unless ineffective/contraindicated/intolerant, and daily calcium 1000 mg and vitamin D ≥ 400 IU supplementation while on romosozumab to reduce the risk of hypocalcemia. The policy also specifies that romosozumab will not be used concomitantly with certain other osteoporosis agents.

OpenPayer

Romosozumab (Evenity) — Coverage Criteria for Osteoporosis

Coverage Criteria for Romosozumab (Evenity)

Coding and Diagnostic Thresholds

Provider Requirements, Prior Authorization, and Denial Triggers

Definitions

Background