CurrentAnthemPolicy CC-0139

Evenity (romosozumab-aqqg) — Coverage Criteria

Clinical criteria for medical-benefit coverage and prior authorization of Evenity (romosozumab-aqqg) for postmenopausal women with osteoporosis at high risk for fracture; defines eligibility, quantity limits, and coding guidance for Anthem.

Policy Summary

PayerAnthem

PolicyEvenity (romosozumab-aqqg) — Coverage Criteria

Policy CodePolicy CC-0139

Change TypeMaterial and administrative updates (annual review)

Effective Date10/01/2025

Next Review DateN/A

Key ActionObtain prior authorization confirming patient is a postmenopausal female meeting high/very high fracture-risk criteria and cumulative Evenity use is <12 months lifetime.

SourceLink

POLICY UPDATE CHANGES

Added denosumab biosimilars Conexxence/Bomyntra, Ospomyv/Xbry and Stoboclo/Osenvelt to criteria.

Removed Fortical as obsolete.

Added ICD-10-CM codes M80.8AXA-M80.8B9S to the diagnosis code range.

12 monthsmaximum lifetime duration of Evenity therapy

2quantity limit (syringes/month)

J3111HCPCS/J-code

Black boxsafety warning

Coverage Criteria for Evenity (romosozumab-aqqg)

Policy Summary

PayerAnthem

PolicyEvenity (romosozumab-aqqg) — Coverage Criteria

Policy CodePolicy CC-0139

Change TypeMaterial and administrative updates (annual review)

Effective Date10/01/2025

Next Review DateN/A

Key ActionObtain prior authorization confirming patient is a postmenopausal female meeting high/very high fracture-risk criteria and cumulative Evenity use is <12 months lifetime.

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.

Initial Therapy — Evenity (romosozumab-aqqg)

Requests for Evenity (romosozumab-aqqg) may be approved when ALL of the following are met:

Population: Individual is a postmenopausal female

see chunk 5

High or very high fracture risk: Individual has a diagnosis of osteoporosis by BMD (T-score ≤ -2.5 in spine, femoral neck, total hip, or distal 1/3 radius) OR a clinical diagnosis based on history of a low-trauma (fragility) fracture, AND meets criteria for very high fracture risk per AACE/ACE (e.g., recent fracture within 12 months; fractures while on approved osteoporosis therapy; multiple fractures; fractures while on drugs causing skeletal harm such as long-term glucocorticoids; very low T-score < -3.0; high risk for falls or injurious falls; or very high FRAX probability such as major osteoporotic fracture >30% or hip fracture >4.5%)

see chunk 8

Prior therapy failure/intolerance: Individual has been refractory to a prior trial of a bisphosphonate OR is intolerant to or has a contraindication to bisphosphonates (e.g., hypersensitivity to two bisphosphonates including alendronate; inability to sit/stand upright ≥30 minutes; specific GI disorders; or severe renal insufficiency per listed creatinine clearance thresholds) OR is refractory to, intolerant of, or has a contraindication to denosumab (Prolia or listed biosimilars), teriparatide (Forteo/Bonsity), or abaloparatide (Tymlos)

see chunk 9

Combination therapy exclusion: Individual is not using Evenity in combination with any of the following: Prolia, Xgeva (denosumab) or denosumab biosimilars (Conexxence/Bomyntra, Jubbonti/Wyost, Ospomyv/Xbry, Stoboclo/Osenvelt); bisphosphonates; Evista (raloxifene); Miacalcin (calcitonin-salmon); Reclast (zoledronic acid); Forteo/Bonsity (teriparatide); or Tymlos (abaloparatide)

see chunk 6

Duration limit: Cumulative lifetime use of Evenity is less than 12 months< 12 months

see chunk 6

Per the FDA label and policy criteria, Evenity (romosozumab-aqqg) carries a black box warning for increased risk of myocardial infarction (MI), stroke, and cardiovascular death. The medication should not be initiated in individuals who have had an MI or stroke within the preceding year, and therapy should be discontinued if an MI or stroke occurs during treatment. For patients with other cardiovascular risk factors, clinicians should weigh the potential benefits against these risks before initiating Evenity.

Use of Evenity beyond the specified treatment limit is not covered. Specifically, therapy is limited to a cumulative lifetime total of less than 12 months; requests for use that would result in a total duration of 12 months or more are not approved. Similarly, use of Evenity when the documented clinical criteria in this policy are not met is not approved.

Coding and Diagnostic Guidance

Covered HCPCS/J CodesHCPCSCovered

J3111

Injection, romosozumab-aqqg, 1 mg [Evenity]

ICD-10 Diagnosis CodesICD-10

M80.00XA-M80.8B9S	Osteoporosis with current pathological fracture (range as listed)
M81.0-M81.8	Osteoporosis without current pathological fracture

inv-06: Very low T-score

Very low T-score thresholdT-score less than -3.0

BMD measurement sites referencedSpine, femoral neck, total hip, or distal 1/3 of the radius

Context for thresholdListed as a criterion for 'very high risk' per AACE/ACE 2020

inv-07: FRAX thresholds example

FRAX - major osteoporotic fracture example thresholdMajor osteoporotic fracture probability > 30%

FRAX - hip fracture example thresholdHip fracture probability > 4.5%

Use of validated algorithmsFRAX or other validated fracture risk algorithms may be used to define very high fracture probability

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Evenity (romosozumab-aqqg). Prior authorization will be granted only when the clinical criteria in the policy are met for a postmenopausal female at high or very high risk for fracture, and treatment duration in the member’s lifetime will be less than 12 months.

Applicable to Evenity (romosozumab-aqqg) requests
Treatment duration limit: < 12 months lifetime
Do not initiate if MI or stroke within prior 12 months; discontinue if MI or stroke occurs during therapy

Step Therapy

Step Therapy / Prior Treatment Requirement

A prior trial of an oral or IV bisphosphonate is required unless the prescriber documents a reason to bypass (refractory disease, intolerance, or contraindication). Acceptable justification for bypass includes: failure of bisphosphonate therapy (decline in BMD ≥5% or fragility fracture while on therapy), hypersensitivity to two bisphosphonates (one must be alendronate), inability to stand/sit upright for ≥30 minutes, certain pre-existing GI disorders, or severe renal insufficiency per agent-specific creatinine clearance thresholds.

Prior trial of a bisphosphonate required OR documented rationale for bypass (refractory, intolerance, contraindication)
Definitions of contraindication/intolerance include: hypersensitivity to two bisphosphonates (one must be alendronate); inability to stand/sit ≥30 minutes; Barrett's esophagus, delayed esophageal emptying, other GI disorders; creatinine clearance thresholds (agent-specific)
Failure/refractory defined as BMD decline ≥5% while on therapy or fragility fracture while on therapy

Documentation Required

Documentation and Denial Triggers

Submit clinical documentation to support the diagnosis of osteoporosis and high/very high fracture risk, including BMD T-score(s) or history of fragility fracture, documentation of prior osteoporosis therapy trials and responses (including bisphosphonate trial), and any contraindications or intolerances that justify bypassing step therapy. Requests lacking required documentation, exceeding the 12-month lifetime treatment limit, or for uses not specified in the criteria may be denied.

Provide BMD T-score in spine, femoral neck, total hip or distal 1/3 radius (≤ -2.5) OR documentation of fragility fracture
Document assessment of high/very high fracture risk (eg, recent fracture within 12 months, fractures on therapy, multiple fractures, very low T-score < -3.0, FRAX probability, glucocorticoid-associated risk)
Include prior therapy records: bisphosphonate trial results or intolerance/contraindication documentation
Treatment duration must be < 12 months lifetime — requests beyond this may be denied

Background

Romosozumab (Evenity) is an FDA‑approved sclerostin inhibitor indicated for postmenopausal women with osteoporosis who are at high risk for fracture. It was approved with a restricted indication and a black box warning because of cardiovascular safety signals observed in pivotal studies. Labeling limits treatment duration to one year, and guidelines reserve romosozumab for patients with high or very high fracture risk — for example, those with prior osteoporotic fracture, multiple fracture risk factors, very low T‑scores, or failure/intolerance of other osteoporosis therapies.

Definitions and Clinical Terms

inv-13: Definition of 'high risk for fracture'

FDA/guideline definition - history of osteoporotic fractureHistory of an osteoporotic (fragility) fracture qualifies as high risk for fracture

Multiple clinical risk factorsPresence of multiple risk factors for fracture counts toward high risk status

Failure or intolerance to other osteoporosis therapiesFailure or intolerance to other approved osteoporosis therapies is a criterion for high risk

Clinical criteria examplesVery low T-score (< -3.0), recent fracture(s), fractures while on therapy, or multiple fractures define very high risk

Regulatory noteFDA labeling narrowed indication to women at high risk for fracture and includes a black box warning for cardiovascular events

inv-14: Definition of refractory disease / failure of therapy

Decline in BMD while on therapyDecline in bone mineral density of ≥5% while on therapy is considered refractory disease / treatment failure

Fragility fracture on therapyOccurrence of a fragility fracture while receiving therapy qualifies as treatment failure

Terminology usedRefractory disease is described as failure of other osteoporosis therapies in FDA label and guidance