CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Evenity (romosozumab) coverage criteria for osteoporosis

Policy governing coverage and clinical criteria for Evenity (romosozumab-aqgg) subcutaneous injection for treatment of osteoporosis for Medicaid, Commercial, and Medicare-Medicaid Plan members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEvenity (romosozumab) coverage criteria for osteoporosis

Policy CodePolicy N/A

Change TypeNo material change — informational/administrative revision

Effective DateOct 1, 2019

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age ≥18, calcium/vitamin D status, DXA T-scores or fracture history, prior osteoporosis therapy trials or contraindications, and absence of MI/stroke within prior year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmax duration

210 mgmonthly dose

J3111; NDC 55513-0880billing codes

P&T reviewedP&T reviewed

210 units/moHCPCS limit

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Coverage Criteria for Evenity (romosozumab)

Initial Approval

Covered when ALL of the following are met:

Age and supplementation: Patient is ≥18 years of age; receiving calcium and vitamin D supplementation if dietary intake is inadequate; and patient must not have hypocalcemia.

Cardiovascular exclusion: Patient has not had a myocardial infarction or stroke within the preceding year.

Consider risks if other cardiovascular disease or risk factors are present.

Patient population: Patient is postmenopausal and at high risk for fracture.

High risk examples include prior osteoporotic fracture, parental hip fracture, low BMI, rheumatoid arthritis, high alcohol intake, current smoking, prolonged glucocorticoid use, inability to sit/stand upright, GI disorders affecting oral therapy, or prior bariatric surgery.

Objective evidence of osteoporosis: One or more of the following: hip/femur (femoral neck or total hip) or lumbar spine DXA T-score ≤ -2.5; forearm DXA at the 33% radius site; T-score ≤ -1 with a history of fragility fracture; or elevated 10-year fracture probability per document.

Prior therapy requirement: Documented treatment failure or ineffective response after a minimum 12-month trial of bisphosphonates (oral or IV) OR documented contraindication/intolerance to BOTH oral and IV bisphosphonates; OR documented treatment failure after a minimum 12-month trial of RANKL-blocking agents (eg, denosumab) OR documented contraindication/intolerance to RANKL-blocking agents.12 months

Patients with very high fracture risk (eg T-score ≤ -3.0, or T-score ≤ -2.5 with fragility fractures or severe/multiple vertebral fractures) are exempt from prior trial and failure requirements.

P&T Committee Coverage Criteria (summary)

Covered when ALL of the following are met

P&T-adopted clinical criteria: Use according to FDA-approved labeling and relevant clinical literature as adopted by Neighborhood's P&T Committee; prescriber must submit supporting information for individual consideration.

Full criteria text adopted by P&T Committee; prescriber documentation will be reviewed for individual consideration.

Coverage for Evenity (romosozumab) is limited to a single treatment course and may NOT be renewed. The maximum authorized duration is 12 monthly doses; requests for additional months beyond this limit will be denied.

For Integrity (Medicare-Medicaid Plan) members, these coverage criteria apply only when there is no applicable Medicare National Coverage Determination (NCD) or Local Coverage Determination (LCD). If an NCD or LCD is in effect, the Medicare coverage policy takes precedence and will be applied instead of these criteria.

Use of Evenity in patients who do not meet the policy’s high fracture risk criteria, or when required documentation of prior therapy, treatment failure, contraindication, or intolerance is not provided, will be considered not medically necessary and is not eligible for coverage under this policy.

Billing and Diagnosis Codes

HCPCS CodesHCPCS

J3111

Injection, romosozumab-aq4g, 1 mg; 1 billable unit = 1 mg

NDCNDC

55513-0880-xx

Evenity 105 mg/1.17 mL single-use prefilled syringe

Covered Diagnosis CodesICD-10Covered

M80.0XXA-M80.08XS	Age-related osteoporosis with current pathological fracture
M81.0	Age-related osteoporosis without current pathological fracture

Medicare Part B Covered Diagnosis CodesICD-10

No codes listed

Medicare Part B Administrative Contractor (MAC) jurisdictionsmixed

No codes listed

DXA T-score thresholds

DXA T-score threshold (hip/femur or lumbar spine)T-score ≤ -2.5 (femoral neck, total hip, or lumbar spine)

Very high fracture risk — T-scoreT-score ≤ -3.0

Very high fracture risk — T-score with fragility fracturesT-score ≤ -2.5 with one or more fragility fractures or severe/multiple vertebral fractures

FRAX 10-year probability

FRAX — major osteoporotic fracture (document text)10-year probability for major fracture reported as 'Z20%' in source (document text unclear)

FRAX — hip fracture (document text)

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Members must be ≥ 18 years of age, be receiving calcium and vitamin D supplementation if dietary intake is inadequate, and must not have hypocalcemia. Requests will be reviewed against the plan's clinical coverage criteria and require prescriber information.

Patient age ≥ 18 years
Confirmation of calcium and vitamin D supplementation if dietary intake is inadequate
No hypocalcemia present

Note

Individual Consideration and Documentation

Prescriber-submitted clinical information will be used for individualized review. Neighborhood will give individual consideration based on submitted documentation and plan-available data. Requests may be denied if the submitted information does not support medical necessity.

Prescriber name and contact
Clinical rationale for therapy

Background

Romosozumab is a monoclonal antibody that acts as a sclerostin inhibitor and is indicated for treatment of osteoporosis in postmenopausal women at high risk for fracture. Clinical trials and the P&T-reviewed rationale supporting this policy demonstrate that romosozumab reduces vertebral, nonvertebral, and hip fractures compared with placebo or other therapies. Common adverse reactions reported include arthralgia and headache. Neighborhood’s P&T Committee adopted the coverage criteria to align use with FDA labeling, ensure appropriate patient selection, and minimize adverse event risk while encouraging use of more cost‑effective options where appropriate.

Definitions and Terms

Ineffective response

Definition of ineffective responseDecrease in T-score compared with baseline DXA scan

Ineffective response — fracture while on therapyOccurrence of a new fracture while on bisphosphonate therapy

ContextUsed to define treatment failure after prior bisphosphonate therapy when considering subsequent therapy

High risk for fracture — examples

Prior osteoporotic fractureHistory of an osteoporotic fracture as an adult

Parental hip fractureParental history of hip fracture

Low BMI

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEvenity (romosozumab) coverage criteria for osteoporosis

Policy CodePolicy N/A

Change TypeNo material change — informational/administrative revision

Effective DateOct 1, 2019

Next Review DateN/A

SourceLink

On This Page

10-year probability for hip fracture reported as '23%' in source (document text unclear)

Note on ambiguityDocument displays unclear/possibly mistranscribed percentage values; refer to supporting documentation or prescriber-provided FRAX output when available

Relevant prior treatments and responses

Documentation Required

Documentation of Disease Severity and Fracture Risk

Providers must document objective measures of osteoporosis and fracture risk when requesting coverage. Required documentation includes DXA T-scores, history of fragility fractures, and FRAX 10-year fracture probabilities where applicable.

DXA T-scores (lumbar spine, femoral neck/total hip, or 33% radius when relevant)
History of fragility fracture (vertebral, hip, or other low-energy fractures)
FRAX 10-year probability for major osteoporotic fracture and hip fracture if used in decision-making

Step Therapy

Treatment Trial Requirements

Patients generally must have documented treatment failure, intolerance, or contraindication to first-line therapies prior to approval, unless they meet very high fracture‑risk criteria. Acceptable documentation includes trials of bisphosphonates and RANKL‑blocking therapy or clear contraindications to these agents.

Documented trial (minimum 12 months) and inadequate response to an oral or IV bisphosphonate (e.g., alendronate, risedronate, ibandronate, zoledronic acid) OR documented contraindication/intolerance to both oral and IV bisphosphonates
Documented trial (minimum 12 months) and inadequate response to a RANKL‑blocking agent (e.g., denosumab) OR documented contraindication/intolerance to RANKL‑blocking agents
Exception: patients at very high fracture risk (e.g., T‑score ≤ -3.0, or T‑score ≤ -2.5 with multiple or severe vertebral fractures) are not subject to prior trial requirements

Denial Risk

Cardiovascular Contraindication — Denial Risk

Cardiovascular history is required. A history of myocardial infarction or stroke within the preceding year is a contraindication and will generally result in denial of coverage. In patients with other cardiovascular disease or risk factors, prescribers should provide justification that benefits outweigh risks.

History of myocardial infarction or stroke within the past 12 months — contraindication
If other cardiovascular disease/risk factors present, provide clinical justification that benefits outweigh risks

Low body mass index (BMI)

Rheumatoid arthritisDiagnosis of rheumatoid arthritis

High alcohol intakeAlcohol intake of 3 or more drinks per day

Other examplesCurrent smoking; prolonged oral glucocorticoid use (≥5 mg prednisone equivalent for >3 months); inability to sit/stand upright ≥30 minutes; GI disorders affecting oral therapy; prior bariatric surgery

Integrity (MMP) members

Applicability to Integrity (MMP) membersThese coverage criteria apply to Integrity (Medicare‑Medicaid Plan) members only in the absence of an applicable National Coverage Determination (NCD) or Local Coverage Determination (LCD)

Individual considerationNeighborhood will give individual consideration to each request based on prescriber-submitted information and other available plan information

P&T adoptionCriteria were adopted following review by Neighborhood's Pharmacy & Therapeutics (P&T) Committee