CurrentAvMedPolicy Pub. 100-2

Prior authorization for Evenity (romosozumab)

This document is an AvMed medical prior authorization and step-edit request governing coverage and documentation requirements for Evenity (romosozumab) used to treat osteoporosis in eligible members; it applies to providers submitting requests to AvMed in North Carolina.

Policy Summary

PayerAvMed

PolicyPrior authorization for Evenity (romosozumab)

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with prescriber signature and required clinical documentation including BMD/FRAX and prior therapy records.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsMax duration

210 mgMax monthly dose

>=50Age requirement

Major≥20%/Hip≥3%FRAX thresholds

Evenity (romosozumab) Coverage Criteria

Initial clinical eligibility

Policy Summary

PayerAvMed

PolicyPrior authorization for Evenity (romosozumab)

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with prescriber signature and required clinical documentation including BMD/FRAX and prior therapy records.

SourceLink

On This Page

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Diagnosis of osteoporosis in a member over the age of 50 established by ONE of the following: presence of fragility hip or spine fracture (in absence of other metabolic bone disorders); T-score ≤ -2.5 at lumbar spine, femoral neck, total hip; T-score between -1 and -2.5 with increased FRAX risk using country-specific thresholds (FRAX major osteoporotic fracture ≥20% or hip fracture ≥3%); or T-score between -1 and -2.5 with a fragility fracture of the proximal humerus, pelvis, or distal forearm.age>50;T-score criteria;FRAX thresholds

See Sections A and Definitions for measurement sites and FRAX thresholds.

Postmenopausal or gender justification: Member is postmenopausal OR the prescriber has provided documentation that the requested agent is medically appropriate for the member's gender.

Per bone density definitions and gender documentation requirements.

Prior therapy requirements

AND prerequisite therapy (ALL of the following apply):

Bisphosphonate trial or documented intolerance: Either: a 12-month minimum trial of ONE listed bisphosphonate (alendronate, ibandronate, risedronate, or zoledronic acid) with evidence of no BMD improvement at end of trial (medication samples/coupons excluded); OR documented intolerance, FDA-labeled contraindication, or hypersensitivity to both an oral and an IV bisphosphonate as defined by TWO of the listed criteria (e.g., hypersensitivity to two bisphosphonates with one being alendronate; inability to sit/stand for ≥30 minutes for oral formulation; pre-existing GI disorders; uncorrected hypocalcemia; severe renal insufficiency with specified creatinine clearance thresholds).12 months trial OR two-criteria documented intolerance

See Section B for drug names and detailed intolerance/renal criteria.

Parathyroid hormone analog trial or documented intolerance: Either: inadequate response to a parathyroid hormone analog (teriparatide/Forteo or abaloparatide/Tymlos) after a 12-month minimum treatment with evidence of no BMD improvement at end of trial; OR documented intolerance, FDA-labeled contraindication, or hypersensitivity to parathyroid hormone/analogs that is not expected to occur with Evenity (documentation must be submitted).12 months trial OR documented intolerance

See Section B for required agents and documentation requirements.

Safety and exclusion criteria

AND safety / exclusion criteria (ALL must be met):

No FDA-labeled contraindications: Member must NOT have any FDA-labeled contraindications to romosozumab.

Section C: FDA-labeled contraindications must be absent.

No thrombotic events: Member must NOT have the presence of a thrombotic event (e.g., deep vein thrombosis, pulmonary embolism).

Section C: Thrombotic events exclude approval.

Dose limits: Requested dose must NOT exceed the FDA-approved dosing of two consecutive subcutaneous injections (105 mg each) for a total of 210 mg once monthly.<=210 mg monthly

Section C: Dose must not exceed two 105 mg injections monthly.

No concurrent excluded therapies: Member must NOT use Evenity in combination with any of the following: denosumab (Prolia), bisphosphonates, raloxifene (Evista), calcitonin nasal spray (Miacalcin/Fortical), zoledronic acid (Reclast), teriparatide (Forteo), or abaloparatide (Tymlos).

Combination use with listed agents is prohibited.

Treatment duration limit: Total duration of treatment with Evenity must NOT have exceeded 12 months per lifetime.<=12 months lifetime

Section C: Lifetime treatment duration limited to 12 months.

Cardiovascular exclusion: Member must NOT have experienced a heart attack, stroke, or other major cardiovascular event in the previous 12 months.no major CV event in past 12 months

Section C: Recent (within 12 months) major cardiovascular events exclude use.

Requests that exceed the FDA-approved dosing or duration are not supported. The maximum approved dose is two consecutive 105 mg subcutaneous injections (total 210 mg) once monthly, and requests for doses above this are not covered. Total treatment with Evenity is limited to 12 months per lifetime. Additionally, Evenity is not supported for members who have experienced a major cardiovascular event (e.g., heart attack or stroke) within the prior 12 months or who have thrombotic events such as DVT/PE.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J3111

romosozumab (Evenity) injection

inv-07: FRAX 10-year probability thresholds

FRAX 10-year probability thresholdsMajor osteoporotic fracture >= 20% OR hip fracture >= 3%

Use contextApplied when BMD T-score between -1 and -2.5 with other risk factors or fragility fracture per criteria

Documentation requiredProvider must submit FRAX score when indicated as part of BMD/diagnostic results

inv-08: Maximum dose

Maximum approved doseTwo consecutive 105 mg injections (210 mg total) once monthly

Per-dose descriptionEach administration consists of two consecutive 105 mg subcutaneous injections

Authorization noteRequests with doses exceeding 210 mg monthly are not supported

inv-09: Bisphosphonate trial duration

Required bisphosphonate trial duration12 months minimum trial of one listed bisphosphonate with evidence of no BMD improvement

Excluded trial typesMedication samples/coupons/discount cards are excluded from consideration as a trial

Alternative to trialDocumented intolerance or FDA contraindication to both oral and IV bisphosphonates defined by two specified criteria may substitute

Required Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Evenity (romosozumab) J3111 (Medical). The prescribing physician must sign and clearly print their name (preprinted stamps not valid) on the PA request. Fax completed request and all required documentation to 1-877-535-1391. Incomplete, incorrect, or illegible information may delay or result in denial of authorization.

Prior authorization required for J3111 (Evenity)
Prescriber signature required (hand-signed; preprinted stamps not valid)
Fax to 1-877-535-1391

Step Therapy

Required Prior Therapies

Member must have trial and failure of a minimum 12-month bisphosphonate OR documented intolerance/contraindication to oral and IV bisphosphonates as defined in the criteria. Documentation of inadequate response must include evidence of no BMD improvement at the end of trials. Alternative prerequisite: inadequate response to a parathyroid hormone analog (e.g., teriparatide, abaloparatide) after a 12-month minimum trial, or documented intolerance/contraindication to these agents.

Minimum 12-month trial of one bisphosphonate with evidence of no BMD improvement (alendronate, ibandronate, risedronate, or zoledronic acid)
OR documented intolerance/contraindication to both oral and IV bisphosphonates (documentation required)
OR inadequate response to parathyroid hormone analog after 12 months (e.g., Forteo, Tymlos, teriparatide)
Documentation of contraindications/hypersensitivity must be submitted

Documentation Required

Required Documentation for Prior Authorization

To support the PA request, submit legible documentation including: prescriber signature, prescriber and patient contact information, diagnosis and ICD code, BMD results with T-scores (lumbar spine, femoral neck, total hip), FRAX score or country-specific fracture risk assessment if applicable, details of prior osteoporosis therapies (drug name, dose, start/stop dates, evidence of 12-month trial and objective lack of BMD improvement), documentation of fragility fractures if claimed, documentation of any contraindications or hypersensitivity (including criteria used to define intolerance), weight and date measured (if applicable), and relevant lab or imaging results. All documentation, including lab results, diagnostics, and chart notes, must be provided or the request may be denied.

Prescriber signature (hand-signed)
Patient and prescriber contact information (phone and fax)
Diagnosis and ICD code
BMD results and T-scores (lumbar spine, femoral neck, total hip)
FRAX score when applicable
Documentation of fragility fractures (hip, spine, proximal humerus, pelvis, distal forearm)
Details of prior therapies: drug name, dose, start/stop dates, evidence of 12-month trial, and BMD outcomes
Documentation of contraindications/intolerance/hypersensitivity (as defined in policy)
Weight and date weight obtained (if applicable)
Relevant lab/imaging/chart notes

Denial Risk

Incomplete or Illegible Requests May Delay or Deny Authorization

If information provided is incomplete, incorrect, or illegible authorization can be delayed or result in denial. Ensure all required fields on the PA form are completed and legible; medication samples/coupons/discount cards are excluded as evidence of a trial.

Incomplete, incorrect, or illegible requests may be delayed or denied
Do not use medication samples/coupons/discount cards as evidence of a prior trial
Ensure phone and fax numbers are correct to avoid unnecessary delays

Background

Evenity (romosozumab) is indicated for treatment of osteoporosis and is administered as two consecutive 105 mg subcutaneous injections once monthly (total 210 mg). Prior authorization documentation must demonstrate an appropriate osteoporosis diagnosis and that safety criteria are met prior to approval. Key safety considerations include absence of FDA-labeled contraindications, no recent thrombotic events, adherence to the FDA dosing limit of 210 mg monthly, no concurrent use of excluded bone-active therapies, and that cumulative therapy with Evenity has not exceeded the 12-month lifetime limit.

Key Definitions and T-score Ranges

inv-15: Osteoporosis — Definition

Osteoporosis (T-score)T-score < -2.5

Measurement sitesBased on BMD measurements from lumbar spine (≥2 vertebral bodies), hip (femoral neck, total hip), or radius (1/3 radius)

Alternative diagnostic evidenceHistory of fragility fracture (e.g., vertebral compression, hip) within past 5 years may establish diagnosis

inv-16: Low bone mass (osteopenia)

Low bone mass (osteopenia)T-score between -1.0 and -2.5

Context for treatmentT-score in this range requires additional risk assessment (e.g., FRAX) or fragility fracture to qualify

Measurement sitesBased on lumbar spine, hip, or radius BMD measurements as specified

inv-17: Normal — Normal bone density

Normal bone densityT-score > -1.0

ImplicationDoes not meet criteria for osteoporosis or low bone mass

Measurement sitesDefined by standard BMD sites: lumbar spine, hip, or radius