CurrentMass General Brigham Health PlanPolicy N/A

Romosozumab (Evenity) — Coverage Criteria and Prior Authorization

Criteria and prior authorization requirements for coverage of Evenity (romosozumab-aqqg) for treatment of postmenopausal women at high risk for fracture under Mass General Brigham Health Plan pharmacy benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRomosozumab (Evenity) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 1, 2020

Next Review Date

Key ActionObtain prior authorization and document diagnosis, pre-treatment T-score or FRAX, and bisphosphonate trial or reason to avoid one.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmaximum approval duration

T-score ≤ -2.5osteoporosis threshold

FRAX >20%/hip ≥3%high FRAX definition

CreCl <35renal cutoff for bisphosphonate avoidance

Coverage Criteria for Romosozumab (Evenity)

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Initial authorization

Authorization may be granted when ALL of the following are met (or for members currently receiving Evenity):

Eligible population: Diagnosis of postmenopausal osteoporosis

(policy applies to postmenopausal women at high risk for fracture)

High risk criteria: Member has a history of fragility fractures OR indicators of higher fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3.5, increased fall risk)

Documentation of one or more of these risk indicators required

Bone density / FRAX requirements: Pre-treatment T-score ≤ -2.5 OR osteopenia (pre-treatment T-score > -2.5 and < -1) with high pre-treatment FRAX probabilityFRAX major >20% or hip ≥3%

See Appendix A for FRAX adjustment with glucocorticoids

Bisphosphonate history or contraindication: Member has completed an oral bisphosphonate trial of at least 1 year OR there is a documented clinical reason to avoid oral bisphosphonate therapy

See Appendix B for acceptable clinical reasons to avoid oral bisphosphonates (e.g., esophageal abnormality, inability to remain upright, CrCl <35 mL/min, history of intolerance)

Duration limit: Approvals limited to a maximum of 12 months of therapy12 months

Approvals may be granted for members currently receiving Evenity for up to 12 months

Clinical Thresholds and Coding-related Definitions

T-score thresholds

Osteoporosis T-score thresholdT-score ≤ -2.5

Osteopenia definitionPre-treatment T-score > -2.5 and < -1

Osteopenia qualifying requirementOsteopenia must be accompanied by high pre-treatment FRAX probability and meet additional criteria (e.g., bisphosphonate trial or contraindication)

Maximum approval durationApprovals are limited to a maximum of 12 months of therapy

Provider Requirements and Prior Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals may be granted for up to 12 months for members currently receiving treatment with Evenity (romosozumab-aqqg).

Authorization may be granted for a total of 12 months for members currently receiving treatment
Prior authorization required for new starts

Documentation Required

Bisphosphonate Trial or Contraindication

Documentation must show either a completed oral bisphosphonate trial of at least 1 year or a documented clinical reason to avoid oral bisphosphonates per Appendix B.

At least a 1-year oral bisphosphonate trial required unless clinical contraindication exists
See Appendix B for acceptable clinical reasons to avoid oral bisphosphonate therapy

Denial Risk

Required Clinical Documentation / Insufficient Documentation Risk

Provide complete clinical documentation to support the request. Lack of adequate documentation that the member meets clinical criteria (history of fragility fracture, indicators of high fracture risk, pre-treatment T-score, pre-treatment FRAX when applicable, or documentation of bisphosphonate trial/contraindication) may lead to denial.

Diagnosis of postmenopausal osteoporosis
History of fragility fracture or indicators of higher fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3.5, increased fall risk)
Pre-treatment T-score (≤ -2.5 for osteoporosis or osteopenia range with high FRAX)
Pre-treatment FRAX score when applicable (see Appendix A for high-risk thresholds)
Documentation of 1-year oral bisphosphonate trial OR clinical reason to avoid oral bisphosphonates (see Appendix B)

Definitions and Risk Thresholds

High FRAX fracture probability

FRAX major osteoporotic fracture threshold10-year major osteoporotic fracture risk > 20%

FRAX hip fracture threshold10-year hip fracture risk ≥ 3%

Glucocorticoid adjustmentIf glucocorticoid treatment > 7.5 mg/day, multiply FRAX major risk by 1.15 and hip fracture risk by 1.2

Fragility fracture

Defined fragility fractureHistory of osteoporotic (fragility) fracture qualifies as a high-risk history for treatment

Examples supporting eligibilityPrior osteoporotic fracture or multiple risk factors (advanced age, frailty, glucocorticoid use, very low T-scores, increased fall risk)

Documentation requirementClinical documentation of prior fragility fractures is required for authorization consideration