CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zoledronic Acid Reclast 2380 A Sgm P2022A

Defines prior authorization coverage criteria, documentation requirements, duration of authorization, continuation criteria, and excluded uses for zoledronic acid (Reclast) for FDA-approved indications (postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis, Paget's disease). All other indications are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZoledronic Acid Reclast 2380 A Sgm P2022A

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit supporting chart notes or medical record indicating history of fractures, pre-treatment T-score, and FRAX fracture probability as applicable to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

4FDA-Approved Indications Covered (listed)

1Paget's single-dose authorization

12 monthsTypical authorization length

24 monthsContinuation benefit assessment threshold

This policy covers FDA-approved uses of zoledronic acid (Reclast) including: treatment and prevention of postmenopausal osteoporosis; treatment to increase bone mass in men with osteoporosis; treatment and prevention of glucocorticoid-induced osteoporosis; and treatment of Paget's disease of bone. All other indications are considered experimental/investigational and not medically necessary. References supporting these indications include the Reclast package insert (April 2020), the zoledronic acid injection package insert (August 2021), and relevant clinical guidelines and reviews.

Continuation Therapy Criteria (Reauthorization)

Initial authorization is typically for 12 months for osteoporosis (postmenopausal and in men) and for glucocorticoid-induced osteoporosis; Paget's disease may be authorized for a single 5 mg dose. Continuation beyond initial authorization ties to the continuation criteria: members receiving 24 months or more of therapy must demonstrate clinical benefit (improvement or stabilization in T-score) and absence of adverse effects to be reauthorized.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required with documentation

Submit supporting chart notes or the medical record that document the indication-specific findings listed below to initiate prior authorization review.

History of fragility fracture (documented in chart notes)
Pre-treatment T-score (e.g., ≤ -2.5 or osteopenia range)
FRAX fracture probability (when applicable per indication)

Prior Authorization

Authorization duration

Initial authorization durations vary by indication. For osteoporosis (postmenopausal, men) and glucocorticoid-induced osteoporosis, initial authorizations may be granted for 12 months. For Paget's disease of bone, authorization of one 5 mg dose may be granted.

12 months (typical) for osteoporosis and glucocorticoid-induced osteoporosis
Paget's: single 5 mg dose authorization

Documentation Required

Continuation documentation

For continuation after 24 months or more, provide documentation showing clinical benefit and absence of adverse effects. Clinical benefit is defined as improvement or stabilization in T-score since the previous bone mass measurement. Also document that the member has not experienced clinically significant adverse events during therapy.

Evidence of clinical benefit: improvement or stabilization in T-score since prior bone mass measurement
Documentation of absence of adverse effects/clinically significant adverse events

Clinical Evidence & References

Evidence and references include: Reclast [package insert] (April 2020); Zoledronic acid injection [package insert] (August 2021); and multiple clinical guidelines and reviews (including National Osteoporosis Foundation clinician's guide, AACE/ACE guidelines, ACR glucocorticoid-induced osteoporosis guideline, Endocrine Society Paget's disease guideline, and others). Appendix A is referenced for FRAX adjustments based on glucocorticoid dose.

Definitions

Fragility fracture: history of fracture from low-level trauma typical for osteoporosis (documented in chart notes).

High FRAX fracture probability: 10-year major osteoporotic fracture risk ≥ 20% or hip fracture risk ≥ 3%; FRAX risk should be adjusted for glucocorticoid dose per Appendix A.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZoledronic Acid Reclast 2380 A Sgm P2022A

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit supporting chart notes or medical record indicating history of fractures, pre-treatment T-score, and FRAX fracture probability as applicable to initiate prior authorization review.

SourceLink

On This Page

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Zoledronic Acid Reclast 2380 A Sgm P2022A

Coverage Summary

Initial Therapy Criteria (Authorization / Indications)

Continuation Therapy Criteria (Reauthorization)

Unproven Uses / Not Medically Necessary

Provider Actions & Authorization Requirements

Applicable Codes

Clinical Evidence & References

Definitions

Revision History