CurrentCareSourcePolicy N/A

Bone Modifiers — Zoledronic Acid (Reclast) Utilization Management Medical Policy

Defines prior authorization criteria, dosing, approved indications, and not-recommended situations for zoledronic acid (Reclast) medical benefit coverage for CareSource members.

Policy Summary

PayerCareSource

PolicyBone Modifiers — Zoledronic Acid (Reclast) Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeMaterial revisions and clarifications (added prostate cancer on ADT, repositioned exception language, clarified supplement concurrency)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of prior bisphosphonate trial or reason for intolerance and relevant T-scores or fracture history.

SourceLink

POLICY UPDATE CHANGES

Exceptions for patients having an osteoporotic or fragility fracture while on oral bisphosphonate therapy were removed and incorporated into notes as examples of inadequate efficacy or significant intolerance to oral bisphosphonate trial.

Clarified that concurrent use exclusion does not apply to calcium and/or vitamin D supplements used with zoledronic acid (Reclast).

Treatment of bone loss in patients with prostate cancer receiving androgen deprivation therapy was added as a condition with dosing and approval duration.

5 mgstandard single dose per infusion

once yearlytypical maximum dosing frequency

up to 2 yrsprevention dosing interval

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.

2025-03-19policy review date

Indications and Coverage Criteria

FDA-Approved Indications and other supported uses

Covered when the following indication-specific criteria are met:

Glucocorticoid-Induced Osteoporosis Prevention and Treatment

A: Glucocorticoid use: Patient is either initiating OR continuing systemic glucocorticoids (example: prednisone) and is anticipated to remain on glucocorticoids >= 12 months.
B: Prior therapy or exception
- i: Patient has tried zoledronic acid intravenous infusion (Reclast).
- ii: Patient has tried at least one oral bisphosphonate and meets ONE of: (a) inadequate efficacy after ~12 months (examples: ongoing significant BMD loss, lack of BMD increase, or a fragility fracture); OR (b) significant intolerance to an oral bisphosphonate (examples: severe gastrointestinal adverse events, severe musculoskeletal adverse events, femoral fracture).
- iii: Patient cannot take an oral bisphosphonate due to ONE of: inability to swallow/difficulty swallowing; pre-existing gastrointestinal condition where IV bisphosphonate is warranted (examples: esophageal lesions, ulcers, esophageal emptying delay such as stricture or achalasia); inability to remain upright after oral dosing.
- iv: Patient has had an osteoporotic or fragility fracture.

Osteoporosis Prevention — Postmenopausal

A: Patient meets ONE of: prior zoledronic acid (Reclast) trial; OR prior oral bisphosphonate with inadequate efficacy after ~12 months; OR significant intolerance to oral bisphosphonate; OR cannot take oral bisphosphonate; OR prior osteoporotic/fragility fracture.
B: If patient previously received Reclast for prevention, at least 24 months must have elapsed since the last dose for some prevention dosing statements.
Dosing note: Dosing: approve one 5 mg IV infusion up to once every 2 years for prevention in some statements (refer to indication-specific dosing).

Osteoporosis Treatment — Men

A: Patient meets ONE of: T-score <= -2.5 (current or past) at lumbar spine, femoral neck, total hip, and/or 33% radius; OR history of an osteoporotic/fragility fracture; OR low bone mass with prescriber statement of high fracture risk.
B: Patient meets ONE of: prior zoledronic acid OR trial of >=1 oral bisphosphonate with inadequate efficacy after ~12 months OR significant intolerance to oral bisphosphonate OR cannot take oral bisphosphonate OR prior osteoporotic/fragility fracture.
Dosing note: Dosing: approve one 5 mg IV infusion up to once every year for treatment dosing.

Osteoporosis Treatment — Postmenopausal

A: Patient meets ONE of: T-score <= -2.5 (current or past) at lumbar spine, femoral neck, total hip, and/or 33% radius; OR history of an osteoporotic/fragility fracture; OR low bone mass with prescriber statement of high fracture risk.
B: Patient meets ONE of: prior IV ibandronate (Boniva IV) or prior zoledronic acid OR trial of >=1 oral bisphosphonate with inadequate efficacy after ~12 months OR significant intolerance to oral bisphosphonate OR cannot take oral bisphosphonate OR prior osteoporotic/fragility fracture.
Dosing note: Dosing: approve one 5 mg IV infusion up to once every year for treatment dosing.

Paget's disease of bone

i: Elevated serum alkaline phosphatase >= 2 times the upper limit of age-specific normal.
ii: Patient is at risk for complications (immobilization, bone deformity, fractures, nerve compression).
iii: Patient is symptomatic (bone pain, hearing loss, osteoarthritis).

Osteogenesis Imperfecta: Approve for 1 year for treatment of osteogenesis imperfecta (supportive evidence).

Treatment-related bone loss in prostate cancer on ADT: Approve for 1 year if the patient is receiving androgen deprivation therapy; dosing: one 5 mg IV infusion up to once yearly.

Requests for concurrent administration of zoledronic acid (Reclast) with other osteoporosis medications are not recommended for approval. Examples of medications that should not be given concomitantly with Reclast for osteoporosis-related indications include oral bisphosphonates (e.g., alendronate, risedronate, ibandronate), other IV bisphosphonates (e.g., IV ibandronate), denosumab (Prolia), romosozumab (Evenity), the parathyroid hormone analogs teriparatide (Forteo) and abaloparatide (Tymlos), and calcitonin nasal spray. Calcium and/or vitamin D supplements may be used concomitantly with Reclast.

Coverage is not recommended for uses and circumstances that are not specifically listed in the Recommended Authorization Criteria; the criteria set will be updated as new published data become available.

Billing Codes and Key Numeric Criteria

Covered HCPCS (implied)HCPCS

J3487

Zoledronic acid (per document: zoledronic acid intravenous infusion — Reclast) (example billing code — not explicitly listed in document)

T-score — numeric threshold

Numeric thresholdT-score <= -2.5

Anatomic sites referencedLumbar spine, femoral neck, total hip, and/or 33% (one-third) radius (wrist)

Use in criteria setsSupports osteoporosis treatment indication for men and postmenopausal women when met

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for zoledronic acid (Reclast). Approvals are typically provided for the durations specified in the policy (commonly 1 year for most indications; single 5 mg IV infusions are approved on the dosing schedule noted). Requests for doses or schedules outside the established dosing will be reviewed case-by-case by a clinician (e.g., Medical Director or Pharmacist).

Approvals: generally 1 year for ongoing indications; single 5 mg IV infusion approvals documented per dosing interval (e.g., once yearly or once every 2 years where specified).
Automation: None.

Documentation Required

Required Clinical Rationale and Prior Therapy Documentation

Prescriber must document clinical rationale and prior therapy when requesting coverage. For glucocorticoid‑induced osteoporosis, the prescriber must confirm systemic glucocorticoid use (example: prednisone) and provide supporting details. For osteoporosis prevention or treatment, the prescriber must document prior trials or reasons oral or IV bisphosphonates are inappropriate as described below.

Clinical Background

Zoledronic acid (Reclast) is an intravenous bisphosphonate used for osteoporosis-related indications and other bone disorders. It is administered as an IV infusion and, for osteoporosis, is typically given as a single 5 mg infusion at the approved interval per indication. Clinical use should follow the authorization criteria and dosing frequency specified for each covered indication.

Key Definitions and Thresholds

Systemic glucocorticoid — example threshold

Example systemic glucocorticoid and dosePrednisone 7.5 mg (or greater)

Exposure duration for GIOP criteriaAnticipated to remain on glucocorticoids for at least 12 months

Context of useDefines patients initiating or continuing systemic glucocorticoids for prevention and treatment of glucocorticoid-induced osteoporosis

T-score threshold for osteoporosis

T-score thresholdT-score at or below -2.5

Applicable anatomic sitesLumbar spine, femoral neck, total hip, and/or 33% (one-third) radius (wrist)

Policy Summary

PayerCareSource

PolicyBone Modifiers — Zoledronic Acid (Reclast) Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeMaterial revisions and clarifications (added prostate cancer on ADT, repositioned exception language, clarified supplement concurrency)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of prior bisphosphonate trial or reason for intolerance and relevant T-scores or fracture history.

SourceLink

On This Page

Document systemic glucocorticoid initiation or continuation when claiming glucocorticoid‑induced osteoporosis.
If prior zoledronic acid (Reclast) has been given, document date of last dose (e.g., ≥24 months since prior dose where policy requires).
If relying on prior oral bisphosphonate therapy, document at least a 12‑month trial and prescriber assessment of inadequate efficacy (examples: continued significant BMD loss, lack of BMD increase, or occurrence of a fragility fracture).
If asserting intolerance or inability to take oral bisphosphonates, document specific reason(s): inability to swallow, inability to remain upright after dosing, severe GI adverse events or pre‑existing GI conditions (e.g., esophageal lesions/ulcers, strictures, achalasia) that warrant IV therapy, or other cited intolerance (e.g., severe musculoskeletal adverse events).

Step Therapy

Step Therapy / Prior Trial Requirements

Step therapy is required: member should have tried zoledronic acid IV (Reclast) previously OR tried at least one oral bisphosphonate unless there is documented intolerance or contraindication. Where prior oral therapy is used as the trial, documentation must meet the inadequate efficacy or intolerance criteria described above.

Acceptable prior therapies include: zoledronic acid IV (Reclast) or at least one oral bisphosphonate (examples: alendronate, risedronate, ibandronate).
If using oral bisphosphonate trial: prescriber attestation of ≥12 months trial and evidence of inadequate efficacy OR documentation of significant intolerance/contraindication.
If prior Reclast administered, ensure interval meets policy dosing intervals (e.g., at least 24 months since last dose where indicated).

Denial Risk

Concurrent Use Exclusion

Concurrent use of zoledronic acid (Reclast) with other osteoporosis medications is generally not recommended and will not be approved except where policy explicitly allows (calcium and/or vitamin D supplementation is allowed). Requests for concurrent use with other listed osteoporosis agents should include clinical justification and will be reviewed for medical necessity.

Concurrent agents that are generally excluded: oral bisphosphonates (alendronate, risedronate, ibandronate), other IV bisphosphonates (e.g., IV ibandronate), denosumab (Prolia), romosozumab (Evenity), teriparatide (Forteo), abaloparatide (Tymlos), calcitonin nasal spray.
Permitted concomitant supplements: calcium and vitamin D.

Role in approvalMeets ONE criterion (among T-score <= -2.5, prior fragility fracture, or low bone mass with high fracture risk) supporting treatment approval