CurrentNeighborhood Health Plan of Rhode IslandPolicy 2380-A

Zoledronic acid (Reclast) prior authorization and coverage criteria

Defines medical necessity criteria, documentation requirements, and authorization durations for zoledronic acid (Reclast) for osteoporosis, glucocorticoid‑induced osteoporosis, Paget's disease, and treatment‑related bone loss in prostate cancer; applies to members of the payer product referenced.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZoledronic acid (Reclast) prior authorization and coverage criteria

Policy CodePolicy 2380-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with chart notes showing fracture history, pre‑treatment T‑score, FRAX probability, and documentation of androgen deprivation therapy when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization length

1 dosePaget's authorization

≤ -2.5T-score threshold

Major ≥20% / Hip ≥3%High FRAX

Coverage Criteria for Zoledronic Acid (Reclast)

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Postmenopausal Osteoporosis, Treatment and Prevention

Authorization of 12 months may be granted when ANY of the following are met:

Postmenopausal Osteoporosis criteria: Member has a history of fragility fractures (e.g., low trauma fracture from force similar to a fall from standing position)

12-month authorization

Postmenopausal Osteoporosis criteria: Member has a pre-treatment T-score less than or equal to -2.5

12-month authorization

Postmenopausal Osteoporosis criteria: Member has osteopenia (pre-treatment T-score greater than -2.5 and less than -1)

12-month authorization

Osteoporosis in Men

Authorization of 12 months may be granted when ANY of the following are met:

Osteoporosis in men criteria: Member has a history of an osteoporotic vertebral or hip fracture

12-month authorization

Osteoporosis in men criteria: Member has a pre-treatment T-score less than or equal to -2.5

12-month authorization

Osteoporosis in men criteria: Member has osteopenia (pre-treatment T-score greater than -2.5 and less than -1) with a high pre-treatment FRAX fracture probability

12-month authorization

Glucocorticoid‑Induced Osteoporosis

Authorization of 12 months may be granted when BOTH of the following are met:

Glucocorticoid-Induced Osteoporosis criteria: (1) Member is currently receiving or will be initiating glucocorticoid therapy at an equivalent prednisone dose of greater than or equal to 2.5 mg/day for at least 3 months; AND (2) Member meets ANY of the following: history of a fragility fracture OR pre-treatment T-score ≤ -2.5 OR osteopenia (pre-treatment T-score > -2.5 and < -1) with a high pre-treatment FRAX fracture probability

12-month authorization

Paget's Disease of Bone

Authorization may be granted when indication is Paget's disease of bone:

Paget's disease criteria: Treatment of Paget's disease of bone; continuation requests must meet coverage criteria

1 month (one 5 mg dose) authorization for treatment; continuation requires meeting coverage criteria

Prostate Cancer (treatment‑related bone loss)

Authorization of 12 months may be granted when ALL of the following are met:

Prostate cancer with ADT: Member has prostate cancer and is receiving androgen deprivation therapy (e.g., gosarelin, leuprolide, triptorelin); use consistent with compendial listing

12-month authorization

Continuation Therapy / All Other Indications

Authorization of 12 months may be granted for members currently receiving the medication through a previously authorized benefit when EITHER of the following are met:

Continuation criteria A: Member has received less than 24 months of therapy and has not experienced clinically significant adverse events during therapy

12-month authorization

Continuation criteria B: Member has received 24 months of therapy or more AND has experienced clinical benefit (improvement or stabilization in T-score since the previous bone mass measurement) AND has not experienced any adverse effects

12-month authorization

Indications that are not listed as FDA‑approved indications or supported by recognized compendia (e.g., uses outside those specified for treatment or prevention of osteoporosis, glucocorticoid‑induced osteoporosis, Paget’s disease of bone, or compendial listing for ADT‑related bone loss in prostate cancer) are considered experimental/investigational and not medically necessary.

Requests for therapy when the indication falls beyond the listed FDA‑approved indications or accepted compendial uses will be denied as not medically necessary on the basis of being experimental/investigational. Providers should submit documentation demonstrating that the requested use is FDA‑approved or is supported by the compendia to avoid denial.

Clinical Thresholds and Definitions

T-score criteria — Definitions and coverage use

Osteoporosis (diagnostic threshold)Pre-treatment T-score less than or equal to -2.5

Osteopenia (definition)Pre-treatment T-score greater than -2.5 and less than -1

Use in coverage criteriaT-score thresholds are applied for postmenopausal women and men when determining eligibility for a 12‑month authorization

FRAX thresholds and adjustments

High FRAX threshold — major fracture10‑year major osteoporotic fracture risk ≥ 20%

High FRAX threshold — hip fracture10‑year hip fracture risk ≥ 3%

FRAX calculation resourceUse the FRAX tool (https://frax.shef.ac.uk/FRAX/) to calculate 10‑year probabilities

Glucocorticoid adjustment noteFRAX estimated major fracture risk should be multiplied by 1.15 and hip fracture risk by 1.2 when glucocorticoid dose > 7.5 mg/day (prednisone equivalent)

Glucocorticoid exposure criteria

Glucocorticoid exposure thresholdPrednisone-equivalent dose greater than or equal to 2.5 mg/day

Minimum durationExposure for at least 3 months

Context of useCriterion used to define glucocorticoid‑induced osteoporosis eligibility for a 12‑month authorization

High FRAX fracture probability — definition and adjustments

Definition — major osteoporotic fracture10‑year major osteoporotic fracture risk ≥ 20%

Definition — hip fracture10‑year hip fracture risk ≥ 3%

Glucocorticoid dose adjustmentsMultiply FRAX major fracture estimate by 1.15 and hip fracture estimate by 1.2 when glucocorticoid dose exceeds 7.5 mg/day (prednisone equivalent)

Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage of the medications in this policy. Authorization durations vary by indication (see clinical criteria), but commonly: 12 months for osteoporosis indications (postmenopausal, men, glucocorticoid‑induced, and prostate cancer–related bone loss) and 1 month (one 5 mg dose) for Paget’s disease of bone.

Prior authorization required for requests for indications not listed as FDA‑approved or compendial uses will be considered experimental/investigational and not medically necessary.
Typical authorization durations: Postmenopausal osteoporosis — 12 months; Osteoporosis in men — 12 months; Glucocorticoid‑induced osteoporosis — 12 months; Prostate cancer–related bone loss (on ADT) — 12 months; Paget’s disease of bone — 1 month (one 5 mg dose).

Note

Duration Considerations

Optimal duration of therapy has not been determined. For patients at low risk for fracture, consider discontinuing therapy after 3 to 5 years. Continue to reassess fracture risk, benefit, and adverse effects when determining ongoing need for therapy.

Documentation Required

Required Documentation for Prior Authorization

Submit supporting clinical documentation with the prior authorization request to enable medical-necessity review. Evidence should be current and relevant to the requested indication.

Chart notes or medical record documentation indicating history of fragility fractures, pre‑treatment T‑score, and Fracture Risk Assessment Tool (FRAX) fracture probability when applicable.
Chart notes, medical record documentation, or claims history supporting use of androgen deprivation therapy (for treatment‑related bone loss in prostate cancer).
For members currently receiving therapy through a previously authorized benefit, include documentation of duration of therapy, evidence of clinical benefit (e.g., improvement or stabilization in T‑score), and absence of clinically significant adverse events where applicable.

OpenPayer

Zoledronic acid (Reclast) prior authorization and coverage criteria

Coverage Criteria for Zoledronic Acid (Reclast)

Clinical Thresholds and Definitions

Authorization, Documentation, and Provider Responsibilities

Background on Zoledronic Acid (Reclast)

Definitions and Thresholds