CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zoledronic Acid Zometa 2382 A Sgm P2023

Defines coverage indications, authorization durations, and reauthorization criteria for zoledronic acid (Zometa), including FDA-approved and specified compendial uses; states that other indications are investigational/not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZoledronic Acid Zometa 2382 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must obtain authorization for zoledronic acid; initial and reauthorization durations vary by indication (2 months for hypercalcemia of malignancy; 12 months for most other covered indications).

SourceLink

POLICY UPDATE CHANGES

No material changes — policy maintained with existing covered indications, authorization durations, and reauthorization criteria.

8Covered Indications Listed

1Investigational/Not Medically Necessary

2/12Auth Durations

Coverage Summary & Indications

This policy defines coverage for zoledronic acid (Zometa) for FDA-approved indications and specified compendial uses. Covered FDA-approved indications include treatment of hypercalcemia of malignancy (albumin-corrected calcium cCa ≥ 12 mg/dL) and use in patients with multiple myeloma or with documented bone metastases from solid tumors in conjunction with standard antineoplastic therapy. Compendial uses considered covered include selected indications such as prevention or treatment of osteoporosis in cancer-related settings and treatment of bone disease in systemic mastocytosis and Langerhans cell histiocytosis. All other uses are considered investigational/not medically necessary. The policy references the Zometa and zoledronic acid package inserts and the NCCN Drugs & Biologics Compendium for details on indications and compendial uses.

Covered Indications (FDA-approved and Compendial)

Covered when ALL of the following are met:

One of the following indications

Hypercalcemia of malignancy defined as albumin-corrected calcium (cCa) >= 12 mg/dLcCa >= 12 mg/dL
cCa formula: cCa (mg/dL) = Ca (mg/dL) + 0.8 (4.0 g/dL - patient albumin [g/dL])
Multiple myeloma for treatment or prevention of skeletal-related events in conjunction with standard antineoplastic therapy
Bone metastases from solid tumors for treatment or prevention of skeletal-related events in conjunction with standard antineoplastic therapy; prostate cancer should have progressed after at least one hormonal therapy
Prostate cancer (ADT) - osteoporosis prevention/treatment: Prevention/treatment of osteoporosis during androgen-deprivation therapy (ADT) in prostate cancer patients with high fracture risk (compendial use)
Breast cancer - bone density/fracture risk: Postmenopausal patients with breast cancer receiving adjuvant therapy to maintain or improve bone mineral density and reduce fracture risk (compendial use)
Breast cancer - distant metastasis risk reduction: Postmenopausal patients with breast cancer receiving adjuvant therapy to reduce the risk of distant metastases (compendial use)
Systemic mastocytosis: Treatment for osteopenia or osteoporosis in patients with systemic mastocytosis (compendial use)
Langerhans cell histiocytosis with bone disease (compendial use)

No exclusions and indication criteria

No exclusions: Member has no exclusions to the prescribed therapy
Indication-specific criteria met: All approval criteria specific to the indication are met

Not Covered / Investigational

Investigational / Not Medically Necessary: All other indications not listed in Section I (FDA-approved or compendial uses) are considered experimental/investigational and not medically necessary

Hyperparathyroidism/non-tumor hypercalcemia: Treatment of hypercalcemia associated with hyperparathyroidism or other non-tumor-related conditions — safety and efficacy not established

Authorization Durations and Continuation Criteria

Authorization Durations — Initial

Authorization durations granted for initial treatment by indication:

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Authorization Durations — Reauthorization / Continued Therapy

Reauthorization durations and criteria

Hypercalcemia of malignancy reauthorization: Authorization of 2 months may be granted for continued treatment when member is experiencing benefit as evidenced by disease stability or disease improvement2 months
Benefit must be documented (disease stability or improvement)
All other listed indications reauthorization: Authorization of 12 months may be granted for continued treatment when member is experiencing benefit as evidenced by disease stability or disease improvement12 months
Benefit must be documented (disease stability or improvement)

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Prior Authorization & Documentation Requirements

Prior Authorization

Authorization required with indication-based durations

Providers must obtain authorization for zoledronic acid. Initial and reauthorization durations vary by indication: hypercalcemia of malignancy — authorization of 2 months may be granted; most other covered indications — authorization of 12 months may be granted.

Documentation Required

Document clinical benefit for reauthorization

For reauthorization, the provider must document that the member is experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Clinical Evidence & References

Evidence and references cited in this policy include: Zometa [package insert], Novartis Pharmaceuticals Corporation; December 2018; Zoledronic acid [package insert], Fresenius Kabi; March 2023; and The NCCN Drugs & Biologics Compendium 2023 (accessed October 12, 2023). These sources are referenced by the policy for FDA-approved indications and compendial uses.

Albumin‑corrected calcium (cCa) formulacCa (mg/dL) = Ca (mg/dL) + 0.8 (4.0 g/dL - patient albumin [g/dL])

Policy Background

Background: Zoledronic acid (Zometa) is covered for FDA-approved indications and selected compendial uses. FDA-approved uses include treatment of hypercalcemia of malignancy (using the albumin-corrected calcium formula to define cCa ≥ 12 mg/dL) and treatment of patients with multiple myeloma or documented bone metastases from solid tumors in conjunction with standard antineoplastic therapy. Examples of compendial or selected uses covered by the policy include prevention or treatment of osteoporosis during androgen-deprivation therapy in prostate cancer, use in postmenopausal breast cancer patients receiving adjuvant therapy to maintain bone mineral density or reduce distant metastasis risk, treatment of osteopenia/osteoporosis in systemic mastocytosis, and management of bone disease in Langerhans cell histiocytosis. The policy relies on the Zometa and zoledronic acid package inserts and the NCCN Drugs & Biologics Compendium for clinical detail and support.