CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zoledronic acid (Zometa) coverage and authorization criteria

Defines covered indications, authorization durations, compendial uses, and reauthorization criteria for zoledronic acid (Zometa) for members; lists which indications are considered investigational/not covered.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZoledronic acid (Zometa) coverage and authorization criteria

Policy CodePolicy N/A

Change TypeClarified

Effective Date

Next Review Date

Key ActionSubmit a prior authorization request and provide documentation of disease stability or improvement for reauthorization per indicated durations.

POLICY UPDATE CHANGES

Policy lists covered FDA-approved and compendial indications and specifies authorization durations and reauthorization requirements.

7Covered/Compendial Indications Listed

2Time-limited authorization for hypercalcemia (months)

12Authorization length for most indications (months)

Coverage Summary

Defines coverage for zoledronic acid (Zometa) tied to the listed FDA‑approved indications and recognized compendial uses. Covered indications are those listed in the criteria groups below; any other uses are considered investigational/not covered.

Covered Indications (general)

The following FDA-approved indications and compendial uses are covered provided all approval criteria are met and the member has no exclusions to the prescribed therapy:

ANY of the following

Treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. (Prostate cancer should have progressed after treatment with at least one hormonal therapy.)
Treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) >= 12 mg/dL [3.0 mmol/L] using the formula: cCa in mg/dL = measured Ca + 0.8*(4 - albumin [g/dL]).>= 12 mg/dL (3.0 mmol/L)
Limitation: safety/efficacy not established for hypercalcemia associated with hyperparathyroidism or non-tumor-related conditions.
Compendial use: treatment in postmenopausal patients with breast cancer receiving adjuvant therapy to maintain or improve bone mineral density and reduce risk of fractures.
Compendial use: treatment or prevention of osteoporosis during androgen-deprivation therapy (ADT) in prostate cancer patients with high fracture risk.
Compendial use: treatment in postmenopausal patients with breast cancer receiving adjuvant therapy to reduce the risk of distant metastases (high-risk node negative or node positive tumors).
Compendial use: Langerhans Cell Histiocytosis with bone disease.
Compendial use: treatment for osteopenia or osteoporosis in patients with systemic mastocytosis.

Authorization Durations & Reauthorization Criteria

Authorization Durations and Reauthorization Criteria

Authorization durations granted per indication and reauthorization evidence requirements:

By indication

Hypercalcemia of malignancy: initial authorization of 2 months may be granted.2 months
Reauthorization: 2 months will be granted for continued treatment if member is experiencing benefit as evidenced by disease stability or disease improvement.
Multiple myeloma: authorization of 12 months may be granted for prevention of skeletal-related events.12 months
Reauthorization: 12 months may be granted if benefit demonstrated by disease stability or improvement.
Bone metastases from a solid tumor: authorization of 12 months may be granted for prevention of skeletal-related events.12 months
Reauthorization: 12 months may be granted if benefit demonstrated.
Prostate cancer (ADT): Prostate cancer (treatment or prevention of osteoporosis during ADT): authorization of 12 months may be granted.12 months
Reauthorization: 12 months may be granted if benefit demonstrated.
Alternate breast cancer indication: Breast cancer (postmenopausal receiving adjuvant therapy to maintain/improve BMD and reduce fractures): authorization of 12 months may be granted when the requested medication will be used to maintain or improve bone mineral density and reduce the risk of fractures.12 months
See alternate: requested medication used for risk reduction of distant metastasis in high-risk node negative or node positive tumors.
Systemic mastocytosis (osteopenia or osteoporosis): authorization of 12 months may be granted.12 months
Reauthorization: 12 months may be granted if benefit demonstrated.
Langerhans Cell Histiocytosis with bone disease: authorization of 12 months may be granted.12 months
Reauthorization: 12 months may be granted if benefit demonstrated.
Reauthorization general: All diagnoses excluding hypercalcemia of malignancy: reauthorization of 12 months will be granted for continued treatment if member is experiencing benefit from therapy as evidenced by disease stability or disease improvement.12 months

Prior Authorization

Prior Authorization Required

Prior authorization is required for zoledronic acid (Zometa). Initial authorization lengths vary by indication as listed below.

Hypercalcemia of malignancy: 2 months
Multiple myeloma: 12 months
Bone metastases from a solid tumor: 12 months
Prostate cancer (treatment or prevention of osteoporosis during ADT): 12 months
Breast cancer (postmenopausal receiving adjuvant therapy for BMD preservation or fracture risk reduction): 12 months
Systemic mastocytosis (osteopenia/osteoporosis): 12 months
Langerhans Cell Histiocytosis with bone disease: 12 months

Documentation Required

Documentation Required for Reauthorization

For reauthorization, submit documentation demonstrating that the member is experiencing benefit from therapy. Acceptable evidence includes demonstrations of disease stability or disease improvement.

Evidence of disease stability
Evidence of disease improvement

Background & Clinical Evidence

Zoledronic acid (Zometa) is FDA‑indicated for treatment of skeletal complications of malignancy including multiple myeloma and documented bone metastases from solid tumors (used with standard antineoplastic therapy) and for treatment of hypercalcemia of malignancy defined as an albumin‑corrected calcium (cCa) >= 12 mg/dL (3.0 mmol/L) using the formula cCa = measured Ca + 0.8*(4 - albumin [g/dL]). Compendial uses cited in the policy include osteoporosis‑related indications in cancer treatment (for example, postmenopausal breast cancer receiving adjuvant therapy to maintain/improve bone mineral density and reduce fracture risk; prevention or treatment of osteoporosis during androgen‑deprivation therapy in prostate cancer) and certain rare bone diseases (systemic mastocytosis with osteopenia/osteoporosis; Langerhans Cell Histiocytosis with bone disease). The policy ties coverage to these FDA indications and recognized compendia.

Primary supporting references for the policy include the Zometa and zoledronic acid package inserts (Novartis and Northstar Rx), IBM Micromedex (DRUGDEX), the NCCN Drugs & Biologics Compendium, and AHFS Drug Information.

Definitions

TermcCa (albumin-corrected calcium)

Definition / formulacCa (mg/dL) = measured Ca (mg/dL) + 0.8 × (4 - albumin [g/dL])

Threshold for hypercalcemia of malignancyAlbumin-corrected calcium (cCa) ≥ 12 mg/dL (3.0 mmol/L)

Revision History

2022-10-11reviewLatest

Policy last reviewed (non-material): document references package inserts and compendia (NCCN, Micromedex, AHFS) for supporting indications; clarifying language about covered FDA-approved and compendial indications and authorization/reauthorization requirements.

coverage_definition

Covered indications include treatment of multiple myeloma and documented bone metastases from solid tumors in conjunction with standard antineoplastic therapy; prostate cancer should have progressed after at least one hormonal therapy.

coverage_definition

Covered indication: treatment of hypercalcemia of malignancy defined as albumin-corrected calcium (cCa) ≥ 12 mg/dL (3.0 mmol/L) using formula cCa = measured Ca + 0.8*(4 - albumin [g/dL]); safety/efficacy not established for hypercalcemia from hyperparathyroidism or non-tumor conditions.

compendial_use

Compendial uses covered: postmenopausal breast cancer receiving adjuvant therapy to maintain/improve bone mineral density and reduce fracture risk; reduce risk of distant metastases in high‑risk tumors; osteoporosis prevention/treatment during ADT in prostate cancer with high fracture risk; Langerhans cell histiocytosis with bone disease; osteopenia/osteoporosis in systemic mastocytosis.

authorization

Authorization durations: hypercalcemia of malignancy initial authorization of 2 months; multiple myeloma, bone metastases, prostate cancer (ADT), breast cancer adjuvant BMD preservation, systemic mastocytosis, and Langerhans Cell Histiocytosis: authorization of 12 months may be granted.

reauthorization_requirement

Reauthorization: for hypercalcemia of malignancy, 2 months will be granted for continued treatment if benefit shown by disease stability or improvement; for all other listed diagnoses, 12 months will be granted for continued treatment if benefit demonstrated by disease stability or improvement.

OpenPayer

Zoledronic acid (Zometa) coverage and authorization criteria

Coverage Summary

Not Covered / Investigational

Authorization Durations & Reauthorization Criteria

Applicable Codes

Background & Clinical Evidence

Revision History