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Neighborhood Health Plan RI zoledronic acid Coverage | OpenPayer

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OpenPayerPolicy UpdatesHematology/OncologyNeighborhood Health Plan RI zoledronic acid Covera…

CurrentNeighborhood Health Plan of Rhode IslandPolicy 2382-A

Zoledronic acid (Zometa) therapy — coverage criteria

This policy defines covered indications, authorization durations, documentation requirements, and limitations for zoledronic acid (Zometa) for Neighborhood Health Plan of Rhode Island members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZoledronic acid (Zometa) therapy — coverage criteria

Policy CodePolicy 2382-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization; document indication and supportive medical records for approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2hypercalcemia auth length (months)

≥12typical auth length (months)

3references cited

1reference number

Coverage Criteria for Zoledronic Acid (Zometa)

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Covered Indications

Covered when ALL of the following are met for each indication as specified below

Hypercalcemia of Malignancy - Initial: Member has hypercalcemia of malignancy defined as albumin-corrected calcium (cCa) >= 12 mg/dL.cCa >= 12 mg/dL

Authorization of 2 months may be granted.

Hypercalcemia of Malignancy - Reauthorization: Member is experiencing benefit from therapy as evidenced by disease stability or improvement.

Authorization of 2 months may be granted for continued treatment.

Multiple Myeloma: Member has multiple myeloma and zoledronic acid is to be used in conjunction with standard antineoplastic therapy.

Authorization of 12 months may be granted.

Bone Metastases from Solid Tumor: Member has documented bone metastases from a solid tumor and zoledronic acid is to be used in conjunction with standard antineoplastic therapy.

Authorization of 12 months may be granted for treatment or prevention of skeletal-related events.

Breast Cancer - Adjuvant Aromatase Inhibitor: Member is postmenopausal receiving adjuvant aromatase inhibition therapy and zoledronic acid will be used to maintain or improve bone mineral density and reduce fracture risk.

Authorization of 12 months may be granted.

Breast Cancer - Adjuvant Risk Reduction: Member is postmenopausal receiving adjuvant therapy for breast cancer and zoledronic acid will be used for risk reduction of distant metastasis in high-risk node negative or node positive tumors.

Authorization of 12 months may be granted.

Systemic Mastocytosis: Member has systemic mastocytosis with osteopenia or osteoporosis and zoledronic acid is requested for treatment.

Authorization of 12 months may be granted.

Langerhans Cell Histiocytosis with Bone Disease: Member has Langerhans cell histiocytosis with bone disease and zoledronic acid is requested for treatment.

Authorization of 12 months may be granted.

Use of zoledronic acid (Zometa) for non-tumor-related hypercalcemia (for example, hypercalcemia associated with hyperparathyroidism) has not been established. Requests for uses outside the FDA-approved and compendial indications listed in this policy should be evaluated against the policy’s covered indications; if the indication is not listed, the use is treated as experimental/investigational and is not medically necessary.

For indications that are listed (for example, hypercalcemia of malignancy, multiple myeloma, documented bone metastases from solid tumors, and the compendial uses in postmenopausal breast cancer, systemic mastocytosis, and Langerhans cell histiocytosis), follow the specific clinical criteria and documentation requirements in this policy, including the relevant laboratory thresholds and prior authorization timeframes.

All indications other than the FDA-approved and compendial uses explicitly listed in this policy are considered experimental/investigational and not medically necessary and are subject to denial. Compendial uses cited include adjuvant bone-protective therapy and metastasis risk reduction in certain postmenopausal breast cancer patients, treatment of osteopenia/osteoporosis in systemic mastocytosis, and treatment of bone disease in Langerhans cell histiocytosis.

Coding and Laboratory Definitions

Albumin-corrected calcium (cCa)

Albumin-corrected calcium (cCa) threshold>= 12 mg/dL

Unitmg/dL

PurposeDefines hypercalcemia of malignancy for treatment eligibility

Hypercalcemia of malignancy (cCa ≥ 12 mg/dL)

Formula for cCacCa (mg/dL) = measured calcium (mg/dL) + 0.8 × (4.0 g/dL − albumin [g/dL])

Threshold defining hypercalcemia of malignancycCa ≥ 12 mg/dL

Equivalent SI unit3.0 mmol/L (for cCa ≥ 12 mg/dL)

Clinical useThreshold used to identify patients eligible for treatment of hypercalcemia of malignancy

Administration/Procedure Codesmixed

No codes listed

Prior Authorization, Documentation, and Limitations

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests. Authorization durations vary by indication: 2 months for hypercalcemia of malignancy; 12 months for other covered indications (e.g., multiple myeloma, bone metastases from solid tumors, breast cancer indications, systemic mastocytosis, Langerhans cell histiocytosis).

Prior authorization required
Authorization duration: 2 months for hypercalcemia of malignancy
Authorization duration: 12 months for other covered indications

Documentation Required

Documentation Required for Review

Submit chart notes, medical record documentation, or claims history supporting the requested use. Include documentation of concurrent therapies when relevant (for example, adjuvant aromatase inhibitor therapy for breast cancer) and clinical measures demonstrating benefit for reauthorization requests (disease stability or improvement).

Required documentation: chart notes, medical records, or claims history
For reauthorization: evidence of benefit (disease stability or improvement)

Denial Risk

Experimental/Investigational Exclusions

Requests for indications not listed in the coverage criteria (including uses outside FDA-approved and listed compendial indications) are considered experimental/investigational and are not medically necessary.

All other indications are considered experimental/investigational and not medically necessary

Note

Provider Action

Providers should ensure prior authorization is obtained before initiating therapy and include supporting clinical documentation at time of request to avoid delays or denials.

Obtain prior authorization prior to therapy start when possible
Include full supporting documentation to facilitate timely review

Use with Antineoplastic Therapy and Therapy Line Criteria

Covered when used with antineoplastic therapy

In conjunction with standard antineoplastic therapy: Zoledronic acid is indicated for treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors in conjunction with standard antineoplastic therapy.

Background and Indications

Zoledronic acid (Zometa) is a bisphosphonate indicated for treatment of hypercalcemia of malignancy and for treatment of patients with multiple myeloma or documented bone metastases from solid tumors when used in conjunction with standard antineoplastic therapy. Compendial (NCCN) and manufacturer references additionally support use for specific adjuvant breast cancer indications to preserve bone density and reduce distant metastasis risk, and for bone disease associated with systemic mastocytosis and Langerhans cell histiocytosis. The safety and efficacy of zoledronic acid have not been established for hypercalcemia related to hyperparathyroidism or other non-tumor causes.

References and Revision History

References cited include the Zometa and zoledronic acid package inserts and the NCCN Drugs & Biologics Compendium: 1) Zometa [package insert], Novartis Pharmaceuticals Corporation; December 2018. 2) Zoledronic acid [package insert], Fresenius Kabi; September 2023. 3) The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. (accessed October 11, 2024).

2024-10-11reference_update

NCCN Drugs & Biologics Compendium cited (accessed October 11, 2024) in references list.

2023-09reference_update

Zoledronic acid package insert (Fresenius Kabi) dated September 2023 added to references.

2018-12reference_updateLatest

Zometa package insert (Novartis) dated December 2018 cited in references.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZoledronic acid (Zometa) therapy — coverage criteria

Policy CodePolicy 2382-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization; document indication and supportive medical records for approval.

SourceLink

On This Page

Coverage Criteria for Zoledronic Acid (Zometa)Coding and Laboratory Definitions Prior Authorization, Documentation, and Limitations Use with Antineoplastic Therapy and Therapy Line Criteria Background and Indications References and Revision History