Subject: zoledronic acid-Zometa 2382-A SGM P2023

Drug

ZOMETA  (zoledronic acid )

zoledronic acid

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          A.  FDA-Approved Indications
               1.  Zometa/zoledronic acid is indicated for the treatment of hypercalcemia of malignancy
                    defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3.0
                    mmol/L] using the formula: cCa in mg/dL= Ca in mg/dL + 0.8 (4.0 g/dL - patient albumin
                    [g/dL]).
               2.  Zometa/zoledronic acid is indicated for the 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.

          Limitations of Use: The safety and efficacy of Zometa/zoledronic acid in the treatment of
          hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions
          have not been established.

          B.  Compendial Uses
               1.  Treatment or prevention of osteoporosis during androgen-deprivation therapy (ADT) in
                    prostate cancer patients with high fracture risk
               2.  Treatment in postmenopausal patients with breast cancer who are receiving adjuvant
                    therapy to maintain or improve bone mineral density and reduce risk of fractures
               3.  Treatment in postmenopausal patients with breast cancer who are receiving adjuvant
                    therapy to reduce the risk of distant metastases
               4.  Treatment for osteopenia or osteoporosis in patients with systemic mastocytosis
               5.  Langerhans cell histiocytosis with bone disease

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


    II.  CRITERIA FOR INITIAL APPROVAL

          A.  Hypercalcemia of malignancy
               Authorization of 2 months may be granted for treatment of hypercalcemia of malignancy.

          B.  Multiple myeloma
               Authorization of 12 months may be granted for treatment or prevention of skeletal-related
               events in members with multiple myeloma.

          C.  Bone metastases from a solid tumor
               Authorization of 12 months may be granted for treatment or prevention of skeletal-related
               events in members with bone metastases from a solid tumor (e.g., breast cancer, non-small
               cell lung cancer, thyroid carcinoma, kidney cancer, prostate cancer).

          D.  Prostate cancer
               Authorization of 12 months may be granted for members with prostate cancer for treatment
               or prevention of osteoporosis during androgen deprivation therapy (ADT).

          E.  Breast cancer
               Authorization of 12 months may be granted for postmenopausal (natural or induced by
               ovarian suppression) members receiving adjuvant therapy for treatment of breast cancer
               when either of the following criteria is met:
               1.  The requested medication will be used to maintain or improve bone mineral density and
                    reduce the risk of fractures
               2.  The requested medication will be used for risk reduction of distant metastasis in high-risk
                    node negative or node positive tumors

          F.  Systemic mastocytosis
               Authorization of 12 months may be granted for treatment of osteopenia or osteoporosis in
               members with systemic mastocytosis.

         G.  Langerhans cell histiocytosis
               Authorization of 12 months may be granted for treatment of Langerhans cell histiocytosis
               with bone disease.


   III.  CONTINUATION OF THERAPY

          A.  Hypercalcemia of malignancy
               Authorization of 2 months may be granted for continued treatment in members requesting
               reauthorization for hypercalcemia of malignancy who are experiencing benefit from therapy
               as evidenced by disease stability or disease improvement.

          B.  All other indications
               Authorization of 12 months may be granted for continued treatment in members requesting
               reauthorization for an indication listed in Section II who are experiencing benefit from
               therapy as evidenced by disease stability or disease improvement.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Zometa [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; December 2018.
2. Zoledronic acid [package insert]. Lake Zurich, IL: Fresenius Kabi; March 2023.
3. The NCCN Drugs & Biologics Compendium 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 12, 2023.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 14, 2024