Subject: zoledronic acid-Zometa 2382-A SGM P2021

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 12mg/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.

      Limitation 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 for osteopenia or osteoporosis in patients with systemic mastocytosis           

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 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 prevention of skeletal-related events in member with
      bone metastases from a solid tumor.

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 to maintain or
      improve bone mineral density and reduce the risk of fractures. 

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

III. CONTINUATION OF THERAPY 

A.   Hypercalcemia of malignancy
      Authorization of 2 months will 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 Diagnosis (excluding hypercalcemia of malignancy)
      Authorization of 12 months will be granted for continued treatment in members requesting reauthorization
      for an indication listed in Section II (excluding hypercalcemia of malignancy) 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]. Memphis, TN: Northstar Rx LLC; August 2021.
3. IBM Micromedex DRUGDEX (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/ (cited: November 8, 2021).
4. American Society of Health System Pharmacists. AHFS Drug Information (electronic version). Bethesda, MD. Available at: http://online.lexi.com. Accessed November 8, 2021.
5. The NCCN Drugs & Biologics Compendium 2019 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 8, 2021.

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 17, 2022