Subject: zoledronic acid-Zometa 2382-A SGM P2022
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ZOMETA
(zoledronic acid)
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zoledronic acid
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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 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 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 when one of the following 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 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:
- Zometa [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; December 2018.
- Zoledronic acid [package insert]. Memphis, TN: Northstar Rx LLC; May 2020.
- IBM Micromedex DRUGDEX (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/ . Accessed October 10, 2022.
- American Society of Health System Pharmacists. AHFS Drug Information (electronic version). Bethesda, MD. Available at: http://online.lexi.com. Accessed October 10, 2022.
- The NCCN Drugs & Biologics Compendium 2019 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 11, 2022.
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.
May 26, 2023
