Subject: Xgeva 2152-A SGM P2023
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. Prevention of skeletal-related events in patients with multiple myeloma and in patients
with bone metastases from solid tumors
2. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that
is unresectable or where surgical resection is likely to result in severe morbidity
3. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy
B. Compendial Uses
1. Second-line therapy for osteopenia/osteoporosis in patients with systemic mastocytosis
2. Thyroid cancer as palliative care for bone metastases
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Multiple myeloma
Authorization of 12 months may be granted for prevention of skeletal-related events in
members with multiple myeloma.
B. Bone metastases from a solid tumor
Authorization of 12 months may be granted for either of the following:
1. For 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)
2. As palliative care for bone metastases from thyroid carcinoma
C. Giant cell tumor of bone
Authorization of 12 months may be granted for treatment of giant cell tumor of bone.
D. Hypercalcemia of malignancy
Authorization of 2 months may be granted for treatment of hypercalcemia of malignancy that
is refractory to intravenous (IV) bisphosphonate therapy OR there is a clinical reason to
avoid IV bisphosphonate therapy (see Appendix).
E. Systemic mastocytosis
Authorization of 12 months may be granted for second-line therapy for osteopenia or
osteoporosis in members with systemic mastocytosis that have not responded to therapy
with bisphosphonates or who are not candidates for bisphosphonates because of renal
insufficiency.
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.
IV. APPENDIX
Clinical reasons to avoid IV bisphosphonate therapy
• Renal insufficiency (creatinine clearance <35 mL/min)
• Acute renal impairment
• History of intolerance to an IV bisphosphonate
Place of Service:
Outpatient
The above policy is based on the following references:
- Xgeva [package insert]. Thousand Oaks, CA: Amgen Inc.; June 2020.
- The NCCN Drugs & Biologics Compendium™ © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 6, 2023.
- Hu M, Glezerman IG, Leboulleux S, et al. Denosumab for treatment of hypercalcemia of malignancy. J Clin Endocrinol Metab. 2014;99(9):3144-3152.
- Drug Facts and Comparisons. Facts & Comparisons® eAnswers. Wolters Kluwer Health Inc. Riverwoods, IL. Accessed October 6, 2023. https://online.factsandcomparisons.com
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
