Subject: Xgeva 2152-A SGM P2022

Drug

XGEVA  (denosumab)

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 or osteoporosis in
                    patients with systemic mastocytosis
               2.  Thyroid cancer as palliative care for bone metastases
               3.  Prevention of skeletal-related events in prostate cancer in
                    patients with 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 any of the
               following:
               1.  For the 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
               Initial 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 for patients who are not candidates
               for bisphosphonates because of renal insufficiency.

 
  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.

 
   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:

1. Xgeva [package insert]. Thousand Oaks, CA: Amgen Inc.; June 2020.
2. The NCCN Drugs & Biologics Compendium™ © 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 17, 2022.
3. Hu M, Glezerman IG, Leboulleux S, et al. Denosumab for treatment of hypercalcemia of malignancy. J Clin Endocrinol Metab. 2014; 99(9):3144-3152.
4. Drug Facts and Comparisons. Facts & Comparisons^® eAnswers [online]. 2020. Available from Wolters Kluwer Health, Inc. Accessed October 17, 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.

April 11, 2023