Pharmacy Prior Authorization Criteria

Xgeva (denosumab)

Indications for Prior Authorization

Xgeva (denosumab)

• For diagnosis of Multiple myeloma and Bone metastasis from solid tumors
  Indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

• For diagnosis of Giant cell tumor of bone
  Indicated for the 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.

• For diagnosis of Hypercalcemia of malignancy
  Indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Criteria

Xgeva

If patient meets criteria above, please approve at GPI-12.

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Skeletal prevention in multiple myeloma and bone metastasis from solid tumors (BMST)

• One of the following:
• Both of the following:
• Diagnosis of multiple myeloma
AND
• Trial and failure, contraindication (e.g., renal insufficiency), or intolerance, to one intravenous bisphosphonate (e.g., zoledronic acid) [9]
OR
• Both of the following:
• Diagnosis of solid tumors (e.g., breast cancer, kidney cancer, lung cancer, prostate cancer, thyroid cancer) [1-5]
AND
• Documented evidence of one or more metastatic bone lesions

Xgeva

If patient meets criteria above, please approve at GPI-12.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Giant cell tumor of bone

• Diagnosis of giant cell tumor of bone
AND
• One of the following:
• Tumor is unresectable
OR
• Surgical resection is likely to result in severe morbidity

Xgeva

If patient meets criteria above, please approve at GPI-12.

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)
For diagnosis of Giant cell tumor of bone

• Patient does not show evidence of progressive disease while on Xgeva therapy [A]

Xgeva

If patient meets criteria above, please approve at GPI-12.

Prior Authorization (Initial Authorization)

Length of Approval: 2 Month [B]
For diagnosis of Hypercalcemia of malignancy

• Diagnosis of hypercalcemia of malignancy
AND
• Trial and failure, contraindication, or intolerance to one intravenous bisphosphonate (e.g., pamidronate, zoledronic acid) [6, 7]

Xgeva

If patient meets criteria above, please approve at GPI-12.

Prior Authorization (Reauthorization)

Length of Approval: 2 Month [B]
For diagnosis of Hypercalcemia of malignancy

• Documentation of positive clinical response to Xgeva therapy

P & T Revisions

2024-09-12, 2024-06-28, 2023-06-23, 2022-07-06, 2022-05-23, 2021-07-24, 2021-05-26, 2021-05-25, 2020-07-01, 2020-06-28, 2019-07-15

References

1. Xgeva prescribing information. Amgen Inc. Thousand Oaks, CA. June 2020.
2. Stopeck AT, Lipton A, Body JJ, et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010;28:5132-39.
3. Fizazi K, Carducci MA, Smith MR, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011;377(9768):813-22.
4. Henry DH, Costa L, Goldwasser F, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011;29(9):1125-32.
5. Lipton A, Fizazi K, Stopeck AT, Henry DH, et al. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials. Eur J Cancer. 2012;48(16):3082-92.
6. Hu MI, Glezerman IG, Leboulleux S, et al. Denosumab for treatment of hypercalcemia of malignancy. J Clin Endocinol Metab. 2014;99(9):3144-52.
7. Stewart AF. Hypercalcemia associated with cancer. N Engl J Med. 2005; 352(4):379-9.
8. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Bone Cancer v1.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/bone.pdf. Accessed June 9, 2021.
9. National Comprehensive Cancer (NCCN) Drugs & Biologics Compendium [internet database]. Updated periodically. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed May 2, 2022.

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End Notes

1. Xgeva should be continued until disease progression in responding patients. [8]
2. Median time on the study for the treatment of hypercalcemia of malignancy was 56 days. [6]

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Revision History

• 2024-09-12: No changes to criteria. Added operational note.
• 2024-06-28: 2024 UM Annual Review. No criteria changes
• 2023-06-23: 2023 UM Annual Review. Removal of specialist requirement.
• 2022-07-06: 2022 Annual Review - No changes to criteria
• 2022-05-23: Clarified that ST is through IV bisphosphonate for multiple myeloma. Added example of contraindication (renal insufficiency). For hypercalcemia of malignancy, removed reference to brand Zometa and Aredia as drugs are no longer available.
• 2021-07-24: Updated references section.
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2020-07-01: Added embedded step requirement for multiple myeloma indication.
• 2020-06-28: Updated references.
• 2019-07-15: Copy of GL-50128 but created GL-50653 to account for minor update to PI reference (no changes to clinical criteria were made). Task notes from GL-50128 still apply: "2019 Annual Review - background updates; no changes to clinical criteria; Approved at 2019 June P&T for eff 8/1/2019; Removed 7 Cedars/Jamestown/Innoviant from benefit coverage per 2019 AR Training PPT slides"; Disregard GL-50128.

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