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Coverage criteria policies

Denosumab (Prolia®, Xgeva®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Denosumab requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

Coverage for denosumab is subject to the indications listed below, and per your plan documents.

Prolia is generally covered:

  • When used for patients with osteoporosis at high risk of fracture (T-score </= -2.5 at either the lumbar spine or the total hip) and an inadequate response, intolerance or contraindication to oral bisphosphonates; OR,
  • When used to increase bone mass in women at high risk of fracture (T-score </= -2.5 at either the lumbar spine or the total hip; OR history of fracture) receiving adjuvant aromatase inhibitor therapy for breast cancer and who have had an inadequate response, intolerance or contraindication to a bisphosphonate; OR
  • When used to increase bone mass in men at high risk of fracture (>70 years of age or </= 70 years of age with T-score < -1.0 at either the lumbar spine or the total hip; OR history of fracture) receiving androgen deprivation therapy for nonmetastatic prostate cancer and who have had an inadequate response, intolerance or contraindication to a bisphosphonate; OR

Xgeva is generally covered:

  • When used for prevention of skeletal-related events in patients with bone metastases from solid tumors and who have had an inadequate response, intolerance or contraindication to IV bisphosphonates including renal insufficiency (defined as creatinine clearance < 60 mL/min).
  • When used in 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.
  • When used in the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

An inadequate response to bisphosphonate therapy is defined as a new fracture in members on therapy for at least six months or significant loss of bone mineral density on follow-up scans after 12 to 24 months of therapy.

Definitions

Osteoporosis is a disease in which the bones become weak and are more likely to break.

Skeletal-related events (SREs) in patients with cancer may include bone fractures, radiation to bone, surgery to bone and spinal cord compression. Cancer patients may experience SREs due to metastases to bone or to decreased bone mineral density which can be a side effect of drugs used to treat cancers.

Prolia (denosumab) is FDA-approved for:

  • Treatment of postmenopausal women with osteoporosis at high risk for fracture.
  • Treatment to increase bone mass in men with osteoporosis at high risk for fracture
  • Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Prolia is a subcutaneous injection administered by a healthcare professional. The approved regimen is 60mg every six months.

Xgeva (denosumab) is FDA-approved for:

  • Prevention of skeletal-related events in patients with bone metastases from solid tumors. The approved regimen is 120 mg every 4 weeks.
  • 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. The approved regimen is 120 mg every 4 weeks with an additional 120 mg doses on Days 8 and 15 of the first month of therapy.
  • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. The approved regimen is 120 mg every 4 weeks with an additional 120 mg doses on Days 8 and 15 of the first month of therapy.

It is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

The National Cancer Centers Network (NCCN) guidelines recommend the use of either denosumab or an IV bisphosphonate in breast, prostate, NSCLC and other solid tumors.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPCS Code

Codes

Description

J0897

Injection, denosumab, 1 mg

NDC Codes

Codes

Description

55513071001

60mg/1mL in a single-use prefilled syringe

55513073001

120 mg/1.7 mL in a single-use vial

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Prolia prescribing information. Amgen Inc. August 2016.
  2. Xgeva prescribing information. Amgen Inc. March 2016.
  3. Cummings SR, San Martin J, McClung MR, et.al., Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis. N Eng J Med 2009;361:756-765.
  4. Brown JP, Prince RL, Deal C, et.al., Comparison of the Effect of Denosumab and Alendronate on BMD and Biochemical Markers of Bone Turnover in Postmenopausal Women with Low Bone Mass: A Randomized, Blinded, Phase 3 Trial. J Bone Miner Res 2009;24:153-161.
  5. Kendler DL, Roux C, Benhamou CL, et.al., Effects of Denosumab on Bone Mineral Density and boneTurnover in Postmenopausal Women Transitioning from Alendronate Therapy. J Bone Miner Res 2010;25(1):72-81.
  6. Smith MR, Egerdie B, Toriz NH, et.al., Denosumab in Men Receiving Anderogen-Deprivation Therapy for Prostate Cancer. N Eng J Med 2009;361:745-755.
  7. National Comprehensive Cancer Network Guidelines for Breast Cancer
  8. VanPoznak C, Temin S, Yee G, et al. American Society of Clinical Oncology Clinical Practice Guideline Update on the Role of Bone-Modifying Agents in Metastatic Breast Cancer. J Clin Oncology March 20, 2011:1221-1227.
  9. Stopeck AT, Lipton A, Body J, 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 28:5132:5139.
  10. Smith MR, Saad F, Coleman R, et al., Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet 2012 Jan 7;379(9810):39-46.
  11. 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 29(9):1125-32.
  12. Scagliotti GV, Hirsh V, Siena S, et al., Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study. J Thorac Oncol. 2012 Dec;7 (1):1823-9.

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Policy activity

  • 09/21/2010 - Date of origin
  • 01/01/2011 - Effective date
Review date
  • 11/2016

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