Denosumab (Prolia® , Xgeva® )

• Denosumab (Prolia® ) subcutaneous injection for administration by a healthcare professional 
• Denosumab (Xgeva® ) subcutaneous injection for administration by a healthcare professional 

• Denosumab (Prolia® ) 
  • 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 of glucocorticoid-induced osteoporosis in men and women 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
• Denosumab (Xgeva® ) 
  • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors 
  • 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 
  • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The request is for Prolia (denosumab); AND
   1. The patient is 18 years of age or older; AND 
   2. The patient has a diagnosis of osteoporosis; AND 
      1. ONE of the following:
         1. The patient is a male over 50 years old; OR
         2. The patient is a postmenopausal female; AND
      2. The patient is at high risk for fracture defined by one of the following:
         1. History of osteoporotic fracture; OR
         2. Multiple risk factors for fracture; AND
      3. The patient has previously been treated with a bisphosphonate and experienced a therapeutic failure or inadequate response; OR
      4. The patient is unable to receive a bisphosphonate due to a contraindication/hypersensitivity; OR 
   3. The patient has a diagnosis of breast cancer; AND
      1. The patient is currently receiving aromatase inhibitor therapy (e.g., anastrozole, letrozole, exemestane) for breast cancer; AND
      2. The patient has previously been treated with a bisphosphonate and experienced a therapeutic failure or inadequate response; OR
      3. The patient is unable to receive a bisphosphonate due to a contraindication/hypersensitivity; OR
   4. The patient has a diagnosis of nonmetastatic prostate cancer; AND
      1. The patient is currently receiving androgen deprivation therapy; AND
      2. The patient has previously been treated with a bisphosphonate and experienced a therapeutic failure or inadequate response; OR
      3. The patient is unable to receive a bisphosphonate due to a contraindication/hypersensitivity; OR
   5. The patient has been diagnosed with glucocorticoid-induced osteoporosis at high risk for fracture defined by one of the following:
      1. History of osteoporotic fracture; OR
      2. Multiple risk factors for fracture; AND
      3. The patient is initiating or continuing systemic glucocorticoids in a daily dosage equal to 7.5 mg or greater of prednisone and expected to remain on therapy for at least 6 months; AND
      4. The patient has previously been treated with a bisphosphonate and experienced a therapeutic failure or inadequate response; OR
      5. The patient is unable to receive a bisphosphonate due to a contraindication/hypersensitivity; OR
2. The request is for Xgeva (denosumab); AND
   1. The patient has a diagnosis of multiple myeloma; AND
      1. The requested agent will be used for prevention of skeletal-related events; OR
   2. The patient has a solid tumor with bone metastases; AND
      1. The requested agent will be used for prevention of skeletal-related events; OR 
   3. The patient is an adult or skeletally mature adolescent diagnosed with giant cell tumor of bone; AND
      1. The tumor is recurrent; OR
      2. The tumor is unresectable; OR
      3. Surgical resection is likely to result in severe morbidity; OR
   4. The patient is using the requested agent for treatment of hypercalcemia of malignancy; AND
      1. The patient has had prior treatment with an intravenous bisphosphonate and experienced a therapeutic failure or inadequate response; OR
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to intravenous bisphosphonate therapy; AND
3. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).

Duration of Approval: 365 days (1 year)

NOTE:

Use of Denosumab may be considered medically necessary for clinical indications not listed above when the drug is prescribed for the treatment of cancer either: 

1. In accordance with FDA label (when clinical benefit has been established, and it is not determined to be investigational as defined in the Blue Cross NC Corporate Medical Policy (CMP), “Investigational (Experimental) Services.” [please refer to CMP “Investigational (Experimental) Services” for a summary of evidence standards from nationally recognized compendia]; OR 
2. In accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached.

Other applicable codes may include:

ICD-10 Codes: C00.0-C49.9, C4A.0-C4A.9, C50.011-C79.9, C7A.00-C7A.8, C7B.00-C7B.8, C80.0- C86.6, C88.2-C96.Z, D00.00-D09.9, M81.0, M81.8, T50.905, Z51.11, Z51.12, Z79.811, Z87.311 For oncology use, the cancer diagnosis code must also be included when the following codes are used: M81.0, M81.8, T50.905, Z79.811, Z87.311

All information referenced is from FDA package insert unless otherwise noted below.

1. Ellis GK, Bone HG, Chlebowski R, et al. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. 2008 Oct;26:4875-4882. 
2. McClung MR, Lewiecki EM, Cohen SB, et al. Denosumab in postmenopausal women with low bone mineral density. N Engl J Med. 2006; 354:821-831. 
3. North American Menopause Society (NAMS). Management of osteoporosis in postmenopausal women: 2010 position statement of The North American Menopause Society. Menopause. 2010:17(1):25-54.

June 2021: Criteria change: Added trial and failure or contraindication/hypersensitivity to a bisphosphonate for patients with breast cancer or prostate cancer at high risk for fracture; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.