WHA

Prolia (denosumab)

Indications for Prior Authorization

Prolia (denosumab)
  • For diagnosis of Treatment of postmenopausal women with osteoporosis at high risk for fracture
    Indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, nonvertebral, and hip fractures.

  • For diagnosis of Treatment to increase bone mass in men with osteoporosis at high risk for fracture
    Indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

  • For diagnosis of Treatment of bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer [A]
    Indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia also reduced the incidence of vertebral fractures.

    NOTE: The use of Prolia for the treatment of bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer should not be confused with the use of Xgeva (another injectable formulation of denosumab) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors (including breast cancer and prostate cancer).

  • For diagnosis of Treatment of bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer [B]
    Indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

    NOTE: The use of Prolia for the treatment of bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer should not be confused with the use of Xgeva (another injectable formulation of denosumab) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors (including breast cancer and prostate cancer).

  • For diagnosis of Treatment of Glucocorticoid-Induced Osteoporosis
    Indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Criteria

Prolia

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

Prior Authorization (Initial Authorization)

Length of Approval: 12 months [D]
For diagnosis of Bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer

  • Diagnosis of nonmetastatic prostate cancer
    • AND
  • Patient is undergoing androgen deprivation therapy with one of the following: [11,A]
    • Luteinizing hormone-releasing hormone (LHRH)/gonadotropin releasing hormone (GnRH) agonist [e.g., Eligard/Lupron (leuprolide), Trelstar (triptorelin), Vantas (histrelin), and Zoladex (goserelin)]
      • OR
    • Bilateral orchiectomy (i.e., surgical castration)
    AND
  • One of the following:
    • Age greater than or equal to 70 years [11,C]
      • OR
    • Both of the following:
      • Age less than 70 years [11]
        • AND
      • One of the following:
        • Bone mineral density (BMD) scan T-score less than -1.0 (1.0 standard deviation or greater below the mean for young adults) [11]
          • OR
        • History of one of the following resulting from minimal trauma: [9,11]
          • Vertebral compression fracture
          • Fracture of the hip
          • Fracture of the distal radius
          • Fracture of the pelvis
          • Fracture of the proximal humerus
    AND
  • Trial and failure, intolerance, or contraindication to one bisphosphonate (e.g., zoledronic acid) [19]
Prolia

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

Prior Authorization (Reauthorization)

Length of Approval: 12 months [D]
For diagnosis of Bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer

  • Patient is undergoing androgen deprivation therapy with one of the following: [11,A]
    • Luteinizing hormone-releasing hormone (LHRH)/gonadotropin releasing hormone (GnRH) agonist [e.g., Eligard/Lupron (leuprolide), Trelstar (triptorelin), Vantas (histrelin), and Zoladex (goserelin)]
      • OR
    • Bilateral orchiectomy (i.e., surgical castration)
    AND
  • No evidence of metastases
    • AND
  • Patient demonstrates positive clinical response to therapy (e.g., improved or stabilized BMD, no new fractures, improved biochemical markers, etc.)
Prolia

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

Prior Authorization (Initial Authorization)

Length of Approval: 12 months [D]
For diagnosis of Bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer

  • Diagnosis of breast cancer
    • AND
  • Patient is receiving adjuvant aromatase inhibitor therapy (e.g., Arimidex [anastrozole], Aromasin [exemestane], Femara [letrozole]) [12,B]
    • AND
  • One of the following:
    • Bone mineral density (BMD) scan T-score less than -1.0 (1.0 standard deviation or greater below the mean for young adults) [12,E]
      • OR
    • History of one of the following resulting from minimal trauma: [9]
      • Vertebral compression fracture
      • Fracture of the hip
      • Fracture of the distal radius
      • Fracture of the pelvis
      • Fracture of the proximal humerus
    AND
  • Trial and failure, intolerance, or contraindication to one bisphosphonate (e.g., alendronate) [20]
Prolia

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

Prior Authorization (Reauthorization)

Length of Approval: 12 months [D]
For diagnosis of Bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer

  • Patient is receiving adjuvant aromatase inhibitor therapy (e.g., Arimidex [anastrozole], Aromasin [exemestane], Femara [letrozole]) [12]
    • AND
  • Patient demonstrates positive clinical response to therapy (e.g., improved or stabilized BMD, no new fractures, improved biochemical markers, etc.)
Prolia

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

Prior Authorization (Initial Authorization)

Length of Approval: 24 Month(s)
For diagnosis of Postmenopausal women with osteoporosis or osteopenia at a high risk for fracture

  • Diagnosis of postmenopausal osteoporosis or osteopenia [2,5]
    • AND
  • One of the following: [5,17]
    • Bone mineral density (BMD) scan indicative of osteoporosis: T-score less than or equal to -2.5 in the lumbar spine, femoral neck, total hip, or radius (one-third radius site)
      • OR
    • Both of the following:
      • BMD scan indicative of osteopenia: T-score between -1.0 and -2.5 (BMD T-score greater than -2.5 and less than or equal to -1.0) in the lumbar spine, femoral neck, total hip, or radius (one-third radius site)
        • AND
      • One of the following FRAX (Fracture Risk Assessment Tool) 10-year probabilities:
        • Major osteoporotic fracture at 20% or more in the U.S., or the country-specific threshold in other countries or regions
        • Hip fracture at 3% or more in the U.S., or the country-specific threshold in other countries or regions
      OR
    • History of one of the following resulting from minimal trauma:
      • Vertebral compression fracture
      • Fracture of the hip
      • Fracture of the distal radius
      • Fracture of the pelvis
      • Fracture of the proximal humerus
    AND
  • Trial and failure, intolerance, or contraindication to one bisphosphonate (e.g., alendronate)
Prolia

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

Prior Authorization (Reauthorization)

Length of Approval: 24 Month(s)
For diagnosis of Postmenopausal women with osteoporosis or osteopenia at a high risk for fracture

  • Patient demonstrates positive clinical response to therapy (e.g., improved or stabilized BMD, no new fractures, improved biochemical markers, etc.) without significant adverse effects
Prolia

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

Prior Authorization (Initial Authorization)

Length of Approval: 24 Month(s)
For diagnosis of Increase bone mass in men at high risk for fracture

  • Patient is a male with osteoporosis or osteopenia
    • AND
  • One of the following: [16,17]
    • Bone mineral density (BMD) scan indicative of osteoporosis: T-score less than or equal to -2.5 in the lumbar spine, femoral neck, total hip, or radius (one-third radius site)
      • OR
    • Both of the following:
      • BMD scan indicative of osteopenia: T-score between -1.0 and -2.5 (BMD T-score greater than -2.5 and less than or equal to -1.0) in the lumbar spine, femoral neck, total hip, or radius (one-third radius site)
        • AND
      • One of the following FRAX (Fracture Risk Assessment Tool) 10-year probabilities:
        • Major osteoporotic fracture at 20% or more in the U.S., or the country-specific threshold in other countries or regions
        • Hip fracture at 3% or more in the U.S., or the country-specific threshold in other countries or regions
      OR
    • History of one of the following resulting from minimal trauma:
      • Vertebral compression fracture
      • Fracture of the hip
      • Fracture of the distal radius
      • Fracture of the pelvis
      • Fracture of the proximal humerus
    AND
  • Trial and failure, intolerance, or contraindication to one bisphosphonate (e.g., alendronate)
Prolia

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

Prior Authorization (Reauthorization)

Length of Approval: 24 Month(s)
For diagnosis of Increase bone mass in men at high risk for fracture

  • Patient demonstrates positive clinical response to therapy (e.g., improved or stabilized BMD, no new fractures, improved biochemical markers, etc.) without significant adverse effects
Prolia

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

Prior Authorization (Initial Authorization)

Length of Approval: 24 Month(s)
For diagnosis of Glucocorticoid-induced osteoporosis at high risk for fracture

  • Diagnosis of glucocorticoid-induced osteoporosis
    • AND
  • Patient is initiating or continuing on greater than or equal to 7.5 mg/day of prednisone (or its equivalent) and is expected to remain on glucocorticoid therapy for at least 6 months
    • AND
  • One of the following: [F]
    • BMD T-score less than or equal to -2.5 based on BMD measurements from lumbar spine, femoral neck, total hip, or radius (one-third radius site)
      • OR
    • One of the following FRAX (Fracture Risk Assessment Tool) 10-year probabilities:
      • Major osteoporotic fracture at 20% or more in the U.S., or the country-specific threshold in other countries or regions
      • Hip fracture at 3% or more in the U.S., or the country-specific threshold in other countries or regions
      OR
    • History of one of the following fractures resulting from minimal trauma:
      • Vertebral compression fracture
      • Fracture of the hip
      • Fracture of the distal radius
      • Fracture of the pelvis
      • Fracture of the proximal humerus
      OR
    • One of the following:
      • Glucocorticoid dosing of at least 30 mg per day
      • Cumulative glucocorticoid dosing of at least 5 grams per year
    AND
  • Trial and failure, contraindication, or intolerance to one bisphosphonate (e.g., alendronate) [G]
Prolia

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

Prior Authorization (Reauthorization)

Length of Approval: 24 Month(s)
For diagnosis of Glucocorticoid-induced osteoporosis at high risk for fracture

  • Patient demonstrates positive clinical response to therapy (e.g., improved or stabilized BMD, no new fractures, improved biochemical markers, etc.) without significant adverse effects

  • Guideline ID
    GL-154925

  • Formulary
    EHB

  • Effective date
    Nov 1, 2024

  • P&T approval date
    Aug 17, 2010

P & T Revisions

2024-09-13, 2024-07-10, 2023-08-01, 2022-08-04, 2021-09-10, 2021-05-21, 2020-07-25, 2020-07-01

  1. Prolia prescribing information. Amgen Inc. Thousand Oaks, CA. March 2024.
  2. Cummings SR, Martin JS, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. NEJM. 2009;361:756-765.
  3. The Bone Health and Osteoporosis Foundation (BHOF). Clinician's guide to prevention and treatment of osteoporosis. Washington (DC): The Bone Health and Osteoporosis Foundation (BHOF); 2022
  4. North American Menopause Society. Management of postmenopausal osteoporosis in postmenopausal women: 2010 position statement of the North American Menopause Society. Menopause 2010;17(1):25-54.
  5. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2020 update. Available at: https://pro.aace.com/disease-state-resources/bone-and-parathyroid/clinical-practice-guidelines/clinical-practice. Accessed July 9, 2021.
  6. Qaseem A, Snow V, Shekelle P, et al. Pharmacologic treatment of low bone density or osteoporosis to prevent fractures: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2008;149:404-415.
  7. Watts NB, Bilezikian JP, Camacho PM, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocr Pract. 2010;16 Suppl 3:1-37.
  8. Reid DM, Doughty J, Eastell R, et al. Guidance for the management of breast cancer treatment-induced bone loss: a consensus position statement from a UK Expert Group. Cancer Treat Rev. 2008;34 Suppl 1:S3-S18.
  9. Body JJ, Bergmann P, Boonen S, et al. Management of cancer treatment-induced bone loss in early breast cancer and prostate cancer – a consensus paper of the Belgian Bone Club. Osteoporos Int. 2007;18:1439-1450.
  10. Hillner BE, Ingle JN, Chlebowski RT, et al. American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer. J Clin Oncol. 2003;21:4042-4057.
  11. Smith MR, Egerdie B, Toriz NH, et al. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N Engl J Med. 2009;361:745-755.
  12. Ellis GK, Bone HG, Chlebowski R, et al. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol. 2008 Oct 20. 26:2875-4882.
  13. National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed July 20, 2020.
  14. Saylor PJ, Kaufman DS, Michaelson MD, Lee RJ, Smith MR. Application of a fracture risk algorithm to men treated with androgen deprivation therapy for prostate cancer. J Urol. 2010;183:2200-2205.
  15. Per clinical consult with oncologist. December 19, 2011.
  16. Watts NB, Adler RA, Bilezikian JP, et al. Endocrine Society. Osteoporosis in men: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(6):1802-22.
  17. Per clinical consultation with endocrinologist. January 30, 2018.
  18. American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis: 2022 edition. Available at: https://rheumatology.org/glucocorticoid-induced-osteoporosis-guideline. Accessed July 2023.
  19. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Prostate Cancer v.2.2020. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed June 18, 2020.
  20. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Breast Cancer v.4.2020. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed June 18, 2020.
  1. Androgen deprivation therapy (ADT) is commonly used in the treatment of prostate cancer. ADT can be accomplished using luteinizing hormone-releasing hormone (LHRH) agonists (medical castration), also known as gonadotropin releasing hormone (GnRH) agonists, or bilateral orchiectomy (surgical castration), which are equally effective. [13] Examples of LHRH agonists include Eligard/Lupron (leuprolide), Trelstar (triptorelin), Vantas (histrelin), and Zoladex (goserelin).
  2. Aromatase inhibitors (AIs) include selective, nonsteroidal AIs (Arimidex [anastrozole] and Femara [letrozole]) and steroidal AIs (Aromasin [exemestane]).
  3. Meta-analyses have shown that advancing age increases fracture risk beyond that predicted by age related loss of BMD. Although typical changes in BMD would predict a 4-fold increase in fracture risk from ages 50 to 90 years, fracture risk actually increases 30-fold. Estimated fracture rates using FRAX calculations reflect a strong influence of older age on risk for clinical fracture. When clinical factors were used without BMD in one cross-sectional study, FRAX estimated that 76.6% of men in their 70s and virtually all men 80 years old or older exceeded the NOF recommended risk threshold for drug therapy. [14]
  4. Most men run a 2-year course of androgen deprivation therapy while most women receive treatment with aromatase inhibitors for about 5 years. A one year treatment authorization is reasonable. [15]
  5. Owing to the rate of bone loss associated with breast cancer treatments (i.e., aromatase inhibitors), and uncertainties about the interaction between aromatase inhibitor use and BMD for fracture risk, the threshold for intervention has been set at a higher level than that generally recommended for postmenopausal osteoporosis. [8]
  6. According to the American College of Rheumatology (ACR) guidelines for the prevention and treatment of glucocorticoid-induced osteoperosis, patients considered at high risk of fractures are as follows: (a) prior osteoporotic fracture, (b) a hip or spine BMD T-score less than or equal to -2.5, or (c) FRAX 10-year risk of hip or major osteoporotic fracture at 3 percent or more and 20 percent or more, respectively. [18]
  7. According to ACR, oral bisphosphonates are considered first-line for patients with glucocorticod-induced osteoperosis at high risk for fractures. For patients in whom oral bisphosphonates are not appropriate, IV bisphosphonates should be considered. [18]
  • 2024-09-13: No changes to criteria. Added operational note.
  • 2024-07-10: 2024 UM Annual Review. Updated reauth language to standard verbiage of "Patient demonstrates positive clinical response to therapy". Background updates
  • 2023-08-01: Updated criteria for Glucocorticoid Induced Osteoporosis to align with 2022 update from ACR to include GC dosing of at least 30 mg or cumulative GC dose of at least 5 grams per year for high risk stratification of patients. Updated references
  • 2022-08-04: 2022 Annual Review - No changes to criteria, updated background information
  • 2021-09-10: Updated references section.
  • 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
  • 2020-07-25: Updated references.
  • 2020-07-01: Added embedded step requirement for bone loss in men receiving ADT for nonmetastatic prostate cancer indication.

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