What are the general requirements for insurance companies to cover the Prolia (denosumab) shot for osteoporosis treatment?

General Requirements for Insurance Coverage of Prolia (Denosumab) Shot

Most insurance companies require documentation of high fracture risk and/or failure of first-line therapies before covering Prolia (denosumab) for osteoporosis treatment. 1, 2

Patient Eligibility Criteria

High-Risk Patient Categories

Insurance coverage typically requires patients to meet one or more of these criteria:

• Postmenopausal women with osteoporosis at high risk for fracture, defined as:

  • History of osteoporotic fracture
  • Multiple risk factors for fracture
  • T-score ≤ -2.5 (or lower, depending on insurer)
  • Failure of or intolerance to other osteoporosis therapies 2

• Men with osteoporosis at high risk for fracture with:

  • History of osteoporotic fracture
  • Multiple risk factors for fracture
  • Failure of or intolerance to other osteoporosis therapies 2

• Glucocorticoid-induced osteoporosis in men and women who are:

  • Taking ≥7.5 mg prednisone daily (or equivalent)
  • Expected to remain on glucocorticoids for at least 6 months
  • At high risk of fracture 3, 2

• Patients with bone loss due to:

  • Androgen deprivation therapy for prostate cancer
  • Aromatase inhibitor therapy for breast cancer 2

Documentation Requirements

Most insurers require:

1. Bone mineral density (BMD) testing via DXA scan showing osteoporosis (T-score ≤ -2.5 or lower) 1

2. FRAX score calculation showing:

   • ≥20% 10-year risk of major osteoporotic fracture, or
   • ≥3% 10-year risk of hip fracture 1

3. Prior treatment failure documentation:

   • Trial of oral bisphosphonates (typically 12 months)
   • Documentation of inadequate response to bisphosphonates
   • OR documented intolerance/contraindication to bisphosphonates 3, 1

4. For very high-risk patients (T-score ≤ -3.5, prior fracture, or FRAX score ≥30% for major osteoporotic fracture), some insurers may approve Prolia as first-line therapy 1

Common Coverage Limitations

• Prior authorization is almost always required
• Quantity limits typically restrict coverage to one 60mg injection every 6 months
• Step therapy protocols often require trial of oral bisphosphonates first
• Reauthorization requirements may include:
  • Documentation of continued need
  • Evidence of treatment response (stable or improved BMD)
  • Absence of adverse effects 4

Special Considerations

Chronic Kidney Disease

• For patients with advanced kidney disease (eGFR <30 mL/min/1.73m²), additional testing is required:
  • Intact parathyroid hormone (iPTH)
  • Serum calcium
  • Vitamin D levels
  • Assessment for chronic kidney disease-mineral bone disorder (CKD-MBD) 2

Rebound Effect Considerations

• Some insurers may require a plan for transitioning to another therapy after Prolia discontinuation due to the risk of rebound bone loss and multiple vertebral fractures 5

Practical Tips for Approval

• Clearly document all fracture risk factors
• Include T-scores from all measured sites (spine, hip, femoral neck)
• Document specific reasons for bisphosphonate failure or intolerance
• For glucocorticoid users, document exact dosage and expected duration of therapy 3
• Include vertebral fracture assessment (VFA) or spinal x-rays showing any existing fractures 1

Common Pitfalls to Avoid

• Incomplete documentation of prior therapy failures
• Missing laboratory values needed to rule out secondary causes of osteoporosis
• Failure to document contraindications to oral bisphosphonates when requesting first-line approval
• Not addressing the need for calcium and vitamin D supplementation in the treatment plan 1

Remember that specific requirements vary by insurance provider, plan type, and state regulations. Prior authorization forms specific to each insurer should be carefully reviewed before submission.