Is Prolia (denosumab) 60 milligrams per milliliter medically necessary for a patient with age-related osteoporosis (M81.0) and a left femoral neck T-score of -2.7, with a history of smoking and previous fracture?

Medical Necessity Determination for Prolia (Denosumab) in Age-Related Osteoporosis

Prolia (denosumab) 60 mg subcutaneously every 6 months is medically necessary for this patient with age-related osteoporosis (M81.0), a left femoral neck T-score of -2.7, and history of prior fracture, meeting established clinical criteria for treatment. 1

Criteria Met for Medical Necessity

Primary Indication Satisfied

• The patient meets the T-score threshold requirement with a left femoral neck T-score of -2.7 (≤ -2.5), which is the established diagnostic criterion for osteoporosis requiring pharmacologic intervention 1
• The American College of Physicians guidelines support treatment in postmenopausal women with T-scores ≤ -2.5 to reduce vertebral and hip fracture risk 2
• The plan's Clinical Policy Bulletin 0804 explicitly states denosumab is medically necessary for postmenopausal osteoporosis when "patient has a pre-treatment T-score less than or equal to -2.5" [@case documentation@]

Additional High-Risk Features Present

• History of prior fracture significantly elevates fracture risk and strengthens the indication for treatment 3, 4
• Active smoking is a documented risk factor that increases fracture probability 2, 3
• The combination of T-score ≤ -2.5 plus prior fracture places this patient in a high-risk category warranting immediate pharmacologic intervention 2, 4

Dosing and Administration Requirements

Standard Dosing Protocol

• FDA-approved dose is 60 mg subcutaneously every 6 months (J0897 for the medication, 96372 for subcutaneous injection administration) 1
• This dosing regimen has demonstrated 68% reduction in vertebral fractures, 40% reduction in hip fractures, and 20% reduction in nonvertebral fractures over 3 years in the pivotal FREEDOM trial 2, 1

Critical Supplementation Requirement

• Calcium (≥1000 mg daily) and vitamin D (≥400-800 IU daily) supplementation is mandatory to prevent hypocalcemia, a potentially serious adverse effect 2, 1
• The plan's criteria state "All persons should receive calcium 1000 mg daily and at least 400 IU vitamin D daily" [@case documentation@]
• Documentation gap identified: The case summary notes "UNSURE IF MET (No documentation that patient takes calcium/vitamin D daily)" [@case documentation@]

Recommendation for Authorization

Approve with Condition

Authorize Prolia 60 mg subcutaneously every 6 months (J0897 and 96372) for 12 months with the following mandatory requirement:

• Prior to first dose administration, the provider must document that the patient is taking or has been prescribed calcium ≥1000 mg daily and vitamin D ≥400 IU daily 1
• This supplementation must continue throughout the entire treatment course to minimize hypocalcemia risk 2, 1

Not Experimental or Investigational

• Denosumab for postmenopausal osteoporosis with T-score ≤ -2.5 is FDA-approved and supported by Level 1 evidence from multiple randomized controlled trials 1, 5
• The FREEDOM trial and its 10-year extension demonstrate sustained efficacy and acceptable safety profile 2, 5
• This indication is considered standard of care and is not experimental 6

Critical Safety Considerations

Pre-Treatment Assessment Required

• Dental examination is strongly recommended before initiating therapy to assess for dental disease and minimize osteonecrosis of the jaw (ONJ) risk 4, 6
• Baseline serum calcium should be checked and corrected if low before first dose 1, 6

Discontinuation Risk Warning

• Denosumab discontinuation carries significant risk of rebound vertebral fractures due to rapid increase in bone turnover after cessation 7, 6
• If denosumab must be stopped for any reason, immediate transition to bisphosphonate therapy (such as zoledronic acid) within 6 months of last dose is mandatory to prevent rebound bone loss and multiple vertebral fractures 7, 4
• This is a unique characteristic of denosumab not seen with bisphosphonates, which have residual skeletal effects after discontinuation 7

Monitoring During Treatment

• Clinical assessment for adverse effects should occur at each 6-month injection visit 4
• Bone mineral density reassessment is recommended at 1-2 year intervals, though not required before each authorization during the first 5 years of treatment 2, 4
• Patients should be monitored for signs of hypocalcemia, particularly if they have renal impairment 1, 6

Common Pitfalls to Avoid

• Do not approve without confirming calcium/vitamin D supplementation - this is a non-negotiable safety requirement 1
• Do not discontinue denosumab without a transition plan - abrupt cessation significantly increases vertebral fracture risk 7
• Do not overlook dental health assessment - ONJ risk, while rare, requires preventive measures 4, 6
• Do not confuse with glucocorticoid-induced osteoporosis criteria - this patient has age-related osteoporosis, which has different treatment thresholds 2