Medical Necessity Determination for Romosozumab (Evenity)
Primary Determination
The injection of romosozumab for this 53-year-old postmenopausal woman with age-related osteoporosis was NOT medically necessary for the dates of service 7/17/25 and 8/14/25. This patient does not meet the established criteria for "very high fracture risk" required for romosozumab approval, and bisphosphonates remain the appropriate first-line therapy with the strongest evidence base 1, 2.
Critical Deficiencies in Meeting Approval Criteria
This patient fails to meet the FDA-approved indication for romosozumab, which requires postmenopausal women 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 3.
Specific Criteria Not Met:
No history of fragility fractures: The patient has no documented osteoporotic fractures—only a childhood ankle fracture that healed with casting 1, 2
Age does not meet "very high risk" threshold: At 53 years old, this patient is significantly younger than the clinical trial populations (mean age >74 years) that established romosozumab efficacy 1, 4
FRAX scores do not indicate very high risk: With 2.8% hip fracture risk and 17% major osteoporotic fracture risk, these scores fall well below thresholds typically requiring anabolic therapy 1
Inadequate bisphosphonate trial: Only 1 year of oral bisphosphonate therapy was completed, and BMD comparison cannot be accurately assessed because DEXA scans were performed at different facilities, making direct comparison unreliable 2
No documented bisphosphonate failure or intolerance: The patient "tolerates this well" per documentation, with no evidence of true treatment failure 1, 2
Guideline-Based Treatment Algorithm
The American College of Physicians strongly recommends bisphosphonates as first-line therapy for postmenopausal osteoporosis, with high-certainty evidence for fracture reduction 1, 2. Romosozumab should be reserved only for postmenopausal women with very high fracture risk, which is a conditional recommendation based on low-certainty evidence 1, 4.
Appropriate First-Line Management:
Continue oral bisphosphonate therapy for minimum 3-5 years with adequate calcium (1200 mg daily) and vitamin D (1000 units daily) supplementation 1, 2
Obtain repeat DEXA scan at the same facility in 2 years to accurately assess bisphosphonate response, as comparing scans from different facilities is unreliable 2
Assess adherence and tolerability at 6-month intervals to ensure optimal bisphosphonate therapy 2
Critical Safety Concerns with Romosozumab
Romosozumab carries an FDA black box warning for potential risk of myocardial infarction, stroke, and cardiovascular death 3. This is particularly concerning given:
Increased cardiovascular events compared to alendronate: Hazard ratio 1.9 (95% CI 1.1-3.1), with 2.5% risk with romosozumab versus 1.9% with alendronate 1, 3, 5
Contraindication in recent cardiovascular events: Romosozumab should not be initiated in patients who have had myocardial infarction or stroke within the preceding year 3
The American College of Rheumatology conditionally recommends against using romosozumab due to cardiovascular risks except in patients intolerant of other agents 1
Cost-Effectiveness Considerations
Romosozumab costs approximately $5,574 annually compared to $39-$2,700 for bisphosphonates 1, 2
No cost-effectiveness analyses support romosozumab as first-line therapy in patients without very high fracture risk 1, 2
Only an estimated 10% of females over 50 years in the U.S. population qualify as "very high risk" by clinical trial definitions 1
When Romosozumab Would Be Appropriate
Romosozumab could be reconsidered for this patient only if she develops any of the following 2:
- Sustains a fragility fracture while on adequate bisphosphonate therapy
- Develops multiple vertebral fractures
- Experiences hip fracture
- Shows continued BMD decline on bisphosphonates (documented at same facility)
- Develops documented bisphosphonate intolerance or contraindication
- Reaches age >65-70 years with persistent high fracture risk features
Sequential Therapy Requirements
If romosozumab were ever appropriate, the FDA label mandates that treatment duration be limited to 12 monthly doses, followed by transition to an anti-resorptive agent 3. The anabolic effect wanes after 12 months, and continued therapy with bisphosphonates or denosumab is required to maintain bone density gains 4, 3.
Common Pitfalls to Avoid
Do not compare DEXA scans from different facilities as technical differences make accurate BMD change assessment impossible 2
Do not escalate to anabolic therapy after only 1 year of bisphosphonate use without documented treatment failure or intolerance 1, 2
Do not use T-scores alone to justify romosozumab without additional very high-risk features such as fragility fractures, advanced age, or multiple risk factors 1, 4, 3
Ensure calcium and vitamin D are adequately supplemented before considering any osteoporosis therapy inadequate 1, 2, 3