Is romosozumab-aqqg (Evenity) injection and comprehensive metabolic panel medically necessary for a patient with other osteoporosis without a current pathological fracture?

Medical Necessity Determination: Romosozumab (Evenity) for M81.8 Osteoporosis

Direct Answer

This request for romosozumab (Evenity) should be NON-CERTIFIED due to insufficient documentation of critical eligibility criteria, specifically the absence of documented T-score, fracture history, prior treatment failures, and cardiovascular risk assessment. 1

Critical Missing Documentation

The case lacks essential information required by both FDA labeling and clinical practice guidelines:

• No documented T-score or bone mineral density (BMD) values - Romosozumab is FDA-approved specifically for postmenopausal women with osteoporosis at high risk for fracture, which requires documented BMD T-score ≤ -2.5 at the total hip or femoral neck 1

• No documented fragility fracture history - The diagnosis code M81.8 explicitly states "without current pathological fracture," but there is no documentation regarding any history of prior fragility fractures 1

• No documented prior treatment failures or contraindications - The case history shows previous non-certifications specifically requesting information about "prior treatment history," which remains undocumented 1

• No cardiovascular risk assessment - The FDA black box warning requires evaluation for myocardial infarction or stroke history, especially within the past year, which is not documented 1

FDA-Approved Indications Not Met

Romosozumab carries a boxed warning for increased risk of myocardial infarction, stroke, and cardiovascular death and is FDA-approved only for: 1

• Postmenopausal women with osteoporosis at high risk for fracture, defined as:
  • History of osteoporotic fracture, OR
  • Multiple risk factors for fracture, OR
  • Patients who have failed or are intolerant to other available osteoporosis therapy 1

None of these criteria are documented in the provided clinical information.

Guideline-Based Requirements

The American College of Physicians (2023) provides conditional recommendations for romosozumab only in postmenopausal females with osteoporosis at very high risk for fracture (mean age >74 years in trials), specifically: 2

• T-score ≤ -2.5 documented
• Very high fracture risk defined by trial enrollment criteria
• After consideration of cardiovascular contraindications 2

The American College of Rheumatology (2023) conditionally recommends against romosozumab in moderate-risk patients due to cardiovascular risks (myocardial infarction, stroke, or death), reserving it only for those unable to tolerate other agents 2, 3

Treatment Duration Concerns

The case history indicates previous Evenity administration (MR #8272630 certified for DOS 05/18/2024), but there is no documentation of the total number of doses received: 1

• FDA labeling limits romosozumab to 12 monthly doses maximum because the anabolic effect wanes after 12 months 1
• The current DOS (03/23/2025) is approximately 10 months after the previous certified dose
• Without documentation of total doses received, it cannot be determined if the patient has exceeded the 12-dose limit 1

Required Sequential Therapy Not Addressed

Romosozumab requires mandatory sequential anti-resorptive therapy (bisphosphonate or denosumab) after completion to maintain BMD gains: 2, 1

• BMD returns to approximately baseline within 12 months without follow-on therapy 1
• No documentation exists regarding plans for sequential therapy 1

Ancillary Services Assessment

Comprehensive Metabolic Panel (80053) and Venous Blood Collection (36415):

• MEDICALLY NECESSARY - These are appropriate for monitoring calcium levels, as romosozumab requires correction of hypocalcemia prior to each dose and adequate calcium/vitamin D supplementation 1
• The patient is documented taking calcium citrate 250 mg BID and ergocalciferol 50,000 units weekly, meeting supplementation requirements 1

Injection Administration (96372, J3111):

• CANNOT BE CERTIFIED without meeting primary drug indication criteria 1

Specific Documentation Required for Approval

To meet medical necessity criteria, the following must be documented:

1. Current BMD T-score ≤ -2.5 at total hip or femoral neck 1
2. Fragility fracture history (low-trauma fractures from standing height or less) 1
3. Prior osteoporosis treatment history including:
   • Specific medications tried (oral bisphosphonates, injectable therapies)
   • Duration of each treatment (minimum 1 year for oral bisphosphonates)
   • Reason for discontinuation or failure 2
4. Cardiovascular history specifically excluding myocardial infarction or stroke within the past year 1
5. Total number of previous romosozumab doses to ensure <12 doses total 1
6. Plan for sequential anti-resorptive therapy after romosozumab completion 2, 1

Common Pitfalls to Avoid

• Do not approve based on diagnosis code alone - M81.8 is insufficient without documented T-scores and fracture risk stratification 1
• Do not overlook cardiovascular contraindications - The black box warning is based on increased cardiovascular events versus alendronate (hazard ratio 1.9) 2, 1
• Do not exceed 12-dose limit - Efficacy data only supports 12 monthly doses 1
• Do not approve without sequential therapy planning - Gains are lost without follow-on bisphosphonate or denosumab 2, 1