Medical Necessity Determination for Romosozumab (Evenity)
Yes, romosozumab is medically indicated for this patient based on documented history of multiple fragility fractures (shoulder, knee, right wrist, ankle, and toe), which meets FDA-approved indications and the insurance plan's coverage criteria for high-risk postmenopausal osteoporosis. 1
FDA-Approved Indication Met
The patient clearly satisfies FDA labeling requirements for romosozumab, which is indicated for postmenopausal women with osteoporosis at high risk for fracture, specifically defined as history of osteoporotic fracture or multiple risk factors for fracture 1. The documented history of multiple fragility fractures (shoulder, knee, right wrist, ankle, toe) unequivocally places this patient in the high-risk category 1.
Insurance Criteria Satisfied
The Aetna CPB 0954 criteria are met:
- History of fragility fractures: Documented multiple low-trauma fractures from falls consistent with standing height 1
- Dosing protocol: 210 mg monthly via two 105 mg subcutaneous injections for 12 months 1
- Calcium and Vitamin D supplementation: Patient is taking Vitamin D3 as documented 1
Critical Guideline Considerations
Treatment Appropriateness
The American College of Physicians (2023) indicates romosozumab for postmenopausal females with osteoporosis at very high risk for fracture 2. This patient's multiple documented fragility fractures clearly establish very high fracture risk 3, 4.
Mandatory Cardiovascular Risk Assessment
Critical safety concern: The FDA boxed warning states romosozumab may increase risk of myocardial infarction, stroke, and cardiovascular death 1. Romosozumab should NOT be initiated in patients who have had MI or stroke within the preceding year 1. The clinical documentation does not indicate cardiovascular history assessment, which is mandatory before approval 2, 1.
Treatment Duration Limitation
Romosozumab must be limited to exactly 12 monthly doses because the anabolic effect wanes after 12 months 2, 1. The patient has already received 4 doses (dates provided), leaving 8 remaining doses eligible for coverage 3.
Sequential Therapy Requirement
After completing 12 doses, mandatory transition to anti-resorptive therapy (bisphosphonate or denosumab) is required to maintain bone mineral density gains 3, 1. This should be documented in the treatment plan 3.
CPT Code 96401 (Chemotherapy Administration) Determination
CPT 96401 is NOT appropriate for romosozumab administration. Romosozumab is administered via simple subcutaneous injection by a healthcare provider, not chemotherapy infusion 1. The correct administration code would be a subcutaneous injection code (e.g., 96372), not chemotherapy administration 1. This represents a coding error that should be corrected.
Required Documentation Before Final Approval
The following must be verified or documented:
- Cardiovascular risk assessment: No MI or stroke within past 12 months 1
- Cardiovascular risk factors: Document presence/absence of coronary disease, prior cardiovascular events 2, 1
- Hypocalcemia status: Must be corrected before initiation 1, 5, 6
- Total dose tracking: Confirm patient has received exactly 4 doses with 8 remaining 3, 1
- Sequential therapy plan: Document planned anti-resorptive agent after month 12 3, 1
Common Pitfalls to Avoid
- Do not exceed 12 total monthly doses - the anabolic effect disappears and no additional benefit occurs 2, 1
- Do not use in patients with recent cardiovascular events (within 1 year) - this is an absolute contraindication per FDA boxed warning 1
- Do not discontinue without sequential therapy - bone loss will occur rapidly without transition to anti-resorptive agent 3, 1
- Do not use CPT 96401 - this is subcutaneous injection, not chemotherapy administration 1
Final Recommendation
Approve J3111 (romosozumab injection) for the remaining 8 doses contingent on documentation of cardiovascular risk assessment showing no MI/stroke within past year and no uncorrected hypocalcemia 1. Deny CPT 96401 and request correction to appropriate subcutaneous injection code 1. Require documentation of planned sequential anti-resorptive therapy after dose 12 3, 1.