Why was a postmenopausal woman with osteopenia, excellent bone microarchitecture, and low fracture risk, denied coverage for romosozumab (Evenity) treatment?

Reason for Romosozumab (Evenity) Coverage Denial

The patient was denied coverage for romosozumab because she does not meet FDA-approved indications, which require postmenopausal women with osteoporosis at high risk for fracture—defined as history of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance to other osteoporosis therapy. 1

Specific Deficiencies in Meeting Approval Criteria

Absence of Osteoporosis Diagnosis

• The patient has osteopenia (T-score -2.4 at lumbar spine), not osteoporosis, which requires a T-score of -2.5 or below 2
• The femoral neck T-score of -1.4 further confirms osteopenia rather than osteoporosis 2

Low Fracture Risk Profile

• The patient's FRAX score for major osteoporotic fracture is 4.5%, well below the National Osteoporosis Foundation treatment threshold of 20% 2
• The hip fracture FRAX score is 0.4%, substantially below the 3% treatment threshold 2
• Excellent bone microarchitecture (TBS 1.341 in normal range) indicates preserved bone quality 2

Absence of High-Risk Features

• No documented history of fragility fractures or osteoporotic fractures 2, 3, 1
• No documentation of multiple risk factors for fracture that would qualify as "very high risk" 2, 1
• No prior trial of bisphosphonate therapy or documentation of bisphosphonate failure or intolerance 2, 3

Guideline-Based Treatment Hierarchy Not Followed

• The American College of Physicians recommends bisphosphonates as first-line therapy for osteoporosis with high-certainty evidence 4
• Romosozumab is conditionally recommended only for postmenopausal females with primary osteoporosis at very high risk of fracture (low-certainty evidence) 4, 2
• The patient has not attempted or failed first-line bisphosphonate therapy 2, 3