Description

Romosozumab-aqqg (Evenity™) is a humanized IgG2 monoclonal antibody and sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Romosozumab (Evenity) has a dual effect of increasing bone formation and, to a lesser extent, decreasing bone resorption.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

The use of Romosozumab (Evenity) may be considered medically necessary for use in post-menopausal women when all of the following criteria are met:

• Diagnosis of osteoporosis; and
• Individual is determined to be at high risk for fracture as defined by ONE of the following:
  • Individual has a bone mineral density (BMD) T-score of less than or equal to -2.5; or
  • Individual has a history of previous hip or vertebral fractures; or
  • Individual has ALL of the following:
    • Individual has BMD T-score between -1 and -2.5; and
    • ONE of the following utilizing the Fracture Risk Algorithm (FRAX) calculator:
      • FRAX 10-year risk of major osteoporotic fracture at 20% or more; or
      • FRAX 10-year risk of hip fracture at 3% or more; and
• Individual has experienced therapeutic failure, contraindication, or intolerance to at least one bisphosphonate; and
• Individual is not receiving Romosozumab (Evenity) in combination with ANY of the following:
  • Parathyroid hormone analogs (e.g., Forteo, Tymlos); or
  • RANKL inhibitors (e.g., Prolia, Xgeva); and
• Romosozumab (Evenity) is limited to 12 injections per lifetime.

The use of Romosozumab (Evenity) for any other indication is considered experimental/investigational, and therefore non-covered. Scientific evidence does not support its use for any other indications.

Procedure Codes

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes