Evenity (romosozumab-aqqg)

Indications for Prior Authorization

Evenity (romosozumab-aqqg)
  • For diagnosis of Postmenopausal women with osteoporosis at high risk of fracture
    Indicated for the treatment of osteoporosis in 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.

    Limitations of Use: The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered.

Criteria

Evenity

Prior Authorization

Length of Approval: 12 Months [A]*

  • Diagnosis of postmenopausal osteoporosis
  • AND
  • One of the following:
    • History of a low-trauma (fragility) fracture of a major osteoporotic site (e.g., hip, spine, proximal humerus, pelvis, or distal forearm)
    • OR
    • Bone mineral density (BMD) T-score of -3.0 or lower in the lumbar spine, femoral neck, total hip, or radius (one-third radius site)
    • OR
    • Both of the following:
      • Bone mineral density (BMD) T-score of -2.5 or lower in the lumbar spine, femoral neck, total hip, or radius (one-third radius site) with no history of fracture
      • AND
      • Trial and failure, contraindication, or intolerance to one anti-resorptive treatment (e.g., alendronate, risedronate, zoledronic acid, Prolia [denosumab]) [B]
      OR
    • All of the following:
      • BMD T-score between -1.0 and -2.5 in the lumbar spine, femoral neck, total hip, or radius (one-third radius site)
      • AND
      • One of the following FRAX (Fracture Risk Assessment Tool) 10-year probabilities: [C]
        • Major osteoporotic fracture at 20% or more in the U.S., or the country-specific threshold in other countries or regions
        • Hip fracture at 3% or more in the U.S., or the country-specific threshold in other countries or regions
        AND
      • Trial and failure, contraindication, or intolerance to one anti-resorptive treatment (e.g., alendronate, risedronate, zoledronic acid, Prolia [denosumab]) [B]
    AND
  • Trial of, contraindication, or intolerance to one of the following:
    • Forteo (teriparatide)
    • Tymlos (abaloparatide)
    AND
  • Treatment duration of Evenity (romosozumab-aqqg) has not exceeded a total of 12 months during the patient's lifetime [A]
P & T Revisions

2026-06-18, 2025-12-18, 2025-06-20, 2024-06-20, 2023-05-09, 2021-06-23, 2020-05-29

  1. Evenity Prescribing Information. Amgen Inc. Thousand Oaks, CA. January 2026.
  2. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2020 update. Available at: https://pro.aace.com/disease-state-resources/bone-and-parathyroid/clinical-practice-guidelines/clinical-practice. Accessed May 13, 2026.
  3. Bone Health & Osteoporosis Foundation. Medicines for Prevention and Treatment. Available at: https://www.bonehealthandosteoporosis.org/patients/treatment/medicationadherence/. Accessed May 13, 2026.
  4. Eastell R, Rosen CJ, Black DM, et al. Pharmacological management of osteoporosis in postmenopausal women: An endocrine society clinical practice guideline. J Clin Endocrin Metab. 2019; 104(5):1595-1622.

  1. The anabolic effect of Evenity wanes after 12 monthly doses of therapy. Therefore, the duration of Evenity use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. [1]
  2. Antiresorptive agents work by slowing the resorption or breakdown part of the remodeling cycle. Examples of antiresorptive agents include bisphosphonates (alendronate, ibandronate, risedronate, zoledronic acid), Prolia (denosumab), calcitonin, and selective estrogen receptor modulators (raloxifene). [2-4]
  3. The FRAX tool is available at https://www.fraxplus.org/ and incorporates multiple clinical factors that predict fracture risk, largely independent of BMD. [2]

  • 2026-06-18: 2026 annual review: Update criteria to allow very high risk patients to bypass anti-resorptive step to align with treatment guidelines. Restructure of guideline flow. Guideline name update to standard format. Background updates.
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-06-20: 2025 annual review: no criteria changes.
  • 2024-06-20: 2024 annual review: no criteria changes. Updated operational note.
  • 2023-05-09: 2023 UM Annual Review. Update criteria to say "For diagnosis of osteoporosis" and "For diagnosis of osteopenia" to align with Tymlos. No changes to clinical intent
  • 2021-06-23: Updated references section.
  • 2020-05-29: Background updates.