WHA

Evenity (romosozumab-aqqg injection)

Indications for Prior Authorization

Evenity (romosozumab-aqqg injection)
  • 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.

Criteria

Evenity

Evenity (romosozumab-aqqg) not to exceed the FDA-recommended treatment duration of 12 monthly doses. *Evenity will not be approved if the patient has already received 12 months of therapy; if the patient has not yet received 12 months of therapy, approval may be granted for the balance of the time remaining.

Prior Authorization

Length of Approval: 12 Months [A]*

  • Diagnosis of postmenopausal osteoporosis or osteopenia
    • AND
  • One of the following:
    • For diagnosis of osteoporosis, 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)
        • AND
      • One of the following:
        • History of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm
          • OR
        • Trial and failure, contraindication, or intolerance to one anti-resorptive treatment (e.g., alendronate, risedronate, zoledronic acid, Prolia [denosumab]) [B]
      OR
    • For diagnosis of osteopenia, both 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:
        • History of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm
          • OR
        • Both of the following:
          • Trial and failure, contraindication, or intolerance to one anti-resorptive treatment (e.g., alendronate, risedronate, zoledronic acid, Prolia [denosumab]) [B]
            • 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 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]

  • Guideline ID
    GL-147054

  • Formulary
    premium

  • Effective date
    Aug 1, 2024

  • P&T approval date
    May 16, 2019

P & T Revisions

2024-06-20, 2023-05-09, 2021-06-23, 2020-05-29

  1. Evenity prescribing information. Amgen Inc. Thousand Oaks, CA. April 2020.
  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 April 29, 2024.
  3. National Osteoporosis Foundation. Treatment and Adherence. Available at: https://www.nof.org/patients/treatment/medicationadherence/. Accessed April 29, 2024.
  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 WHO FRAX tool is available at https://frax.shef.ac.uk/FRAX/ and incorporates multiple clinical factors that predict fracture risk, largely independent of BMD. [2]
  • 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.