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Prior Authorization Protocol

EVISTAR(raloxifene)

HNMC

Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Treatment and prevention of osteoporosis in postmenopausal women
    • Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis
    • Reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer
  2. Health Net Approved Indications and Usage Guidelines:
    • Treatment and prevention of osteoporosis or high risk of osteoporosis

    OR

    • Reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer

    High Risk of Breast Cancer is defined as:

      • Five- year predicted risk of breast cancer (calculated using Breast Cancer Risk Assessment) at least 1.66%
    OR
      • At least one breast biopsy with lobular carcinoma in situ (LCIS) or atypical hyperplasia and one or more first-degree relatives with breast cancer
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • The National Osteoporosis Foundation 2013 guidelines state: There are few indications for combining two antiresorptive treatments, but such options could be considered in the short-term in women who are experiencing active bone loss while on low dose hormone therapy for menopausal symptoms or raloxifene for breast cancer prevention.
    • Evista is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of the risk of noninvasive breast cancer.
    • There is insufficent data on the use of Evista for treatment of menopausal symptoms, i.e. hot flashes (an increased incidence of hot flashes has been observed with Evista in clinical trials).
    • If a patient has a history of non-vertebral (i.e. hip) fractures, the prescribing physician will be advised that:
      • The reduction of non-vertebral fracture risk has not been substantiated with calcitonin or Evista.
      • Bisphosphonates (Actonel and Fosamax) have demonstrated clinical efficacy in reducing the risk of non-vertebral fractures in controlled trials.
    • The Breast Cancer Risk Assessment Profile (BCRP) available at www.cancer.gov/bcrisktool/ is based on the Gail model that includes the following factors: current age, age at menarche, nulliparity or age at first live birth, number of first-degree relatives with breast cancer, number of breast biopsies and other factors. Healthcare professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-545-5979.
    • Increased risk of deep vein thrombosis and pulmonary emobolism has been reported with Evista.
    • Increased risk of death due to stroke occurred in a trial in postmenopausal women with Coronary Heart Disease or at increased risk for major coronary events.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    alendronate
    (FosamaxR)

    Post menopausal Osteoporosis (PMO) prevention
    5 mg PO once daily or
    35 mg PO once weekly
    PMO treatment
    10 mg PO once daily or
    70 mg PO once weekly
    10 mg/day or 70 mg/week

    Fosamax Plus DR
    (alendronate/ cholecalciferol)*

    PMO treatment
    70 mg alendronate/ 2,800 units cholecalciferol or
    70 mg alendronate /5,600 units cholecalciferol PO once weekly

    70 mg alendronate/5,600 units cholecalciferol/week

    risedronate (ActonelR)*
    PMO prevention
    5 mg PO once daily or
    35 mg PO once weekly
    PMO treatment
    5 mg PO once daily or
    35 mg once weekly or
    150 mg PO every month
    5 mg/day
    35 mg/week
    150 mg/month

    calcitonin-salmon nasal spray
    (MiacalcinR Nasal Spray, ForticalR Nasal Spray)

    PMO treatment
    200 IU spray in one nostril daily

    Nasal Spray:
    200 IU/day

    MiacalcinR Injection
    (calcitonin-salmon)*

    PMO treatment
    100 IU SC/IM every other day

    Injection:
    100 IU/day

    ibandronate
    (BonivaR)*

    PMO prevention & treatment (tablets)
    150 mg PO once monthly
    PMO treatment (injection)
    3 mg IV every 3 months over 15 to 30 seconds
    PO: 150 mg /month
    IV: 3 mg per dose
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Evista

    60 mg PO once daily

    Length of benefit

  7. Product Availability:

    Evista 60 mg tablets

  8. References:
    1. Evista [Prescribing Information] Indianapolis, IN: Eli Lilly and Company; January 2011.
    2. National Osteoporosis Foundation-The Clinician`s Guide to Prevention and Treatment of Osteoporosis. Available at: Available at: http://nof.org/hcp/resources/913. Accessed June 17, 2015.
    3. The North American Menopause Society. Management of postmenopausal Osteoporosis: 2010 position statement of the North American Menopause Society. Menopause: The Journal of the North American Menopause Society 2010;17(1): 22-54.
    4. American Association of Clinical Endocrinologists. AACE medical guidelines for clinical practice for management of menopause. Endocrine Practice 2003;9(6):544-564.
    5. National Cancer Institute. www.cancer.gov/bcrisktool/. Accessed June 12, 2015.
    6. Evista. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 12, 2015.
    7. DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 12, 2015.
    8. Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed June 12, 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.