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Prior Authorization Protocol
Aromatase Inhibitors:
ARIMIDEXR
(anastrazole), AROMASINR (exemestane), FEMARAR (letrozole)

HNAZ

Interim Guidelines; Final Review and Approval by the P&T Committee Pending

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    Arimidex:
    • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
    • First-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer
    • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with Estrogen receptor-negative (ER-negative) disease and patients who did not respond to previous tamoxifen therapy rarely responded to Arimidex
    Aromasin:
    • Adjuvant treatment of postmenopausal women with estrogen-receptor positive (ER positive) early breast cancer who have received two to three years of tamoxifen and are switched to Aromasin for completion of a total of five consecutive years of adjuvant hormonal therapy
    • Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy
    Femara:
    • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
    • Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy
    • First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer
  2. Health Net Approved Indications and Usage Guidelines:
    • Breast cancer or ductal carcinoma in situ (DCIS) in postmenopausal women
    • Breast cancer prophylaxis in postmenopausal women at increased risk (Arimidex and Aromasin only)
    • Male breast cancer
    • Endometrial carcinoma
    • Uterine sarcoma
    • Ovarian Cancer
    • Fertility (Femara only)
      • Member is female
    AND
      • Member has a fertility drug benefit
  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:
    • Combination therapy of aromatase inhibitors and human growth hormone to increase final adult height is considered investigational and not medically necessary
    • Aromatase inhibitors are not covered to increase final adult height in children or adolescents with the following conditions:
      • Small for Gestational Age (cosmetic)
      • Idiopathic Short Stature (cosmetic)
      • Constitutional delay of puberty (cosmetic)
      • Precocious puberty (cosmetic)
    • Use for male gynecomastia and breast tenderness associated with puberty is considered not medically necessary as the condition frequently resolves spontaneously
    • Use for normalization of estrogen and testosterone levels in men, normalization of plasma lipids, or reduction of truncal or other fat is considered investigational and not medically necessary
    • Per the National Comprehensive Cancer Network (NCCN) practice guidelines, men with breast cancer should be treated similarly to postmenopausal women, except that use of an aromatase inhibitor is ineffective without concomitant suppression of testicular steroidogenesis
    • Arimidex, Aromasin, and Femara have NCCN practice guideline recommendations of category 2A for endometrial carcinoma
    • Arimidex, Aromasin and Femara have NCCN practice guideline recommendations of category 2A for uterine sarcoma.
    • Arimidex, Aromasin and Femara have NCCN practice guideline recommendations of category 2A for ovarian cancer (epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer). Additionally, Arimidex and Femara have NCCN practice guideline recommendations of category 2A for ovarian cancer (malignant sex cord-stromal tumors). Femara has a Micromedex recommendation of Class IIb for ovulation induction
    • Arimidex and Aromasin have NCCN practice guideline recommendations of category 1 for prophylaxis of breast cancer in postmenopausal women at increased risk. Aromasin additionally has a Micromedex recommendation of Class I for this indication.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Tamoxifen

    20 mg PO QD

    40 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Arimidex

    Breast cancer (treatment or prophylaxis), Endometrial carcinoma, Uterine sarcoma or Ovarian cancer:
    1 mg PO QD
    Length of Benefit

    Aromasin

    Breast cancer (treatment or prophylaxis), Endometrial carcinoma, Uterine sarcoma, or Ovarian cancer:
    25 mg PO QD

    Length of Benefit

    Femara

    Breast cancer, Endometrial carcinoma, Uterine sarcoma or Ovarian cancer: 2.5 mg PO QD
    Fertility: 2.5 to 7.5 mg PO QD days 3-7 of menstrual cycle
    Length of Benefit
  7. Product Availability:
    Arimidex: Tablet 1 mg
    Aromasin: Tablet 25 mg
    Femara: Tablet 2.5 mg
  8. References:
    1. Arimidex [Prescribing Information] Wilmington, DE: AstraZeneca Pharmaceuticals; May 2014.
    2. Aromasin [Prescribing Information] New York, NY: Pfizer Inc; May 2014.
    3. Femara [Prescribing Information] East Hanover, NJ: Novartis Pharmaceuticals; January 2014.
    4. Anastrozole. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 2, 2015.
    5. Exemestane. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 2, 2015.
    6. Letrozole. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 2, 2015.
    7. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. July 2, 2015.
    8. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com. Accessed July 2, 2015.
    9. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 25, 2015.
    10. Dixon JM, Faratian D, White S, et al. DCIS and aromatase inhibitors. J Steroid Biochem Mol Biol 2007;106(1-5):173-179.
    11. Quintero RB, Urban R, Lathi RB, et al. A comparison of letrozole to gonadotropins for ovulation induction, in subjects who failed to conceive with clomiphene citrate. Fertil Steril 2007;88(4):879-885.
    12. Kafy S, Tulandi T. New advances in ovulation induction. Curr Opin Obstet Gynecol 2007;19(3):248-252.
    13. Wit JM, Hero M, Nunez SB. Aromatse inhibitors in pediatrics. Nat Rev Endocrinol 2011;8(3):135-147.
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.