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Prior Authorization Protocol
MENOPURR, REPRONEXR (menotropins), GONAL-F RFF (follitropin alpha, recombinant), FOLLISTIM-AQR (follitropin beta, recombinant), BRAVELLER (urofollitropin), OVIDRELR (choriogonadotropin alfa), CETROTIDER (cetrorelix), LUVERISR (lutropin alfa), Ganirelex acetate

NATL
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:
    • Menotropins:
      • Menopur- indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in the assisted reproductive technology (ART) program.
      • Repronex- in conjunction with human chorionic gonadotropin (hCG), is indicated for multiple follicular development (controlled ovarian stimulation) and ovulation induction in patients who have previously received pituitary suppression.
    • Follitropin alpha (recombinant): Ovulation induction: Women: For the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not caused by ovarian failure. Follicle stimulation: To stimulate the development of multiple follicles in ovulatory undergoing Assisted Reproductive Therapy (ART), e.g., in vitro fertilization.
    • Follitropin beta (recombinant): Ovulation induction: For the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not caused by ovarian failure. Follicle stimulation: To stimulate the development of multiple follicles in ovulatory undergoing Assisted Reproductive Therapy (ART), e.g., in vitro fertilization. Men: for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
    • Urofollitropin: Ovulation induction: For ovulation induction in patients who have previously received pituitary suppression. Multifollicular development during ART: for multiple follicular development (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitarysuppression.
    • Ganirelix: for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
    • Cetrorelix: for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation.
    • Lutropin alfa: coadministered with follitropin alfa (Gonal-F.) is indicated for stimulation of follicular development in infertile, hypogonadotropic, hypogonadal women with profound luteinizing hormone (LH) deficiency (LH less than 1.2 units/L). A definitive effect on pregnancy in this population has not been demonstrated. The safety and efficacy of concomitant administration of lutropin alfa with any other preparation of recombinant human follicle stimulating hormone (FSH) or urinary human FSH is unknown.
    • Choriogonadotropin alfa: indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle-stimulating hormones (FSH) as part of an assisted reproductive technology (ART) program such as in vitro fertilization and embryo transfer
  2. Health Net Approved Indications and Usage Guidelines:

    • For the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not caused by primary ovarian failure.

    OR

    • To stimulate the development of multiple follicles in ovulatory patients undergoing Assisted Reproductive Therapy (ART), e.g., in vitro fertilization.

    OR

    • Inhibition of premature luteinizing hormone in women undergoing controlled ovarian hyperstimulation.

    OR

    • Induction of ovulation in women with primary hypothalamic amenorrhea.
  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:

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  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Various

    Depending on patients diagnosis and previous therapy

    Length of Benefit

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

    All listed above

    Various, see package inserts

    Length of Benefit

  7. Product Availability:
    • Menopur 75 U/ vial
    • Repronex 75 U / vial
    • Gonal-F: 450 u/vial; 1,050 U/vial
    • Gonal-F RRF: 75 U/vial; 300 U/0.5 mL or 450 U/0.5 mL cartridge syringe
    • Follistim AQ: 75 U/vial, 175 U, 350 U, 650 U, 975 U / cartridge syringe
    • Bravelle: 75 U / vial
    • Ovidrel: 250 mcg/0.5 mL syringe
    • Ganirelex acetate: 250 mcg/0.5 mL syringe
    • Cetrotide Kit 0.25 mg
    • Luveris: 75 U / vial
  8. References:
    1. MICROMEDEX. http://www.thomsonhc.com/. Accessed June 2014.
    2. American Hospital Formulary Service Drug Information.Accessed June 2014.
    3. Health Net National Medical Policies, Infertility, April 2011. https://hnconnect.healthnet.com/business_units/medical_management/national_medical_policies/list.jsp Accessed June 2014.
    4. Gonal-F RFF [package insert]. Rockland, MA: EMD Serono; October 2013.
    5. Follistim AQ [package insert] Dublin, Ireland: Organon October 2013.
    6. Menopur [package insert]. Parsippany, NJ: Ferring Pharmaceuticals; February 2014.
    7. Repronex [package insert]. Parsippany, NJ: Ferring Pharmaceuticals; September 2012.
    8. Bravelle [package insert]. Parsippany, NJ: Ferring Pharmaceuticals; February 2014.
    9. Ovidrel [package insert]. Rockland, MA: EMD Serono; June 2012.
    10. Ganirelix acetate [package insert]. Ravensburg, Germany: Vetter Pharma-Fertigung GmbH & Co. KG; December 2013.
    11. Cetrotide [package insert]. Rockland, MA: EMD Serono; January 2014.
    12. Luveris [package insert]. Rockland, MA: EMD Serono; August 2012.
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.