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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), NOVAREL, PREGNYL (human chorionic gonadotropin), CETROTIDER (cetrorelix), Ganirelex acetate



NATL
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:
    • Menopur (menotropins):
      • Development of multiple follicles and pregnancy in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle.
    • Repronex (menotropins):
      • 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.
    • Gonal-F RFF (follitropin alpha, recombinant):
      • Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due toprimary ovarian failure.
      • Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle.
    • Follistim AQ (follitropin beta, recombinant):
      • In women for: Induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure.
      • In women for: Pregnancy in normal ovulatory women undergoing controlled ovarian stimulation as part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) cycle.
      • In men for: Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism (HH) in whom the cause of infertility is not due to primary testicular failure.
    • Bravelle (urofollitropin):
      • Induction of ovulation in women who have previously received pituitary suppression.
      • Development of multiple follicles as part of an Assisted Reproductive Technology (ART) cycle in ovulatory women who have previously received pituitary suppression.
    • Ganirelix:
      • Inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
    • Cetrotide (cetrorelix):
      • For the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation.
    • Ovidrel (choriogonadotropin alfa, recombinant):
      • 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.
      • Induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.
    • Novarel, Pregnyl (human chorionic gonadotropin [HCG]):
      • Prepubertal cryptorchidism not due to anatomic obstruction.
      • Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males
      • Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.
  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 Technology (ART), e.g., in vitro fertilization.

    OR

    • 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

    OR

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

    OR

    • Induction of ovulation in women with primary hypothalamic amenorrhea.

    OR

    • Follistim AQ only: Pregnancy in normal ovulatory women undergoing controlled ovarian stimulation as part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) cycle

    OR

    • Follistim AQ only: In men for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism (HH) in whom the cause of infertility is not due to primary testicular failure

    OR

    • Novarel, Pregnyl only: Prepubertal cryptorchidism not due to anatomical obstruction

    OR

    • Novarel, Pregnyl only: Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males
  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 FSH and 75 U LH/vial
     Repronex 75 U FSH and 75 U LH/vial
     Gonal-F multi dose vial: 450 U/vial; 1,050 U/vial
     Gonal-FRFF single dose vial: 75 U/vial
     Gonal-F RFF Redi-ject: 300 U/0.5 mL, 450 U/0.75 mL, 900 U/1.5 mL prefilled auto-injection device
     Follistim AQ: 150 U, 300 U, 600 U, 900 U/cartridge
     Bravelle: 75 U FSH/vial
     Ovidrel: 250 mcg/0.5 mL prefilled syringe
     Novarel: 10,000 U/vial
     Pregnyl: 10,000 U/vial
     Chorionic gonadotropin: 10,000 U/vial
     ganirelex acetate: 250 mcg/0.5 mL prefilled syringe
     Cetrotide: 0.25 mg/vial

  8. References:
    1. MicromedexR Healthcare Series [Internet database]. Greenwood Village, CO: Thompson Helathcare. Updated periodically. Accessed February 28, 2016.
    2. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed February 28, 2016.
    3. Health Net National Medical Policies, Infertility, April 2011. https://hnconnect.healthnet.com/business_units/medical_management/national_medical_policies/list.jsp Accessed February 28, 2016.
    4. Gonal-F RFF [Prescribing Information] Rockland, MA: EMD Serono;January 2014.
    5. Follistim AQ [Prescribing Information] Ravensburg, Germany: Vetter Pharma-Fertigung GmbH & Co. KG; December 2014.
    6. Menopur [Prescribing Information] Parsippany, NJ: Ferring Pharmaceuticals; February 2014.
    7. Repronex [Prescribing Information] Parsippany, NJ: Ferring Pharmaceuticals; September 2012.
    8. Bravelle [Prescribing Information] Parsippany, NJ: Ferring Pharmaceuticals; February 2014.
    9. Ovidrel [Prescribing Information] Rockland, MA: EMD Serono; September 2014.
    10. Novarel [Prescribing Information] Parsippany, NJ: Ferring Pharmaceuticals; January 2015
    11. Pregnyl [Prescribing Information] Halle, Germany: Baxter Oncology GmbH; January 2015.
    12. Ganirelix acetate [Prescribing Information]. Ravensburg, Germany: Vetter Pharma-Fertigung GmbH & Co. KG; August 2015.
    13. Cetrotide [Prescribing Information] Rockland, MA: EMD Serono; January 2014.
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.