Infertility Therapy – Essential

Restricted Product(s):

• Chorionic gonadotropin (Fresenius brand)
• Crinone 8% (progesterone gel)
• Gonal – F® (follitropin)
• Novarel (chorionic gonadotropin)
• Ovidrel (choriogonadotropin)
• Prometrium (progesterone)

FDA Approved Use:

• Chorionic gonadotropin (Fresenius brand), Novarel (chorionic gonadotropin)
  • For the treatment of hypogonadism secondary to a pituitary deficiency in males
  • For the induction of ovulation and pregnancy in the anovulatory infertile woman in whom the cause of infertility is secondary and not caused by primary ovarian failure, and who has been appropriately treated with human menotropins
  • For the treatment of prepubertal cryptorchidism not caused by anatomic abstruction
• Crinone® 8% (progesterone gel)
  • For progesterone replacement or supplementation as part of an assisted reproductive technology (ART) treatment for infertile women with progesterone deficiency.
  • For the prevention of endometrial hyperplasia in patients with a uterus receiving estrogen therapy (eg, for vasomotor symptoms associated with menopause or secondary amenorrhea).
• Gonal – F® (follitropin)
  • For the induction of ovulation and pregnancy in oligo-anovulatory infertile patients in whom the cause of infertility is functional and not primary ovarian failure.
  • To stimulate the development of multiple follicles in ovulatory patients participating in an assisted reproductive technology (ART) program.
  • For the induction of spermatogenesis in men with azoospermia and primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not primary testicular failure
• Prometrium (progesterone)
  • For the prevention of endometrial hyperplasia in patients with a uterus receiving estrogen therapy (eg, for vasomotor symptoms associated with menopause or secondary amenorrhea)
  • For use as a diagnostic aid to determine endometrial estrogen exposure and/or uterine or outflow tract abnormality
  • Note: Prometrium is not FDA approved as part of Assisted Reproductive Technology
• Ovidrel® (choriogonadotropin)
  • 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 program such as in vitro fertilization and embryo transfer.
  • 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.

Criteria for Approval of Restricted Product(s):

1. The request is for coverage of Crinone 8%; AND
   1. The patient will be using for the treatment of secondary amenorrhea after a trial of Crinone 4%; OR
   2. The patient will be using as part of a fertility treatment plan; AND
      1. The patient has a contraindication/clinical intolerance to Endometrin (progesterone insert) (medical record documentation required); OR
2. The request is for coverage of Gonal-F or Gonal-F RFF Rediject; AND
   1. The patient has a contraindication/clinical intolerance to Follistim (follitropin) (medical record documentation required); OR
3. The request is for coverage of Novarel, Ovidrel or Chorionic Gonadotropin (Fresenius brand); AND
   1. The patient has a contraindication/clinical intolerance to Pregnyl (chorionic gonadotropin) (medical record documentation required); OR
4. The request is for coverage of brand name Prometrium (progesterone); AND
   1. The patient has a contraindication/clinical intolerance to generic progesterone; AND
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 12 weeks

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 12 weeks

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

October 2024: Criteria change: Removed lifetime benefit maximums. Removed obsolete Novarel 10,000 unit vial. Added QL to Clomid, Crinone 8% gel, Endometrin, Menopur.

June 2024: Criteria update: Added menotropins to the benefit limitations section of the policy.

March 2024: Criteria change: Benefit Limitation of follitropin products increased to 10mL.

October 2023: Criteria change: Novarel and Chorionic Gonadotropin (Fresenius) added to restriction. Created Essential only policy.

November 2022: Criteria change: Removed Cetrotide from restricted non-preferred products.

September 2022: Criteria update: Added Fyremadel to policy.

June 2022: Criteria change: Removed QL on Menopur. Updated QL on Cetrotide and Ganirelix to 6 kits/syringes per 30 days.

April 2022: Criteria update: Added quantity limits to policy.

Jan 2019: Original utilization management criteria issued.