Pharmacy Prior Authorization Criteria

Infertility Medications

Indications for Prior Authorization

Cetrotide, Fyremadel, ganirelix acetate

• Indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation
  

Clomid

• Indicated for the treatment of ovulatory dysfunction in women desiring pregnancy
  

Endometrin

• Indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women
  

Follistim AQ

• Indicated 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
  

• Indicated 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
  

• Indicated 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
  

Gonal-F

• Indicated for induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure
  

• Indicated for development of multiple follicles in ovulatory infertile women as part of an assisted reproductive technology (art) cycle
  

• Indicated for induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism for whom the cause of infertility is not due to primary testicular failure
  

Menopur

• Indicated for development of multiple follicles and pregnancy in ovulatory women as part of an assisted reproductive technology (art) cycle
  

Novarel and Pregnyl

• Indicated for prepubertal cryptorchidism not due to anatomic obstruction
  

• Indicated for selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males
  

• Indicated for 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
  

Ovidrel

• 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 as part of an Assisted
  

• Indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure
  

Criteria

Ganirelix, Fyremadel, Cetrotide

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Controlled ovarian stimulation

• Diagnosis of infertility
AND
• For the development of multiple follicles (ovarian stimulation)
AND
• Will be used in conjunction only with assisted reproductive technology (ART)
AND
• The treatment/procedure is listed as a covered benefit under the patient’s infertility supplemental benefit
AND
• The requested treatment or procedure is approved by the member’s medical group, and documentation of current approval is provided with the medication prior authorization request
AND
• Chart note documentation describing the treatment condition, previous therapies tried and failed, and the infertility planned procedure are provided
AND
• For Cetrotide only: Trial and failure, contraindication or intolerance to one of the following
• Generic Ganirelix
• Generic Fyremadel

Pregnyl, generic chorionic gonadotropin, Novarel, Ovidrel

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Ovulation induction

• Diagnosis of infertility
AND
• Infertility is not due to primary ovarian failure
AND
• For induction of ovulation
AND
• Patient has been pre-treated with a follicular stimulating agent (e.g., gonadotropins, clomiphene citrate, letrozole)
AND
• The treatment/procedure is listed as a covered benefit under the patient’s infertility supplemental benefit
AND
• The requested treatment or procedure is approved by the member’s medical group, and documentation of current approval is provided with the medication prior authorization request
AND
• Chart note documentation describing the treatment condition, previous therapies tried and failed, and the infertility planned procedure are provided

Pregnyl, generic chorionic gonadotropin, Novarel, Ovidrel

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Controlled ovarian hyperstimulation

• Diagnosis of infertility
AND
• For the development of multiple follicles (controlled ovarian hyperstimulation)
AND
• Patient has been pre-treated with a follicular stimulating agent (e.g., gonadotropins, clomiphene citrate, letrozole)
AND
• The treatment/procedure is listed as a covered benefit under the patient’s infertility supplemental benefit
AND
• The requested treatment or procedure is approved by the member’s medical group, and documentation of current approval is provided with the medication prior authorization request
AND
• Chart note documentation describing the treatment condition, previous therapies tried and failed, and the infertility planned procedure are provided

Pregnyl, generic chorionic gonadotropin, Novarel, Ovidrel

Prior Authorization

Length of Approval: 6 Week(s)
For diagnosis of Prepubertal cryptorchidism

• Diagnosis of prepubertal cryptorchidism not due to anatomical obstruction

Pregnyl, generic chorionic gonadotropin, Novarel, Ovidrel

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Male hypogonadotropic hypogonadism

• Diagnosis of male hypogonadism secondary to pituitary deficiency
AND
• Low testosterone (below normal reference level provided by the physician’s laboratory)
AND
• One of the following
• Low LH (below normal reference level provided by the physician’s laboratory)
• Low FSH (below normal reference level provided by the physician’s laboratory)

Pregnyl, generic chorionic gonadotropin, Novarel, Ovidrel

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of male hypogonadotropic hypogonadism

• Patient demonstrates positive clinical response to therapy

Clomid (clomiphene), Endometrin (progesterone), Follistim (follicle-stimulating hormone), Gonal-F (follicle-stimulating hormone), Menopur (menotropins)

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Infertility

• The treatment/procedure is listed as a covered benefit under the patient’s infertility supplemental benefit
AND
• The requested treatment or procedure is approved by the member’s medical group, and documentation of current approval is provided with the medication prior authorization request
AND
• Chart note documentation describing the treatment condition, previous therapies tried and failed, and the infertility planned procedure are provided

P & T Revisions

1970-01-01, 2024-11-04

References

1. Cetrotide prescribing information. EMD Serono, Inc. Rockland, MA. December 2023.
2. Clomid prescribing information. Cosette Pharmaceuticals, Inc. South Plainfield, NJ. September 2022
3. Endometrin prescribing information. Ferring Pharmaceuticals Inc. Parsippany, NJ. January 2018.
4. Follistim AQ prescribing information. Merck Sharp & Dohme, LLC. Whitehouse Station, NJ. November 2023.
5. Fyremadel prescribing information. Ferring Pharmaceuticals, Inc. Parsippany, NJ. October 2023
6. Ganirelix acetate prescribing information. Amphastar Pharmaceuticals, Inc. Rancho Cucamonga, CA. April 2022
7. Gonal-F prescribing information. EMD Serono, Inc. Rockland, MA. November 2023.
8. Menopur prescribing information. Ferring Pharmaceuticals Inc. Parsippany, NJ. December 2021.
9. Novarel prescribing information. Ferring Pharmaceuticals Inc. Parsippany, NJ. April 2024
10. Ovidrel prescribing information. EMD Serono, Inc. Rockland, MA. December 2023
11. Pregnyl prescribing information. Baxter Pharmaceutical Solutions, LLC. Bloomington, IN. March 2023

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Revision History

• 2024-11-04: New Program

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