Gonadotropin-Releasing Hormone Antagonists (Infertility Agents)

Indications for Prior Authorization

Cetrotide (cetrorelix), Generic cetrorelix
  • For diagnosis of Controlled ovarian stimulation
    Indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.

  • For diagnosis of Fertility Preservation with Assisted Reproductive Technology (ART)
    May be used in assisted reproductive technology (ART) for fertility preservation. [5,6]

Fyremadel, Generic ganirelix
  • For diagnosis of Controlled ovarian stimulation
    Indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

  • For diagnosis of Fertility Preservation with Assisted Reproductive Technology (ART)
    May be used in assisted reproductive technology (ART) for fertility preservation. [5,6]

Criteria

Brand Fyremadel*, Generic ganirelix*, Generic cetrorelix*

*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity.

Prior Authorization

Length of Approval: 6 Month(s)
For diagnosis of Infertility

  • Diagnosis of infertility
  • AND
  • For the development of multiple follicles (ovarian stimulation)
  • AND
  • Will be used in conjunction only with assisted reproductive technology (ART)
Brand Cetrotide*

*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity.

Prior Authorization

Length of Approval: 6 Month(s)
For diagnosis of Infertility

  • 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
  • Trial and failure, contraindication or intolerance to one of the following:
    • Generic Ganirelix
    • Fyremadel
Brand Fyremadel, Generic ganirelix, Brand Cetrotide, Generic cetrorelix

*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity.

Prior Authorization

Length of Approval: 2 months (or per plan benefit design)
For diagnosis of Fertility Preservation with Assisted Reproductive Technology (ART)* (off-label)

  • Used for fertility preservation
  • AND
  • Patient will undergo gonadotoxic therapy (e.g., chemotherapy, surgery, prolonged hormonal ovarian suppression, radiation therapy)
  • AND
  • Will be used as part of an assisted reproductive technology procedure (e.g., oocyte or embryo cryopreservation)
  • AND
  • Prescribed by or in consultation with a reproductive endocrinologist
P & T Revisions

2025-09-18, 2024-08-19, 2023-11-01, 2023-08-29, 2023-08-21, 2023-05-05, 2023-01-03, 2022-11-30, 2022-08-22, 2022-02-16, 2021-12-01, 2021-09-10, 2020-07-25, 2020-01-06

  1. Cetrotide Prescribing Information. EMD Serono, Inc. Rockland, MA. June 2024.
  2. Ganirelix Acetate Prescribing Information. Lupin Pharmaceuticals, Inc. Naples, FL. March 2025.
  3. Fyremadel Prescribing Information. Ferring Pharmaceuticals Inc. Parsippany, NJ. January 2025.
  4. Cetrorelix Prescribing Information. Apotex Corp. Weston, Florida. June 2025.
  5. Practice Committee of the American Society for Reproductive Medicine. Fertility preservation in patients undergoing gonadotoxic therapy or gonadectomy: a committee opinion. Fertility and Sterility. 2019 Dec;112(6):1022-1033.
  6. Su HI, Lacchetti C, Letourneau J, et al. Fertility preservation in people with cancer: ASCO guideline update. J Clin Oncol. 2025;43(12):1488-1515.

  • 2025-09-18: Added generic cetrorelix to guideline with criteria to mirror generic ganirelix. Added off-label criteria for fertility preservation. Background updates.
  • 2024-08-19: 2024 annual review: no criteria changes, background updates.
  • 2023-11-01: Removed "PA, NF" from guideline name since NF criteria has been removed
  • 2023-08-29: Removed Cetrotide NF criteria and added in trial of generic ganirelix or generic Fyremadel to Cetrotide PA criteria
  • 2023-08-21: Removed criterion 2 requiring a cause of infertility (i.e., unexplained infertility, endometriosis, male factor infertility, tubal factor infertility, any other indication for ART). Updated "controlled ovarian hyperstimulation" to "ovarian stimulation" with no change in intent.
  • 2023-05-05: Removed generic cetrorelix from guideline.
  • 2023-01-03: Minor update
  • 2022-11-30: Addition of new generic, cetrorelix acetate
  • 2022-08-22: Annual review: no criteria changes.
  • 2022-02-16: Program update to add generic Fyremadel to mirror criteria of generic ganirelix.
  • 2021-12-01: Program update to include NF criteria for cetrotide
  • 2021-09-10: Updated references section.
  • 2020-07-25: Annual Review - No changes.
  • 2020-01-06: GPI replication update for Generic ganirelix (added 3009004010E520, removed 30090040102020).