Human Chorionic Gonadotropin (hCG)
Indications for Prior Authorization
Novarel (chorionic gonadotropin), Pregnyl (chorionic gonadotropin)
-
For diagnosis of Ovulation Induction (OI)
Indicated for the induction of ovulation (OI) 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. -
For diagnosis of Prepubertal Cryptorchidism
Indicated for prepubertal cryptorchidism not due to anatomic obstruction. In general, hCG is thought to induce testicular descent in situations when descent would have occurred at puberty. hCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following hCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9. -
For diagnosis of Hypogonadotropic Hypogonadism
Indicated for the treatment of selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males. -
For diagnosis of Infertile women undergoing Assisted Reproductive Technologies (ART)
Used 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. [3]
Ovidrel (chorionic gonadotropin) PreFilled Syringe
-
For diagnosis of Infertile women undergoing Assisted Reproductive Technologies (ART)
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. -
For diagnosis of Ovulation Induction (OI)
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
Generic chorionic gonadotropin*^, Novarel*^, Ovidrel*^, Pregnyl*^
*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity. ^If patient meets criteria above, please approve Generic chorionic gonadotropin, Novarel and Ovidrel at GPI list “XXPAHCGORX”.
Prior Authorization
Length of Approval: 2 Months (or per plan benefit design)
For diagnosis of Ovulation Induction [4, 6]
- Diagnosis of anovulatory 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)
Generic chorionic gonadotropin*^, Novarel*^, Ovidrel*^, Pregnyl*^
*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity. ^If patient meets criteria above, please approve Generic chorionic gonadotropin, Novarel and Ovidrel at GPI list “XXPAHCGORX”.
Prior Authorization
Length of Approval: 2 Months (or per plan benefit design)
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)
Generic chorionic gonadotropin, Novarel, Ovidrel, Pregnyl
Prior Authorization
Length of Approval: 6 Week(s)
For diagnosis of Prepubertal Cryptorchidism
- Diagnosis of prepubertal cryptorchidism not due to anatomical obstruction [A]
Generic chorionic gonadotropin, Novarel, Ovidrel, Pregnyl
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Male Hypogonadotropic Hypogonadism [4, 5]
- 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)
Generic chorionic gonadotropin, Novarel, Ovidrel, Pregnyl
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Male Hypogonadotropic Hypogonadism [4, 5]
- Patient demonstrates positive clinical response to therapy.
P & T Revisions
2025-04-30, 2024-06-17, 2024-04-29, 2023-11-02, 2023-11-02, 2023-08-31, 2022-10-20, 2021-09-21, 2021-05-19, 2020-11-02, 2020-07-18
References
- Novarel prescribing information. Ferring Pharmaceuticals Inc. Parsippany, NJ. June 2023.
- Pregnyl prescribing information. Merck & Co., Inc. Whitehouse Station, NJ. March 2023.
- Ovidrel prescribing information. EMD Serono, Inc. Rockland, MA. December 2023.
- DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically. Accessed August 9, 2021.
- Petak SM, Nankin HR, Spark RF, Swerdloff RS, Rodriguez-Rigau LJ. American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients – 2002 update. Endocr Pract. 2002;8:440-456.
- The Practice Committee of the American Society for Reproductive Medicine. Use of exogenous gonadotropins in anovulatory women: a technical bulletin. Fertil Steril. 2008;90:S7-12.
End Notes
- In general, hCG is thought to induce testicular descent in situations when descent would have occurred at puberty. hCG thus may help predict whether or not orchiopexy (operation to bring an undescended testicle into the scrotum) will be needed in the future. Although, in some cases, descent following hCG administration is permanent, in most cases, the response is temporary. Therapy is usually initiated between the ages of 4 and 9. [1, 2, 4]
Revision History
- 2025-04-30: 2025 UM Annual Review. No changes
- 2024-06-17: Added note for infertility approvals to be approved with the GPI List XXPAHCGORX, as per PA Ops request.
- 2024-04-29: 2024 UM Annual Review. No criteria changes. Background updates
- 2023-11-02: Program update to standard reauthorization language. No changes to clinical intent.
- 2023-11-02: Program update to standard reauthorization language. No changes to clinical intent.
- 2023-08-31: 2023 UM Annual Review. No criteria changes. Updated references
- 2022-10-20: Annual review: no criteria changes.
- 2021-09-21: Updated references section.
- 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
- 2020-11-02: Program Update to remove T/F of Pregnyl due to supply shortage
- 2020-07-18: Updated references section.
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