Subject: hCG 1925-A, 1926-A SGM P2024

Drug

NOVAREL  (chorionic gonadotropin)

PREGNYL  (chorionic gonadotropin)

OVIDREL  (choriogonadotropin alfa)

chorionic gonadotropin

Note: *Hereafter, hCG will be used to describe all products

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          A.  FDA-Approved Indications
               Novarel and Pregnyl are indicated for:
               1.  Prepubertal cryptorchidism not due to anatomic obstruction.
               2.  Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a
                    pituitary deficiency) in males.
               3.  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 gonadotropins.

               Ovidrel is indicated for:
               1.  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 reproductive technology (ART)
                    program such as in vitro fertilization and embryo transfer.
               2.  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.

          B.  Compendial Use
               Infertility, luteal phase support

          All other indications are considered experimental/investigational and not medically necessary.


    II.  MEDICAL BENEFIT ALIGNMENT

          Specialty Guideline Management coverage review will be bypassed for drug(s) being
          requested for a procedure that has been approved under a member’s medical benefit plan.
          Such members will be exempt from the requirements in Sections IV. A medical authorization
          number and confirmation of the approved procedure(s) will be required.

          NOTE: Some plans may opt-out of medical benefit alignment. Members receiving
          coverage under such plans must meet the requirements in Sections IV.


   III.  DOCUMENTATION

          Submission of the following information is necessary to initiate the prior authorization review for
          hypogonadotropic hypogonadism: testosterone, follicle stimulating hormone (FSH), and
          luteinizing hormone (LH) levels.


   IV.  CRITERIA FOR INITIAL APPROVAL

          A.  Induction of oocyte maturation and/or release
               Authorization of 12 months may be granted for members undergoing ovulation induction or
               assisted reproductive technology (ART).

          B.  Prepubertal cryptorchidism
               Authorization of 6 months may be granted for treatment of prepubertal cryptorchidism.

          C.  Hypogonadotropic hypogonadism
               Authorization of 12 months may be granted for treatment of hypogonadotropic
               hypogonadism in members who meet both of the following criteria:
               1.  Member has low pretreatment testosterone levels.
               2.  Member has low or low to normal follicle stimulating hormone (FSH) or luteinizing
                    hormone (LH) levels.


    V.  CONTINUATION OF THERAPY

          All members (including new members) requesting authorization for continuation of therapy
          must meet all initial authorization criteria.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Novarel [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.; April 2024
2. Pregnyl [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2023.
3. Ovidrel [package insert]. Rockland, MA: EMD Serono, Inc.; December 2023.
4. Chorionic Gonadotropin for Injection [package insert]. Lake Zurich, IL: Fresenius Kabi; April 2020.
5. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, CO. Available at: http://www.micromedexsolutions.com Accessed May 14, 2024.
6. Nosarka S, Kruger T, Siebert I, et al. Luteal phase support in in vitro fertilization: meta-analysis of randomized trials. Gynecol Obstet Invest. 2005;60:67-74.
7. 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. 2002:8:439-456.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 30, 2024