Subject: hCG 1925-A, 1926-A SGM P2023

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
                    menotropins

               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 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, FSH, and 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.; November 2020
2. Pregnyl [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2023.
3. Ovidrel [package insert]. Rockland, MA: EMD Serono, Inc.; February 2022.
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 2, 2023.
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 14, 2023