Subject: Follitropins 1914-A, 1915-A SGM P2023

Drug

FOLLISTIM AQ  (follitropin beta injection)

GONAL-F  (follitropin alfa injection)

Note: *Hereafter, follitropin 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.

          FDA-Approved Indications
          A.  Follistim AQ is indicated for:
               1.  Induction of ovulation and pregnancy in anovulatory
                    infertile women in whom the cause of infertility is
                    functional and not due to primary ovarian failure.
               2.  Pregnancy in normal ovulatory women undergoing
                    controlled ovarian stimulation as part of an in vitro
                    fertilization or intracytoplasmic sperm injection (ICSI)
                    cycle.
               3.  Induction of spermatogenesis in men with primary and
                    secondary hypogonadotropic hypogonadism in whom the
                    cause of infertility is not due to primary testicular failure.

          B.  Gonal-f is indicated for:
               1.  Induction of ovulation and pregnancy in oligio-
                    anovulatory women in whom the cause of infertility is
                    functional and not due to primary ovarian failure.
               2.  Development of multiple follicles in ovulatory women as
                    part of an Assisted Reproductive Technology (ART) cycle.
               3.  Induction of spermatogenesis in men with primary and
                    secondary hypogonadotropic hypogonadism in whom the
                    cause of infertility is not due to primary testicular failure.

          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.  Follicle stimulation
               Authorization of 12 months may be granted for members
               undergoing ovulation induction or assisted reproductive
               technology (ART) who meet any of the following criteria:
               1.  Member has completed three or more previous cycles of
                    clomiphene
               2.  Member has a risk factor for poor ovarian response to
                    clomiphene
               3.  Member has a contraindication or exclusion to clomiphene
               4.  Member is 37 years of age or older


          B.  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. Follistim AQ Cartridge [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2023.
2. Gonal-f Multi-Dose [package insert]. Rockland, MA: EMD Serono, Inc.; December 2020.
3. Gonal-f RFF [package insert]. Rockland, MA: EMD Serono, Inc.; December 2020.
4. Gonal-f RFF Redi-ject [package insert]. Rockland, MA: EMD Serono, Inc.; February 2020.
5. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/ Accessed: May 2, 2023.
6. Practice Committee of the American Society for Reproductive Medicine. Evidence-based treatments for couples with unexplained infertility: a guideline. Fertil & Steril. 113(2):305-322.
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