Subject: Follitropins 1914-A, 1915-A SGM P2024

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 (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
               3.  Induction of spermatogenesis in men with primary and secondary hypogonadotropic
                    hypogonadism (HH) 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, follicular stimulating hormone (FSH), and
          luteinizing hormone (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 or letrozole.
               2.  Member has a risk factor for poor ovarian response to clomiphene or letrozole.
               3.  Member has a contraindication or exclusion to clomiphene or letrozole.
               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 2023.
3. Gonal-f RFF [package insert]. Rockland, MA: EMD Serono, Inc.; November 2023.
4. Gonal-f RFF Redi-ject [package insert]. Rockland, MA: EMD Serono, Inc.; May 2024.
5. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/ Accessed: May 14, 2024.
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 30, 2024