Close Window
Aetna
Aetna Aetna
Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Infertility

Status Drug PR PR-QL PR-AL ST M EX‡
Gonadotropin releasing hormone antagonist
P leuprolide          
P Lupron ®  (leuprolide)          
NP Ganirelix®  (ganirelix acetate) X        
NP Cetrotide®  (cetrorelix acetate) X        
Human chorionic gonadotropin
P chorionic gonadotropin X        
P Novarel®  (chorionic gonadotropin) X        
P Pregnyl®  (chorionic gonadotropin) X        
NP Ovidrel®  (choriogonadotropin alfa) X        
Gonadotropins
P Bravelle®  (uFSH-follitropin) X        
P Gonal-F®/Gonal-F RFF  (rFSH-follitropin alfa) X        
P Menopur®  (LH and FSH menotropins) X        
NP Luveris®  (lutropin alfa) X        
FE Follistim AQ®  (rFSH-follitropin beta) X       X
FE Repronex®  (LH and FSH menotropins) X       X
Note:

Note: Precertification review for these medications is handled through Aetna Specialty Precert Unit
Reference : Aetna Medical Clinical Policy: Infertility: #0327 http://aetnet.aetna.com/mpa/cpb/300_399/0327.html



Policy:

The purpose of this policy, the criteria below apply to plans that have elected to use Aetna Pharmacy to manage the fulfillment and the prescription of specialty drugs.

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary, Ganirelix AC, Cetrotide, chorionic gonadotropin, novarel, pregnyl, Ovidrel, Bravelle, Follistim AQ, Gonal-F/Gonal-F RFF, Menopur and Repronex,  are subject to precertification.  If precertification requirements apply Aetna considers these drugs to be  medically necessary for those members who meet the following precertification criteria:

    For Female Members: Ganirelix AC and Cetrotide  

    • A documented diagnosis of prevention of premature LH surge in women  undergoing assisted reproduction techniques (ART) i.e. allowing the follicles to mature for planned oocyte collection

    For Female Members:  chorionic gonadotropin, novarel, pregnyl, Ovidrel, Bravelle, Follistim AQ, Gonal-F/Gonal-F RFF, Menopur, and Repronex

    • A documented diagnosis of any of the following:
      • Clomiphene plus gonadotropins may be considered medically necessary in women who do not ovulate using clomiphene alone
      • For use in pituitary down-regulation as part of in vitro fertilization treatment (Note: coverage of gonadotropins for this indication is limited to plans that cover advanced reproductive technologies. Please check benefit plan descriptions for details.)
      • Pulsatile administration of gonadotropins are considered medically necessary for women with WHO Group I ovulation disorders (hypothalamic pituitary failure, characterized by hypothalamic amenorrhea or hypogonadotropic hypogonadism)
      • Women with WHO Group II ovulation disorders such as polycystic ovary syndrome who do not ovulate with clomiphene citrate or tamoxifen

    AND

    • A documented Contraindication or Intolerance or Allergy or Failure of an adequate trial of one month each of two preferred gonadotropins - For Repronex and Follistim AQ only

    For Male Members: Bravelle, Follistim AQ, Gonal-F, Gonal-F RFF, Menopur, Repronex

    • A documented diagnosis of use with human chorionic gonadotropin (hCG) for the induction of spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure AND
    • A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of 2 preferred gonadotropins (For Follistim AQ and Repronex only)

    For Male Members: hCG, novarel, and pregnyl

    • A documented diagnosis of one of the following:
      • male infertility due to hypogonadotropic hypogonadism (select cases of hypogonadism secondary to pituitary deficiency); or
      • prepubertal cryptorchidism not due to anatomic obstruction.

     

  3. Medical Exception Criteria
  4. Follistim AQ and Repronex are currently listed on the Aetna Formulary Exclusions List.* Therefore, Follistim AQ,  and Repronex are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers these drugs to be medically necessary for those members who meet any of the following criteria:

    For Female Members 

    • A documented diagnosis of any of the following:
      • Clomiphene plus gonadotropins may be considered medically necessary in women who do not ovulate using clomiphene alone
      • For use in pituitary down-regulation as part of in vitro fertilization treatment (Note: coverage of gonadotropins for this indication is limited to plans that cover advanced reproductive technologies. Please check benefit plan descriptions for details.)
      • Pulsatile administration of gonadotropins are considered medically necessary for women with WHO Group I ovulation disorders (hypothalamic pituitary failure, characterized by hypothalamic amenorrhea or hypogonadotropic hypogonadism)
      • Women with WHO Group II ovulation disorders such as polycystic ovary syndrome who do not ovulate with clomiphene citrate or tamoxifen

    AND

    • A documented Contraindication or Intolerance or Allergy or Failure of an adequate trial of one month each of two preferred gonadotropins

    For Male Members

    • A documented diagnosis of use with human chorionic gonadotropin (hCG) for the induction of spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure AND
    • A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of 2 preferred gonadotropins

     


Special Notes:

Note: Growth hormone for infertility treatment is considered experimental and investigational. There is inadequate evidence that the use of adjuvant growth hormone treatment during ovulation induction improves pregnancy rates.

Note: Intravenous immunoglobulins are considered experimental and investigational for treatment of infertility.

Note: Cetrotide, Ganirelix, Luveris, and Ovidrel use in males is considered experimental and investigational for any use including, but not limited to, male infertility

Note: hCG, novarel, and pregnyl use in males or females is considered experimental and investigational for any use except those conditions listed above

Definitions: 

For purposes of this policy, the following definitions will be used:

Classification of ovulatory disorders

Anovulation and oligo-ovulation are ovulatory disorders that are estimated to cause 21% of female fertility problems. The World Health Organization classifies ovulation disorders into three groups

  • Group I: hypothalamic pituitary failure (hypothalamic amenorrhoea or hypogonadotrophic hypogonadism)
  • Group II: hypothalamic pituitary dysfunction (predominately polycystic ovary syndrome)
  • Group III: ovarian failure


Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. American Society for Reproductive Medicine (ASRM). Guidelines for the provision of infertility dervices. ASRM Guidelines. Birmingham, AL: ASRM; July 1996.
7. American Society for Reproductive Medicine. Fertility preservation and reproduction in cancer patients. Fertil Steril. 2005;83(6):1622-1628.
8. World Health Organization (WHO). WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interaction. 4th ed. Cambridge, UK: Cambridge University Press; May 1999.
9. World Health Organization (WHO). WHO Manual for the Standardized Investigation, Diagnosis and Management of the Infertile Male. Cambridge, UK: Cambridge University Press; 2000.
10. World Health Organization (WHO). Current Practices and Controversies in Assisted Reproduction. Report of a Meeting on “Medical, Ethical and Social Aspects of Assisted Reproduction”, WHO Headquarters, Geneva, Switzerland, 17-21 September 2001. E Vayena, PJ Rowe, PD Griffin, eds. Geneva, Switzerland: WHO; 2002. Available at: http://www.who.int/reproductive-health/infertility/
report_content.htm. Accessed June 16, 2005.
11. Howles CM, Saunders H, Alam V, Engrand P; The FSH Treatment Guidelines Clinical Panel. Predictive factors and a corresponding treatment algorithm for controlled ovarian stimulation in patients treated with recombinant human follicle stimulating hormone (follitropin alfa) during assisted reproduction technology(ART) procedures. An analysis of 1378 patients. Curr Med Res Opin. 2006;22(5):907-18.

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.

March 28, 2013
email this page   
Aetna
Skip Past Footer Links
Company Information   |   Site Map Aetna.com Home   |   Help   |   Contact Us   |   Search
Web Privacy Statement   |   Legal Statement   |   Privacy Notices   |   Member Disclosure

Back to top