Drug Therapy Guidelines: Injectable Fertility Medications

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1 Drug Therapy Guidelines: Injectable Fertility Medications Effective Date: 11/20/07 Committee Review Date: 7/12/00, 5/8/01, 1/15/02, 5/6/0, 12/16/0, 6/8/04, 12/16/05, 2/1/06, 10/15/06, 7/20/07, 11/5/07 Policy Statements: Non-Formulary or Prior Authorization drugs will require an appropriate trial of a Formulary agent(s) based on clinical criteria. Members with a closed Formulary (2 Tier) prescription benefit are limited to use of Formulary agents only. A therapeutic trial of samples of a Non-Formulary or Prior Authorization agent will not be accepted as appropriate. Please be sure to list all therapies that have been previously tried on the request form so that your request can be processed in a timely manner. Artificial means to induce pregnancy such as IVF (in-vitro fertilization), GIFT (gamete intra-fallopian transfer), embryo transfer, and costs related to the processing/acquisition of donor sperm sample are NOT covered under ANY BlueCross BlueShield of Western New York contract. In most cases, injectable fertility drugs used in any of these procedures are also NOT covered. These exclusions also apply to unmanaged contracts per the NYS Infertility Mandate. The New York State Infertility Mandate supports coverage for women 21 through 44 years of age only. What they Do and How they are Used: Gonadotropin Releasing Hormone (GnRH) Agonists for inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation. GnRH Antagonists for inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation. Gonadotropins, FSH or combination of FSH/LH for stimulation of ovarian follicular growth. Human Chorionic Gonadotropin (hcg) HCG for induction of ovulation. Rationale for Prior Authorization: To provide coverage for injectable fertility medications for induction of ovulation and pregnancy in the anovulatory infertile patient, where the cause of anovulation is functional (for example, polycystic ovarian disease PCOS) and not caused by primary ovarian failure. Benefit Design: Coverage is determined through a prior authorization process for every claim.

2 Therapeutic Class Antiestrogens Gonadotropin Releasing Hormone (GnRH) Agonists GnRH Antagonists Injectable Fertility Medications Agents Clomid, Serophene, clomiphene generics Lupron ~12.5mg/vial Leuprolide generics Cetrotide 0.25mg/mg Ganirelix 0.25mg Cycle limit Quantity Limits 28 days 5 day supply (i.e tablets) Gonadotropins Follitropin alfa: Gonal-F ~75,450,1050u FSH Gonal-F RFF ~00,450,900u FSH Follitropin beta: Follistim AQ 150,00,600,900u FSH Menotropins: Menopur 75u FSH/LH Repronex 75 or 150 FSH/LH Urofollitropins: Bravelle 75units FSH Lutropin alfa Luveris 75u lutropin Quantity Limits vary based on product selection Human Chorionic Gonadotropin (hcg) Ovidrel (r-hcg) 250µg Novarel, 10K Chorex-10, 10K Profasi, 5K/10K Pregnyl 10K Chorionic gonadotropin,generics 5K, 10K, 20K 1 vial Recommended Guidelines for Female Infertility: Sequential use of injectable fertility drugs to stimulate ovulation will be considered after there is documented treatment failure of oral ovulation induction agents or there is a reasonable expectation that the oral agents will be ineffective. of sequential hormonal therapy (maximum of three of menotropin, urofollitropin or follitropin) and/or GNRH antagonist will be approved when the below criterion are met. This is based on expected success rates for patients who will respond to hormonal fertility therapy. Extended coverage will be determined on a case by case medical review to determine medical necessity. Requested quantities beyond the standard amount will be considered on a case-by-case basis. The cycle limit can either be therapy with one agent for or a mix of these agents for. In situations where a course of therapy is cancelled mid-course, one additional cycle of sequential hormonal therapy will be considered. Prior Authorization Criteria: Coverage for injectable fertility medications is provided for a maximum of three when ONE of the following conditions is met (submission of office notes required): Documented clomiphene failure as defined below:

3 a) failure to become pregnant after ovulatory of therapy, or b) failure to ovulate after consecutive of clomiphene Documented severe (stage 4) endometriosis Documented failure of first-line ovulation induction agents to include six (6) months of: a) Bromocriptine for women with hyperprolactinemia, or b) Prednisone for those with abnormal corticotropin stimulation tests. Women with evidence of diminished ovarian function (DOR) such as a documented elevation in day FSH level (above miu/ml). This is based on the extremely low rate of conception (with or without clomiphene alone) and high reproductive loss associated with an elevated FSH level. Insufficient endogenous LH surge* or lack of ovulatory activity per ultrasound after clomiphene challenge, will be approved for up to of HCG to be taken with oral clomiphene. Trials of clomiphene alone will not be required for these patients. *Insufficient LH surge is determined with the use of home kits that detect the increased level of LH in the urine (eg. Clear Blue Easy) Documented HA (hypothalamic amenorrhea), will be approved for up to of gonadotropin therapy. These patients will not ovulate with clomiphene alone due to the mechanism of the drug. Documented history of ovulatory failure with clomiphene (ie. did not ovulate using several repeated of the drug) or those who have experienced intolerable / untoward side effects from clomiphene. Prior to starting sequential hormone therapy: An infertility work-up needs to be performed (if not previously done). Primary ovarian failure or tubal obstruction should be ruled out. Complete semen analysis should be performed. a) Subsequent swim-up test, should be performed after unsuccessful using clomiphene or if any abnormality is seen with the initial analysis (ie. diminished volume, motility, abnormal shape). b) If the analysis shows severe oligoospermia (<2 million motile sperm after swimup) or azoospermia (undetectable motile/mature sperm), sequential hormone therapy should not be offered. Early pregnancy should be ruled out. An endometrial biopsy should be obtained if not already done for patients who have been anovulatory for more than 6 months. Prior Authorization Criteria for Male Infertility: Coverage for injectable fertility medications is provided when ONE of the following conditions is met: Follitropin (ie. Gonal-F, Follistim AQ ) will be approved ONLY for infertile males with a diagnosis of hypogonadotropic hypogonadism (secondary hypogonadism) where the cause of infertility is not primary testicular failure. a) Follitropin must be given in conjunction with hcg. b) Pretreatment with hcg alone is required at a dose from 1000 to 2250 units 2 to times/week and may be required for to 6 months to achieve normal testosterone levels. c) After normal serum testosterone levels are reached, the recommended dose of follitropin alfa is 150 IU administered SC times/week and the recommended dose of hcg is 1000 units (for the dose required to maintain serum testosterone levels within the normal range) times/week.

4 d) Members will be approved for 4 months of therapy and will require reevaluation after that time. Consideration will be granted for extended therapy if requested by a fertility specialist. hcg will be approved ONLY for infertile males with a diagnosis of hypogonadotropic hypogonadism. a) The dosage range is 500-5,000 IU IM 2- times a week for 6-9 months or a period of time sufficient to achieve serum testosterone levels within normal range or appropriate masculinization (ie appearance of secondary sex characteristics). b) Members will be approved for 6 months of therapy and will require reevaluation after that time. Consideration will be granted for extended therapy if requested by a fertility specialist. Menotropins will be approved for infertile males with a diagnosis of hypogonadotropic hypogonadism ONLY AFTER at least a 6 month treatment with hcg is tried. a) Menotropins 1 amp (ie. Pergonal or Repronex 75 or 150 IU) x / week with hcg 2,000 units twice a week will be approved for 4 months. b) Reevaluation will be required after that time and consideration will be granted for extended therapy if requested by a fertility specialist. Prior to starting sequential hormone therapy: Semen analysis should be performed. If the analysis shows axoospermia (< million motile sperm after swim-up), sequential hormone therapy should not be offered. Coverage Duration: Quantity limits and length of coverage vary according to product selection, as outlined above. References: 1. Al-Inany H. Gonadotropin-releasing hormone anatgonists for assisted conception (Cochrane Review) Cochrane Library 4, Al-Inany H. GnRH antagonist in assisted reproduction (Cochrane Review) Cochrane Library 2002; Vol 17(4): Bates GW, Bates SR, The economics of infertility: Developing an infertility managedcare plan. Am J Obstet Gynecol 1996; 174(4): Bouloux, P, Warne, D, et al. Efficacy and safety of recombinant human folliclestimulating hormone in men with isolated hypogonadotropic hypogonadism. Fertility and Sterility Feb 2002; 77(2): Consultation with fertility specialists in the WNY area. 6. Depenbusch, M, et al. Maintenance of spermatogenesis in hypogonadotropic hypogonadal men with human chorionic gonadotropin alone. Eur J Endocrinol Nov 2002; 147(5): Drug Facts and Comparisons. St. Louis Fertinex Product Information. Serono Labaratories. 9. Follistim Product Information. Organon Labaratories. 10. Gonal-F Product Information. Serono Labaratories. 11. Guzick, David et al. Efficacy of treatment for unexplained infertility, Fertility and Sterility August 1998, Vol 70, No.2, pages Humegon Product Information. Organon Labaratories. 1. Management of Infertility caused by ovulatory dysfunction, Practice Bulletins- Gynecology #4. Obstet Gynecol 2002; 99: Ovulation induction, infertility and ovarian cancer risk. Fertility and Sterility Oct. 1996; 66(4): Pergonal Product Information. Serono Labaratories. 16. Profasi Product Information. Serono Labaratories.

5 17. Repronex Product Information. Ferring Pharm. 18. Speroff L, Glass RH, Kase K. Clinical Gynecologic Endocrinology and Infertility. Fifth ed. Baltimore, MD: Williams and Wilkins; 1994, Chapters 0 and