Close Window
Aetna Medicare
Aetna Aetna
Pharmacy Clinical Policy Bulletins
Aetna Medicare Prescription Drug Plan
Subject: Gonadotropin-Releasing Hormone Analogs/Antagonists

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
Gonadotropin-Releasing Hormone Analogs
C leuprolide injection   X          
C Zoladex®  (goserelin implant)   X       X  
NC Lupron®  (leuprolide acetate)   X       X  
NC Lupron Depo®  (leuprolide acetate)   X       X  
NC Lupron Dep-Ped ®  (leuprolide Acetate)   X       X  
NC Eligard®  (leuprolide acetate)   X       X  
NC Trelstar® LA  (triptorelin pamoate)   X       X  
NC Trelstar® Depo  (triptorelin pamoate)   X       X  
NC Vantas®  (histrelin acetate)   X       X  
NC Viadur®  (leuprolide acetate implant)   X       X  
Gonadotropin-Releasing Hormone Antagonists
NC Plenaxis®  (abarelix)   X       X  


Policy:

  1. Precertification Criteria

    2. Under some plans, including plans that use an open or closed formulary, leuprolide, Lupron, Lupron Depo, Lupron Depot Ped ,Viadur, Eligard, Plenaxis, Trelstar LA, Trelstar Depo Vantas, and Zoladex are subject to precertification. If precertification requirements apply Aetna considers leuprolide, Lupron, Lupron Depo, Lupron Depot Ped ,Viadur, Eligard, Plenaxis, Trelstar LA, Trelstar Depo Vantas, and Zoladex to be medically necessary for those members who meet the following precertification criteria:

    For leuprolide, Lupron, Lupron Depot, Lupron Depot Ped, Eligard and Viadur

    A documented diagnosis of:

    • Endometriosis (see appendix)  OR
    • To decrease fibroid size prior to surgery (see appendix). OR
    • To decrease endometrial thickness prior to endometrial ablation (see appendix). OR
    • For palliative treatment of members with advanced (Stage III or Stage IV) prostate cancer that has metastasized or has recurred after treatment, or member refuses orchiectomy (see appendix). OR
    • For true (central) precocious puberty, defined as sexual maturation before age 8 in girls and age 10 in boys, and tumor has been ruled out by lab tests, CT, MRI, or ultrasound (see appendix). OR
    • For treatment of metastatic breast cancer, when the member is pre-menopausal and the disease has progressed or recurred after a trial of at least 3 months of tamoxifen (see appendix). OR
    • To suppress onset of puberty in cases where the adolescent meets medical necessity criteria for growth hormone supplementation and has early onset of puberty and is not within target growth range (within 1 standard deviation of mean height for age and sex) (see appendix). OR
    • For the treatment of women with chronic refractory pelvic pain (see appendix).

    NOTE:      Aetna considers Lupron experimental and investigational for any of the following conditions since limited information has been published and further research including randomized, controlled trials is required to determine its efficacy:

    • Precocious pubarche alone, or pseudoprecocious puberty (gonadotropin independent precocious puberty); or
    • Polycystic ovarian disease; or
    • Pre-menstrual syndrome; or
    • Endometrial cance; or
    • Ovarian cancer

    For Zoladex

    A documented diagnosis of:

    • Advanced (metastatic) prostatic carcinoma; OR
    • Advanced (metastatic) breast cancer in pre-menopausal members; OR
    • Endometriosis, Stage III or IV; OR
    • Uterine fibroids (leiomyoma uteri) (preoperative adjunct to surgical treatment) (short-term (less than 6 months) use); OR
    • Endometrial ablation or hysterectomy (preoperative adjunct) (short-term (less than 6 months) use)

    For Plenaxis

    A documented diagnosis of:

    • Treatment of the symptoms of men with advanced prostate cancer who cannot take other hormone therapies and who have refused surgical castration

    For Vantas

    A documented diagnosis of:

    • Palliative treatment of advanced prostate cancer

    For Trelstar LA and Trelstar Depo

    A documented diagnosis of:

    • Palliative treatment of advanced prostate cancer
  2. Medical Exception Criteria

    3. Lupron, Lupron Depo, Lupron Depot Ped, Viadur, Eligard, Plenaxis, Trelstar, Vantas and Zoladex are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* Therefore, they 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 Lupron, Lupron Depo, Lupron Depot Ped, Viadur, Eligard, Plenaxis, Trelstar, Vantas and Zoladex to be medically necessary for those members who meet any of the following criteria:

    For Lupron, Lupron Depot, Lupron Depot Ped, Eligard, and Viadur

    A documented diagnosis of:

    • Endometriosis (see appendix)  OR
    • To decrease fibroid size prior to surgery (see appendix). OR
    • To decrease endometrial thickness prior to endometrial ablation (see appendix). OR
    • For palliative treatment of members with advanced (Stage III or Stage IV) prostate cancer  that has metastasized or has recurred after treatment, or member refuses orchiectomy  (see appendix). OR
    • For true (central) precocious puberty, defined as sexual maturation before age 8 in girls  and age 10 in boys, and tumor has been ruled out by lab tests, CT, MRI, or ultrasound (see  appendix). OR
    • For treatment of metastatic breast cancer, when the member is pre-menopausal and the  disease has progressed or recurred after a trial of at least 3 months of tamoxifen (see  appendix). OR
    • To suppress onset of puberty in cases where the adolescent meets medical necessity  criteria for growth hormone supplementation and has early onset of puberty and is not  within target growth range (within 1 standard deviation of mean height for age and sex)  (see appendix). OR
    • For the treatment of women with chronic refractory pelvic pain (see appendix).

    NOTE:      Aetna considers Lupron experimental and investigational for any of the following conditions since limited information has been published and further research including randomized, controlled trials is required to determine its efficacy:

    • Precocious pubarche alone, or pseudoprecocious puberty (gonadotropin independent precocious puberty); or 
    • Polycystic ovarian disease; or
    • Pre-menstrual syndrome; or
    • Endometrial cancer; or
    • Ovarian cancer

    For Zoladex

    A documented diagnosis of:

    • Advanced (metastatic) prostatic carcinoma; OR
    • Advanced (metastatic) breast cancer in pre-menopausal members; OR
    • Endometriosis, Stage III or IV; OR
    • Uterine fibroids (leiomyoma uteri) (preoperative adjunct to surgical treatment)   (short-term (less than 6 months) use); OR
    • Endometrial ablation or hysterectomy (preoperative adjunct) (short-term (less than   6 months) use). 

    For Plenaxis

    A documented diagnosis of:

    • Treatment of the symptoms of men with advanced prostate cancer who cannot take  other hormone therapies and who have refused surgical castration.

    For Vantas

    A documented diagnosis of:

    • Palliative treatment of advanced prostate cancer

    For Trelstar LA and Trelstar Depo

    A documented diagnosis of:

    • Palliative treatment of advanced prostate cancer.
* Coverage is provided through a Medicare Prescription Drug Plan Sponsor with a Medicare contract and benefits, limitations, service areas and premiums are subject to change on January 1 of each year.

Place of Service:

Outpatient

The above policy is based on the following references:
  1. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
  2. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
  3. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
  4. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
  5. Fick DM, Cooper JW, Wade WE, et al.  Updating the Beers criteria for potentially inappropriate medication use in older adults.  Arch Intern Med. 2003;163:2716-24.
  6. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.
  7. Klasco RK (Ed): DRUGDEX® System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: April 14, 2005).
  8. Higham JM. The medical management of menorrhagia. Br J Hosp Med. 1991;45:19-21.
  9. Schriock ED. Practical aspects of pulsatile gonadotropin-releasing hormone administration. Am J Obstet Gynecol. 1990;163(5):1765-1770.
  10. Gompel A, Mauvais-Jarvis P. Induction of ovulation with pulsatile GnRH in hypothalamic amenorrhoea. Hum Reprod. 1988;3(4):473-477.
  11. Macdonald R. Modern treatment of menorrhagia. Br J Obstet Gynecol. 1990;97:3-7.
  12. Dodson WC, Hughes CL, Whitesides DB, et al. The effect of leuprolide acetate on ovulation induction with human menopausal gonadotropins in polycystic ovary syndrome. J Endocrin Metab. 1987;65(1):95-100.
  13. Adamson GD. Treatment of uterine fibroids: Current findings with gonadotropin-releasing hormone agonists. Am J Obstet Gynecol. 1992;166(2):746-751.
  14. Brooks PG, Serden SP. Preparation of the endometrium for ablation with a single dose of leuprolide acetate depot. J Reprod Med. 1991;36(7):477-478.
  15. Shaw RW, Fraser HM. Use of a superactive luteinizing hormone releasing hormone agonist in the treatment of menorrhagia. Br J Obstet Gynecol. 1984;91:913-916.
  16. Schrlock ED. GnRH agonists. Clin Obstet Gynecol. 1989;32(3):550-563.
  17. Hodgen GD. General applications of GnRH agonists in gynecology: Past, present and future. Obstet Gynecol Surv. 1989;44(5):293-296.
  18. McEvoy GK, ed. American Hospital Formulary Service Drug Information 92. Bethesda, MD: American Society of Hospital Pharmacists, Inc.; 1992.
  19. Bennett DR, ed. AMA Drug Evaluations Subscription. Chicago, IL: American Medical Association; Winter 1992.
  20. Schrlock ED. GnRH agonists. Clin Obstet Gynecol. 1989;32(3):550-563.
  21. Bucci KK, Carson DS. Contraception and infertility. In: Pharmacotherapy: A Pathophysiological Approach. JT Dipiro, RL Talbert, PE Hayes, et al, eds. Norwalk, CT: Appleton & Lange; 1993:1211-1130.
  22. U.S. Pharmacopeial Convention, Inc. (USPC). USP Dispensing Information. Volume I -- Drug Information for the Healthcare Professional. 18th ed. Rockville, MD: USPC; 1998.
  23. Medical Economics, Inc. Physicians' Desk Reference. 52nd ed. Montvale, NJ: Medical Economics Data Production; 1998.
  24. Mosby-Year Book, Inc. Mosby's GenRx: The Complete Reference for Generic and Brand Drugs. 8th ed. St. Louis, MO: Mosby; 1998.
  25. American Hospital Formulary Service (AHFS). AHFS Drug Information 98. Bethesda, MD: American Society of Health-System Pharmacists; 1998.
  26. Levitsky AM. Pharmacologic treatment of hypersexuality and paraphilias in nursing home residents. J Am Geriatr Soc. 1999;47(2):231-234.
  27. Vilos GA, Lefebvre G, Graves GR, et al. Guidelines for the management of abnormal uterine bleeding. SOCG Clinical Practice Guidelines No. 106. J Obstet Gynaecol Can. 2001;23(8):704-709.
  28. Duckitt K. Menorrhagia. In: Clinical Evidence, Issue 9. London, UK: BMJ Publishing Group, Ltd.; June 2003.
  29. Lethaby A, Hickey M. Endometrial destruction techniques for heavy menstrual bleeding. Cochrane Database Syst Rev. 2002;(2):CD001501.
  30. Sowter MC, Lethaby A, Singla AA. Pre-operative endometrial thinning agents before endometrial destruction for heavy menstrual bleeding. Cochrane Database Syst Rev. 2002;(3):CD001124.

Precocious Puberty

  1. Brenner PE. Precocious puberty in the female. In: Reproductive Endocrinology, Infertility and Contraception. DR Mishell, VC Davajan, eds. Philadelphia, PA: FA Davis Co.; 1979.
  2. Partsch CJ, Sippell WG. Treatment of central precocious puberty. Best Pract Res Clin Endocrinol Metab. 2002;16(1):165-189.
  3. Mul D, Wit JM, Oostdijk W, et al. The effect of pubertal delay by GnRH agonist in GH-deficient children on final height. J Clin Endocrinol Metab. 2001;86(10):4655-4656.
  4. Cara JF, Kreiter ML, Rosenfield RL. Height prognosis of children with true precocious puberty and growth hormone deficiency: Effect of combination therapy with gonadotropin releasing hormone agonist and growth hormone. J Pediatr. 1992;120(5):709-715.

Pelvic Pain

 

  1. ACOG Committee on Practice Bulletins -- Gynecology. ACOG Practice Bulletin No. 51. Chronic pelvic pain. Obstet Gynecol. 2004;103(3):589-605.
  2. Royal College of Obstetricians and Gynaecologists (RCOG). The initial management of chronic pelvic pain. RCOG Guideline No. 41. London, UK: RCOG; April 2005.

Infertility

 

  1. Albuquerque LE, Saconato H, Maciel MC. Depot versus daily administration of gonadotrophin releasing hormone agonist protocols for pituitary desensitization in assisted reproduction cycles. Cochrane Database Syst Rev. 2005;(1):CD002808.
  2. Al-Inany H, Aboulghar M. Gonadotrophin-releasing hormone antagonists for assisted conception. Cochrane Database Syst Rev. 2001;(4):CD001750.
  3. Nugent D, Vandekerckhove P, Hughes E, et al. Gonadotrophin therapy for ovulation induction in subfertility associated with polycystic ovary syndrome. Cochrane Database Syst Rev. 2000;(3):CD000410. 

Prostate cancer

  1. Wojciechowski NJ, Carter CA, Skoutakis VA, et al. Leuprolide: A gonadotropin-releasing hormone analog for the palliative treatment of prostate cancer. Drug Intell Clin Pharm. 1986;20:746-751.
  2. Debruyne F. Hormonal therapy of prostate cancer. Semin Urol Oncol. 2002;20(3 Suppl 1):4-9.
  3. National Institutes of Health. The management of clinically localized prostate cancer. National Institutes of Health Consensus Development Conference 1987 June 15-17. NCI Monogr. 1988;(7):1-174.
  4. Seidenfeld J, Samson DJ, Aronson N, et al. Relative effectiveness and cost-effectiveness of methods of androgen suppression in the treatment of advanced prostate cancer. Evidence Report/Technology Assessment No. 4. Prepared for the Agency for Healthcare Policy and Research (AHCPR) by the Blue Cross and Blue Shield Association Technology Evaluation Center. AHCPR Pub. No. 99-E0021. Rockville, MD: AHCPR; May 1999.
  5. Seidenfeld J, Samson DJ, Hasselblad V, et al. Single-therapy androgen suppression in men with advanced prostate cancer: A systematic review and meta-analysis. Ann Intern Med, 2000;132(7):566-577.
  6. Prostate Cancer Trialists' Collaborative Group. Maximum androgen blockade in advanced prostate cancer: An overview of the randomised trials. Lancet, 2000;355:1491-1498.
  7. Wilt T, Nair B, MacDonald R, Rutks I. Early versus deferred androgen suppression in the treatment of advanced prostatic cancer. Cochrane Database Syst Rev. 2001;(4):CD003506.
  8. Schmitt B, Bennett C, Seidenfeld J, et al. Maximal androgen blockade for advanced prostate cancer. Cochrane Database Syst Rev. 1999;(2):CD001526.

Leiomyomas

  1. Lefebvre G, Vilos G, Allaire C, et al. The management of uterine leiomyomas. SOGC Clinical Practice Guidelines. No. 128. Society of Obstetricians and Gynaecologists of Canada. J Obstet Gynaecol Can. 2003;25(5):396-405.
  2. Vollenhoven BJ. Uterine fibroids: A clinical review. Br J Obstet Gynecol. 1990;97:285-298.
  3. Friedman AJ. Treatment of leiomyomata uteri with short-term leuprolide followed by leuprolide plus estrogen-progestin hormone replacement therapy for 2 years: A pilot study. Fertil Steril. 1988;51(3):526-528.
  4. Farquhar C, Arroll B, Ekeroma A, et al. An evidence-based guideline for the management of uterine fibroids. Working Party of the New Zealand Guidelines Group. New Zealand Guidelines Group; November 1999.
  5. Lethaby A, Vollenhoven B, Sowter M. Pre-operative GnRH analogue therapy before hysterectomy or myomectomy for uterine fibroids. Cochrane Database Syst Rev. 2001;(2):CD000547. 

Breast cancer

  1. Olin BR. Drug Facts and Comparisons. St. Louis, MO: J.B. Lippincott Company; 1992.
  2. McEvoy GK, ed. Leuprolide. In: AHFS Drug Information. Bethesda, MD: American Society of Hospital Pharmacists; 1993:606-612.
  3. McGuire T. Breast cancer. In: Pharmacotherapy: A Pathophysiologic Approach. 2nd ed. J Dipiro, RL Talbert, PE Hayes, et al, eds. Norwalk, CT: Appleton & Lange; 1993:1930-1945.
  4. Dowsett M, Jacobs S, Aherne J, et al. Clinical and endocrine effects of leuprorelin acetate in pre- and postmenopausal patients with advanced breast cancer. Clin Ther. 1992;14 Suppl A:97-103.
  5. Manni A, Santen R, Harvey H, et al. Treatment of breast cancer with gonadotropin-releasing hormone. Endocr Rev. 1986;7(1):89-94.
  6. Harvey HA, Lipton A, Max DT, et al. Medical castration produced by the GNRH analogue leuprolide to treat metastatic breast cancer. J Clin Oncol. 1985;3(8):1068-1072.
  7. Sunderland MC, Osborne CK. Tamoxifen in premenopausal patients with metastatic breast cancer: A review. J Clin Oncol. 1991;9(7):1283-1297.
  8. No authors listed. Tamoxifen. In: Drug Evaluation Subscriptions. DR Bennett, ed. Chicago, IL: American Medical Association; 1993;5:5.

Endometriosis

  1. Henzl MR, Corson SL, Moghissi K, et al. Administration of nasal nafarelin as compared with oral danazol for endometriosis. N Engl J Med. 1988;318(8):485-489.
  2. Letassy NA, Thompson DF, Britton ML, et al. Nafarelin acetate: A gonadotropin-releasing hormone agonist for the treatment of endometriosis. DICP. 1990;24:1204-1209.
  3. Lemay A, Maheux R, Quesnel G, et al. LH-RH agonist treatment of endometriosis. Contr Gynec Obstet. 1987;16:247-253.
  4. Souney PF, Rossiter A. Focus on naferelin acetate: GnRH agonist for the management of endometriosis. Hosp Formul. 1990;25:1041-1054..
  5. Wheeler JM, Knittle JD, Miller JD. Depot leuprolide versus danazol in the treatment of women with symptomatic endometriosis. Am J Obstet Gynecol. 1992;167(1):283-291.
  6. Gerhard I, Schindler AE, Bruhler K, et al. Treatment of endometriosis with leuprorelin acetate dept: A German multicenter study. Clin Ther.1992;14(Suppl A):3-16.
  7. Crosignani PG, Gastaldi A, Lombardi PL, et al. Leuprorelin acetate depot versus danazol in the treatment of endometriosis: Results of an open multicenter trial. Clin Ther. 1992;14 (Suppl A):29-36.
  8. Tummon IS, Pepping ME, Binor Z, et al. A randomized, prospective comparison of endocrine changes induced with intranasal leuprolide or danazol for treatment of endometriosis. Fertil Steril. 1989;51(3):390-394.
  9. Fayez JA, Collazo LM, Vernon C. Comparison of different modalities of treatment for minimal and mild endometriosis. Am J Obstet Gynecol. 1988;159:927-932.
  10. Moghissi KS, Hull ME, Magyar DM, et al. Comparison of different treatment modalities of endometriosis in infertile women. Controversies Gyncec Obstet. 1987;16:236-240.
  11. Olive DL, Schwartz LB. Endometriosis. New Engl J Med. 1993;328(24):1759-1767.
  12. Saltiel E, Garabedian-Ruffal SM. Pharmacologic management of endometriosis. Clin Pharm. 1991;10:518-531.
  13. Olin BR. Drug Facts and Comparisons. St. Louis, MO: JB Lippincott Company; 1992.
  14. Schmidt CL. Endometriosis: A reappraisal of pathogenesis and treatment. Fertil Steril. 1985;44(2):157-173.
  15. Buckman RW. Endometriosis: Pharmacologic alternatives to surgery. J Pract Nurs. 1994;44(3):47-56.
  16. Rebar RW. The ovaries. In: Cecil Textbook of Medicine. 19th ed. JB Wyngaarden, LH Smith, JC Bennett, eds. Philadelphia, PA: WB Saunders Co.; 1992.
  17. Segraves R, Letassy NA. Gynecologic disorders. In: Applied Therapeutics. 5th ed. MA Koda-Kimble, LY Young, eds. Vancouver, BC: Applied Therapeutics, Inc.; 1992:70-77.
  18. Winkel CA, Scialli AR. Medical and surgical therapies for pain associated with endometriosis. J Womens Health Gend Based Med. 2001;10(2):137-162.
  19. Howard FM. An evidence-based medicine approach to the treatment of endometriosis-associated chronic pelvic pain: Placebo-controlled studies. J Am Assoc Gynecol Laparosc, 2000;7(4):477-488.
  20. Yap C, Furness S, Farquhar C. Pre and post operative medical therapy for endometriosis surgery. Cochrane Database Syst Rev. 2004;(3):CD003678.
  21. Hughes E, Fedorkow D, Collins J, Vandekerckhove P. Ovulation suppression for endometriosis. Cochrane Database Syst Rev. 2003;(3):CD000155.

Premenstrual syndrome

  1. Hussain SY, Massil JH, Matta WH, et al. Buserelin in premenstrual syndrome. Gynecol Endocrinol. 1992;6(1):57-64.
  2. Blackstrom T, Hammarback S. Premenstrual syndrome--psychiatric or gynaecological disorder? Ann Med. 1991;23(6):625-633.
  3. Mortola JF, Girton L, Fischer U. Successful treatment of severe premenstrual syndrome by combined use of gonadotropin-releasing hormone agonist and estrogen/progestin. J Clin Endocrinol Metab. 1991;72(2):252A-252F.
  4. Hammarback S, Backstrom T. Induced anovulation as treatment of premenstrual tension syndrome. A double-blind cross-over study with GnRH-agonist versus placebo. Acta Obstet Gynecol Scand. 1988;67(2):159-166.
  5. Bancroft J, Boyle H, Warner P, et al. The use of an LHRH agonist, buserelin, in the long-term management of premenstrual syndromes. Clin Endocrinol (Oxf). 1987;27(2):171-182.
  6. Muse KN, Cetel NS, Futterman LA, et al. The premenstrual syndrome. Effects of 'medical ovariectomy'. N Engl J Med. 1984;311(21):1345-1349.

Zoladex

  1. No authors listed. Endocrine drugs: Drugs used for gynecologic indications. In: Drug Evaluations Subscription. DR Bennett, ed. Chicago, IL: American Medical Association; 1993; II/ENDO-6:11-12.
  2. No authors listed. Oncolytic drugs: Antineoplastic agents: Hormonal agents. In: Drug Evaluations Subscription. DR Bennett, ed. Chicago, IL: American Medical Association; 1993; III/ONC-5:12-15.
  3. United States Pharmacopeial Convention, Inc. (USPC). Goserelin (Systemic). In: USP Dispensing Iinformation. Volume 1 - Drug Information for the Healthcare Professional, 15th ed. Rockville, MD:,USPC; 1995:1410-1411.
  4. United States Pharmacopeial Convention, Inc. (USPC). Additional products and indications In: USP Dispensing Information. Volume 1 - Drug Information for the Healthcare Professional. 15th ed. Rockville, MD: USPC; 1995:2849.
  5. Lu PY, Ory SJ. Endometriosis: Current management. Mayo Clin Proc. 1995;70:453-463.
  6. Goldhirsch A, Wood WC, Senn HJ, et al. Meeting highlights: International consensus panel on the treatment of primary breast cancer (commentary). J Natl Cancer Inst. 1995;87(19):1441-1445.
  7. Vercellini P, Fedele L, Maggi R, et al. Gonadotropin releasing hormone agonist for chronic anovulatory uterine bleeding and severe anemia. J Reprod Med. 1993;38(2):127-129.
  8. DeVita VT, Hellman S, Rosenberg SA, eds. Cancer: Principles and Practice of Oncology. 4th ed. Philadelphia, PA: JB Lippincott Co.; 1993.
  9. United States Pharmacopeial Convention, Inc (USPC). USP Dispensing Information. Volume I -- Drug Information for the Health Care Professional. Rockville, MD: USPC; 1998.
  10. American Society of Health-System Pharmacists, Inc. American Hospital Formulary Service Drug Information 98. Bethesda, MD: American Society of Health-System Pharmacists; 1998.
  11. Medical Economics, Inc. Physicians' Desk Reference. 52nd ed. Montvale, NJ: Medical Economics; 1998.
  12. Mosby-Year Book, Inc. Mosby's GenRx: The Complete Reference for Generic and Brand Drugs, 8th ed. St. Louis, MO: Mosby; 1998.
  13. Korman LB. Treatment of prostate cancer. Clin Pharm. 1989;8:412-424.
  14. Furr BA, Woodburn JR. Luteinizing hormone-releasing hormone and its analogues: A review of biological properties and clinical uses. J Endocrinol Invest. 1988;11:535-537.
  15. Hughes E, Collins J, Vandekerckhove P. Gonadotropin releasing hormone analogue as an adjunct to gonadotropin therapy for clomiphene-resistant PCOS. Cochrane Database of Systematic Reviews. Oxford, U.K.: Update Software; 1998.

Plenaxis

  1. Cook T, Sheridan WP. Development of GnRH antagonists for prostate cancer: New approaches to treatment. Oncologist. 2000;5(2):162-168.
  2. McLeod D, Zinner N, Tomera K, et al. A phase 3, multicenter, open-label, randomized study of abarelix versus leuprolide acetate in men with prostate cancer. Urology. 2001;58(5):756-761.
  3. Trachtenberg J, Gittleman M, Steidle C, et al. A phase 3, multicenter, open label, randomized study of abarelix versus leuprolide plus daily antiandrogen in men with prostate cancer. J Urol. 2002;167(4):1670-1674.
  4. Koch M, Steidle C, Brosman S, et al. An open-label study of abarelix in men with symptomatic prostate cancer at risk of treatment with LHRH agonists. Urology. 2003;62(5):877-882. 
  5. Reddy GK. Abarelix (Plenaxis): A gonadotropin-releasing hormone antagonist for medical castration in patients with advanced prostate cancer. Clin Prostate Cancer. 2004;2(4):209-2
Property of 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.

September 8, 2006
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