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COMBINED ANDROGEN BLOCKADE FOR THE TREATMENT OF PROSTATE CANCER MED201.015 _____________________________________________________________________ COVERAGE: Combined Androgen Blockade using a combination of a luteinizing hormone-releasing hormone agonist with an antiandrogen is not eligible for coverage, as this form of treatment of prostate cancer is considered investigational. _____________________________________________________________________ DESCRIPTION: Prostate cancer is a hormone sensitive tumor in that prostate cancer cells need the hormone testosterone to grow and divide. When testosterone is removed, the majority of the cells die. However, a few prostate cancer cells remain and can grow without the stimulation provided by testosterone (hormone insensitive). With time these few cells can grow and metastasize. The testis produce approximately 90% of the body's testosterone and the balance is produced by the adrenal gland. Several strategies have been devised to rid the body of testosterone and therefore slow down the growth of prostate cancer. Androgen (generic term for testosterone) suppression can be achieved surgically by the bilateral removal of the testes (orchiectomy) or medically with the use of drugs that either suppress the production of androgens (luteinizing hormone-releasing hormone [LHRH] agonist) OR drugs that block their effect at the prostate tissue level (anti-androgens). Combined Androgen Blockade (CAB) is a common treatment strategy to obstruct the adrenal and testicular testosterone formation by: 1. 2. combining an orchiectomy with an anti-androgen or simultaneously administering a LHRH agonist AND an antiandrogen. Pharmaceutical CAB is preferred by patients over the surgical intervention as pharmaceutical therapy blocks approximately the 10% of the circulating androgens without serious side effects. LHRH agonists, given intramuscularly or intranasally, include: • • Leuprolide acetate (Lupron), or Goserelin acetate (Zoladex). Anti-androgens (nonsteroidal agents), given orally, include: • • • Flutamide (Eulexin) - FDA labeled indications lists use with LHRH for treatment of prostate cancer, Bicalutamide (Casodex) - FDA labeled indications lists use with LHRH for treatment of prostate cancer, or Nilutamide (Nilandron) - FDA labeled indications lists use with orchiectomy for treatment of metastatic prostate cancer. NOTE: This policy addresses the combined use of LHRH agonists AND antiandrogens compared to the surgical intervention with LHRH agonists. However, the policy does not address the use of either LHRH agonist OR anti-androgens ALONE. _____________________________________________________________________ RATIONALE: The treatment of metastatic prostate cancer is controversial. The controversy exists over what type of treatment to initiate, when to initiate these treatments, and what type of hormonal therapy to use. One controversy is whether or not the addition of an anti-androgen provides additional benefit to an orchiectomy or just to LHRH therapy. Theoretically, CAB is sound, but further clinical testing is necessary to determine the efficacy of the treatment. Currently CAB does not surpass the greater benefits of monotherapy (a single treatment course). There is no statistically significant difference in survival at two years between patients treated with CAB and those with monotherapy. At five years, the limited data shows a slight favor when using CAB. There is insufficient evidence to determine whether to start testosterone suppression when advance prostate cancer is detected or wait until symptoms develop, thereby sparing the patient of serious side effects (such as impotence). The evidence comparing adverse effects is limited, but favors monotherapy over CAB. Evidence comparing quality of life also favored monotherapy over CAB. _____________________________________________________________________ DISCLAIMER: State and federal law, as well as contract language, including definitions and specific inclusions/exclusions, takes precedence over Medical Policy and must be considered first in determining coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Any benefits are subject to the payment of premiums for the date on which services are rendered. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. HMO Blue Texas physicians who are contracted/affiliated with a capitated IPA/medical group must contact the IPA/medical group for information regarding HMO claims/reimbursement information and other general polices and procedures. ______________________________________________________________________ Blue Cross and Blue Shield of Texas, a Division of Health Care Service Corporation, a Mutual Legal Reserve Company* Southwest Texas HMO, Inc.* d/b/a HMO Blue Texas * Independent Licensees of the Blue Cross and Blue Shield Association ______________________________________________________________________ Posted Jan. 7, 2003