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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