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MP 5.01.14 Combined Androgen Blockade for the Treatment of Metastatic Prostate Cancer

Medical Policy
Section
Prescription Drug
Original Policy Date
12/1/99
Last Review Status/Date
Reviewed with literature search/1:2003
Issue
1:2003
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Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

The initial therapy of prostate cancer with either regional or distant metastases focuses on androgen suppression. Androgen suppression can be achieved surgically with bilateral orchiectomy or medically with the use of drugs that either suppress the production of androgens (i.e., luteinizing hormone-releasing hormone (LHRH] agonists) or drugs that block their effect at the tissue level (i.e., antiandrogen). Medical approaches are generally preferred over orchiectomy due both to patient preferences and to the fact that 10%–15% of circulating androgens are produced by the adrenal glands.

LHRH agonists commercially available in the United States include leuprolide acetate (i.e., Lupron) or goserelin acetate (Zoladex). LHRH agonists are given either intramuscularly or intranasally and function by down regulating the androgen receptors. However, until the down regulation occurs, which may take 2 to 3 weeks, the LHRH agonists will function as agonists and may cause short-term disease flares, characterized by tumor growth or an increase in pain related to bone metastases. Therefore, when LHRH agonists are initiated as a treatment of prostate cancer, they are combined with antiandrogens on a short-term basis to prevent disease flares.

 

Antiandrogens commercially available in the United States include flutamide (Eulexin), bicalutamide (Casodex), and nilutamide (Nilandron). Antiandrogens are given orally. It should be noted that the U.S. Food and Drug Administration’s (FDA) labeled indication for flutamide and bicalutamide states that these drugs can be used in combination therapy with an LHRH agonist in the treatment of prostate cancer. The FDA-labeled indication for Nilutamide states that it can be used in combination with surgical castration for the treatment of metastatic prostate cancer.

 

Note: This policy only addresses the medical necessity of combined androgen blockade and not the medical necessity of either LHRH agonists or antiandrogens alone. In addition, this policy focuses on metastatic prostate cancer and does not address the use of combined androgen blockade in neoadjuvant treatment of prostate cancer.


Policy

Combined androgen blockade may be considered medically necessary as a treatment for metastatic prostate cancer only on a short-term basis (2–3 weeks) at the initiation of therapy with an LHRH agonist to prevent disease flares.

Compared to monotherapy with an LHRH agonist or an antiandrogen alone, long-term combined androgen blockade using a combination of an LHRH agonist with an antiandrogen may be considered not medically necessary in the treatment of prostate cancer.


Policy Guidelines

Long-term combined androgen blockade is a common treatment strategy. Therefore, this policy may be best used as the basis for physician profiling and education.


Benefit Application

BlueCard/National Account Issues

Long-term combined androgen blockade is a common treatment strategy. Therefore, this policy may be best used as the basis for physician profiling and education.


Rationale

This policy is based on a technology assessment published by the Agency for Health Care Policy and Research (AHCPR; renamed Agency for Healthcare Research and Quality, AHRQ). (1) The Assessment was performed by the Technology Evaluation Center of BCBSA acting in its capacity as an AHCPR-designated Evidence-based Practice Center. This Assessment examined the data regarding the effectiveness and quality of life of long-term combined androgen blockade compared to monotherapy using orchiectomy or an LHRH agonist. The following conclusions were offered:

Long-Term Combined Androgen Blockade

  • There is no statistically significant difference in survival at 2 years between patients treated with combined androgen blockade or monotherapy. Meta-analysis of the limited data available shows a statistically significant difference in survival at 5 years in favor of combined androgen blockade. However, the magnitude of this difference is of questionable clinical significance.
  • For patients in a subgroup with a good prognosis, there is no statistically significant difference in survival between combined androgen blockade and monotherapy.
  • There is no statistically significant difference in survival among patients given combined androgen estrogens and different nonsteroidal antiandrogens.

Monotherapy

  • There is no statistically significant difference in survival among patients treated with different LHRH agonists.
  • The evidence shows a trend toward lower survival after nonsteroidal antiandrogens used as monotherapy than after orchiectomy or LHRH agonists.
  • LHRH agonists and nonsteroidal antiandrogens differ in their adverse effects. The evidence on differences in adverse effects among the agents within each class is limited, but does not suggest that one agent is superior to the others.

Quality of Life

  • The evidence comparing adverse effects is limited, but favors monotherapy over combined androgen blockade. Evidence comparing quality of life was available from only 1 study and also favored monotherapy
  • There is insufficient evidence to compare the effects of the various monotherapies on quality of life.

2003 Update

 

For the 2003 update, a search of the peer-reviewed literature on MEDLINE, extending from January 2001 to January 2003, failed to identify any randomized clinical studies that would change the above conclusions; therefore, the policy statement is unchanged.

References:

  1. AHCPR Evidence Report/Technology Assessment No.4. Relative Effectiveness and Cost-Effectiveness of Methods of Androgen Suppression in the Treatment of Advanced Prostatic Cancer. AHCPR publication No. 99-B012. (This report is available free of charge from the Agency for Healthcare Research and Quality Publications Clearinghouse by calling 1.800.358.9295. The report is also available on the Internet at www.ahrq.gov.)

 

Codes

Number

Description

CPT  90772  Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular (new code effective 1/1/06) 
ICD-9 Procedure     
ICD-9 Diagnosis  185  Prostate cancer 
HCPCS  J1950  Injection, leuprolide acetate (for depot suspension), per 3.75 mg 
  J9202  Goserelin acetate implant, per 3.6 mg 
Type of Service  Prescription drug 
Place of Service  Physician office (i.e., injection) 


Index

Casodex, Combined Androgen Blockade
Combined Androgen Blockade
Eulexin, Combined Androgen Blockade
Lupron, Combined Androgen Blockade
Nilandron, Combined Androgen Blockade
Prostate Cancer, Treatment with Combined Androgen Blockade
Zoladex, Combined Androgen Blockade  


Policy History

Date Action Reason
12/1/99 Add to Prescription section New Policy
8/15/01 Replacement Policy Policy revised to clarify use of short term androgen blockade
04/29/03 Replace Policy Policy updated; no change in policy statement
12/14/05 Replace Policy – coding update only CPT coding updated


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