DESCRIPTION
Cryoablation is one of several methods available to treat clinically localized prostate cancer and may be considered an alternative to radical prostatectomy or radiation therapy.
Cryosurgical ablation (cryoablation or cryosurgery) involves exposing tissues to extreme cold in order to produce well-demarcated areas of cell injury and destruction. The tissue is usually cooled below -20 degrees C. The cold is usually produced by use of a probe containing liquid nitrogen. Cryosurgical ablation may be performed as an open surgical technique, percutaneously, or laparoscopically with ultrasound, magnetic resonance imaging (MRI), or computed tomography (CT) guidance.
Subtotal prostate cryoablation is also being evaluated as a form of a more localized therapy (also referred to as a “male lumpectomy”) for small localized prostate cancers.
POLICY
Cryosurgical ablation for the treatment of prostate tumors is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Subtotal prostate cryosurgical ablation for the treatment of prostate tumors is considered investigational.
Policies with similar titles:
MEDICAL APPROPRIATENESS
Cryosurgical ablation for the treatment of prostate tumors is considered medically appropriate if ANY ONE of the following criteria are met:
Performed as an initial treatment
As salvage treatment for recurrent tumors following radiation therapy with ANY ONE of the following:
Stage T2b or below
A Gleason score < 9
A PSA < 8 ng/ml
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
The lack of randomized controlled trials and studies provide little evidence of the safety and efficacy to support the use of subtotal prostate cryosurgical ablation for the treatment of prostate tumors.
Refer to the prostate tumor staging, the Gleason score, and the prostate specific antigen (PSA) definitions located in the Glossary section of this manual.
SOURCES
Agency for Healthcare Research and Quality. (2008, February). Comparative effectiveness review No.13: Comparative effectiveness of therapies for clinically localized prostate cancer (AHRQ Publication No. 08-EHC010-EF). Retrieved March 28, 2011 from http://www.effectivehealthcare.ahrq.gov/repFiles/2008_0204ProstateCancerFinal.pdf.
American Urological Association. (2008). Best practice policy statement on cryosurgery for the treatment of localized prostate cancer. Retrieved March 28, 2011 from http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines/main-reports/cryosurgery08.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2009). Cryoablation of prostate cancer (7.01.79). Retrieved March 28, 2011 from BlueWeb. (20 articles and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Cryosurgery of prostate (NCD 230.9, p. 2-183). Ingenix.
Donnelly, B., Saliken, J., Brasher, P., Ernst, S., Rewcastle, J., Lau, H. et al. (2010) A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer. Cancer, 116 (2), 323-330. (Level 3 Evidence - Independent)
ECRI Institute. Health Technology Information Service. Evidence Reports. (2000, December). Cryosurgical ablation of the prostate (CSAP) for the primary treatment of localized prostate cancer. Retrieved March 28, 2011 from ECRI Institute. (72 articles and/or guidelines reviewed)
Eisenberg, M., & Shinohara, K. (2008) Partial salvage cryoablation of the prostate for recurrent prostate cancer after radiotherapy failure. Urology, 72 (6), 1315-1318. (Level 4 Evidence – Independent)
Finley, D., Pouliot, F., Miller, D., & Belldegrun, A. (2010). Primary and salvage cryotherapy for prostate cancer. Urologic Clinics of North America, 37 (1), 67-82.
Lambert, E., Bolte, K., Masson, P., & Katz. A. (2007). Focal cryosurgery: Encouraging health outcomes for unifocal prostate cancer. Urology, 69 (6), 1117-1120. (Level 4 Evidence - Independent)
Levy, D., Li, J., & Jones, S. (2010) Disease burden predicts for favorable post salvage cryoablation PSA. Urology, 76 (5), 1157-161.
National Comprehensive Cancer Network (NCCN). (2010, December). NCCN clinical practice guidelines in oncology™. Prostate cancer. V.1.2011. Retrieved March 28, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.
National Institute for Health and Clinical Excellence (NICE). (2005, November). Cryotherapy as a primary treatment for prostate cancer. Retrieved May 28, 2011 from http://www.nice.org.uk/nicemedia/pdf/ip/IPG145guidance.pdf.
National Institute for Health and Clinical Excellence (NICE). (2005, May). Cryotherapy for recurrent prostate cancer. Retrieved March 28, 2011 from http://www.nice.org.uk/nicemedia/live/11084/30948/30948.pdf.
Polascik, T. J., Nosnik, I., Mayes, J. M., & Mouraviev, V. (2007). Short-term cancer control after primary cryosurgical ablation for clinically localized prostate cancer using third-generation cryotechnology. Urology, 70 (1), 117-121. (Level 3 Evidence - Industry sponsored)
Siddiqui, S. A., Mynderse, L. A., Zincke, H., Hoffmann, N. E., Lobo, J. R., Wilson, T. M., et al. (2007). Treatment of prostate cancer local recurrence after radical retropubic prostatectomy with 17-gauge interstitial transperineal cryoablation: Initial experience. Urology, 70 (1), 80-85. (Level 4 Evidence - Industry sponsored)
U. S. Food and Drug Administration. (2005, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K050347. Retrieved March 28, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050347.pdf.
U. S. Food and Drug Administration. (2005, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K052530. March 28, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052530.pdf.
Winifred S. Hayes. Medical Technology Directory. (2006, November; last updates December 2010). Cryoablation for prostate cancer. Retrieved March 28, 2011 from www.Hayesinc.com/subscribers. (88 articles and/or guidelines reviewed)
MOST RECENT REVIEW DATE: 6/9/2011
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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