Cryoablation is one of several methods available to treat clinically localized prostate cancer and may be considered an alternative to radical prostatectomy or external beam radiation therapy. Whole gland (also known as total) cryoablation may also be used for salvage of nonmetastatic relapse following initial therapy for clinically localized disease.
Cryosurgical ablation (cryoablation or cryosurgery) involves inserting cryoprobes percutaneously into the prostate gland to rapidly freeze and thaw tissue causing necrosis. The cold is usually produced by use of liquid nitrogen. Cryosurgical ablation may also be performed as an open surgical technique or laparoscopically with ultrasound, magnetic resonance imaging (MRI), or computed tomography (CT) guidance.
Subtotal prostate cryoablation is also being evaluated as a form of focal therapy (also referred to as a “male lumpectomy”) for small localized prostate cancers. In these cases the tumor is frozen but leaves the remainder of the prostate intact.
Cryosurgical ablation for the treatment of prostate tumors is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Policies with similar titles:
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 of less than 9
A PSA of less than 8 ng/ml
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
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.
Abreu, A., Bahn, D., Leslie, S., Shoji, S., Silverman, P., Desai, M., et al. (2013) Salvage focal and salvage total cryoablation for locally recurrent prostate cancer after primary radiation therapy. BJU International, 112, 298-307. (Level 3 evidence)
American Urological Association. (2017). Clinically localized prostate cancer: AUA/ASTRO/SUO guideline. Retrieved August 10, 2017 from http://www.auanet.org/guidelines/clinically-localized-prostate-cancer-new-(aua/astro/suo-guideline-2017).
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2016). Whole gland cryoablation of prostate cancer (7.01.79). Retrieved August 10, 2017 from BlueWeb. (47 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2016). Focal treatments for prostate cancer. Retrieved August 10, 2017 from BlueWeb. (65 articles and/or guidelines reviewed)
Center for Medicare and Medicaid Services. CMS.gov. NCD for cryosurgery of prostate (230.9). Retrieved November 24, 2015 from: https://www.cms.gov.
Gao, L., Yang, L., Qian, S., Tang, Z., Qin, F., Wei, Q., et al. (2016). Cryosurgery would be an effective option for clinically localized prostate cancer: a meta-analysis and systematic review. Scientific Reports, 6:27490. DOI:10.1038/srep27490. (Level 2 evidence)
National Comprehensive Cancer Network (NCCN). (2017). NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Prostate cancer. V.2,2017. Retrieved August 9, 2017 from the National Comprehensive Cancer Network.
National Institute for Health and Clinical Excellence. (2005, May). Cryotherapy for recurrent prostate cancer. Retrieved August 9, 2017 from www.nice.org.uk/guidance/ipg119.
National Institute for Health and Clinical Excellence. (2005, November). Cryotherapy as a primary treatment for prostate cancer. Retrieved August 9, 2017 from www.nice.org.uk/guidance/ipg145.
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, July). Comparative effectiveness review of cryoablation for salvage treatment of recurrent prostate cancer following radiotherapy. Retrieved August 9, 2017 from www.Hayesinc.com/subscribers. (94 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, July). Comparative effectiveness review of cryoablation for primary treatment of localized prostate cancer. Retrieved August 9, 2017 from www.Hayesinc.com/subscribers. (61 articles and/or guidelines reviewed)
Xiong, T., Turner, R., Wei, Y., Neal, D., Lyratzopoulos, G., & Higgins, J. (2014). Comparative efficacy and safety of treatments for localized prostate cancer: an application of network meta-analysis. BMJ Open, 4, e004285. DOI:10.1136/bmjopen-2013-004285. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 3/14/2008
MOST RECENT REVIEW DATE: 9/14/2017
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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