Cryosurgical Ablation for Prostate Cancer
Transcript Of Cryosurgical Ablation for Prostate Cancer
Medical Policy: Cryosurgical Ablation for Prostate Cancer (Commercial)
POLICY NUMBER
Last Review Date
APPROVED BY
MG.MM.SU.53c
10/8/2021
MPC (Medical Policy Committee)
IMPORTANT NOTE ABOUT THIS MEDICAL POLICY:
Property of ConnectiCare, Inc. All rights reserved. The treating physician or primary care provider must submit to ConnectiCare, Inc. the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, ConnectiCare will not be able to properly review the request for prior authorization. This clinical policy is not intended to pre-empt the judgment of the reviewing medical director or dictate to health care providers how to practice medicine. Health care providers are expected to exercise their medical judgment in rendering appropriate care. The clinical review criteria expressed below reflects how ConnectiCare determines whether certain services or supplies are medically necessary. ConnectiCare established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). ConnectiCare, Inc. expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Identification of selected brand names of devices, tests and procedures in a medical coverage policy is for reference only and is not an endorsement of any one device, test or procedure over another. Each benefit plan defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by ConnectiCare, as some plans exclude coverage for services or supplies that ConnectiCare considers medically necessary. If there is a discrepancy between this guideline and a member's benefits plan, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of the State of CT and/or the Federal Government. Coverage may also differ for our Medicare members based on any applicable Centers for Medicare & Medicaid Services (CMS) coverage statements including National Coverage Determinations (NCD), Local Coverage Determinations (LCD) and/or Local Medical Review Policies (LMRP). All coding and web site links are accurate at time of publication.
Definitions
Cryosurgery (aka cryotherapy or cryoablation)
Cryosurgery (aka cryotherapy or cryoablation) is a minimally invasive therapy performed with ultrasound guidance that destroys prostate tumor tissue through local freezing. The modality involves either complete or focal ablation (subtotal cryoablation) only targeting diseased tissue while leaving normal tissue intact.
r
Guideline
Cryosurgery is considered medically necessary as salvage therapy for prostate cancer recurrence
after treatment with radiation when disease is localized to one lobe of the prostate.
Limitations/Exclusions
Salvage therapy is not considered medically necessary when radiation was not utilized as a primary therapy.
Cryosurgery as a primary treatment modality is not considered medically necessary because it is not supported by the National Comprehensive Cancer Network® (NCCN).
Applicable Procedure Codes
55873
Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring)
Proprietary information of ConnectiCare. © 2020 ConnectiCare, Inc. & Affiliates
Page 1 of 3
Medical Policy: Cryosurgical Ablation for Prostate Cancer (Commercial)
Applicable ICD-10 Diagnosis Codes
C61 D07.5
Malignant neoplasm of prostate Carcinoma in situ of prostate
References
Bahn D, et al. Focal cryotherapy for clinically unilateral, low-intermediate risk prostate cancer in 73 men with a median follow- up of 3.7 years. Eur Urol 2012 Jul;62(1):55-63.
BlueCross BlueShield Association (BCBS), Technology Evaluation Center. Cryoablation for the primary treatment of clinically localized prostate cancer. TEC Assessment Program. Chicago IL: BCBSA; 2001;16(6).
BlueCross BlueShield Association Technology Evaluation Center (TEC). Cryoablation for the primary treatment of clinically localized prostate cancer. 2001 Sep;16(6).
Cheetham P, et al. Long term cancer-specific and overall survival for men followed more than 10 years after primary and salvage cryoablation of the prostate. J Endourol 2010 Ju;24(7):1123-9.
Chou R, et al. Treatments for localized prostate cancer: systematic review to update the 2002 U.S. Preventive Services Task Force Recommendation. Rockville (MD) 2011.
Dhar N, et al. Primary full-gland prostate cryoablation in older men (> age of 75 years): results from 860 patients traced with the COLD Registry. BJU Int 2011 Aug;108(4):508-12.
Donnelly BJ, et al. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer. Cancer 2010;116:323–30.
Durand M, et al. Focal cryoablation: a treatment option for unilateral low-risk prostate cancer. BJU Int 2014 Jan;113(1):56-64.
Li YH, et al. Salvage focal prostate cryoablation for locally recurrent prostate cancer after radiotherapy: initial results from the cryo on-line data registry. Prostate 2015 Jan;75(1):1-7.
Malcolm JB, et al. Quality of life after open or robotic prostatectomy cryoablation or brachytherapy for localized prostate cancer. J Urol 2010 May;183:1822-9.
Mouraviev V, et al. Cryoablation for locally recurrent prostate cancer following primary radiotherapy. Eur Urol 2012;61:1204- 11.
National Comprehensive Cancer Network. Prostate Cancer Guidelines. V1.2022. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed October 15, 2021.
National Institute for Health and Clinical Excellence (NICE). Cryotherapy as a primary treatment for prostate cancer. Interventional Procedure Guidance 145. London, UK: NICE; November 2005.
National Institute for Health and Clinical Excellence (NICE). Cryotherapy for recurrent prostate cancer. Interventional Procedure Guidance No. 119. London, UK: NICE; May 2005.
Parekh A, et al. Cancer control and complications of salvage local therapy after failure of radiotherapy for prostate cancer: a systematic review. Semin Radiat Oncol 2013 Jul;23(3):222- 34.
Punnen S, et al. Management of biochemical recurrence after primary treatment of prostate cancer: a systematic review of the literature. Eur Urol 2013 Dec;64(6):905-15.
Shelley M, et al. Cryotherapy for localised prostate cancer. Cochrane Database Syst Rev 2007;(3):CD005010. Ullal AV, et al. A report on major complications and biochemical recurrence after primary and salvage cryosurgery for prostate cancer in patients with prior resection of benign prostatic hyperplasia: a single-center experience. Urology 2013 Sep;82(3):648-52.
Ward JF, et al. Cryoablation for locally advanced clinical stage T3 prostate cancer: a report from the
Cryo-On-Line Database (COLD) Registry. BJU Int 2014 May;113(5):714-8.
Proprietary information of ConnectiCare. © 2020 ConnectiCare, Inc. & Affiliates
Page 2 of 3
Medical Policy: Cryosurgical Ablation for Prostate Cancer (Commercial)
Xiong T, et al. Comparative efficacy and safety of treatments for localized prostate cancer: an application of network meta- analysis. BMJ Open 2014;4:e004285.
Revision history
DATE
REVISION
10/8/2021
• Updated positive coverage statement to communicate cryotherapy applicability to one lobe, post-radiation, and removed test parameter prerequisites of stage T2b or below, and PSA of < 8 ng/mL
11/11/2019
• Removed Gleason Score prerequisite
09/13/2019
• Connecticare has adopted the clinical criteria of its parent corporation, EmblemHealth
• Reformatted and reorganized policy, transferred content to new template
• Removed primary treatment as a covered indication
Proprietary information of ConnectiCare. © 2020 ConnectiCare, Inc. & Affiliates
Page 3 of 3
POLICY NUMBER
Last Review Date
APPROVED BY
MG.MM.SU.53c
10/8/2021
MPC (Medical Policy Committee)
IMPORTANT NOTE ABOUT THIS MEDICAL POLICY:
Property of ConnectiCare, Inc. All rights reserved. The treating physician or primary care provider must submit to ConnectiCare, Inc. the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, ConnectiCare will not be able to properly review the request for prior authorization. This clinical policy is not intended to pre-empt the judgment of the reviewing medical director or dictate to health care providers how to practice medicine. Health care providers are expected to exercise their medical judgment in rendering appropriate care. The clinical review criteria expressed below reflects how ConnectiCare determines whether certain services or supplies are medically necessary. ConnectiCare established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). ConnectiCare, Inc. expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Identification of selected brand names of devices, tests and procedures in a medical coverage policy is for reference only and is not an endorsement of any one device, test or procedure over another. Each benefit plan defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by ConnectiCare, as some plans exclude coverage for services or supplies that ConnectiCare considers medically necessary. If there is a discrepancy between this guideline and a member's benefits plan, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of the State of CT and/or the Federal Government. Coverage may also differ for our Medicare members based on any applicable Centers for Medicare & Medicaid Services (CMS) coverage statements including National Coverage Determinations (NCD), Local Coverage Determinations (LCD) and/or Local Medical Review Policies (LMRP). All coding and web site links are accurate at time of publication.
Definitions
Cryosurgery (aka cryotherapy or cryoablation)
Cryosurgery (aka cryotherapy or cryoablation) is a minimally invasive therapy performed with ultrasound guidance that destroys prostate tumor tissue through local freezing. The modality involves either complete or focal ablation (subtotal cryoablation) only targeting diseased tissue while leaving normal tissue intact.
r
Guideline
Cryosurgery is considered medically necessary as salvage therapy for prostate cancer recurrence
after treatment with radiation when disease is localized to one lobe of the prostate.
Limitations/Exclusions
Salvage therapy is not considered medically necessary when radiation was not utilized as a primary therapy.
Cryosurgery as a primary treatment modality is not considered medically necessary because it is not supported by the National Comprehensive Cancer Network® (NCCN).
Applicable Procedure Codes
55873
Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring)
Proprietary information of ConnectiCare. © 2020 ConnectiCare, Inc. & Affiliates
Page 1 of 3
Medical Policy: Cryosurgical Ablation for Prostate Cancer (Commercial)
Applicable ICD-10 Diagnosis Codes
C61 D07.5
Malignant neoplasm of prostate Carcinoma in situ of prostate
References
Bahn D, et al. Focal cryotherapy for clinically unilateral, low-intermediate risk prostate cancer in 73 men with a median follow- up of 3.7 years. Eur Urol 2012 Jul;62(1):55-63.
BlueCross BlueShield Association (BCBS), Technology Evaluation Center. Cryoablation for the primary treatment of clinically localized prostate cancer. TEC Assessment Program. Chicago IL: BCBSA; 2001;16(6).
BlueCross BlueShield Association Technology Evaluation Center (TEC). Cryoablation for the primary treatment of clinically localized prostate cancer. 2001 Sep;16(6).
Cheetham P, et al. Long term cancer-specific and overall survival for men followed more than 10 years after primary and salvage cryoablation of the prostate. J Endourol 2010 Ju;24(7):1123-9.
Chou R, et al. Treatments for localized prostate cancer: systematic review to update the 2002 U.S. Preventive Services Task Force Recommendation. Rockville (MD) 2011.
Dhar N, et al. Primary full-gland prostate cryoablation in older men (> age of 75 years): results from 860 patients traced with the COLD Registry. BJU Int 2011 Aug;108(4):508-12.
Donnelly BJ, et al. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer. Cancer 2010;116:323–30.
Durand M, et al. Focal cryoablation: a treatment option for unilateral low-risk prostate cancer. BJU Int 2014 Jan;113(1):56-64.
Li YH, et al. Salvage focal prostate cryoablation for locally recurrent prostate cancer after radiotherapy: initial results from the cryo on-line data registry. Prostate 2015 Jan;75(1):1-7.
Malcolm JB, et al. Quality of life after open or robotic prostatectomy cryoablation or brachytherapy for localized prostate cancer. J Urol 2010 May;183:1822-9.
Mouraviev V, et al. Cryoablation for locally recurrent prostate cancer following primary radiotherapy. Eur Urol 2012;61:1204- 11.
National Comprehensive Cancer Network. Prostate Cancer Guidelines. V1.2022. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed October 15, 2021.
National Institute for Health and Clinical Excellence (NICE). Cryotherapy as a primary treatment for prostate cancer. Interventional Procedure Guidance 145. London, UK: NICE; November 2005.
National Institute for Health and Clinical Excellence (NICE). Cryotherapy for recurrent prostate cancer. Interventional Procedure Guidance No. 119. London, UK: NICE; May 2005.
Parekh A, et al. Cancer control and complications of salvage local therapy after failure of radiotherapy for prostate cancer: a systematic review. Semin Radiat Oncol 2013 Jul;23(3):222- 34.
Punnen S, et al. Management of biochemical recurrence after primary treatment of prostate cancer: a systematic review of the literature. Eur Urol 2013 Dec;64(6):905-15.
Shelley M, et al. Cryotherapy for localised prostate cancer. Cochrane Database Syst Rev 2007;(3):CD005010. Ullal AV, et al. A report on major complications and biochemical recurrence after primary and salvage cryosurgery for prostate cancer in patients with prior resection of benign prostatic hyperplasia: a single-center experience. Urology 2013 Sep;82(3):648-52.
Ward JF, et al. Cryoablation for locally advanced clinical stage T3 prostate cancer: a report from the
Cryo-On-Line Database (COLD) Registry. BJU Int 2014 May;113(5):714-8.
Proprietary information of ConnectiCare. © 2020 ConnectiCare, Inc. & Affiliates
Page 2 of 3
Medical Policy: Cryosurgical Ablation for Prostate Cancer (Commercial)
Xiong T, et al. Comparative efficacy and safety of treatments for localized prostate cancer: an application of network meta- analysis. BMJ Open 2014;4:e004285.
Revision history
DATE
REVISION
10/8/2021
• Updated positive coverage statement to communicate cryotherapy applicability to one lobe, post-radiation, and removed test parameter prerequisites of stage T2b or below, and PSA of < 8 ng/mL
11/11/2019
• Removed Gleason Score prerequisite
09/13/2019
• Connecticare has adopted the clinical criteria of its parent corporation, EmblemHealth
• Reformatted and reorganized policy, transferred content to new template
• Removed primary treatment as a covered indication
Proprietary information of ConnectiCare. © 2020 ConnectiCare, Inc. & Affiliates
Page 3 of 3