Medical Policy High-Dose Rate Temporary

Table of Contents  Policy: Commercial  Coding Information  Information Pertaining to All Policies  Policy: Medicare  Description  References  Authorization Information  Policy History

Policy Number: 353 BCBSA Reference Number: 8.01.33

Related Policies  Stereotactic and Stereotactic Body , #277  Cryosurgical Ablation of the Prostate, #149  Brachytherapy for clinically localized using permanently implanted seeds, #175  Intensity-Modulated Radiation Therapy (IMRT) of the Prostate, #090

Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Medicare HMO BlueSM and Medicare PPO BlueSM Members High-dose rate prostate brachytherapy may be MEDICALLY NECESSARY as monotherapy or in conjunction with external beam radiation therapy in the treatment of localized prostate cancer. High-dose rate prostate brachytherapy is INVESTIGATIONAL in the treatment of prostate cancer when used as salvage therapy.

Prior Authorization Information Commercial Members: Managed Care (HMO and POS) Prior authorization is NOT required. Commercial Members: PPO, and Indemnity Prior authorization is NOT required. Medicare Members: HMO BlueSM Prior authorization is NOT required. Medicare Members: PPO BlueSM Prior authorization is NOT required.

CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an 1 individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

CPT Codes CPT codes: Code Description 55860 Exposure of prostate, any approach, for insertion of radioactive substance 55875 Transperineal placement of needles or catheters into prostate for interstitial radioelement application, with or without cystoscopy 76873 Ultrasound, transrectal; prostate volume study for brachytherapy treatment planning 76965 Ultrasound guidance for interstitial radioelement application 77326 Brachytherapy isodose plan; simple 77327 Brachytherapy isodose plan; intermediate 77328 Brachytherapy isodose plan; complex 77776 Interstitial radiation source application, simple 77777 Interstitial radiation source application, intermediate 77778 Interstitial radiation source application, complex 77785 Remote afterloading high dose rate brachytherapy; 1 channel 77786 Remote afterloading high dose rate radionuclide brachytherapy; 2-12 channels 77787 Remote afterloading high dose rate radionuclide brachytherapy; over 12 channels 77790 Supervision, handling, loading of radiation source

HCPCS Codes HCPCS codes: Code Description C1717 Brachytherapy source, nonstranded, high dose rate iridium-192, per source C2638 Brachytherapy source, stranded, iodine-125, per source C2639 Brachytherapy source, nonstranded, iodine-125, per source C2640 Brachytherapy source, stranded, palladium-103, per source C2641 Brachytherapy source, nonstranded, palladium-103, per source C2642 Brachytherapy source, stranded, cesium-131, per source C2643 Brachytherapy source, nonstranded, cesium-131, per source Q3001 Radioelements for brachytherapy, any type, each

ICD-9 Diagnosis Codes ICD-9-CM diagnosis codes: Code Description 185 Malignant of prostate 233.4 Carcinoma in situ of prostate

ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description C61 Malignant neoplasm of prostate D07.5 Carcinoma in situ of prostate

Description High-dose rate temporary prostate brachytherapy is a technique of delivering a high-intensity radiation source directly to the prostate gland for the treatment of prostate cancer. The radiation source is inserted through hollow catheters or needles inserted precisely into several areas of the prostate gland using 2 ultrasound guidance and treatment planning computed tomography or ultrasound images. The radiation source is allowed to dwell in the target areas until the prescribed radiation dose is reached and is then removed with the goal of increasing direct tumor necrosis while reducing toxicity and surrounding tissue damage. Prostate brachytherapy can be delivered in a variety of ways. Perhaps the most familiar technique is the use of radioactive seeds permanently implanted into prostate tissue. These seeds contain isotopes that slowly emit radiation of relatively low energy. In contrast, temporary prostate brachytherapy involves use of higher energy radioisotopes such as iridium-192. These isotopes deliver radiation at higher dose rates, which may be more effective in destroying rapidly dividing cancer cells. In patients with locally advanced disease, it is hypothesized that local failure may be related to the large volume of tumor and radio resistant cell clones, both of which might respond to higher radiation doses. High-dose rate prostate brachytherapy has been primarily investigated as an adjunct to external-beam radiotherapy (EBRT) as a technique of dose escalation. Other techniques for dose escalation include EBRT using intensity- modulated radiation therapy (IMRT) for treatment planning and delivery, proton beam radiotherapy (which may also use IMRT), or EBRT combined with brachytherapy using interstitial seeds.

Summary High-dose rate temporary prostate brachytherapy is a technique of delivering a high-intensity radiation source directly to the prostate gland for the treatment of prostate cancer. Based on data from published studies and clinical input, its use may be considered medically necessary combined with EBRT in the treatment of patients with localized prostate cancer. While data on HDR monotherapy are more limited, given what is known about temporary and permanent brachytherapy and based on existing data and clinical input, HDR monotherapy may also be considered an option. While quality studies differentiating superiority of any type of radiation technique are not available, the available evidence for use of HDR prostate brachytherapy as monotherapy or in conjunction with EBRT in the treatment of localized (organ-confined) prostate cancer is sufficient to conclude treatments result in improvement in net health outcome. Because published data are still limited and clinical trials are ongoing, use of HDR in the treatment of prostate cancer as salvage therapy is considered investigational.

Policy History Date Action 9/2014 New references added from BCBSA National medical policy. 5/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015. 8/2013 New references from BCBSA National medical policy. 11/2011- Medical policy ICD 10 remediation: Formatting, editing and coding updates. 4/2012 No changes to policy statements. 1/1/2012 New policy, effective 01/01/2012, describing covered and non-covered indication.

Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References 1. Holmberg L, Bill-Axelson A, Helgesen F et al. A randomized trial comparing radical with watchful waiting in early prostate cancer. N Engl J Med 2002; 347(11):781-9. 2. Hoskin PJ, Rojas AM, Bownes PJ et al. Randomised trial of external beam radiotherapy alone or combined with high-dose-rate brachytherapy boost for localised prostate cancer. Radiother Oncol 2012; 103(2):217-22.

3 3. Hoskin PJ, Motohashi K, Bownes P et al. High dose rate brachytherapy in combination with external beam radiotherapy in the radical treatment of prostate cancer: initial results of a randomised phase three trial. Radiother Oncol 2007; 84(2):114-20. 4. Kupelian PA, Potters L, Khuntia D et al. Radical prostatectomy, external beam radiotherapy <72 Gy, external beam radiotherapy > or =72 Gy, permanent seed implantation, or combined seeds/external beam radiotherapy for stage T1-T2 prostate cancer. Int J Radiat Oncol Biol Phys 2004; 58(1):25-33. 5. Pollack A, Zagars GK, Starkschall G et al. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys 2002; 53(5):1097-105. 6. Vicini FA, Abner A, Baglan KL et al. Defining a dose-response relationship with radiotherapy for prostate cancer: is more really better? Int J Radiat Oncol Biol Phys 2001; 51(5):1200-8. 7. Zaorsky NG, Doyle LA, Yamoah K et al. High dose rate brachytherapy boost for prostate cancer: a systematic review. Cancer Treat Rev 2014; 40(3):414-25. 8. Bannuru RR, Dvorak T, Obadan N et al. Comparative evaluation of radiation treatments for clinically localized prostate cancer: an updated systematic review. Ann Intern Med 2011; 155(3):171-8. 9. Yamada Y, Rogers L, Demanes DJ et al. American Brachytherapy Society consensus guidelines for high-dose-rate prostate brachytherapy. Brachytherapy 2012; 11(1):20-32. 10. Martinez AA, Gonzalez J, Ye H et al. Dose escalation improves cancer-related events at 10 years for intermediate- and high-risk prostate cancer patients treated with hypofractionated high-dose-rate boost and external beam radiotherapy. Int J Radiat Oncol Biol Phys 2011; 79(2):363-70. 11. Martinez A, Gonzalez J, Spencer W et al. Conformal high dose rate brachytherapy improves biochemical control and cause specific survival in patients with prostate cancer and poor prognostic factors. J Urol 2003; 169(3):974-9; discussion 79-80. 12. Galalae RM, Martinez A, Mate T et al. Long-term outcome by risk factors using conformal high- dose-rate brachytherapy (HDR-BT) boost with or without neoadjuvant androgen suppression for localized prostate cancer. Int J Radiat Oncol Biol Phys 2004; 58(4):1048-55. 13. Demanes DJ, Rodriguez RR, Schour L et al. High-dose-rate intensity-modulated brachytherapy with external beam radiotherapy for prostate cancer: California endocurietherapy's 10-year results. Int J Radiat Oncol Biol Phys 2005; 61(5):1306-16. 14. Phan TP, Syed AM, Puthawala A et al. High dose rate brachytherapy as a boost for the treatment of localized prostate cancer. J Urol 2007; 177(1):123-7; discussion 27. 15. Khor R, Duchesne G, Tai KH et al. Direct 2-arm comparison shows benefit of high-dose-rate brachytherapy boost vs external beam radiation therapy alone for prostate cancer. Int J Radiat Oncol Biol Phys 2013; 85(3):679-85. 16. Deutsch I, Zelefsky MJ, Zhang Z et al. Comparison of PSA relapse-free survival in patients treated with ultra-high-dose IMRT versus combination HDR brachytherapy and IMRT. Brachytherapy 2010; 9(4):313-8. 17. Wilder RB, Barme GA, Gilbert RF et al. Preliminary results in prostate cancer patients treated with high-dose-rate brachytherapy and intensity modulated radiation therapy (IMRT) vs. IMRT alone. Brachytherapy 2010; 9(4):341-8. 18. Tselis N, Tunn UW, Chatzikonstantinou G et al. High dose rate brachytherapy as monotherapy for localised prostate cancer: a hypofractionated two-implant approach in 351 consecutive patients. Radiat Oncol 2013; 8:115. 19. Demanes DJ, Martinez AA, Ghilezan M et al. High-dose-rate monotherapy: safe and effective brachytherapy for patients with localized prostate cancer. Int J Radiat Oncol Biol Phys 2011; 81(5):1286-92. 20. Martinez AA, Demanes J, Vargas C et al. High-dose-rate prostate brachytherapy: an excellent accelerated-hypofractionated treatment for favorable prostate cancer. Am J Clin Oncol 2010; 33(5):481-8. 21. Corner C, Rojas AM, Bryant L et al. A Phase II study of high-dose-rate afterloading brachytherapy as monotherapy for the treatment of localized prostate cancer. Int J Radiat Oncol Biol Phys 2008; 72(2):441-6. 22. Grills IS, Martinez AA, Hollander M et al. High dose rate brachytherapy as prostate cancer monotherapy reduces toxicity compared to low dose rate palladium seeds. J Urol 2004; 171(3):1098-104. 23. Chen CP, Weinberg V, Shinohara K et al. Salvage HDR Brachytherapy for Recurrent Prostate Cancer After Previous Definitive Radiation Therapy: 5-Year Outcomes. Int J Radiat Oncol Biol Phys 2013; 86(2):324-9. 4 24. Jo Y, Fujii T, Hara R et al. Salvage high-dose-rate brachytherapy for local prostate cancer recurrence after radiotherapy - preliminary results. BJU Int 2012; 109(6):835-9. 25. National Comprehensive Cancer Network. Prostate cancer. Clinical Practice Guidelines in Oncology, v.2.2014. Available online at: http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Last accessed May 26, 2014. 26. The American Brachytherapy Society (ABS). Prostate High-Dose Rate Task Group. Available online at: http://www.americanbrachytherapy.org/guidelines/HDRTaskGroup.pdf. Last accessed May 26, 2014. 27. Hsu IC, Yamada Y, Assimos DG et al. ACR Appropriateness Criteria high-dose-rate brachytherapy for prostate cancer. Brachytherapy 2014; 13(1):27-31.

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