This policy addresses the use of high intensity focused ultrasound (HIFU) for the treatment of prostate cancer.

Note: For information regarding other uses of HIFU, please see the following documents: 

• MRI Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids (MED.00057)
• Surgery for Benign Prostatic Hypertrophy (BPH) (SURG.00028)

Investigational/Not Medically Necessary:

The use of high intensity focused ultrasound (HIFU) is considered investigational/not medically necessary for the treatment of prostate cancer.
 

The available peer-reviewed published literature addressing the use of high intensity focused ultrasound (HIFU) to treat prostate cancer consists of non-randomized studies. Most of these studies are case series reports with follow-up of no longer than 2 years, with median follow-up times substantially shorter.  Three case series studies have follow-up periods between 3 and 5 years, but loss to follow-up impairs the strength of these results (Poissonnier, 2007; Uchida, 2006a; Uchida, 2006b). 

The results of only two controlled trials were available at the time of this writing.  The first involved 125 patients, 14 who received HIFU one to two weeks prior to radical prostatectomy and the remainder of the study participants received HIFU alone (Beerlage, 1999a).  In the HIFU plus surgery group, four patients had small viable tumors upon post-surgical examination of the prostate. Of the HIFU group, negative biopsy and prostate-specific antigen (PSA) levels less than 4ng/ml are reported in 60% of patients.  Short and long term morbidity and mortality data were not reported. 

The other controlled study by Chaussy and others (2003), involved 271 patients receiving either HIFU plus transuretheral resection of the prostate (TURP) or HIFU alone.  The authors report a significant improvement in catheter time, infection and incontinence in the HIFU group.  Retreatment rates were 4% for the combination group and 25% for the HIFU alone group.  Again, long term morbidity and mortality data were not reported.

The remainder of the literature addressing HIFU for prostate cancer consists of uncontrolled case series studies (Beerlage, 1999b; Blana, 2004; Chaussy, 2001; Gelet, 2000; Gelet, 2004; Poissonnier, 2007; Thuroff, 2003; Uchida, 2002; Uchida, 2005; Uchida, 2006a; Uchida, 2006b). While these studies all report significant benefits from HIFU, lack of randomized control groups receiving standard of care treatments limit their utility in evaluating the relative efficacy and safety of this procedure.  Additionally, the lack of long term studies does not allow for conclusions to be made regarding disease recurrence, morbidity, and mortality rates.

High intensity focused ultrasound (HIFU) is a technology that has been proposed as a method for treating prostate cancer.  HIFU involves the use of a specialized rectal ultrasound probe that emits a focused high-intensity convergent ultrasound beam to destroy targeted tissue. One proposed benefit to this method is that requires no invasive surgery and allows treatment of prostate cancer without damaging intervening and surrounding tissue, eliminating the need for incisions and shortening healing time.

At the time of this writing, no HIFU device has received pre-market approval or 510k clearance by the U.S. Food and Drug administration for the treatment of prostate cancer.

High intensity focused ultrasound (HIFU): a surgical procedure that uses focused high energy sound waves to destroy target tissues in the body

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Services are Investigational/Not Medically Necessary:
When the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

CPT

ICD-9 Diagnosis

Peer Reviewed Publications:

1. Beerlage HP, Thuroff S, Debruyne FM, et al. Transrectal high-intensity focused ultrasound using the Ablatherm device in the treatment of localized prostate carcinoma. Urology. 1999a; 54(2):273-277. 
2. Beerlage HP, van Leenders GJ, Oosterhof GO, et al.  High-intensity focused ultrasound (HIFU) followed after one to two weeks by radical retropubic prostatectomy: results of a prospective study. Prostate. 1999b; 39(1):41-46. 
3. Blana A, Walter B, Rogenhofer S, Wieland WF. High-intensity focused ultrasound for the treatment of localized prostate cancer: 5-year experience. Urology. 2004; 63(2):297-300.  
4. Boccon-Gibod L, Djavan WB, Hammerer P, et al. Management of prostate-specific antigen relapse in prostate cancer: a European Consensus. Int J Clin Pract. 2004; 58(4):382-390. 
5. Chaussy C, Thuroff S, Rebillard X, Gelet A.  Technology insight: High-intensity focused ultrasound for urologic cancers. Nat Clin Pract Urol. 2005; 2(4):191-198.  
6. Chaussy C, Thuroff S.  The status of high-intensity focused ultrasound in the treatment of localized prostate cancer and the impact of a combined resection. Curr Urol Rep. 2003; 4(3):248-252. 
7. Chaussy C, Thuroff S. Results and side effects of high-intensity focused ultrasound in localized prostate cancer. J Endourol. 2001; 15(4):437-440. 
8. Colombel M, Gelet A. Principles and results of high-intensity focused ultrasound for localized Prostate Cancer. Prostate Cancer Prostatic Dis. 2004;7(4):289-294
9. Gardner TA, Koch MO.  Prostate cancer therapy with high-intensity focused ultrasound. Clin Genitourin Cancer. 2005; 4(3):187-192.
10. Gelet A, Chapelon JY, Bouvier R, et al.  Transrectal high-intensity focused ultrasound: minimally invasive therapy of localized prostate cancer. J Endourol. 2000; 14(6):519-528. 
11. Gelet A, Chapelon JY, Poissonnier L, et al. Local recurrence of prostate cancer after external beam radiotherapy: early experience of salvage therapy using high-intensity focused ultrasonography. Urology. 2004; 63(4):625-629. 
12. Pickles T, Goldenberg L, Steinhoff G. Technology review: high-intensity focused ultrasound for prostate cancer. Can J Urol. 2005; 12(2):2593-2597. 
13. Poissonnier L, Chapelon JY, Rouviere O, et al. Control of prostate cancer by transrectal HIFU in 227 patients. Eur Urology. 2007; 51(2): 381-387.
14. Rebillard X, Gelet A, Davin JL, et al. Transrectal high-intensity focused ultrasound in the treatment of localized prostate cancer. J Endourol. 2005; 19(6):693-701. 
15. Thuroff S, Chaussy C, Vallancien G, et al. High-intensity focused ultrasound and localized prostate cancer: efficacy results from the European multicentric study. J Endourol. 2003; 17(8):673-677.
16. Thuroff S, Chaussy C.  High-intensity focused ultrasound: complications and adverse events. Mol Urol. 2000; 4(3):183-187.
17. Uchida T, Baba S, Irie A, et al. Transrectal high-intensity focused ultrasound in the treatment of localized prostate cancer: a multicenter study. Hinyokika Kiyo. 2005; 51(10):651-658. 
18. Uchida T, Sanghvi NT, Gardner TA, et al. Transrectal high-intensity focused ultrasound for treatment of patients with stage T1b-2n0m0 localized prostate cancer: a preliminary report. Urology. 2002; 59(3):394-398.
19. Uchida T, Ohkusa H, Yamashita H, et al. Five years experience of transrectal high-intensity focused ultrasound using the Sonablate device in the treatment of localized prostate cancer. Int J Urol. 2006a; 13(3):228-233.
20. Uchida T, Ohkusa H, Nagata Y, et al. Treatment of localized prostate cancer using high-intensity focused ultrasound. BJU Int. 2006b; 97(1):56-61.

Government Agency, Medical Society, and Other Authoritative Publications:

1. National Institute for Clinical Excellence. Interventional procedures programme: Interventional procedures overview of high- intensity focused ultrasound for prostate cancer. March 2004. Available at: http://www.nice.org.uk/ip230overview. Accessed on January 25, 2007.

1. National Library of Medicine. Medical Encyclopedia. Prostate Cancer. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000380.htm. Accessed on January 26, 2007.

Ablatherm®
Sonablate® 200
Sonablate® 500

The use of specific product names is illustrative 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.
 

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

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