Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Prostate Cancer. 
Treatment: Outpatient ablation of malignant prostate tissue, transrectal, with high intensity focused ultrasound (HIFU) including ultrasound guidance. 

The insurer denied outpatient ablation of malignant prostate tissue, transrectal, with high intensity focused ultrasound (HIFU) including ultrasound guidance. 
The determination is upheld. 

The patient has a diagnosis of non-metaststic prostate cancer (intermediate risk, Gleason 7). At issue is whether outpatient ablation of malignant prostate tissue, transrectal, with high intensity focused ultrasound (HIFU) including ultrasound guidance is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 

Outpatient ablation of malignant prostate tissue, transrectal, with high intensity focused ultrasound (HIFU) including ultrasound guidance is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. HIFU consists of focused ultrasound waves, emitted from a transducer, that cause tissue damage by mechanical and thermal effects as well as by cavitation . The goal of HIFU is to heat malignant tissues above 65 degrees Celsius (C) so that they are destroyed by coagulative necrosis. 
HIFU has been increasingly used for treatment of localized prostate cancer within the last decade. It has the theoretical potential of decreasing gastrointestinal, genitourinary and sexual toxicity. Potential candidates are patients with low to moderate risk prostate cancer. The available literature mainly consists of prospective case series and retrospective studies from Europe showing short to intermediate term outcomes for localized prostate cancer. No controlled trials are available for analysis, and no long-term survival data are available. There are no validated biochemical and surrogate end-point for cure. 
The National comprehensive Cancer Network Guideline on Prostate Cancer, 2019 states the following about focal therapy and HIFU, "At this time, the panel recommends only cryosurgery and HIFU as options for radiation therapy (RT) recurrence in the absence of metastatic disease." 
The National Cancer Institute (website source, updated April 2015) does not list HIFU as one of the "seven standard" treatments for treatment of prostate cancer. It lists it under "new types of treatments that are being tested in clinical trials." 
The European Association of Urology (EAU) Guidelines for prostate cancer, 2019 states, "Similar to cryosurgery, the lack of any long-term prospective comparative data on oncological outcomes prevents whole-gland HIFU from being considered as a reasonable alternative to the established curative treatment options." 
The American Urological Association (AUA)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) Guideline of Clinically Localized Prostate Cancer, 2017 states, "Clinicians should inform low-risk prostate cancer patients who are considering focal therapy or high intensity focused ultrasound (HIFU) that these interventions are not standard care options because comparative outcome evidence is lacking. " 
As such, HIFU is not considered a clinically appropriate and generally accepted standard of care for management of localized prostate cancer.