The FDA’s perspective on the approval of HIFU in the USA

For those able to access the February 2016 issue of the AUA News, it carries an interesting article outlining the U.S. Food and Drug Administration’s perspective on exactly why the agency decided to approve two forms of high-intensity focused ultrasound (HIFU) technology for the transrectal ablation of prostate tissue.

The article by Jarrow and Baxley (“FDA approves HIFU as a prostate ablation tool” on page 15 of the AUA News) explains carefully that the FDA was unable to approve HIFU explicitly for the treatment of prostate cancer, but that it was able to approve the technical methodology as a tool to ablate prostate tissue in the same way as a scalpel is an approved surgical tool to cut through tissue.

For those who are unable to access the full text of the article, the following are a few quotations from the article that may be of interest:

The clinical evidence generated and submitted to the FDA does not support approval of HIFU for the specific treatment of prostate cancer.

In the case of ablation of prostate tissue the manufacturers were able to demonstrate that the devices ablate the targeted tissue with reasonable safety.

The short-term data on PSA, prostate volume and prostate biopsy findings could support a tool type of indication (ablation of the prostate) and the FDA approved marketing of these HIFU devices as a means to promote further evolution of the technology and foster further evidence generation.

The FDA has the responsibility of protecting patients and ensuring that a device provides reasonable assurance of safety and efficacy for its intended use. However, it is up to physicians, patients and professional societies to determine the treatment of individual patients with prostatic disorders based on the best available evidence.

The bottom line is that the ball is squarely in the court of physicians and manufacturers. They have the approval they sought to use the HIFU technique. Now they need to generate the data that will convince patients that the technique really is effective and payers that it is sufficiently effective to be worth paying for — and in which specific categories of patient.

3 Responses

  1. I guess it’s sort of like “off label” use of drugs — once the FDA approves it for one use, the doctor and patient may use it for other indications. Typically, insurance companies won’t cover it unless it’s part of a clinical trial or registry. I don’t know where CMS enters into this. For drugs, they have to cover whatever the FDA approves, but I don’t know if that holds true for all treatments as well. It seems that individual MACs may have discretion, but this is all very mysterious to me.

  2. Perhaps this is really where new medtech needs to be, in the eyes of the patient.

  3. As a post-HIFU patient of 2.5 years with no after-effects, and a PSA of 0.16, I am thrilled the FDA has finally done right for every male in the United States! It’s only 24 years behind Europe, 14 years behind Canada and millions of patients with post-treatment maladies later. I would think it would be less expensive for insurance to cover than surgery or radiation.

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