Men hoping to avoid some of the adverse effects of prostate cancer treatment are shelling out big bucks for a procedure whose long-term effects are unknown and that insurers, including Medicare, won’t pay for, according to a report from Kaiser Health News. The price of the procedure––high-intensity focused ultrasound (HIFU)––can range from $15,000 to $25,000. HIFU devices cost doctors $500,000 and up.
HIFU is the latest treatment to prompt concerns over whether limits—such as requiring tracking of results—should be placed on expensive new technology while additional data are gathered, the Kaiser article notes.
“This is going to join the group of uncertain-yet-available therapies that physicians can use, [and] yet we have no clear understanding of who will benefit in a real-world population,” said Dr. Art Sedrakyan, a professor of health care policy and research at Weill Cornell Medicine in New York.
HIFU devices direct ultrasound waves to heat prostate tissue to approximately 195 degrees, ablating all or portions of the gland. Focusing on just a portion of the gland is a newer trend in prostate cancer treatment. Anesthesia is used.
While the devices are approved in Canada, the national health program there does not pay for it. Until recently, some U.S. men traveled to have the procedure done by U.S. doctors who set up shop in Mexico, the Bahamas, or Bermuda.
FDA advisory committees twice turned down applications from manufacturers to market HIFU devices as a treatment for prostate cancer, citing the lack of enough long-term evidence. But in October 2015, the FDA approved SonaCare Medical’s device for the ablation of prostate tissue. Data submitted by the company included an analysis of 116 men who had their entire prostrate treated and were followed for 12 months. “While the oncological outcomes from this study are inconclusive, the results provide reasonable assurance of safety and effectiveness of the device in the context of prostate tissue ablation,” the FDA said in its review.
A device by the French company EDAP won similar approval shortly afterwards.
Data from ongoing and previous studies of HIFU from abroad are available but have limitations, including fairly short follow-up periods.
“The biggest studies in the world are only four or five years into it,” said Dr. Michael Koch, chairman of the urology department at Indiana University School of Medicine. “We don’t have survival data to see if [HIFU] does better than surgery or radiation.”
Dr. Jim Hu, a urologist at Weill Cornell, remarked: “The financial piece of this is somewhat perverse. Men are being charged $25,000 for this, yet no one feels pressure to demonstrate the efficacy of the treatment.”
SonaCare said it has sold more than 30 of the machines in the United States, with medical centers in California, Florida, New York, North Carolina, and Texas using them. Competitor EDAP reported late in August that earnings from its HIFU division rose 68% during the first six months of 2016.
Source: Kaiser Health News; October 5, 2016.