News

This is an excerpt of an article by Kaiser Health News. Read the full story here. 

Men hoping to avoid some side effects of prostate cancer treatment are shelling out tens of thousands of dollars for a procedure whose long-term effects are unknown and insurers, including Medicare, won’t pay for.

Proponents say Jim Hu, M.D.  (HIFU) can have fewer negative side effects than surgery or radiation, while giving some patients another option between actively watching their cancer and those more aggressive steps. Critics, however, say the procedure is being oversold, leading some patients to get a treatment they don’t need.

Device makers are busy selling the $500,000-and-up machines to doctors around the country and offering training courses. Billboards advertising this “new non-invasive treatment for prostate cancer” are springing up, while treatment center websites promise “a safer method” with benefits such as “no erectile dysfunction and no incontinence,” although studies show those side effects can occur, but less often than with other types of more aggressive treatments. The treatment can range in cost from $15,000 to $25,000.

HIFU is the latest treatment to prompt concerns over whether there should be limits — such as requiring tracking of results — placed on expensive new technology while additional data is gathered.

“This is going to join the group of uncertain-yet-available therapies that physicians can use, yet we have no clear understanding of who will benefit in a real world population,” said Art Sedrakyan, a professor of health care policy and research at Weill Cornell Medicine. The treatment of prostate cancer has been a particularly controversial — and lucrative — niche, since the disease for some men can be slow growing and their tumors wouldn’t be fatal. A host of new “non-surgical’ treatments are now also on offer using sophisticated machines to destroy cancer cells with proton beams or other types of high dose radiation.

Using HIFU, devices direct ultrasound waves to heat prostate tissue to about 195 degrees, ablating all or just portions of the gland. Focusing on just a portion of the gland is a newer trend in prostate cancer treatment. Anesthesia is used.

HIFU machines have been used in Europe longer than in the U.S, although national health programs in the United Kingdom and elsewhere limit coverage to patients enrolled in clinical trials or other research programs. While the devices are approved in Canada, the national health program 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.

In the U.S., advisory committees to the Food and Drug Administration twice turned down applications from manufacturers to market HIFU devices as a treatment for prostate cancer, citing not enough long-term evidence.

But in October 2015, the FDA approved Charlotte, N.C.-based 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 form 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 Lyon, France-based EDAP gained a similar approval shortly thereafter.

Researchers say it’s too soon to state conclusively that partially treating the disease works as well as totally removing it. There is also debate over the type of patients best suited for the treatment: low risk, intermediate risk or those who have failed other types of prostate cancer treatment.

Ongoing and previous studies 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 Michael Koch, chairman of the urology department at Indiana University School of Medicine, a proponent of HIFU for some patients. “We don’t have survival data to see if [it] does better than surgery or radiation.”

To get more complete answers, some physicians say it’s critical to track outcomes with de-identified patient information in a nationwide registry.

It’s not a new idea. Indeed, some technologies have been granted approval by the FDA or coverage by Medicare with a condition that patients must be enrolled in clinical trials or registries.

“Short of the FDA saying to device makers, ‘You need to do this,’” establishing a comprehensive tracking method is challenging, said Jim Hu, a urologist and a robotic surgery specialist at Weill Cornell.

Hu co-authored a paper in the Journal of the American Medical Association in July with Sedrakyan and UCLA urology resident Aaron Laviana calling for a registry. Meetings between registry proponents, the FDA and the device makers are ongoing, but challenges remain, Hu said.

A registry is currently operating in England that will soon open to U.S. users of SonaCare Medical’s HIFU devices. While SonaCare funds the registry, it does not have control of the data, said SonaCare CEO Mark Carol.  His firm will also contribute funding to a broader U.S. registry that Hu and his co-authors support, which would incorporate results from other HIFU devices as well, calling the plan an “ambitious and worthwhile undertaking.”

The evidence gathered could convince Medicare and other insurers that a treatment is valuable — and worth covering. But some practitioners may not want insurers to cover the treatment because when a treatment isn’t covered, cash payments by patients can often exceed what practitioners would be paid by insurers. Currently, men usually pay for it themselves.

“The financial piece of this is somewhat perverse,” said Hu. “Men are being charged $25,000 for this, yet no one feels pressure to demonstrate the efficacy of the treatment.”

....