麻豆传媒

NASHVILLE -- Men with Peyronie's disease treated with injections of collagenase clostridium histolyticum (CCH, Xiaflex) had fewer complications and hospitalizations than surgically-treated patients, a researcher reported here.

In an analysis of data from a medical and pharmacy claims database, men who had surgery had a higher hospitalization rate for Peyronie's disease complications than CCH-treated patients (2.9% vs 0.5%, P=0.002), according to Landon Trost, MD, who was at the the Mayo Clinic in Rochester, Minnesota, at the time of the study.

Also, a higher percentage of surgically-treated patients had erectile dysfunction (55% vs 44.8%) and penile pain (17.9% vs 8.9%) versus CCH-treated patients at the Sexual Medicine Society of North America (SMSNA) fall meeting.

The analysis was one of several SMSNA posters that explored treatments for Peyronie's disease, which is characterized by a curving of the penis, caused by fibrous scar tissue that can make erections painful, and even prevent intercourse when the bend is significant.

"We only treat men with significant bother from the condition, or if they can't have sex or if sex causes their partner pain," urologist Tobias Kohler, MD, also of the Mayo Clinic, told 麻豆传媒.

In 2013, CCH injections became the first FDA-approved drug treatment for Peyronie's, indicated for men with palpable plaque and curvature of at least 30 degrees. The treatment costs around $4,000 per injection, with a standard therapeutic course involving eight total injections.

The treatment's cost has been controversial in urology. Trost, who is now at the Male Fertility and Peyronie's Clinic in Orem, Utah, suggested that the cost of the medical treatment favorably compares with surgery when surgical complications and rehospitalizations are factored into the equation.

Trost's group analyzed data from the Real-World Data Adjudicated Claims-U.S. Database included claims for penile surgery (plication, incision/excision and grafting, and prostheses) and claims for CCH from early 2014 until mid-2017.

Clinical events were compared for 620 patients in each treatment cohort and complications and penile-related events 1 year post-treatment were recorded.

"The main take-home...is that whenever you see cost-effectiveness studies comparing surgery versus [CCH], it is way over-simplified to just look at the cost of the intervention. You have to look at complications, readmissions, repeat surgery -- all these other factors that go into it," Trost said.

But in response to another presentation that examined outcomes in patients treated with 16 CCH injections, SMSNA past-present Laurence Levine, MD, of Rush University Medical Center, Chicago, expressed alarm.

In the study by Andrew Sun, MD, of the UCLA Geffen School of Medicine in Los Angeles, patients treated with one round of CCH (four cycles; eight total injections), 21% of men experienced improvement of ≥20%, while a total of 43.8% of men experienced a ≥20% after two rounds (16 injections). Seven patients saw no improvement with the second round of CCH and one patient got worse.

The average change in the degree of curvature after the first round was 11.5 degrees;, while the average change after the second round was 13.4 degrees;. The average percent change in curvature after eight and 16 injections, respectively, was 18.6% and 29.1%.

"I can't help it. I'm going there," Levine said. "You saw a 10% additional improvement with eight more injections times, $4,000 per injection, and that is good? I think we need to put the breaks on and look at this a little more carefully because somebody has to pay for this."

He added that pairing a single cycle of CCH with penile traction may as effective as extending CCH therapy at a much lower total cost.

The RestoreX penile traction device, developed by Trost, has been to improve outcomes in men undergoing CCH injections.

Trost told 麻豆传媒 that he a single, eight-injection round of CCH may be cost effective, but 16 injections clearly is not.

"We looked at that, and we aren't doing it," he said. "The cost isn't really justifiable for the degree of improvement you get."