NICE Evaluation and Tariff Code Announcements to Increase UroLift® System Availability in UK NHS Patients with Enlarged Prostate

National Institute for Health and Care Excellence (NICE) could give
major boost to UroLift
® System adoption on the
NHS across the UK with guidance finding the treatment is less costly
than other treatments, is minimally invasive and preserves sexual
function

PLEASANTON, Calif.–(BUSINESS WIRE)–NeoTract, Inc., today welcomed the announcement by NICE that its
UroLift® System (Prostatic Urethral Lift) to treat an enlarged prostate
(benign prostatic hyperplasia) saves the National Health Service (NHS)
up to £286 ($443) per patient as a day case, compared to the most
commonly used surgical intervention. NICE acknowledged the UroLift
System has unique benefits, including preservation of sexual function,
improved quality of life, reduced recovery time and the ability to treat
high risk patients.

In its report, which assessed both clinical and economic benefits,
NICE’s Medical Technologies Evaluation Program committee noted that the
UroLift System “relieves lower urinary tract (LUTS) symptoms while
avoiding the risk to sexual function associated with transurethral
resection of the prostate (TURP) and holmium laser enucleation of the
prostate (HoLEP)… and represents a significant advantage for men who
wish to preserve their sexual function. Using the system reduces the
length of a person’s stay in hospital. It can also be used in a
day-surgery unit.”

NICE “accepted expert advice that catheterization time would be reduced
and in many cases… [this] would be avoided, especially as surgeons gain
experience with the procedure. It also concluded that it was reasonable
and likely that the UroLift System would be used as a day-surgery
procedure, often under local anesthetic.”

“The NICE report dovetails well with an analysis we published December
2013 in Population Health Management that showed an anticipated
30% savings of UroLift versus standard surgery, based on a two year
horizon of care within the US Medicare system,” stated Dr. David Nash,
Dean of the Jefferson College of Population Health.

In the UK, it is estimated that more than £180 million ($279M) is spent
on BPH treatments each year, with 60% of these costs incurred in
secondary care as a direct result of managing BPH complications.

The report stated that the UroLift System “should be considered as an
alternative to current surgical procedures for use in a day-case setting
in men with lower urinary tract symptoms of benign prostatic hyperplasia
who are aged 50 years and older and who have a prostate of less than 100
ml.”

The UK’s General Practice Research Database (GPRD) from 1992 to 2001
reveals an increasing prevalence of lower urinary tract symptoms, which
is most commonly caused by BPH, with older age, from 3.5% in men aged
45–49 years to more than 30% in men aged 85 years and above. A
significant proportion of these men could benefit from treatment with
the UroLift System.

In a separate development, the NHS has released “more appropriate”
financial arrangements for reimbursing hospitals undertaking the UroLift
procedure that better reflect the cost of care.

“Both of these announcements independently, as well as the recent
inclusion of UroLift into the European Association of Urology
Guidelines, further support the clinical and economic value of this
game-changing technology,” stated Dave Amerson, President and CEO,
NeoTract, Inc. “We now expect that the tariff change coupled with this
very supportive NICE advice will mean that most, if not all, UK
hospitals can choose to offer UroLift in the near future.”

About Benign Prostatic Hyperplasia (BPH)

BPH, also known as enlarged prostate, is a medical condition in which
the prostate gland that surrounds the male urethra becomes enlarged with
advancing age and begins to obstruct the urinary system. The condition
is common, affecting approximately 500 million men worldwide. BPH
symptoms include sleepless nights and urinary problems, and can cause
loss of productivity, depression and decreased quality of life. About
one in four men experience BPH-related symptoms by age 55 and by age 70,
over 80 percent of men suffer from BPH.

Medication is often the first-line therapy for enlarged prostate, but
relief can be inadequate and temporary. Side effects of treatment can
include sexual dysfunction, dizziness and headaches, prompting many
patients to quit using the drugs. For these patients, the classic
alternative is surgery that cuts or ablates prostate tissue to open the
blocked urethra. While current surgical options, such TURP can be very
effective in relieving symptoms, it can also leave patients with
permanent side effects such as urinary incontinence, erectile
dysfunction and retrograde ejaculation (dry orgasm).

About the UroLift® System

The UroLift system is a novel, minimally invasive technology for
treating lower urinary tract symptoms due to benign prostatic
hyperplasia (BPH). The UroLift permanent implants, delivered during a
minimally invasive transurethral outpatient procedure, relieve prostate
obstruction and open the urethra directly without cutting, heating, or
removing prostate tissue. Clinical data from a pivotal 206-patient
randomized controlled study showed that patients with enlarged prostate
receiving UroLift implants reported rapid and durable symptomatic and
urinary flow rate improvement without compromising sexual function.
Patients also experienced a significant improvement in quality of life.
Most common adverse events reported include hematuria, dysuria,
micturition urgency, pelvic pain, and urge incontinence. Most symptoms
were mild to moderate in severity and resolved within two to four weeks
after the procedure. The UroLift System received positive NICE guidance
and is FDA-cleared. It is available in the U.S., Europe, Australia,
Canada and Mexico. Learn more at www.UroLift.com.

About NeoTract

NeoTract, Inc. is dedicated to developing innovative, minimally invasive
and clinically effective devices that address unmet needs in the field
of urology. The company’s initial focus is on improving the standard of
care for patients with BPH using the UroLift System, a minimally
invasive permanent implant system that treats symptoms while preserving
normal sexual function. Learn more at www.NeoTract.com.

Contacts

for NeoTract, Inc.
EMEA Media Contact:
Amanda Hayhurst,
44.772.0205581
Amanda@amandahayhurst.com
or
US
Media Contact:
Nicole Osmer, 650-454-0504
Nicole@nicoleosmer.com

Alrededor de la web