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, CA, US – September 17 2015 - 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 NHS up to £286 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 Programme 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 catheterisation 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 anaesthetic.”
In the UK, it is estimated that more than £180 million 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.
Consultant urologist Neil Barber, who was one of the first surgeons to introduce UroLift into the NHS, says: “My experience is that it’s men who are nervous of surgery altogether – be it because of fear of hospitals, of a general anaesthetic, or more commonly because of worries about effects upon sexual function, and who may be dependent on long-term medical therapy, often suffering the side effects in silence – who will most benefit from the wider introduction of UroLift into the NHS.”
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.
EMEA Vice President and General Manager, Justin Hall, says, “Both of these announcements independently, as well as the recent inclusion of UroLift into the European Association of Urology Guidelines, endorse UroLift on a European-wide level as an effective and more cost-efficient way of treating eligible men with urinary symptoms due to an enlarged prostate. NICE has done a thorough job independently assessing the economic and clinical case for the UroLift System. Their announcement is in line with their NHS drive to incentivize proven day case procedures like UroLift that improve NHS efficiency at the same time as making life better for patients. 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.co.uk.
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.
A case study presentation on UroLift will be given in a free to attend Pre-Conference Breakfast Meeting hosted by Neotract Inc at the British Association of Day Surgery conference ‘Innovation & Quality in Day Surgery’ to be held in London on Thursday 26 November 2015.
9.20-9.45am 'Urolift-The real deal’, A truly day case BPH procedure which actually shows economic value to the system
Professor Tom McNicholas Consultant Urologist Lister Hospital and President for the Urology Section The Royal Society of Medicine
• Case study, A business man with BPH who had issues with work through his symptoms, and had problems with sexual dysfunction which impacted his relationship and family life.
• Anaesthesia regime and Post-operative complications.
• New NICE recommendations and costing analysis showing how Urolift can increase capacity in hospitals .
Further information about the conference and booking details is available at http://www.healthcareconferencesuk.co.uk/day-surgery-conference
EMEA Media Contact:
28 October 2015