The medical technology guidance supports using the GreenLight XPS laser system in patients who aren’t at high risk of complications from treatment. This means men who don’t have an increased risk of bleeding, whose prostates are smaller than 100 ml and who don’t have urinary retention. For men who are high risk, there are limited alternative treatment options depending on their clinical situation. An estimated 13,600 men with enlarged prostates could benefit from treatment with this device, and it could save the NHS millions of pounds each year.

Prostate enlargement – also called benign prostatic hyperplasia – is a common condition in older men; around 60% of men aged 60 or over have the condition.  An enlarged prostate can push against the urethra, making it difficult for a man to pass urine. It may also lead to repeated urinary tract infections, urinary retention and sleep problems due to the urge to urinate in the night, but the condition doesn’t pose other direct risks to health.

The device, GreenLight XPS, involves using a laser to vaporise excess prostate tissue, which eases the blocked urethra and leaves a clear channel for urine to flow. The benefits of the system include a quicker return to normal activity following treatment and a shorter period of time in hospital because the procedure can be done as a day-case. The NHS could save up to an estimated £3 million by using this device when compared with the commonly used procedure transurethral resection of the prostate (TURP) because TURP requires an overnight stay in hospital.

The guidance notes that there’s currently not enough evidence to support the use of the device in high-risk patients so it recommends that specialists should collect information on outcomes if they do use the device in these patients.  It also recommends that where GreenLight XPS is used, urology services should be redesigned to ensure day-case surgery is available.

Professor Carole Longson MBE, director of the NICE Centre for Health Technology Evaluation, said: “Whilst benign enlarged prostates may not be life threatening, the condition can impact on men’s lives significantly. A procedure to reduce the amount of excess prostate tissue can improve the quality of life for men. Using the GreenLight XPS is more convenient for patients than other surgical procedures as they don’t need to stay in hospital overnight and they can return to normal activity faster.  We recommend that specialists collaborate to collect and publish data if GreenLight XPS is used in treating enlarged prostates in men classed as high risk. This will help improve the evidence base and could enable future recommendations on its use in these patients.”

More information on the medical technology guidance for GreenLight XPS  is available at http://www.nice.org.uk.

ENDS

For more information contact Dr Tonya Gillis at the NICE press office.

1. The guidance, ‘GreenLight XPS for treating benign prostatic hyperplasia’ is available from the NICE website from Tuesday 14 June 2016 at www.nice.org.uk/mtg29. 

2. The GreenLight XPS is manufactured by Boston Scientific.

3. The recommendations are:

a) The case for adopting GreenLight XPS for treating benign prostatic hyperplasia is supported in non-high-risk patients. GreenLight XPS is at least as effective in these patients as transurethral resection of the prostate (TURP), but can more often be done as a day-case procedure, following appropriate service redesign.

b) There is currently insufficient high-quality, comparative evidence to support the routine adoption of GreenLight XPS in high-risk patients, that is those who:
• have an increased risk of bleeding or
• have prostates larger than 100 ml or
• have urinary retention.
NICE recommends that specialists collaborate in collecting and publishing data on the comparative effectiveness of GreenLight XPS for high-risk patients to supplement the currently limited published evidence.

c) Cost modelling indicates that in non-high-risk patients, cost savings with GreenLight XPS compared with TURP are determined by the proportion of procedures done as day cases. Assuming a day-case procedure rate of 36%, and that the GreenLight XPS console is provided at no cost to the hospital (based on a contracted commitment to fibre usage), the estimated cost saving is £60 per patient. NICE’s resource impact report estimates that the annual cost saving for the NHS in England is around £2.3 million. In a plausible scenario of 70% of treatments being done as day cases the cost saving may be up to £3.2 million.

d) NICE recommends that hospitals adopting GreenLight XPS plan for service redesign to ensure that day-case treatment can be delivered appropriately.

4. The cost of the device: the company submission stated that the GreenLight XPS laser console is usually provided at no cost to the NHS, as part of a contractual arrangement with the company to purchase a minimum number of laser fibres over a specified time period at an average price of £550 per fibre (excluding VAT).

5. TURP (transurethral resection of the prostate) is a procedure where excess prostate tissue is cut away using a loop of heated wire.

6. NICE issued guidance supporting the use of the UroLift system (inserting prostatic urethral lift implants): “UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia”, in September 2015, available at http://www.nice.org.uk/guidance/mtg26.

7. NICE issued guidance supporting the use of the TURis system for transurethral resection of the prostate (a bipolar electrosurgery system to cut away or vaporise excess prostate tissue) in February 2015: http://www.nice.org.uk/guidance/mtg23.

About the Medical Technologies Evaluation Programme

8. The Medical Technologies Evaluation Programme focuses specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory. More information is available at http://www.nice.org.uk/MT.