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UroLift for Treating Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance Update (2022)
Laura Knight · Megan Dale · Andrew Cleves · Charlotte Pelekanou · Rhys Morris
Abstract
Lower urinary tract symptoms (LUTS) commonly occur as a consequence of benign prostatic hyperplasia (BPH), also known as prostate enlargement. Treatments for this can involve electrosurgical removal of a section of the prostate via transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), or prostatic urethral lift using the UroLift system. The UroLift system implants to pull excess prostatic tissue away so that it does not narrow or block the urethra. In this way, the device is designed to relieve symptoms of urinary outflow obstruction without cutting or removing tissue. National guidance recommending the use of UroLift in the UK NHS was first issued in 2015 by the National Institute for Health and Care Excellence (NICE MTG26). We now report on the process to update the economic evaluation of UroLift, leading to updated NICE guidance published in May 2021 (NICE MTG58). The conclusions of the available clinical evidence were mixed and suggested that whilst UroLift improves symptoms over time, this improvement is smaller than that of TURP for symptom severity (IPSS) and urological outcomes. However, UroLift appears to be superior to Rezum for symptom severity and measures of erectile dysfunction and ejaculatory dysfunction. The updated economic model estimated that using UroLift as a day-case procedure for people with a prostate of volume 30–80 mL creates a saving of £981 per person compared with bipolar TURP, £1242 compared with monopolar TURP, and £1230 compared with HoLEP.
1 Introduction
The aim of medical technologies guidance (MTG) issued by the UK National Institute for Health and Care Excellence (NICE) is to support the adoption of clinically effective and cost-saving technologies in the UK National Health Service (NHS). This paper summarises Cedar’s assessment report update [1] and how it was used to inform NICE MTG58: ‘The UroLift system for treating lower urinary tract symptoms of benign prostatic hyperplasia [2]. This is an update of the original guidance MTG26 [3]. Cedar is a healthcare technology research center formed through collaboration between Cardiff and Vale University Health Board and Cardiff University. This paper is part of a series that report the development of NICE MTG. NICE produces guidance on new or innovative medical devices or diagnostics, Medical Technologies Guidance (MTG). The aim of this paper is to provide an insight into the development of updated recommendations for the use of the UroLift system.
1.1 Background to the Technology and Application
Prostatic urethral lift using the UroLift system is an endoscopic treatment for men with lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH). The UroLift system comprises a single-use pistol-gripped endoscopic delivery device (probe), used to deliver an implant. Each UroLift implant consists of two ‘anchors’ connected by a nonabsorbable suture. The surgeon inserts the probe into the urethra until it reaches the prostatic urethra. A fine needle at the end of the probe deploys the suture through a lateral lobe of the prostate and the capsular anchor fixes the suture outside of the prostate. The needle is withdrawn, tensioning the suture, which is then secured in the urethra with the urethral anchor. The result is that the lobe is pulled away from the area of obstruction, thus opening the urethra. This is repeated on the other lateral lobe of the prostate. A procedure uses an average of 3.5 implants and can be done with the patient under local or general anesthetic and as an in-patient, out-patient or day-case procedure. There have been no changes to the technology since NICE MTG26 and UroLift have a current CE mark.
4 Key Challenges and Learning Points
There is a clinical evidence base of moderate to high quality and up to 5-year follow-up in support of UroLift as a treatment for people with LUTS, though few of the available studies were conducted in the UK and therefore direct applicability to the NHS setting is lacking.
There are published economic evaluations of UroLift used to treat men with LUTS but these have low applicability to the UK NHS and inconsistent findings. Therefore, an approach using a de novo economic model with a UK NHS and social care perspective was warranted. The economic model demonstrated that UroLift resulted in cost savings compared to HoLEP, bTURP, and mTURP under most conditions. However, the economic model demonstrated uncertainty in the cost case for UroLift when compared to Rezum. The cost saving resulting from the use of UroLift is dependent upon some important assumptions. Two assumptions are based on unpublished NHS patient tracker data provided by the manufacturer:
• UroLift theatre time is reduced from 30 min at the time of developing NICE MTG26 [3] to 14 min
• UroLift procedures today use fewer implants than at the time of developing NICE MTG26 [3]: 3.5 versus 4 implants per procedure, respectively
A further two assumptions have no evidence base:
• Rezum has a longer length of hospital stay (0.5 days, based on NICE MTG 49 [23]) than UroLift (0.125 days)
• Patients who undergo UroLift procedures are followed up by telephone call with a nurse, whereas all other procedures require an outpatient visit with a consultant. In sensitivity analysis telephone follow-up was modeled for all comparators. UroLift remained cost-saving versus all comparators with the exception of Rezum
5 Conclusions
The available clinical evidence suggests that UroLift improves LUTS but the magnitude of improvement is not as big as for TURP for several symptoms and urological outcome measures. When compared to Rezum, however, UroLift resulted in bigger improvements for symptom severity and erectile dysfunction measures. The benefits for men with LUTS gained by UroLift appear to be sustained in the long term. In addition, the number of adverse events was reduced in UroLift patients when compared to TURP. UroLift has been shown to be suitable as a day-case treatment under local anesthetic, resulting in reductions in catheterization rates, catheterization time, and length of hospital stay.
The economic model estimated that UroLift resulted in a cost-saving compared to mTURP, bTURP, and HoLEP. The model estimated that UroLift resulted in a small cost saving compared to Rezum under most conditions, provided that important assumptions hold. Under some conditions, the comparator treatment Rezum may be cost-saving compared to UroLift.
Laura Knight · Megan Dale · Andrew Cleves · Charlotte Pelekanou · Rhys Morris
Abstract
Lower urinary tract symptoms (LUTS) commonly occur as a consequence of benign prostatic hyperplasia (BPH), also known as prostate enlargement. Treatments for this can involve electrosurgical removal of a section of the prostate via transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), or prostatic urethral lift using the UroLift system. The UroLift system implants to pull excess prostatic tissue away so that it does not narrow or block the urethra. In this way, the device is designed to relieve symptoms of urinary outflow obstruction without cutting or removing tissue. National guidance recommending the use of UroLift in the UK NHS was first issued in 2015 by the National Institute for Health and Care Excellence (NICE MTG26). We now report on the process to update the economic evaluation of UroLift, leading to updated NICE guidance published in May 2021 (NICE MTG58). The conclusions of the available clinical evidence were mixed and suggested that whilst UroLift improves symptoms over time, this improvement is smaller than that of TURP for symptom severity (IPSS) and urological outcomes. However, UroLift appears to be superior to Rezum for symptom severity and measures of erectile dysfunction and ejaculatory dysfunction. The updated economic model estimated that using UroLift as a day-case procedure for people with a prostate of volume 30–80 mL creates a saving of £981 per person compared with bipolar TURP, £1242 compared with monopolar TURP, and £1230 compared with HoLEP.
1 Introduction
The aim of medical technologies guidance (MTG) issued by the UK National Institute for Health and Care Excellence (NICE) is to support the adoption of clinically effective and cost-saving technologies in the UK National Health Service (NHS). This paper summarises Cedar’s assessment report update [1] and how it was used to inform NICE MTG58: ‘The UroLift system for treating lower urinary tract symptoms of benign prostatic hyperplasia [2]. This is an update of the original guidance MTG26 [3]. Cedar is a healthcare technology research center formed through collaboration between Cardiff and Vale University Health Board and Cardiff University. This paper is part of a series that report the development of NICE MTG. NICE produces guidance on new or innovative medical devices or diagnostics, Medical Technologies Guidance (MTG). The aim of this paper is to provide an insight into the development of updated recommendations for the use of the UroLift system.
1.1 Background to the Technology and Application
Prostatic urethral lift using the UroLift system is an endoscopic treatment for men with lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH). The UroLift system comprises a single-use pistol-gripped endoscopic delivery device (probe), used to deliver an implant. Each UroLift implant consists of two ‘anchors’ connected by a nonabsorbable suture. The surgeon inserts the probe into the urethra until it reaches the prostatic urethra. A fine needle at the end of the probe deploys the suture through a lateral lobe of the prostate and the capsular anchor fixes the suture outside of the prostate. The needle is withdrawn, tensioning the suture, which is then secured in the urethra with the urethral anchor. The result is that the lobe is pulled away from the area of obstruction, thus opening the urethra. This is repeated on the other lateral lobe of the prostate. A procedure uses an average of 3.5 implants and can be done with the patient under local or general anesthetic and as an in-patient, out-patient or day-case procedure. There have been no changes to the technology since NICE MTG26 and UroLift have a current CE mark.
4 Key Challenges and Learning Points
There is a clinical evidence base of moderate to high quality and up to 5-year follow-up in support of UroLift as a treatment for people with LUTS, though few of the available studies were conducted in the UK and therefore direct applicability to the NHS setting is lacking.
There are published economic evaluations of UroLift used to treat men with LUTS but these have low applicability to the UK NHS and inconsistent findings. Therefore, an approach using a de novo economic model with a UK NHS and social care perspective was warranted. The economic model demonstrated that UroLift resulted in cost savings compared to HoLEP, bTURP, and mTURP under most conditions. However, the economic model demonstrated uncertainty in the cost case for UroLift when compared to Rezum. The cost saving resulting from the use of UroLift is dependent upon some important assumptions. Two assumptions are based on unpublished NHS patient tracker data provided by the manufacturer:
• UroLift theatre time is reduced from 30 min at the time of developing NICE MTG26 [3] to 14 min
• UroLift procedures today use fewer implants than at the time of developing NICE MTG26 [3]: 3.5 versus 4 implants per procedure, respectively
A further two assumptions have no evidence base:
• Rezum has a longer length of hospital stay (0.5 days, based on NICE MTG 49 [23]) than UroLift (0.125 days)
• Patients who undergo UroLift procedures are followed up by telephone call with a nurse, whereas all other procedures require an outpatient visit with a consultant. In sensitivity analysis telephone follow-up was modeled for all comparators. UroLift remained cost-saving versus all comparators with the exception of Rezum
5 Conclusions
The available clinical evidence suggests that UroLift improves LUTS but the magnitude of improvement is not as big as for TURP for several symptoms and urological outcome measures. When compared to Rezum, however, UroLift resulted in bigger improvements for symptom severity and erectile dysfunction measures. The benefits for men with LUTS gained by UroLift appear to be sustained in the long term. In addition, the number of adverse events was reduced in UroLift patients when compared to TURP. UroLift has been shown to be suitable as a day-case treatment under local anesthetic, resulting in reductions in catheterization rates, catheterization time, and length of hospital stay.
The economic model estimated that UroLift resulted in a cost-saving compared to mTURP, bTURP, and HoLEP. The model estimated that UroLift resulted in a small cost saving compared to Rezum under most conditions, provided that important assumptions hold. Under some conditions, the comparator treatment Rezum may be cost-saving compared to UroLift.
