The Urolift System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance
- PMID: 26832146
- PMCID: PMC5025508
- DOI: 10.1007/s40258-015-0218-x
The Urolift System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance
Abstract
As part of its Medical Technologies Evaluation Programme (MTEP), the National Institute for Health and Care Excellence (NICE) invited Neotract (manufacturer) to submit clinical and economic evidence for their prostatic urethral lift device, Urolift, for the relief of lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS BPH). The Urolift System uses implants to retract the prostatic lobe away from the urethral lumen. The clinical evidence used in the manufacturer's submission shows that Urolift is effective for the treatment of BPH. Urolift delivers a weighted mean International Prostate Symptom Score (IPSS) improvement of between 9.22 and 11.82 points. These Urolift improvements are greater than a published 'marked improvement' in IPSS score of 8.80. Comparison with randomised controlled trials (RCTs) of TURP (Transurethral Resection of Prostate) and HoLEP (Holmium Laser Enucleation of Prostate) show that Urolift does not yield better clinical outcomes from baseline compared to TURP and HoLEP in terms of IPSS, QoL (Quality of Life) and Qmax (maximum urinary flow). However, Urolift appears to have the advantage in terms of minimal and mild complications, and this may be of interest to patients and urologists. The economic case for Urolift was made using a very detailed and thorough de novo cost model. The base case posed by the manufacturer placed Urolift at almost cost-neutral (£3 cost incurring, based on 2014 prices) compared to TURP, and £418 cost incurring compared to HoLEP. In an additional scenario comparing day-case Urolift with in-patient TURP, the estimated per-patient savings with Urolift were £286 compared with monopolar TURP (mTURP) and £159 compared with bipolar TURP (BiTURP). NICE guidance MTG26 recommends that the case for adoption of Urolift was supported by the evidence, when implemented in a day-case setting.
Conflict of interest statement
Compliance with Ethical Standards NICE technical analysts Kimberley Carter and Ailish Higgins and technical adviser Bernice Dillon provided advice on NICE processes and wrote the scope for the evaluation. KC, AH and BD work for the National Institute for Health and Care Excellence, and have no conflicts of interests to declare. KC had no role in the production of the EAC report. Cedar is contracted by NICE to provide evidence preparation, assessment and development services. GCR is an NHS employee, and AR and HM are Cardiff University employees with honorary NHS contracts as part of their role at Cedar. AW is an independent contractor who holds an honorary NHS contract as part of his work with Cedar, so is indirectly funded by NICE and the NHS. The NHS has a financial interest in the guidance on which this project is based. This summary of the Medical Technology Guidance was produced following the publication of the final guidance report. This article not been externally peer reviewed by Applied Health Economics and Health Policy. Author contributions AR, HM, AW, KC and GCR contributed to the preparation of the manuscript.
References
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- National Institute for Health and Care Excellence. Medical Technologies Evaluation Programme: Methods Guide. http://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE.... Accessed 7 Apr 2015. - PubMed
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- National Institute for Health and Care Excellence. Lower urinary tract symptoms. The management of lower urinary tract symptoms in men. Clinical guideline 97. http://www.nice.org.uk/guidance/cg97/resources/guidance-lower-urinary-tr.... NICE 2010; Accessed 7 April 2015.
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- National Institute for Health and Care Excellence. Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia. NICE 2014. http://www.nice.org.uk/guidance/ipg475. Accessed 7 Apr 2015.
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- National Institute for Health and Care Excellence. MTG217 The TURis system for transurethral resection of the prostate. https://www.nice.org.uk/guidance/mtg23. Accessed 15 March 2015.
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