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3 Evidence

NICE commissioned an external assessment centre (EAC) to review the evidence submitted by the company. This section summarises that review. Full details of all the evidence are in the project documents on the NICE website.

Clinical evidence from the original guidance

The GOLIATH trial shows GreenLight XPS is as clinically effective as TURP

3.1 The company submissions included 3 publications of a single trial (GOLIATH study: Bachmann et al. 2014, Bachmann et al. 2015, Thomas et al. 2015) that compared GreenLight XPS with transurethral resection of the prostate (TURP). GOLIATH was a European multicentre randomised controlled trial in 281 people with benign prostatic hyperplasia (BPH; who were not considered as high risk). Results showed no statistically significant difference in BPH symptom improvement (measured on the International Prostate Symptom Score [IPSS] or maximum urinary flow [Qmax]) between GreenLight XPS and TURP up to 2 years, and using GreenLight XPS resulted in a significantly shorter duration of catheterisation and shorter lengths of stay. The committee at the time of the original guidance concluded that GreenLight XPS was as effective as TURP in treating BPH in non-high-risk groups.

There was not enough evidence in the high-risk population at the time of the original guidance

3.2 The EAC identified 10 studies in total, including 2 from the 3 that the company submitted, that were relevant to the high-risk groups. High risk was defined in the previous guidance as people with a higher risk of bleeding (such as those on anticoagulants), larger prostates (over 100 ml) and urinary retention. Five of these studies included comparative clinical data. There were significant improvements from baseline in all clinical outcomes (p<0.001). The clinical experts said that GreenLight XPS may be a safe alternative to TURP in this population. However, the committee agreed that there was not enough evidence to show any notable differences in effectiveness or adverse events using GreenLight XPS in the high-risk population compared with TURP and holmium laser enucleation of the prostate (HoLEP). The committee therefore concluded in the original guidance that multicentre prospective studies with GreenLight XPS were needed in this population.

3.3 Following a review of the evidence base in 2019, NICE decided to update the guidance to consider the new evidence on its use in high-risk groups since the original guidance.

New clinical evidence

The EAC prioritised 37 studies out of 58 new publications

3.4 For the guidance update, the EAC considered a total of 58 new studies relevant to the decision problem. Because of the size of the evidence base, the EAC prioritised 37 of these studies:

  • 1 randomised controlled trial (RCT) comparing standard GreenLight XPS 180 W photoselective vaporisation of the prostate (PVP) with GreenLight XPS ejaculatory hood-sparing technique (Abolazm et al. 2020)

  • 3 propensity-matched cohorts (Azizi et al. 2017, Castellani et al. 2018, Cimino et al. 2017)

  • 7 non-randomised, non-propensity-matched comparative studies (Cindolo et al. 2017, Gondran-Tellier et al. 2021, Hibon et al. 2017, Mathieu et al. 2017, Mattevi et al. 2020, Mesnard et al. 2021, Reimann et al. 2019)

  • 9 cohort studies that stratified by patient risk (Campobasso et al. 2020, Eken and Soyupak 2018, Goueli et al. 2017, Knapp et al. 2017, Lee et al. 2016, Meskawi et al. 2019, Meskawi et al. 2017, Waters et al. 2021) or procedure setting (Xu et al. 2021)

  • 17 single arm studies that reported on rare adverse events (Aboutaleb et al. 2018, Berquet et al. 2015, Castellucci et al. 2020, Chen and Chiang 2016, Ferrari et al. 2021b, Gasmi et al. 2021, Ghahhari et al. 2021, Ghahhari et al. 2018, Law et al. 2021, Liu et al. 2020, Rajih et al. 2017, Reimann et al. 2018, Tao et al. 2019, Thomas et al. 2019, Trail et al. 2021, Trujilo et al. 2021, Zhou et al. 2017).

    For full details of the clinical evidence, see section 3 of the assessment report update (2022).

There was no new randomised evidence comparing GreenLight XPS with TURP or HoLEP

3.5 No new RCTs comparing GreenLight XPS with TURP or HoLEP were identified at guidance update. The GOLIATH trial remained the only randomised controlled evidence comparing GreenLight XPS with TURP. There was no randomised evidence comparing GreenLight XPS with HoLEP. At guidance update, 6 observational studies compared GreenLight XPS with TURP. The EAC said that further randomised comparative studies in people at high risk exclusively may not be ethical. This is because of the increased risk of bleeding, complications and longer hospital stays associated with TURP.

Evidence suggests clinical benefits with GreenLight XPS, including in high-risk groups

3.6 The new evidence suggested that, when compared with TURP, GreenLight XPS was associated with a significantly shorter hospital stay, significantly shorter postoperative catheterisation period and significantly higher preservation of ejaculatory function at 12 months (Reimann et al. 2019, Cimino et al. 2017, Mattevi et al. 2017, Gondran-Tellier et al. 2021, Mathieu et al. 2017). While most of this new evidence included people at high risk (50 of 58 studies), only 4 reported on high-risk populations exclusively. Two were comparative studies (Gondran-Tellier et al. 2021, Mesnard et al. 2021) and 2 were retrospective cohorts (Meskawi et al. 2017, Eken and Soyupak 2018). An additional 4 cohort studies stratified by anticoagulation status (Lee et al. 2016, Knapp et al. 2017, Meskawi et al. 2019, Eken and Soyupak et al. 2018). Details of these studies are in section 4.2 of the assessment report update overview (2022).

Cost evidence

Published economic evidence reports cost benefits using GreenLight XPS

3.7 The original guidance included 2 published cost-effectiveness studies, both of which compared GreenLight XPS with TURP (Thomas 2015a, Bunejam-Gual 2014). Both studies suggested that reduced length of stay, or an increased proportion of procedures done as day cases would be associated with a cost saving when using GreenLight XPS.

3.8 The EAC identified 6 economic studies published since the original guidance. None were done in the UK. Two studies reported GreenLight XPS to be cost saving against TURP (Masucci et al. 2018, Ulchaker and Martinson 2018), 1 reported GreenLight XPS to be more costly but more effective than TURP (Caicedo et al. 2019), 2 studies reported TURP to be more cost effective (Erman et al. 2018, Ulchaker and Martinson 2018) and 1 reported cost savings when compared with HoLEP or ThuLEP in people with a prostate volume greater than 80 ml (Mathieu et al. 2017). For full details of the cost evidence, see section 9 of the assessment report update (2022).

The EAC updated the original decision tree cost model

3.9 In the original guidance the company developed a decision tree model, which was used to inform the committee's recommendation. These compared the cost consequences of using GreenLight XPS with:

  • monopolar or bipolar TURP in a non-high-risk BPH population (people who did not have urinary retention, not taking anticoagulation therapy or with prostates less than 100 ml)

  • HoLEP in a high-risk BPH population (people with urinary retention, taking anticoagulation therapy or with prostates more than 100 ml).

    The model used a 6‑month time horizon. The EAC corrected some minor errors and updated the model costs and clinical parameters, including: shortening the length of stay, reducing the calculated cost for HoLEP and removing excess bed day costs. For full details see the assessment report update (2022).

The updated decision tree model suggests that GreenLight XPS is cost saving compared with TURP but cost incurring compared with HoLEP

3.10 With the updated clinical and cost parameters, the EAC's base case results suggested that GreenLight XPS remains cost saving by £70 per person compared with TURP, but cost-incurring when compared with HoLEP (an additional cost of £114 per person). The latter was because of reduced capital costs associated with increased use per year of HoLEP in the updated model. Base case estimates assume 4% of TURP procedures and 36% of GreenLight XPS procedures were done as a day case procedure. The key driver of the cost saving was the proportion of procedures that could be carried out as day cases. The EAC's threshold analysis suggested that when maintaining 68% of GreenLight XPS done as a day-case procedure, using GreenLight XPS would be cost-incurring if the proportion of day-case procedures for TURP or HoLEP increased above 43.6% and 56% respectively.

The company presented a new Markov model, which included a high-risk population scenario

3.11 The company submitted a new cost model during the guidance update. It applied a Markov model structure and had a 4‑year time horizon. The model included everyone who needed treatment for BPH and had a high-risk group scenario, which was informed by the results of an unpublished systematic review. The model allowed for retreatment.

The EAC modelled all people treated for BPH because there was limited comparative evidence in high-risk groups

3.12 The EAC considered that the company's unpublished review was low quality, and its results were not robust enough to inform economic modelling for high-risk populations. The EAC noted that the GOLIATH trial remained the most robust comparative evidence and that there was no new prospective comparative evidence specifically on using GreenLight XPS in high-risk populations, since the original guidance. The EAC considered that modelling all people whose BPH was treated was more appropriate and more generalisable to the NHS. The EAC made some changes in the model costs and clinical parameters, including: extending the time horizon to 5 years, reducing the capital cost of HoLEP, and increasing the length of stay. Full details are in the assessment report update (2022).

The revised EAC base case results from the Markov model show that GreenLight XPS is cost-saving compared with TURP or HoLEP

3.13 The EAC's revised base case analysis for the Markov model showed that GreenLight XPS is cost saving, per person, by £304.83 compared with TURP and £269.52 compared with HoLEP. The EAC conducted limited probabilistic sensitivity analysis, varying two parameters due to availability of data. Base case cost savings were driven by the duration of procedures and the length of stay after procedures. Additional threshold analyses suggested that GreenLight XPS would become cost-incurring if TURP and HoLEP were done less than 43.7 and 60.0 minutes respectively (relative to 49.6 minutes for GreenLight XPS). GreenLight XPS would also become cost-incurring if the length of hospital stay following TURP or HoLEP were less than 1.5 and 0.9 days respectively (relative to 1.6 days for GreenLight XPS).