GreenLight XPS for treating benign prostatic hyperplasia

The committee concluded that the new clinical evidence on GreenLight XPS showed its effectiveness in relieving the lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). Evidence also suggested that, compared with transurethral resection of the prostate (TURP), GreenLight XPS was associated with significantly shorter hospital stays, significantly shorter postoperative catheterisation, and significantly higher preservation of ejaculatory function at 12 months. The clinical experts confirmed that, in their experience, GreenLight XPS is an effective treatment option for people with BPH. The committee noted that there are no randomised trials that directly compare GreenLight XPS with holmium laser enucleation of the prostate (HoLEP), and no new randomised trials with TURP (other than the GOLIATH study). But it was satisfied that the available trial evidence, alongside real-world evidence and expert opinion, showed the clinical benefits associated with GreenLight XPS in practice.

The committee noted that most of the evidence included people considered high risk, but there was little comparative data in these groups exclusively. The external assessment group (EAG) highlighted the possible ethical challenges in getting randomised comparative evidence in these high-risk groups. The committee agreed that a large volume of evidence has been published after the original guidance but the comparative evidence in high-risk populations remains limited.

Clinical experts described how the risk profile of people with BPH has changed in practice since the previous guidance. They explained that urinary retention is common in people being treated for BPH (up to 50% of the population). The committee was satisfied that GreenLight XPS has been used for treating BPH in people with urinary retention, who are not now considered as a high-risk group in practice.

The clinical experts said that they considered GreenLight XPS to be a safe treatment option for people with a higher risk of bleeding or who were taking anticoagulants. They estimated that 20% of people having GreenLight XPS were in this high-risk group. The clinical experts said that anticoagulants can usually be taken through GreenLight XPS surgery, unlike with TURP. They said this means people who were at risk of bleeding could be referred across hospitals for treatment with GreenLight XPS. The clinical experts also advised that treatment for people with large prostates may be more varied because of laser technology availability and clinicians' experience. All of them considered that using GreenLight XPS to treat BPH was safe with prostates up to 100 ml in volume. They agreed that up to 150 ml was appropriate for GreenLight XPS if the clinician was experienced. People with prostates bigger than 150 ml are more likely to be considered for HoLEP treatment. The committee understood prostate size was a key factor in how long the procedure may take, so patient selection and the clinician's experience were important considerations in this high-risk group. The committee was satisfied that the evidence showed the clinical effectiveness of GreenLight XPS in BPH in larger prostates and people with a high risk of bleeding but concluded that more comparative evidence on the use of GreenLight XPS in these groups is needed.

Evidence from 12 studies reported that between 0% and 2.2% of people needed blood transfusions intraoperatively and 0.6% and 0.8% within 30 days. Seventeen studies recorded 0.1% to 5.6% of people with capsular perforation. Six studies reported no adverse events. The clinical experts explained that GreenLight XPS was rarely associated with postoperative bleeding. They said that continuous bladder irrigation (to prevent clot formation) was not normally needed after GreenLight XPS surgery, which reduces nursing requirements and improves the patient experience. Three-way catheters can help identify any issues with secondary bleeds, but clinical experts reported bleed risk to be low. The committee was satisfied that the risk of bleeding is low with GreenLight XPS.

The company said that fibre breakage was rare, and that it had modified the device to promote the cooling of the fibres, to minimise breakage. The EAG confirmed that there were no concerns over device safety and no adverse events related to patient harm. The clinical experts agreed that fibre breakage was rare (around 1 in 200 cases) and was not associated with patient harm. They explained that fibre breakage is more likely when a clinician first starts to use the device because they may position the fibre too close to the tissue. The committee was satisfied that there were no patient or clinician safety concerns about fibre breakage.

The company confirmed that GreenLight XPS is used in 26 specialist centres in the UK. The clinical experts explained that GreenLight XPS is used routinely in people needing surgical treatment for BPH, including those in the high-risk groups (people with large prostates or with a higher risk of bleeding). GreenLight XPS is one of the technologies covered by the MedTech funding mandate in 2022 to 2023.

The evidence reported that 68% of GreenLight XPS procedures were done as a day case (Trail et al. 2021). The clinical experts said that in their experience most people having GreenLight XPS are seen as a day case and do not need hospital admission. One said that, compared with TURP or HoLEP, GreenLight XPS is more likely to be a day case procedure. But they added that it depended on individual circumstances, such as the size of their prostate gland, social reasons, and the use of anaesthetics, which may mean some people needed an overnight stay.

Clinical experts explained that NHS urology centres varied in how services were set up. For example, some hospitals have extended opening hours to support day case surgery for GreenLight XPS but other centres require hospital admission. The committee understood that how services were set up could explain the large variations in length of stay and proportion of day cases across the centres. It agreed that willingness to set up day case services would be important to optimise the potential savings with GreenLight XPS.

The clinical experts explained that urologists need specialist training to use GreenLight XPS. But they suggested that it may be quicker to learn than TURP or HoLEP. The clinical experts also highlighted the importance of minimum procedure levels across centres to ensure skills are maintained.

The clinical experts said that laser treatment is available across urology departments for treating conditions such as kidney stones and BPH. Urologists are routinely trained in laser techniques and laser safety. Using GreenLight XPS requires laser equipment, including goggles. The cost of the equipment was not included in the cost model. The EAG considered that laser equipment is reusable, with a long lifespan and that costs would be negligible. The committee was satisfied that this would not be a significant additional cost requirement for services.

The committee was told that 2 people who identified as women and retained a prostate had GreenLight XPS treatment. No change in technique or concerns in carrying out the procedure in this population were reported.

The EAG's cost modelling results from the Markov model showed that GreenLight XPS is likely to be cost saving compared with TURP by £305 per person over 5 years. They showed that it was also likely to be cost saving compared with HoLEP by £270 per person over 5 years. The estimates applied to all people with BPH, including those considered to be high risk. The EAG considered the model to accurately reflect treatment complication and retreatment costs but that the size of the cost savings was uncertain in high-risk groups because of a lack of comparative evidence. The clinical experts also advised that modelling high-risk populations collectively may not be appropriate or generalisable to clinical practice. The committee agreed that the EAG's approach to modelling using the GOLIATH data was appropriate. It concluded that using GreenLight XPS is likely to be cost saving but by how much is uncertain, particularly for high-risk groups.

Length of stay was one of the key drivers of the estimated cost savings with GreenLight XPS compared with standard treatments such as TURP in the Markov model. GreenLight XPS becomes cost incurring if the length of stay with TURP is reduced to a level similar to GreenLight XPS. Length of stay was not a key driver in the original guidance, because the decision tree model presented it as the proportion of day cases, which was the key driver (see the assessment report update in the supporting documentation, Newcastle EAG 2022). The clinical experts said that people having GreenLight XPS are likely to be discharged on the same day and are not usually admitted to hospital after the procedure. However, the length of stay is likely to be influenced by personal factors and hospital infrastructure (see section 4.9). The clinical experts agreed that the scenarios for length of stay or proportion of day cases that would make GreenLight XPS cost incurring are unlikely in clinical practice in the NHS. However, given there is uncertainty in the size of the cost saving from length of stay in the cost model, the committee suggested data should continue to be collected on cost-saving outcomes such as length of stay when treating people who may be considered high risk (including those with larger prostates and a higher risk of bleeding).

The economic analysis included an assumed average procedure length of 49.6 minutes for GreenLight XPS, 66 minutes for TURP and 80 minutes for HoLEP. The clinical experts considered these procedure durations to be reasonable. However, they advised that duration is affected by prostate size and the clinician's experience. The clinical experts said that using GreenLight XPS for larger prostates might extend procedure duration. This could reduce the cost saving of using GreenLight XPS compared with TURP or HoLEP. However, it should be noted that there is a lack of data on procedural duration. The committee agreed that more data, including audit data, would be helpful to inform the uncertainty in the cost benefit of length of procedure across the comparators for the high-risk population (including those with larger prostates and a higher risk of bleeding).

The committee agreed that more data on the resource impact of GreenLight XPS compared with other treatments is needed in the high-risk groups (including those with larger prostates and higher risk of bleeding). It recommended collecting more data to address the cost-saving outcomes, including the length of hospital stay and the procedure duration, in high-risk groups.