4 Committee discussion
4.1 The committee concluded that UroLift is clinically effective, with sustained relief of lower urinary tract symptoms up to 5 years after treatment. It is implanted using a minimally invasive procedure. The clinical experts confirmed that in their practice, UroLift is an effective treatment that is well tolerated.
4.2 The committee concluded that there was no evidence to suggest the UroLift procedure increases the risk of developing sexual dysfunction. The clinical experts explained that during the procedure there is no resection or ablation of prostate tissue. This is an important difference between UroLift and other invasive treatments for benign prostatic hyperplasia. Therefore, the committee considered that the reduced incidence of sexual dysfunction with UroLift, compared with comparator treatments, was plausible.
The person's preference is important in choosing an appropriate treatment for benign prostatic hyperplasia
4.3 The clinical experts explained that there are several invasive treatments for managing benign prostatic hyperplasia symptoms when drug treatment has not worked. Also, they explained that treatment is guided by what the person prefers because there is no definitive evidence that one treatment is better than another for all clinical outcomes. The committee noted that the updated evidence allowed direct comparison of UroLift with transurethral resection of the prostate (TURP). This evidence suggested that although the improvement in lower urinary tract symptoms may be greater after TURP the incidence of sexual dysfunction was lower with UroLift. The clinical experts explained that people for whom UroLift is considered suitable are also able to have Rezum treatment. The committee noted that there is only 1 study comparing Rezum with UroLift, with a follow-up period of 30 days. This showed that UroLift was better than Rezum for the short-term relief of lower urinary tract symptoms and for improving erectile dysfunction, but any comparative benefits beyond 30 days were uncertain. The committee concluded that the evidence supported the use of UroLift. But, deciding whether to use UroLift or other technologies should be guided by clinical expertise and counselling for the person having the procedure.
The evidence for using UroLift for people with an obstructive median lobe is limited but shows promising clinical effectiveness
4.4 The clinical evidence for using UroLift for people with an obstructive median lobe consisted of 1 small study of 45 people with a 12‑month follow-up period. The results showed a statistically significant improvement in lower urinary tract symptoms and quality of life after UroLift without the development of sexual dysfunction. The clinical experts explained that they have successfully used UroLift to treat an obstructive median lobe. The committee concluded that the evidence was limited but promising for using UroLift to treat an obstructive median lobe.
4.5 The urinary tract infection rate after UroLift was 2.9% (Roehrborn et al. 2013). The clinical experts explained that the risk of urinary tract infection was, in their experience, lower with UroLift than with other procedures. This was likely to be because of the reduced need for urinary catheterisation after the procedure.
4.6 The clinical experts explained that UroLift has a good success rate in adequately relieving lower urinary tract symptoms, with an early failure rate of less than 5%. However, they considered that people may need further treatment, for example if the prostate enlarges further, so should expect a reintervention rate of up to 20%. The clinical evidence from the LIFT study showed a 13.6% reintervention rate at 5 years after the procedure. This reintervention rate was used in the economic model for UroLift.
UroLift is an option for treating lower urinary tract symptoms caused by benign prostatic hyperplasia in the NHS
4.7 A clinical expert confirmed that UroLift is widely used in the NHS since the publication of the original NICE guidance. However, there are now other minimally invasive procedures available to treat the condition in the same population, such as Rezum.
4.8 The clinical experts stated that in clinical practice, UroLift is done under either general anaesthesia or local anaesthesia (with or without sedation). The method of anaesthesia is tailored to the needs of the person having the procedure. If light sedation is needed with local anaesthesia, the clinical experts emphasised that it is important to have an appropriately trained professional, other than the surgeon, monitoring the person during and after the procedure. They also explained that doing flexible cystoscopy in the outpatient clinic to plan treatment is a good opportunity to assess tolerance and suitability for doing the procedure under local anaesthesia.
4.9 The clinical experts explained that they do not currently offer UroLift as an outpatient treatment themselves but were aware that some clinicians do. UroLift procedures are offered in a small number of NHS trusts with outpatient facilities equipped for implant procedures and with recovery space to monitor people after the procedure. The clinical experts stated that if such facilities were available in their own centres they would also consider doing UroLift as an outpatient procedure.
4.10 There is limited clinical evidence on using UroLift for prostates over 80 ml in volume. The clinical experts confirmed that in their own practice, they consider UroLift is most appropriate for prostates under 80 ml. They explained their experience that if UroLift is done on prostates over 80 ml, more implants are needed. Also, the results are not likely to be as good and symptoms may recur. Clinical decision making is best supported by measuring prostate size objectively using transrectal ultrasound or MRI, but it can also be estimated from preoperative cystoscopy.
The proportion of flexible cystoscopies routinely carried out before a UroLift procedure is uncertain
4.11 Two of the clinical experts stated that they did flexible cystoscopy routinely before deciding whether to offer UroLift. This allowed them to see whether there is an obstructive median lobe and estimate the number of implants needed. They could also assess whether there are any other conditions, including bladder stones or bladder cancer, which might affect whether the procedure is done. One expert stated that they do not routinely do flexible cystoscopy before UroLift because of the added time and cost implications. There is uncertainty about the proportion of flexible cystoscopies routinely carried out before the procedure.
4.12 The clinical experts agreed that on average, the UroLift procedure takes 10 to 15 minutes per person to do. However, they noted that this does not take into account variations in time taken for the administration of local or general anaesthetic or for changeover time between procedures. The clinical experts also noted that the length of hospital stay can vary. This is because of local hospital procedures, the time taken to recover from the anaesthetic and for the person to empty their bladder (a requirement for leaving hospital).
4.13 Telephone follow up by a nurse was now routine with UroLift, Rezum, TURP and holmium laser enucleation of the prostate (HoLEP). People having Rezum, TURP or HoLEP also need to have a trial period without the urinary catheter in place, but the clinical experts explained that this was usually done in the community. The clinical experts also explained that people may return a few months after their procedure for objective tests to assess clinical outcomes such as flow rate and International Prostate Symptom Score.
4.14 The clinical experts explained that TURP and HoLEP are unsuitable for some people with lower urinary tract symptoms, because of frailty or comorbidities. Although UroLift is minimally invasive, they considered that it may be unsuitable for some people in poor health and those who do not wish to have implants in their bodies. The decision to use UroLift should be made on an individual basis. The clinical experts noted that the implants can sometimes leave traces on MRI scans, which may be confusing if people are being investigated for possible prostate cancer. But if the radiologists interpreting the scans are aware that the person has UroLift implants, this should not be a problem.
4.15 Eight people who identify as women have had UroLift treatment. One of these procedures was done in the NHS. The clinical experts stated that doing a UroLift procedure in people who have had gender reassignment surgery did seem possible. Gender reassignment is a protected characteristic under the Equality Act 2010.
4.16 The external assessment centre (EAC) revised the company's base case and showed that UroLift remained cost saving compared with the standard treatments, TURP and HoLEP. The committee accepted the EAC's conclusions. It noted that using UroLift was estimated to save, per person, £981 compared with bipolar TURP, £1,242 compared with monopolar TURP and £1,230 compared with HoLEP. This was over a 5‑year time horizon and if UroLift was done as a day-case procedure.
4.17 Further analysis was done to look at the use of telephone follow up for all treatments and a trial without a catheter in the community for Rezum. UroLift remained cost saving when all treatments had a telephone follow up instead of an outpatient appointment. Rezum and UroLift were cost neutral when there was a trial without a catheter in the community, instead of as an outpatient, after Rezum. The committee considered that it was unclear which assumptions on follow-up care most closely resembled routine NHS practice. It concluded that this introduced some uncertainty in the cost case between UroLift and Rezum.
4.18 The economic analysis included an assumption that an average of 3.5 implants were used per person with UroLift treatment. The clinical experts thought this was an underestimate and that an average of 4 implants was more appropriate, with a range of between 2 and 6 implants depending on prostate size. There was a learning curve associated with accurately judging the number of implants needed and usually after 15 to 25 procedures a surgeon can confidently do this. The committee acknowledged that the economic model was sensitive to the cost and number of implants used. But varying the number of implants used was unlikely to affect the cost savings when compared with TURP and with HoLEP. It concluded, however, that the cost case compared with Rezum was less certain if the number of implants varied. The clinical experts commented that this may mean that using UroLift for smaller prostates, with no obstructive median lobe, might be cost saving when compared with Rezum.
4.19 UroLift (if done as an outpatient procedure) was cost saving in the base case by £121 compared with Rezum for everyone who had treatment, over a 5‑year time horizon. However, the EAC's sensitivity analysis showed that Rezum would be cheaper if several parameters were changed individually, including:
if the procedure time was the same for both procedures
if the average number of UroLift implants exceeded 3.61.
Further economic analysis showed that Rezum was likely to be cost saving if flexible cystoscopy was done before UroLift treatment. However, there was uncertainty around whether only people being considered for UroLift would have flexible cystoscopy. The clinical experts stated that they sometimes use flexible cystoscopy in assessing suitability for procedures other than UroLift.
The cost case for UroLift when treating an obstructive median lobe is uncertain because of the increasing number of implants
4.20 Between 5% and 20% of people with lower urinary tract symptoms of benign prostatic hyperplasia have an obstructive median lobe, which may not be identified before the procedure. The committee discussed that having an obstructive median lobe made UroLift's potential case for cost savings for the full population uncertain. The base case assumed that 5.3% of people have an obstructive median lobe, which means on average, 1.3 additional implants per procedure. The clinical experts stated that in their practice, the average is more likely to be 2 additional implants. This led to increasing uncertainty in the cost case for UroLift compared with Rezum. Rezum's cost is not affected by the presence of an obstructive median lobe.
4.21 Further evidence to address uncertainties about the relative clinical and cost effectiveness of UroLift compared with Rezum, especially in the NHS, would be welcome. This should include:
exploring long-term clinical outcomes and reintervention rates after UroLift
assessing the suitability of UroLift for prostates larger than 80 ml and for those with an obstructive median lobe.
This evidence could be generated by collating UK registry data and including the number of implants used, the length of the procedure and procedural outcomes.