Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia

Relevant evidence comes from 4 studies presented in 10 publications, including 1 randomised controlled trial

3.1 Four studies were relevant to the decision problem in the scope:

The randomised controlled trial was in 197 people with an International Prostate Symptom Score (IPSS) of 13 or more and an estimated prostate volume between 30 cm³ and 80 cm³, who had had no previous surgical interventions for their prostate. The observational studies included people with prostate sizes from 20 cm³ to 110 cm³ who underwent the Rezum procedure. All are non-UK studies.

The evidence shows that Rezum is clinically effective

3.2 The Rezum II study showed that Rezum was associated with statistically significant improvements in lower urinary tract symptoms (LUTS) compared with sham at 3‑month follow up. These improvements were sustained throughout 4 years of follow up. The treatment benefits of Rezum in relieving LUTS were also consistently observed in the observational studies. These improvements were gained without significantly adversely affecting sexual function, at least in the short term. Overall, the evidence base shows that Rezum is an effective treatment for LUTS in people with benign prostatic hyperplasia (BPH). Rezum also improved measures of quality of life (McVary et al. 2019, Darson et al. 2017; Dixon et al. 2015 and 2016).

There is no evidence that directly compares Rezum with other interventions for BPH

3.3 None of the included studies compared Rezum with other commonly used treatments for BPH. Clinical experts suggested that more invasive treatments such as transurethral resection of the prostate (TURP) were likely to be associated with a more substantial relief of urinary symptoms than Rezum. But there is currently no direct evidence to support this. Similarly, there are no direct comparisons of Rezum with UroLift, holmium laser enucleation of the prostate (HoLEP), or GreenLight laser. Expert opinion indicated that recruiting participants to clinical trials that directly compare different minimally invasive and invasive treatments is challenging because people often express a preference to avoid more invasive treatment.

An indirect comparison suggests that Rezum is as effective as UroLift

3.4 In the absence of direct comparative evidence, the company did an indirect comparison of Rezum and UroLift to relieve LUTS. This was based on the results of the Rezum II study and the Luminal Improvement Following prostatic Tissue (LIFT) study (Roehrborn et al. 2017b). Both technologies are minimally invasive procedures to treat LUTS, and the trial designs and study populations were similar. The main exception was that the Rezum II study included people with median lobe obstruction (31.1% of study participants) while the LIFT study did not. A comparison of the results from the 2 trials indicated that the therapeutic effects of Rezum and UroLift in relieving LUTS were similar, but people were less likely to need further operations after Rezum than after UroLift. The retreatment rate was 4.4% at year 4 with Rezum and 13.6% at year 5 with UroLift.

Rezum is considered a safe procedure

3.5 The Rezum II study reported 3 procedure-related serious adverse events in the 3‑month follow up, including extended urinary retention, and nausea and vomiting, which were considered to be due to the sedative medication. An additional 3 procedure-related serious adverse events were reported with Rezum during the 3 to 12‑month follow-up period, including bladder contracture, bladder stone, and urosepsis after cystoscopy. The clinical experts did not identify any specific safety concerns with Rezum.

The company suggests that using Rezum is cost saving compared with other treatments for BPH

3.6 The company developed a decision analytic model with a time horizon of 4 years. The model compared Rezum with 4 comparators: UroLift, GreenLight laser, HoLEP and TURP. The model assumed that all the technologies had equal efficacy in alleviating LUTS associated with BPH. The model incorporated a cohort Markov structure. Erectile dysfunction and urinary incontinence were included as permanent adverse events that inform long-term health states. The need for surgical retreatment for recurrence of LUTS was also considered. The results of the company model indicated that Rezum was cost saving by £737, £532, £25 and £758 per person when compared to TURP, UroLift, GreenLight and HoLEP respectively over 4 years.

The EAC's changes to the cost model more accurately reflect empirical evidence and expert opinion

3.7 The main parameters in the model were the technology costs, theatre time, hospital length of stay, adverse events and the need for another operation. The external assessment centre (EAC) adjusted some of the model's parameters, including the surgical retreatment rate and the adverse event rates, to more accurately reflect published empirical data and expert opinion.

Rezum is cost saving compared with TURP, UroLift and HoLEP but cost neutral compared with GreenLight

3.8 The EAC base case results showed that Rezum was cost saving by £569, £497 and £651 compared with TURP, UroLift, and HoLEP per patient respectively over 4 years. Rezum remains cost saving when all parameters are subjected to a one-way deterministic sensitivity analysis. In the base case, Rezum is cost incurring by £62 per patient over 4 years compared with GreenLight laser. The model assumed that GreenLight, like Rezum, was used as a day case. If, in practice, this is not the case, then Rezum is anticipated to be cost saving. Overall, the EAC considered Rezum, therefore, to be approximately cost neutral compared with GreenLight over the course of 4 years.