5.1 The company's searches for economic evidence identified 5 studies that it considered relevant to the decision problem. None of these studies included the UroLift system, but were all economic studies of the comparators. The External Assessment Centre considered that none of these studies were appropriate for inclusion as they did not include the UroLift system. The External Assessment Centre's searches also did not find any relevant economic studies.
5.2 The company presented a de novo cost model, in which the intervention was the UroLift system and the comparators were monopolar or bipolar transurethral resection of the prostate (TURP) and holmium laser enucleation (HoLEP). The population was men with lower urinary tract symptoms of benign prostatic hyperplasia who are aged 50 years or older and who have a prostate of less than 100 ml. The model had a decision tree structure with an arm for each technology considered. Post‑treatment outcomes were success or failure, with further options for relapse or no relapse after a successful procedure. Both the relapse and failure branches had options for re‑treatment (which may succeed or fail) or no re‑treatment. The model had an NHS perspective with a 2‑year time horizon.
5.3 The clinical parameters that the company used were based on data from Chin et al. (2012), Woo et al. (2011) and Roehrborn et al. (2014). The probability of procedural success (defined as a 10% or better improvement in International Prostate System Score [IPSS] at 12 months) varied from 89.08% for the UroLift system to 96.71% for HoLEP. The probability of long‑term relapse after a successful procedure ranged from 0% for the UroLift system to 0.99% for bipolar TURP, and the probability of re‑treatment within 31 days ranged from 0.21% for HoLEP to 0.75% for UroLift. The model values for UroLift length of stay (0.5 days) and procedure time (30 minutes) were both based on clinical advice.
5.4 The company calculated the capital costs for each technology based on an assumed 10‑year lifespan and use for 250 patients a year. The UroLift system has a capital cost of £5199, equating to a cost per procedure of £2.50. For HoLEP, with a capital cost of £167,555, the cost per procedure is £80.60. It was assumed that there were no capital costs associated with monopolar or bipolar TURP. The company assumed that 4 UroLift implants were used per procedure, giving a consumables cost of £1320 per procedure for the system. For bipolar and monopolar TURP the consumable cost was £52.50 for a loop electrode. The consumable cost for HoLEP was £97.18 per procedure based on a reusable fibre and morcellator.
5.5 The results of the company's base‑case analysis showed that using the UroLift system in an inpatient setting had an incremental cost of £3 per patient compared with monopolar TURP, £40 compared with bipolar TURP and £418 per patient compared with HoLEP. The UroLift system was associated with higher equipment costs but lower costs for clinical supplies and services. It became cost neutral compared with monopolar TURP when the cost per UroLift implant was lowered to £329.
5.6 The External Assessment Centre considered the overall model structure to be unwieldy because it included comparators outside the scope, pre‑ and post‑operative tests which were common across the interventions, and perspectives outside the scope (and not referred to in the submission). However, the External Assessment Centre considered the costs included in the model to be thorough, detailed and taken from reliable sources.
5.7 The External Assessment Centre agreed with the main assumptions informing the company's model for using the UroLift system in an inpatient setting, but established or revised some parameters as follows:
It calculated a weighted mean procedural time of 59.6 minutes based on the published literature and used this instead of the 30 minutes in the company submission.
It also changed the operating time associated with monopolar TURP from 60 minutes to 66 minutes, based on the published literature.
It calculated the weighted mean number of devices per procedure to be 4.4 and revised the value of 4 implants used in the company submission.
It increased staffing costs associated with TURP to include an extra band 5 nurse based on clinical advice that the nurse may be needed to deal with irrigation fluid.
It increased staffing costs associated with HoLEP to include an extra band 5 nurse based on clinical advice that the nurse may be needed as a laser operator.
It reduced the cost of blood transfusion from £862.17 in the company's model to £329, based on the NHS Blood and Transplant List (2014/15).
It included a capital equipment cost for TURP of £10 per‑procedure cost (bringing the total capital cost to £20,799). There was no capital cost for TURP included in the company's model.
It assumed a cost of £368.61 for single‑use HoLEP fibres (from the NHS supply chain); in the company's model HoLEP fibres were priced at £614.27 for fibres that could be used 20 times.
5.8 When all the External Assessment Centre's parameter revisions were incorporated into the model, the results from the base case showed that the UroLift system, when used in an inpatient setting, costs more than either of the comparators. It costs £227 per patient more than HoLEP, £272 per patient more than monopolar TURP and £400 more than bipolar TURP. The External Assessment Centre identified the cost of the UroLift implants as the key cost driver of the analysis. Analysis showed that the UroLift system becomes cost neutral compared with monopolar TURP if the price per UroLift implant is £268.
5.9 Based on the company's claimed benefits and expert advice, the External Assessment Centre also explored a scenario in which the UroLift system was done in a day‑surgery unit. Day surgery was defined as the patient being 'admitted and discharged on the same day, with day surgery as the intended management'. In this scenario, the length of stay in the day unit was 3 hours with a procedure time of 30 minutes, based on clinical expert opinion. It was assumed that the procedure would be done under local anaesthetic and so the cost of a consultant anaesthetist was removed from the model. All of the External Assessment Centre's assumptions for this scenario were supported by published information or by clinical experts who are currently using the UroLift system in the NHS.
5.10 Results from the day‑surgery scenario showed that a UroLift procedure costs £2355, HoLEP costs £2315, bipolar TURP costs £2564 and monopolar TURP costs £2691. Therefore, using the UroLift system produced savings of £336 per patient compared with monopolar TURP and £209 per patient compared with bipolar TURP. It incurred an additional cost of £40 per patient compared with HoLEP.
5.11 At its meeting to develop provisional recommendations, the Committee asked the External Assessment Centre to develop an additional day‑surgery scenario which included the cost of a consultant anaesthetist (see section 5.14). This added £50 to the cost of the UroLift system, bringing the total to £2405. In this scenario, using the UroLift system produced savings of £286 per patient compared with monopolar TURP and £159 per patient compared with bipolar TURP. It incurred an additional cost of £90 per patient compared with HoLEP.
5.12 The Committee noted the cost modelling presented by the company and the adjustments made by the External Assessment Centre, and considered these adjustments to be both reasonable and plausible.
5.13 The Committee noted that in both the company's and the External Assessment Centre's base‑case models of a hospital inpatient setting, the UroLift system was more costly than TURP and HoLEP. The main cost driver was the cost of the UroLift implants.
5.14 The Committee was advised by the clinical experts that the External Assessment Centre's base‑case analysis was based on evidence from studies done under trial conditions in other countries where procedure times were longer than in UK practice and where catheters were always used. The External Assessment Centre advised that even when the procedure time was reduced to 30 minutes, the UroLift system was not cost‑saving in an inpatient setting, with implants at their current price.
5.15 The Committee noted that the cost modelling showed the UroLift system to be cost saving only when used in the day‑surgery scenario (see section 5.8). The clinical experts advised that a consultant anaesthetist would usually be present when the UroLift system was used in a day‑surgery scenario. The Committee asked the External Assessment Centre to update its analysis to include the cost of the consultant anaesthetist (see section 5.10). The clinical experts also stated that the day‑surgery scenario is feasible and is current practice in some hospitals.
5.16 The Committee noted that the costs of cystoscopy were not included in the cost model. The External Assessment Centre confirmed that the cost of cystoscopy was similar for both the UroLift system and the comparators, and so this cost was not considered in the model.
5.17 The Committee considered that preservation of sexual function by using the UroLift system would mean less need for erectile dysfunction consultations and treatments such as sildenafil, compared with current practice, but it noted that these potential cost savings had not been included in the model.
5.18 The Committee noted that UroLift incurred an additional cost of £40 per patient in comparison with HoLEP in a day‑surgery scenario. However, the Committee was advised by the clinical experts and by the External Assessment Centre that a number of uncertainties remained in the model concerning the lifespan of the HoLEP equipment and the number of uses per year. It was advised that HoLEP is used very little in the NHS. In the light of that information and in view of the clinical advantages of the UroLift system, the Committee considered that this cost difference should not affect the recommendation to adopt UroLift for use in day surgery.
5.19 The Committee noted the difference in the cost for TURP in the economic model for this evaluation and that in published NICE medical technology guidance on the TURis system for transurethral resection of the prostate. The External Assessment Centre explained that this was because costs that are common to TURis or TURP (for example theatre overheads and some theatre staff costs) were excluded from the cost model used in the TURis evaluation. The cost model for comparing the UroLift system with TURP includes many of these costs because the interventions do not share so many common cost consequences.