The PLASMA system for transurethral resection and haemostasis of the prostate

Previous evidence about clinical outcomes is still relevant now the technology name has changed from TURis to PLASMA

4.1 The committee noted that the name change from TURis to PLASMA was not accompanied by any change to the technology. Therefore, they concluded that the previous evidence of equivalent clinical outcomes with mTURP is still relevant, and they saw no new contradictory evidence.

The evidence shows that PLASMA resection with a loop electrode is clinically effective

4.2 The committee discussed updated evidence on resection with PLASMA using the loop electrode and it concluded that the procedure is clinically effective. The professional experts advised that it is straightforward to switch from a loop to a roller or button electrode for haemostasis. The committee concluded from the published and expert evidence that using the button and roller electrodes is clinically effective for haemostasis after resection.

Using a PLASMA button electrode for vaporisation and the PLASMA system for other procedures such as incision and enucleation are not in the scope of this guidance

4.3 The professional experts advised that, in most cases after resection with loop electrodes, a separate roller or button electrode is needed to achieve haemostasis. They indicated that while this will inevitably result in some vaporisation of the prostate, this is not considered as a vaporisation procedure. The committee agreed that using the PLASMA button electrode for vaporisation of the prostate is not covered by the scope and so should therefore not be the subject of this assessment. It acknowledged that transurethral vaporisation of the prostate (TUVP) is not recommended in NICE's clinical guideline on management of lower urinary tract symptoms in men.

4.4 The committee agreed that using the PLASMA system for needle incision or enucleation is also out of scope for this evaluation.

Resection with the PLASMA system may increase the incidence of urethral strictures

4.5 The committee noted that 1 study reported an 19% incidence of urethral stricture after PLASMA treatment, compared with 6.6% for mTURP (Komura et al. 2015). The professional experts advised that this higher incidence did not reflect their own experience or practice. They informed the committee that they see urethral stricture in 5% or less of people who have treatment with PLASMA. The committee concluded that, based on the current evidence, it is difficult to be definitive about the incidence of urethral stricture after PLASMA. But, it was reassured that when this condition does develop, treatment is available.

Serious adverse events are reduced by using the PLASMA system compared with mTURP

4.6 The committee considered the incidence of serious adverse events, including transurethral resection (TUR) syndrome and blood transfusion with bipolar and monopolar TURP, during the production of MTG23. The committee noted that the evidence shows that the PLASMA system reduces the risk of TUR syndrome and reduces the need for blood transfusion compared with mTURP. The committee considered that these original conclusions about adverse events are still relevant and that there is no new data that would contradict their previous conclusions.

The PLASMA system and mTURP are used in the NHS

4.7 The committee heard that use of the PLASMA system for resection of the prostate has increased in the NHS over the last 5 years, with the number of centres offering this treatment rising from around 60 to over 110. The professional experts advised that the use of bipolar TURP is superseding mTURP. But, uptake across the UK is variable, and bipolar TURP is not yet established as standard care. The professional experts advised that mTURP is still used in people with small prostates when prolonged procedures are unlikely and when the incidence of TUR syndrome is likely to be low. The committee concluded that PLASMA and mTURP are both used in the NHS.

Collecting real-world evidence during post-market surveillance is encouraged

4.8 The committee encouraged the collection of real-world clinical data on PLASMA. They considered that this would represent good clinical practice and routine post-market surveillance.

PLASMA can be used with a reduced length of stay

4.9 The committee heard that PLASMA is now more expensive than it was when the original guidance was published. This is because of increased costs for components of the PLASMA system, including consumables, and increased inpatient day costs. However, the professional experts advised that PLASMA can now be used with a shorter length of stay. They stated that the length of stay for mTURP had not changed and so 3.3 days was still correct. Assumptions about length of stay for PLASMA were contained in the original model, that is, reduced by 0.19 days compared with mTURP. Accounting for this and the increase in the cost of PLASMA, the treatment would be cost incurring if applied in this way. However, with a reduction in length of stay to 2 days, the technology becomes cost saving. There are even more cost savings when treatment is given as a day case. The professional experts advised that a plausible and conservative length of stay with PLASMA in their practice is 2 days. One professional expert advised that he does the procedure as a day case in most of his patients. The committee concluded that PLASMA can be used with a reduced length of stay compared with mTURP.

PLASMA can be used with existing compatible equipment to save costs

4.10 The committee agreed that sites that already have compatible Olympus equipment for mTURP would be able to use some of this equipment for PLASMA. This could result in greater cost savings for these sites. However, the committee also noted that for sites where purchase of Olympus equipment would be needed for PLASMA treatment to be offered, cost savings would still be possible.

A second electrode is often needed to stop bleeding (haemostasis)

4.11 The professional experts advised that a second electrode is needed to achieve haemostasis in most cases. The EAC modelled this in a scenario of 65% of procedures. It advised that PLASMA is still cost saving under these circumstances.

A urinary catheter is used after treatment with PLASMA and mTURP

4.12 The professional experts advised that a urinary catheter is used after PLASMA and mTURP and that for day-case surgery with PLASMA, the catheter is removed after discharge from hospital in a community setting. The EAC estimated that the cost of catheter placement was included in the procedure costs. The cost of removal of the catheter at an outpatient appointment with a single healthcare professional is £68 (NHS tariff). The cost of removal in community care during a 1-hour appointment is £84 for a band 7 healthcare professional. The EAC advised the committee that neither of these costs for catheter removal would negate the cost savings for PLASMA compared with mTURP.

Length of stay was the main cost driver

4.13 The length of stay was the main driver of cost savings in the model. The committee discussed with professional experts using the PLASMA system for day-case surgery. One professional expert advised that PLASMA was used routinely for day-case TURP in his centre, but the experts acknowledged that this is not the case in all centres. The experts agreed that day-case use of PLASMA is possible, especially in people with low risk.

The PLASMA system is cost saving with reduced length of stay

4.14 The committee considered an updated base case and 4 additional scenarios presented by the EAC in the assessment report update (sections 3.16 to 3.21 of this guidance).

4.15 It agreed that reduced length of stay for the PLASMA system compared with mTURP was plausible. The committee also agreed that even when a second electrode is used to achieve haemostasis, cost savings are still possible with PLASMA because of the reduced hospital stay.