Mega Soft Patient Return Electrode for use during monopolar electrosurgery

No published economic evidence on the Mega Soft Patient Return Electrode was identified by the sponsor. The external assessment centre found 1 study (ECRI 2000) that undertook a cost consequences analysis of the Mega 2000 in the USA. The external assessment centre noted that ECRI reported that the frequency of use and cost differential meant that with greater use Mega 2000 became more cost saving; however, the values used in the study were not considered relevant to the decision problem.

The external assessment centre stated that no clinical evidence was presented on which to base the incidence of skin burns from standard disposable single-use patient return electrodes and their associated costs in the sponsor's model. Evidence was not included on the cost of procuring, storing and disposing of standard disposable single-use patient return electrodes. No independent evidence was supplied on the time saved in theatre by using the Mega Soft Patient Return Electrodes rather than standard disposable single-use patient return electrodes.

The sponsor submitted a de novo economic model that estimated the cost per operation for the Mega Soft Patient Return Electrode compared with a split standard disposable single-use patient return electrode and a non-split standard disposable single-use patient return electrode in adult and paediatric patients undergoing monopolar electrosurgery. The analysis was from the NHS and personal social services perspective. Full details of all cost evidence and modelling considered by the committee are available in the assessment report overview.

The model used linear formulae that described the relationships between the resource and cost variables. The model did not use any health states. The external assessment centre noted that this structure was appropriate to quantify the main cost differences between the technologies given the level of clinical evidence available.

The sponsor stated that several parameters were not included in the model because a lack of data meant that cost savings were not quantifiable. These included:

• disposal of standard disposable single-use patient return electrodes

• further surgery to treat skin burns from standard disposable single-use patient return electrodes

• litigation because of skin burns from standard disposable single-use patient return electrodes

• treatment of skin irritation from standard disposable single-use patient return electrodes

• ordering and storing boxes of standard disposable single-use patient return electrodes.

The sponsor's base-case analysis included several key assumptions:

• The cost of the adult or paediatric Mega Soft Patient Return Electrode (without VAT) is £,1900.

• The Mega Soft Patient Return Electrode is used 3 times a day, 5 days a week, and 52 weeks a year (based on expert adviser estimates).

• Four types of standard disposable single-use patient return electrode are used in the NHS. The prices given are based on prices from the manufacturers of the different electrodes. (The sponsor did not supply any prices for electrodes without lead wires.)

  • Split adult standard disposable single-use patient return electrodes with lead wire: £2.44 per electrode.

  • Non-split adult standard disposable single-use patient return electrodes with lead wire: £2.60 per electrode.

  • Split paediatric standard disposable single-use patient return electrodes with lead wire: £1.92 per electrode.

  • Non-split paediatric standard disposable single-use patient return electrodes with lead wire: £1.74 per electrode.

• The price of an operating table pressure-relieving mattress was taken from 1 manufacturer and is £334.

• The pressure-relieving mattress is used 3 times a day, 5 days a week for 52 weeks a year based on assumptions and estimates.

• Costs of razors to shave patients were from razor manufacturers and are £1.13 for a disposable razor and £2.09 for a clipper head.

• All patients need shaving before using a standard disposable single-use patient return electrode.

• The discount rate of the Mega Soft Patient Return Electrode is 3.5% applied in year 0.

• The lifespan of the Mega Soft Patient Return Electrode is 24 months.

• The resource costs from the Personal Social Services Research Unit (PSSRU) are based on 'per operation hour' and are £347 per hour each for a surgeon and an anaesthetist and £41 per nurse.

• The estimated time needed for site preparation when using a standard disposable single-use patient return electrode is 5 minutes.

The sponsor tested several of the base-case assumptions in deterministic 2-way sensitivity analyses. In these analyses, the following parameters were increased and decreased by 50% (with no probabilities attached for the likelihood of these events occurring):

• number of operations per week

• cost of standard disposable single-use patient return electrodes

• cost of an operating table pressure-relieving mattress

• life of an operating table pressure-relieving mattress

• cost of razors for shaving

• staff time and hourly staff costs.

The sponsor's base-case analysis estimated the cost per operation using the Mega Soft Patient Return Electrode compared with a standard disposable single-use patient return electrode with a lead wire. The findings showed savings of £70.83 per operation for adults and £70.31 for children when using the adult or the paediatric Mega Soft Patient Return Electrode respectively when the Mega Soft Patient Return Electrode was compared with split pad standard disposable single-use patient return electrodes. These were greater savings than when the Mega Soft Patient Return Electrode was compared with non-split pad standard disposable single-use patient return electrodes because of the higher cost of the split pads. More than 95% of the savings were from improving efficiency by saving 5 minutes per operation. More than 80% of the savings were from surgeon and anaesthetist time saved. The largest contribution to the cost saving was from surgeon and anaesthetist time saved (£57.84 per operating hour). Nurse time saved resulted in a further saving of £10.25 per operating hour.

The external assessment centre noted that the sponsor had not justified why its assumptions were the most plausible range of values. Furthermore, the sensitivity analysis did not capture the lower prices for standard disposable single-use patient return electrodes in 1 NHS trust. The sensitivity analyses demonstrated that the results of the sponsor's model were sensitive to assumptions about staff time and the cost per hour for surgeons, anaesthetists and nurses.

The external assessment centre expressed particular concerns about a number of parameters in the sponsor's model and carried out additional analyses to examine the impact of changing the following parameters:

• Inclusion of VAT in the price of the Mega Soft Patient Return Electrode (£2,280).

• The most common type of disposable single-use patient return electrode used in the NHS is the split adult disposable single-use patient return electrode with no lead wire (£0.87). This is based on NHS Supply Chain figures.

• The Mega Soft Patient Return Electrode is used 3 times a day, 4 days a week for 50 weeks a year (based on clinician estimates). This equates to 600 operations per year.

• A razor costs £2.09 (disposable razors are no longer used).

• Shaving of 40% of patients (based on clinician estimates that were obtained by the external assessment centre as part of its assessment).

• There is no overall delay for site preparation when using a standard disposable single-use patient return electrode based on clinician advice.

The overall cost per operation when using the parameters described in section 5.10 is £2.16 for the comparator and £1.97 for an adult Mega Soft Patient Return Electrode. Therefore, this analysis demonstrated a cost saving of £0.19 per operation when using an adult Mega Soft Patient Return Electrode compared with a standard disposable single-use patient return electrode.

The overall cost per operation when using the parameters described in section 5.10 for the paediatric comparator (split paediatric standard disposable single-use patient return electrode with no lead wire) is £2.30 and for the paediatric Mega Soft Patient Return Electrode it is £1.97. This demonstrated a cost saving of £0.33 per operation using a paediatric Mega Soft Patient Return Electrode compared with a standard disposable single-use patient return electrode.