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Early value assessment consultation document for HTE10040 Robot-assisted surgery for soft tissue procedures

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1 Recommendations

These recommendations do not include robot-assisted surgery for prostatectomy. Robot-assisted surgery for prostatectomy is established practice in the NHS, so this procedure was excluded from the scope of this early value assessment.

1.1

Five technologies can be used in the NHS during the evidence generation period as options for robot-assisted surgery for soft tissue procedures. The technologies are:

  • Da Vinci SP

  • Da Vinci X and Xi

  • Hugo robotic-assisted surgery system

  • Senhance Surgical System

  • Versius Surgical System.

    These technologies can only be used:

  • if the evidence outlined in the evidence generation plan is being generated

  • once they have appropriate regulatory approval, including NHS England's Digital Technology Assessment Criteria (DTAC) approval.

1.2

The companies must confirm that agreements are in place to generate the evidence (as outlined in NICE's evidence generation plan). They should contact NICE annually to confirm that evidence is being generated and analysed as planned. NICE may withdraw the guidance if these conditions are not met.

1.3

At the end of the evidence generation period (3 years), the companies should submit the evidence to NICE in a form that can be used for decision making. NICE will review the evidence and assess if the technology can be routinely adopted in the NHS.

What evidence generation is needed

1.4

Evidence generation is needed on:

  • the learning curve for the surgeon and centre

  • resource use for robot-assisted surgery services:

    • set up, including staff training

    • delivery, including staffing, technology maintenance, additional training and consumables

  • costing structures to procure a robotic system

  • the effect on outcomes including:

    • rates of conversion to open surgery

    • length of hospital stay

    • complications

    • health-related quality of life

    • procedure-related discomfort and ergonomics for the surgeon

    • rates of minimally invasive surgery compared with open surgery after introduction of robot-assisted surgery into a centre

    • number of procedures and robot use

    • hospital capacity and surgical waiting lists

    • readmissions

    • long-term outcomes for people having robot-assisted surgery.

      The evidence generation plan gives further information on the prioritised evidence gaps and outcomes, ongoing studies and potential real-world data sources. It includes how the evidence gaps could be resolved through real-world evidence studies.

Potential benefits of use in the NHS with evidence generation

  • Access: Robot-assisted surgery for soft tissue procedures may increase access to minimally invasive surgery for some procedures and some groups of people.

  • System benefit: Some features of robotic systems may make it easier for surgeons to train to do minimally invasive surgery. All the technologies allow the surgeon to sit at a console to control surgical tools during the procedure. This may mean that more surgeons can do more physically and ergonomically challenging procedures, and that these procedures are easier to do. Also, it may enable surgeons to work for more years because work is less physically demanding.

  • Clinical benefit: Evidence suggests that robot-assisted surgery for soft tissue procedures is generally comparable with standard minimally invasive surgery for a range of clinical outcomes. Some evidence shows that length of hospital stay is shorter compared with open surgery and may be shorter than some standard minimally invasive procedures.

  • Resources: These technologies are likely to reduce length of hospital stay for some procedures, and may reduce surgical waiting lists and need for additional treatment after surgery.

  • Equality: Minimally invasive surgery may not be suitable for some groups of people without use of robot-assisted surgery. This can depend on the type of procedure and a mix of factors such as age and comorbidities.

Managing the risk of use in the NHS with evidence generation

  • Training: All members of the surgical team must be trained on each robotic system that they use. There is a surgeon and centre learning curve associated with robot-assisted surgery. Patient outcomes and service efficiency may not be maximised until the end of the learning curve.

  • Costs: Early economic modelling shows that robot-assisted surgery for soft tissue procedures could be cost effective in the long term, depending on some assumptions. It is more likely to be cost effective when it replaces open surgery. There are substantial budgetary costs to introduce a robot-assisted surgery service to a centre, like the cost of purchasing and maintaining the technology. There are different costing structures available, which may affect cost effectiveness and feasibility of acquisition. This guidance will be reviewed within 3 years and the recommendations may change. Centres should take this into account when negotiating the length of contracts and licence costs.

  • Resource: There may be resource implications when staff who provide open and standard minimally invasive surgery services train in robot-assisted surgery.

  • Technology selection: All technologies are systems used to do soft tissue surgical procedures. But the technologies do have differences in their indications for use, physical features, capabilities, costs and available costing structures. Each centre should consider the benefits and limitations of each for their intended use case and budget.

  • Equality and access: Minimally invasive surgery is done less frequently in the most deprived areas of the NHS than the least deprived. Also, there has been lower uptake of robot-assisted surgery in some parts of England and most high-volume centres are based in and around London. The geographical placement of robotic systems, and the availability of training, resources and staff to implement robot-assisted surgery services for soft tissue procedures, could worsen equalities issues. An NHS England robot-assisted surgery steering group has been assembled to address some of these challenges.

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