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  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?

EARLY VALUE ASSESSMENT PROGRAMME

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1 Recommendations

Can be used while more evidence is generated

1.1

Five technologies can be used in the NHS during the evidence generation period as an option for robot-assisted surgery for knee or hip replacements in children, young people and adults. The technologies are:

  • ApolloKnee System

  • CORI Surgical System 

  • Mako SmartRobotics 

  • ROSA Knee Solution 

  • VELYS Robotic-Assisted Solution. 

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 generations 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 (2 years), the company 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.

Can only be used in research

1.4

More research is needed on SkyWalker for robot-assisted surgery for knee or hip replacements in children, young people and adults before it can be used in the NHS.

1.5

Access to SkyWalker should be through company, research, or non-core NHS funding, and clinical or financial risks should be appropriately managed.

What evidence generation and research is needed

1.6

Evidence generation and more research is needed on:

  • health-related quality of life, including patient-reported outcome measures

  • immediate consumables and resourcing associated with surgery, including:

    • preoperative CT imaging requirements

    • training time and costs

    • surgical and theatre accessories

    • staffing (number and NHS band)

    • total theatre time and total surgical time

    • volume of procedures per day and

    • implant costs

  • post-surgery treatment and service use including:

    • length of hospital stay

    • readmission rates

    • number of physiotherapy sessions and

    • revision rates (stratified by implant type).

  • characteristics of people having the procedure, such as age, body mass index and American Society of Anesthesiologists risk score

  • population subgroups, such as people from Southeast Asian backgrounds

  • where in the country the procedures are done.

    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: While conventional orthopaedic surgery is widely available, robot-assisted orthopaedic surgery is currently limited to a small number of hospitals in the UK. If future evidence shows that robot-assisted surgery improves patient outcomes, it could be more widely implemented across the UK. This would allow more people the choice of conventional or robot-assisted orthopaedic surgery.

  • System benefit: A key benefit of robot-assisted surgery is the precise positioning of the implant. This allows the surgeon to position and align the implants in the correct position for each person. An individualised approach to surgery may improve patient satisfaction following surgery and reduce the demand for revision surgery.

  • Clinical benefit: Clinical evidence comparing robot-assisted surgery with conventional surgery suggests that improvements in patient-reported outcomes and complications are similar. Implant alignment was consistently better with robot-assisted surgery than with conventional surgery. But the committee was uncertain about the best way to measure alignment and if better alignment results in better clinical outcomes.

  • Resources: More accurate joint replacement may improve patient satisfaction and shorten recovery time, reducing the need for follow-up appointments with GPs, surgeons and physiotherapists, and the prescription of pain management medicines.

  • Equality: Robot-assisted surgery may improve access to surgery for people who are at higher risk. This includes older people and people with a high body-mass index or multimorbidity. People from Southeast Asian backgrounds may also experience greater benefits from robot-assisted surgery for knee replacements due to anatomical differences that can result in poor alignment with conventional surgery.

Managing the risk of use in the NHS with evidence generation

  • Training: All members of the surgical team must be trained on each robotic technology 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 was based on the limited evidence available including utility values with a high degree of uncertainty. Results from the modelling were highly sensitive to the utility values used. For total or partial knee arthroplasty, the results suggest the technologies in this guidance are not likely to be cost-effective and for total hip arthroplasty, the CORI and Mako platforms may be cost-effective. For a robust economic assessment more evidence is needed to inform the parameters for each technology. This guidance will be reviewed within 2 years and the recommendations may change. Take this into account when negotiating the length of contracts and licence costs.

  • Patient outcomes: Experts and the identified evidence suggest that adverse events are rare and unlikely to differ between robot-assisted surgery and conventional surgery. But, adverse events should still be captured in future evidence to ensure the safety of robot-assisted surgery in the NHS.

  • Equality: Robot-assisted surgery may not be suitable for people with mental or neuromuscular conditions, conditions affecting joint articulation or, with some technologies, people who are pregnant or have kidney disorders. Conventional surgery may be more appropriate for these people.

  • Access: Introducing robot-assisted surgery could potentially increase geographic inequalities in the availability of surgery. Regional adoption should be monitored to ensure access to robot-assisted surgery is not limited to people living in central locations where there are high-volume centres. An NHS England robot-assisted surgery steering group has been assembled to address some of these challenges.