AposHealth for knee osteoarthritis

The committee noted that the authors of the randomised controlled trial (RCT) publication said that there was uncertainty in whether the improvements were clinically important. But the committee was reassured by the clinical and patient expert advisers reporting very positive outcomes. A patient expert adviser said that they continue to use the technology effectively as pain relief. The committee acknowledged that the rest of the evidence base is limited in methodological quality, but the outcomes reported across the evidence base are consistent. The committee concluded that AposHealth may lead to improvements in pain, function and stiffness for people with knee osteoarthritis.

The EAG reported that 2 non-comparative studies based in the US and UK included the rate of total knee replacement as a primary outcome. Drew (2022) and Greene (2022) reported an 86% and 84% rate, respectively, of total knee replacement avoidance for people using AposHealth at 2 years. The clinical and patient expert advisers agreed that these rates reflected their experience of using the technology in the NHS for up to 7 years. The committee noted that the rate of surgery avoidance reported in Greene (2022) may be an overestimation. This is because the study follow up overlapped with the COVID‑19 pandemic, when elective surgeries were often put on hold. The committee acknowledged that the clinical evidence was non-comparative and uncertain but accepted the support from clinical and patient expert advisers.

The committee discussed patient selection and the position of AposHealth in the care pathway. It noted that the clinical evidence does not specify a clear place or patient population for AposHealth in the care pathway. Clinical expert advisers using the technology stated that AposHealth is usually delivered as part of the musculoskeletal secondary care service. They also explained that people must have tried other non-surgical standard care and have met the referral criteria for a total knee replacement. The committee concluded that the appropriate population and place in the care pathway should be if non-surgical standard care has not worked well enough and the person's condition meets the referral criteria for total knee replacement surgery.

The decision to undergo knee surgery is a shared decision and there are multiple factors involved (see NICE's guidance on shared decision making). A patient expert adviser felt that surgery was not their preferred treatment option because of their young age and negative past experiences in their family. Clinical expert advisers agreed that a person's age, social and economic factors, comorbidities and understanding of the procedure may all influence their decision to have surgery. The committee acknowledged that there are many reasons people may not want surgery, and more strategies to manage symptoms for this group, such as AposHealth, are necessary.

The committee discussed patient eligibility and monitoring for AposHealth. It noted that AposHealth may be contraindicated for people with balance issues or especially severe osteoporosis. Clinical expert advisers explained that eligibility for AposHealth is reviewed on an individual basis. This is to ensure people are not put at risk of falls and can control the instability of the shoes. They also noted that healthcare professionals trained in using AposHealth, such as physiotherapists or podiatrists, continue to assess people's eligibility during follow-up visits through clinical assessment and observational gait analysis. The committee acknowledged that the technology may not be suitable for some people but accepted that healthcare professionals will use clinical judgement when referring and assessing people for AposHealth.

Clinical expert advisers said they rarely find that people do not use AposHealth as recommended. People are advised to wear the technology at home or at work for short periods of time. A patient expert adviser said that wearing the technology at home was convenient, and that they are eager to wear the device because of an immediate relief of symptoms. Clinical expert advisers noted that the instant symptom relief experienced by people can lead to overuse, which may result in muscle stiffness or soreness if not monitored appropriately. The committee noted that current users are selectively sampled and there is no data on adherence in a wider NHS setting. But it accepted that it is unlikely that people may not use AposHealth as recommended.

Clinical experts stated that using the technology daily improves muscle activity around the joint, which can lead to benefits when not actively wearing the technology. After the initial programme, people are advised to use the technology 2 to 4 times a week to remain stable. A patient expert adviser confirmed that wearing the technology as instructed has enabled them to do more exercise outside of the treatment programme. Now they only use the technology in response to acute joint pain or stiffness. The committee acknowledged that AposHealth may become less effective over time if use is stopped.

Clinical expert advisers noted that people with knee osteoarthritis often have comorbidities, such as back pain. Clinical expert advisers confirmed that they assess the impact of AposHealth on other lower limb joints during the initial AposHealth assessment to ensure the calibration of the technology is beneficial to all joints. The company noted that there is clinical evidence available for people with lower back and hip pain. This evidence was not presented to the committee or reviewed by the EAG, but the committee was reassured that AposHealth was unlikely to have adverse effects on other joints.

The EAG reported that AposHealth was cost saving at 5 years but became cost incurring at 10 years. The committee accepted that the main cost savings come from reduced total knee replacement surgery. The committee noted that there is limited evidence for reduced total knee replacement beyond 2 years. But it acknowledged that clinical expert advisers who have up to 7 years of experience using the technology also support the plausibility of reduced knee replacement surgery sustained over time. Clinical expert advisers also noted that AposHealth continues to be funded in their local area. The committee concluded that there are still uncertainties about the evidence for delaying total knee replacement surgery, but accepted the potential cost savings for the technology up to 5 years.

The EAG's sensitivity analysis showed that the reduced standard care costs when using AposHealth is one of the main drivers for increasing cost savings in the model. The EAG explained that the assumption of a 15% reduction in standard care costs comes from published clinical evidence showing reduced pain and increased function, and unpublished audit data from the US and UK suggesting a decrease in resource use. A patient expert adviser noted that they have not needed further help from their local service and have used less medication since using the technology. The committee acknowledged that the experience of clinical and patient experts also suggests AposHealth may reduce use of healthcare resources.

The committee suggested that real-world data could be collected to determine the clinical effectiveness and cost benefit of AposHealth for people whose condition meets the criteria for surgery but who do not want it over a longer time horizon. The committee noted that there is already a high-quality RCT comparing AposHealth with a sham device and acknowledged that there are difficulties in designing comparative studies because of the uncertainties in the standard care pathway. The committee supported the use of the technology in the NHS alongside the collection of high-quality real-world data, with outcomes including standard care resource use, health-related quality of life, and long-term outcomes such as rates of total knee replacement. The committee suggested that this data could be collected through a high-quality national registry (such as the National Joint Registry). The committee agreed that long-term data collection over 5 to 10 years will help establish the cost benefits of AposHealth.

The committee recommended that further research is needed for people whose condition meets the referral criteria for knee replacement surgery, but who cannot have surgery because it would be unsafe, and for the wider population of people with knee osteoarthritis because of the uncertainty around the clinical and cost evidence. The committee agreed that research with outcomes including standard care resource use, health-related quality of life, and long-term outcomes such as rates of total knee replacement should be collected. It noted that health-related quality of life data may be collected using standardised patient-reported outcome measures, such as the EQ‑5D.