AposHealth for knee osteoarthritis

Clinical-effectiveness overview

NHS considerations

Adherence

4.5 AposHealth can provide immediate symptom relief, which may encourage adherence for people using it. Clinical expert advisers said that they rarely find 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 in symptoms. Clinical expert advisers noted that the instant symptom relief experienced by people can lead to over-use 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 accepted that it is unlikely that people may not use AposHealth as recommended.

4.6 AposHealth needs continued use for ongoing benefits. 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, and now only uses the technology in response to acute joint pain or stiffness. The committee acknowledged that the treatment may become less effective over time if use is stopped.

Other patient benefits or issues

4.7 AposHealth may benefit other lower limb joints. 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 use of AposHealth was unlikely to have adverse effects on other joints.

Decision modelling overview

4.8 There are uncertainties in the economic modelling because of limited data. 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 a reduction in total knee replacement surgery. The committee noted that there is limited evidence for a reduction in total knee replacement beyond 2 years. But it acknowledged that clinical expert advisers who have up to 7 years of experience delivering the technology also support the plausibility of reductions in 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 around the evidence for delaying total knee replacement surgery but accepted the potential cost savings for the technology up to 5 years.

4.9 The EAG's sensitivity analysis showed that the reduction in standard care costs when using AposHealth is one of the main drivers in the cost 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 haven't needed further help from their local service and have used less medication since using the technology. The committee acknowledged that the clinical and patient expert adviser user experience is positive for reducing use of healthcare services

Further research

4.10 The committee suggested that real-world data could be collected to determine the clinical effectiveness and cost benefit of AposHealth over a longer time horizon. The committee noted that there is 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 agreed that 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 may be appropriate. The committee recommended that data should continue to be collected for the wider population of people with knee osteoarthritis, as well as people who have met the referral criteria for a total knee replacement. It noted that health-related quality of life data may be collected using standardised patient reported outcome measures, such as the EQ-5D. The committee agreed that long-term data collection over 5 to 10 years will help to establish the cost benefits of AposHealth over a longer time horizon. The committee suggested that this data could be collected through a high-quality national registry (such as the National Joint Registry).