Med Tech-related health technology assessments from NIHR in July 2024

The National Institute for Health and Care Research (NIHR) funds valuable independent research for health and social care decision-makers in England. Reports from the Health Technology Assessment (HTA) Programme are published in the NIHR HTA Journal and inform NICE guidance. 

In July 2024, five MedTech-related assessments were published in the NIHR HTA Journal:

• A cloud-based medical device for predicting cardiac risk in suspected coronary artery disease: a rapid review and conceptual economic model. The CaRi-Heart Risk (by Caristo Diagnostics) was considered for the assessment, which estimates the risk of 8-year cardiac death using a prognostic model, which includes perivascular fat attenuation index, atherosclerotic plaque burden, and clinical risk factors. It was concluded that the evidence about the clinical utility of CaRi-Heart Risk is underdeveloped and has considerable limitations, both in terms of risk of bias and applicability to UK clinical practice. There is some evidence that CaRi-Heart Risk may be predictive of an 8-year risk of cardiac death for patients undergoing computed tomography coronary angiography for suspected coronary artery disease. However, whether and to what extent CaRi-Heart represents an improvement relative to the current standard of care remains uncertain. The evaluation of the CaRi-Heart device is ongoing, and currently, available data are insufficient to fully inform the cost-effectiveness modeling;
• Devices for remote continuous monitoring of people with Parkinson's disease, based on a systematic review and cost-effectiveness analysis. The systematic review included five devices: Personal KinetiGraph, Kinesia 360, KinesiaU, PDMonitor, and STAT-ON. A de novo decision-analytic model was developed to estimate the cost-effectiveness of Personal KinetiGraph and Kinesia 360 compared to the standard of care in the UK NHS over a 5-year time horizon. The base-case analysis considered two alternative monitoring strategies: one-time and routine device use. It was concluded that Personal KinetiGraph could reasonably be used in practice to monitor patient symptoms and modify treatment where required. There was too little evidence on STAT-ON, Kinesia 360, KinesiaU, or PDMonitor to be confident that they are clinically useful. The cost-effectiveness of remote monitoring appears to be largely unfavorable, with incremental cost-effectiveness ratios above £30,000 per quality-adjusted life-year across a range of alternative assumptions;
• Home-monitoring for neovascular age-related macular degeneration in older adults within the UK, based on diagnostic test accuracy cohort study (MONARCH). The study included three tests for home use (KeepSight Journal, MyVisionTrack®, and MultiBit) compared with diagnosis by hospital follow-up. It was concluded that none of the evaluated tests provided adequate test accuracy to identify lesions diagnosed as active in follow-up clinics. If used to detect conversion, patients would still need to be monitored at the hospital. Associations of older age and worse deprivation with study participation highlight the potential for inequities with such interventions. The provision of reliable electronic testing was challenging;
• Treatment options for patients with pilonidal sinus disease based on a mixed-methods evaluation (PITSTOP). It was concluded that the burden of pilonidal surgery is greater than reported previously. This can be mitigated with a better selection of interventions according to disease type and patient desired goals. Results indicate a framework for future higher-quality trials that stratify disease and utilize broad groupings of common interventions with the development of a patient-centered core outcome set;
• Accuracy of glomerular filtration rate estimation using creatinine and cystatin C for identifying and monitoring moderate chronic kidney disease based on a longitudinal, prospective study (eGFR-C). It was concluded that including cystatin C in glomerular filtration rate-estimating equations marginally improved accuracy but not the detection of disease progression. Obtained data do not support cystatin C use for monitoring glomerular filtration rate in stage 3 chronic kidney disease.

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