Med Tech-related health technology assessments from NIHR in August 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 August 2024, eight MedTech-related assessments were published in the NIHR HTA Journal:

• Automated devices for identifying peripheral arterial disease (PAD) in people with leg ulceration: an evidence synthesis and cost-effectiveness analysis. A systematic review included 24 studies evaluating five devices (BlueDop Vascular Expert, BOSO ABI-System 100, Dopplex Ability, MESI ankle–brachial pressure index MD, and WatchBP Office ABI). Two studies assessing people with leg ulcers found that automated devices often gave higher ankle–brachial pressure index readings than manual Doppler (underestimation of arterial disease). Meta-analysis of 12 studies showed a pooled sensitivity of 64% and a pooled specificity of 96% for detection of PAD. The results of the cost-effectiveness analysis were highly uncertain, dependent on many assumptions, and should be interpreted cautiously. The limited evidence identified for each automated device, especially in people with leg ulcers, and its clinical heterogeneity precludes any firm conclusions on the diagnostic performance and cost-effectiveness of these devices in clinical practice;
• A systematic review and economic evaluation regarding the clinical and cost-effectiveness of left ventricular assist devices (LVAD) compared to medical management for patients with advanced heart failure ineligible for heart transplantation (destination therapy). There is evidence of the efficacy of destination therapy; however, it is not currently commissioned within the UK NHS due to the lack of economic evidence. A systematic review of evidence was carried out, and an economic model (Markov) was developed with deterministic and probabilistic sensitivity analyses. Where possible, all analyses focused on the only currently available device in the UK (HeartMate 3 by Abbott). It was concluded that using the UK's cost-effectiveness criteria, LVADs, compared to medical management, may not be cost-effective for patients with advanced heart failure ineligible for heart transplants. When available, data from the ongoing evaluation of HeartMate 3 compared to medical management can be used to update cost-effectiveness estimates. An audit of the costs of medical management in the UK is required to further decrease uncertainty in the economic evaluation;
• Cerclage suture type to prevent pregnancy loss in women requiring a vaginal, cervical cerclage based on superiority open randomized controlled trial (C-STICH). The study aimed to examine the effectiveness of using a monofilament suture material as opposed to a braided suture material on pregnancy loss in women requiring a vaginal cervical cerclage. No evidence was identified of a difference in pregnancy loss between a monofilament suture and a braided suture;
• Gynecological cancer surveillance for women with Lynch syndrome: a systematic review and cost-effectiveness evaluation. There was insufficient evidence to recommend for or against gynecological cancer surveillance in Lynch syndrome on clinical grounds, but modeling suggested that surveillance could be cost-effective. Further research is needed, but it must be rigorously designed and well-reported to be of benefit;
• Image-directed redesign of bladder cancer treatment pathways: the BladderPath RCT. The study assessed the feasibility and efficacy of introducing multiparametric magnetic resonance imaging (MRI) ahead of transurethral resection (TUR) of bladder tumors in the staging of suspected muscle-invasive bladder cancer. It was concluded that the multiparametric MRI-directed pathway led to a substantial 45-day reduction in time to correct treatment for muscle-invasive bladder cancer without detriment to non-muscle-invasive bladder cancer participants. The incorporation of multiparametric MRI ahead of TUR of bladder tumor into the standard pathway should be considered for all patients with suspected muscle-invasive bladder cancer.
• Feasibility of in-home monitoring for people with glaucoma based on a multiphase mixed-methods feasibility study with key components informed by theoretical and conceptual frameworks (I-TRAC). The patient measured intraocular pressure with a home tonometer and used a tablet computer with a visual function application. Patients were asked to use the technology weekly for 12 weeks. The study has demonstrated 'cautious optimism' when considering patients' and healthcare professionals' views on the acceptability of digital technologies for home monitoring of patients with glaucoma. However, the study also highlighted several unknowns relating to the research question and the design of a future evaluative study that requires addressing them before progression to a randomized controlled trial;
• Real-time ultrasound elastography in the diagnosis of newly identified thyroid nodules in adults based on a pragmatic, unblinded, multicentre randomized controlled trial (ElaTION). Strain and shear wave elastography, which is commonly used with concurrent real-time imaging known as real-time ultrasound shear/strain wave elastography, is a new diagnostic technique that has been reported to be useful in the diagnosis of nodules in several organs. There is conflicting evidence regarding its benefit over ultrasound-guided fine-needle aspiration cytology alone in thyroid nodules. It was concluded that ultrasound shear/strain wave elastography does not appear to have additional benefit over ultrasound-guided fine-needle aspiration cytology in the diagnosis of thyroid nodules;
• Artificial intelligence software for analyzing chest X-ray images to identify suspected lung cancer: an evidence synthesis early value assessment. The objective was to identify evidence on adjunct AI software for analyzing chest X-rays for suspected lung cancer and to develop a conceptual cost-effectiveness model to inform discussion of what would be required to develop a fully executable cost-effectiveness model for future economic evaluation. None of the studies identified in the searches or submitted by the companies met the inclusion criteria of the review. It was concluded that there is currently no evidence applicable to this review on the use of adjunct AI software for the detection of suspected lung cancer on chest X-rays in either people referred from primary care with symptoms of lung cancer or for other reasons.

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