MedTech-related health technology assessments from UK NIHR in March 2021

The National Institute for Health 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 March 2021, six MedTech-related assessments were published in the NIHR HTA Journal:

• Universal late pregnancy ultrasound screening to predict adverse outcomes in nulliparous women: a systematic review and cost-effectiveness analysis. It was concluded that screening all pregnant women with an ultrasound scan in late pregnancy may be justified for identifying breech presentation but not for identifying fetal growth problems
• Patch augmentation surgery for rotator cuff repair, based on the mixed-methods feasibility study (Patch Augmented Rotator Cuff Surgery, PARCS) of a randomized controlled trial. It was concluded that the need for further clinical studies is clear, particularly given the range and number of different patches available. Randomized comparisons of on-lay patch use for completed rotator cuff repairs and bridging patch use for partial rotator cuff repairs were identified as further research areas. The value of an observational study to assess safety concerns of patch use was also highlighted. These elements are included in the trial designs proposed in this study
• Assistive technology and telecare to maintain independent living at home for people with dementia, based on the ATTILA randomized controlled trial. It was concluded that a full package of assistive technology and telecare did not increase the length of time that participants with dementia remained in the community and participants' health and social care or societal costs, nor did it decrease caregiver burden
• Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT. An assessment of sacral nerve stimulation (SNS) versus the magnetic sphincter augmentation device (FENIX) for adults suffering from moderate to severe faecal incontinence was based on the multicenter, parallel-group, unblinded, randomized trial (SaFaRI). The SaFaRI study was terminated in 2017, having recruited 99 participants of the target sample size of 350, therefore, substantially underpowered to detect differences between the treatment groups, with significant uncertainty in the cost-effectiveness analysis. Both FENIX and SNS's success was low (on average 12.5%), with no statistically significant difference between the two groups. A higher rate of postoperative complications was in the FENIX group (73.3%) than in the SNS group (22.5%). A total of 15 out of 50 (30%) participants in the FENIX group ultimately had to have their device explanted. Slightly higher costs and quality-adjusted life-years were observed in the FENIX group. However, this was reversed over the lifetime horizon, when SNS was the optimal option, with only a 45% chance of FENIX being cost-effective. Further research is needed to clarify the treatment pathways for SNS and determine its actual clinical and cost-effectiveness
• Modelling of hypothetical SARS-CoV-2 point-of-care tests on admission to hospital from A&E: rapid cost-effectiveness analysis. This study described the likely impact of "acceptable" and "desirable" SARS-CoV-2 point-of-care tests within a hospital in terms of A&E waiting for bay occupancy, diagnostic accuracy, and cost-effectiveness. If a SARS-CoV-2 point-of-care test with the desired target product profile becomes available, this looks promising. Future work is needed to obtain more data on the diagnostic accuracy of SARS-CoV-2 point-of-care tests and the impact of these tests on the occupancy of waiting bays and isolation bays. These parameters are currently uncertain
• Prognostic tools for identification of high risk in people with Crohn's disease: a systematic review and cost-effectiveness study. The aim was to assess the prognostic test accuracy, clinical impact, and cost-effectiveness of IBDX® and PredictSURE-IBD™ (serological biomarkers panels) in identifying those at high risk of following a severe course of Crohn's disease. Although the model indicates that standard care dominates the tests, the lack of evidence of prognostic accuracy of the two tests and the uncertainty around the benefits of the top-down and step-up treatment approaches mean that the results should be interpreted as indicative rather than definitive

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