MedTech-related health technology assessments from NIHR in December 2022

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 December 2022, six MedTech-related assessments were published in the NIHR HTA Journal:

• Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema, based on a pragmatic, multicenter, allocation-concealed, double-masked, randomized, non-inferiority clinical trial (DIAMOND). It was concluded that the subthreshold micropulse laser was equivalent to the standard threshold macular laser but required a slightly higher number of laser treatments;
• EarlyCDT Lung blood test for risk classification of solid pulmonary nodules: systematic review and economic evaluation. The objectives were to determine the diagnostic accuracy, clinical effectiveness, and cost-effectiveness of EarlyCDT Lung. The study showed that evidence on EarlyCDT Lung among patients with pulmonary nodules is insufficient to draw any firm conclusions as to its diagnostic accuracy or clinical or economic value;
• Impact of video-assisted thoracoscopic lobectomy versus open lobectomy for lung cancer on recovery assessed using a self-reported physical function, based on a multicenter, superiority, parallel-group, randomized controlled trial (VIOLET) with blinding of participants and outcome assessors. The study was carried out in nine NHS hospitals; 503 patients were randomized. It was concluded that video-assisted thoracoscopic surgery lobectomy was associated with less pain, fewer complications, and better quality of life without any compromise to oncologic outcome; the use of video-assisted thoracoscopic surgery was shown to be highly likely cost-effective for the NHS;
• Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women, based on a pragmatic non-inferiority randomized controlled trial (SIMS). A total of 600 participants were randomized. The study showed that adjustable anchored single-incision mini-slings were non-inferior to standard tension-free mid-urethral slings in patient-reported success rates up to three years of follow-up;
• Prognostic indicators of severe disease in late preterm pre-eclampsia to guide decision-making on the timing of delivery based on a prospective observational cohort study in 36 maternity units across England and Wales (PEACOCK). The study evaluated the diagnostic accuracy of placental growth factor (PlGF) and sFlt-1 in determining the risk of complications requiring delivery in late preterm (34+0 to 36+6 weeks gestation) pre-eclampsia. Angiogenic biomarkers were measured using the Quidel (PlGF) and Roche (sFlt-1:PlGF ratio) assays. It was concluded that angiogenic biomarkers do not add to clinical assessment to help determine the need for delivery for women with late preterm pre-eclampsia. Existing models developed in women with early-onset pre-eclampsia to predict complications cannot be used to predict clinically indicated need for delivery in women with late preterm pre-eclampsia;
• Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation, based on a placebo-controlled, individually randomized, multicenter Phase III superiority trial (LiTEFORM). The study lacked statistical power because it only recruited 21% of its target. However, its novel qualitative findings and sham design can inform photobiomodulation researchers and service providers. Further well-designed randomized controlled trials are needed to investigate low-level laser therapy in head and neck cancer irradiation.

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