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Early value dossiers for medical technologies

The essential tool to understand the value proposition for your product and position it well with reimbursement/HTA stakeholders

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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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Med Tech-related health technology assessments from NIHR in March 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 March 2024, four MedTech-related assessments were published in the NIHR HTA Journal:

  • Effectiveness of septoplasty compared to medical management in adults with obstruction associated with a deviated nasal septum based on a multicenter randomized controlled trial (NAIROS). The aim of the study was to determine the clinical effectiveness and cost-effectiveness of septoplasty, with or without turbinate reduction, compared with medication therapy, in the management of nasal obstruction associated with a deviated nasal septum. It was concluded that septoplasty, with or without turbinate reduction, is more effective than medical management with a nasal steroid and saline spray. Baseline severity predicts the degree of improvement in symptoms. Septoplasty has a low probability of cost-effectiveness at 12 months but may be considered cost-effective at 24 months. Future work should focus on developing a decision aid for a septoplasty;
  • Software with AI-derived algorithms for analyzing computed tomography (CT) brain scans in people with a suspected acute stroke. The design was based on a systematic review (up to July 2021), and the health economic analysis focused on the addition of AI-derived software-assisted review of CT angiography brain scans for guiding mechanical thrombectomy treatment decisions for people with an ischemic stroke. It was concluded that the available evidence is unsuitable for determining the clinical effectiveness of using AI-derived software to support the review of CT brain scans in acute stroke. The economic analyses did not provide evidence to support the AI-derived software strategy over current clinical practice. However, results indicated that if the addition of AI-derived software-assisted review for guiding mechanical thrombectomy treatment decisions increased the sensitivity of the diagnostic pathway (i.e., reduced the proportion of undetected large-vessel occlusions), this might be considered cost-effective;
  • KardiaMobile 6L (six-lead) for measuring QT interval in people having antipsychotic medication to inform early value assessment based on a systematic review. It was concluded that there is insufficient evidence to support a full diagnostic assessment evaluating the clinical and cost-effectiveness of KardiaMobile 6L in the context of QT interval-based cardiac risk assessment for service users who require antipsychotic medication. The evidence to inform the aims of this early value assessment (i.e., to assess whether the device has the potential to be clinically effective and cost-effective) was also limited. This report includes a comprehensive list of research recommendations, both to reduce the uncertainty around this early value assessment and to provide the additional data needed to inform a full diagnostic assessment, including cost-effectiveness modeling;
  • Surgical versus non-surgical management of lateral compression type-1 pelvic fracture in adults 60 years and older based on a pragmatic, randomized controlled superiority trial (L1FE). The trial closed early, at the end of the internal pilot, due to low recruitment (only 11 patients were randomized). It was not feasible to recruit to this trial in the current context. Further research to understand the treatment and recovery pathways of this group of patients, along with their outcomes, would be needed prior to undertaking a future trial.

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This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.