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Evidence gap analysis

Strategic analysis of the sufficiency of evidence to obtain reimbursement and HTA approval in Europe and recommendations about evidence generation

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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 January 2025

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 Programme are published in the NIHR HTA Journal and inform the National Institute for Health and Care Excellence (NICE) guidance. 

In January 2025, two Med Tech-related assessments were published in the NIHR HTA Journal:

  • A clinical decision support tool for Primary Care Management of Lower Urinary Tract Symptoms (LUTS) in men based on the prospective diagnostic accuracy study (PriMUS study). The assessment provided the sensitivity and specificity of the four developed mathematical models (one model for bladder outlet obstruction, one model for detrusor underactivity, and two models - for detrusor overactivity (“Detrusor overactivity main” and “Detrusor overactivity sensitivity analysis 2”), which combined results from the prostate examination, prostate-specific antigen blood test, symptoms questionnaires, and home-based urine flow measurements. It was concluded that age, voiding symptoms subscore, prostate-specific antigen level, median maximum flow rate, median voided volume, and post-void residual volume served as predictors for the diagnosis in the developed models. The prototype tool for clinical decision support was developed (not yet intended for use in practice) and is available online at Primary Care Management of Lower Urinary Tract Symptoms decision aid for LUTS. There was favorable feedback from general practitioners during tool development and small-scale user testing in simulated consultation scenarios. Patients supported such management in primary care;
  • A systematic literature review concerning multi-cancer early detection tests for general population screening. The clinical evidence identified 36 studies that met the inclusion criteria. The diagnostic accuracy was examined for the following currently available multi-cancer early detection tests: Galleri (by GRAIL), CancerSEEK (by Exact Sciences), SPOT-MAS (by Gene Solutions), Trucheck (by Datar Cancer Genetics), Cancer Differentiation Analysis (by AnPac Bio), AICS (by AminoIndex Cancer Screening). It was concluded that all currently available multi-cancer early-detection tests reported high specificity (> 96%). Sensitivity was highly variable and influenced by study design, population, reference standard test used, and length of follow-up.

See the full details here.

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.