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Analytical White Papers

Free analytical and research White Papers on the topic of reimbursement, HTA and evidence requirements for medical devices and IVD tests in Europe

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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 technology assessments from NICE in August 2024

The National Institute for Health and Care Excellence (NICE) develops Interventional Procedures Guidance (IPG) for most novel interventional procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit." Recommendations are not binding, although they are followed by providers and commissioners.

In August 2024, NICE published three new IPGs and made the following recommendations:

  • Caval valve implantation for tricuspid regurgitation in adults should only be done as part of a formal research study. There is very limited short- and long-term evidence on the efficacy and safety of this procedure. Also, the evidence comes from studies that used different techniques to do the procedure and varied in the number and type of implants used. It is also unclear who would benefit from this procedure;
  • Phrenic nerve pacing for ventilator-dependent high cervical spinal cord injury can be used with standard arrangements for clinical governance, consent, and audit. The evidence for this procedure shows benefits, such as increased ventilator-free time, reduced respiratory infections and living longer. People with high cervical spinal cord injury have multiple comorbidities, and their quality of life is often limited. This procedure only treats one part of a very complex condition, so the benefits of the procedure are limited. The evidence does not raise any major safety concerns;
  • Phrenic nerve pacing for congenital central hypoventilation syndrome (CCHS) can be used with standard arrangements for clinical governance, consent, and audit. Because CCHS is a rare genetic condition, there is limited evidence for the procedure in this population. The available evidence shows benefits such as an increase in ventilator-free time and tracheostomy tube removal. The evidence does not raise any major safety concerns.

Two new clinical guidelines were published by NICE in August 2024:

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.