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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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MedTech-related technology assessments and clinical guidelines from NICE in May 2023

NICE develops Interventional Procedures Guidance (IPG) for most of the 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 May 2023, NICE published one IPG on intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from high spinal cord injuries. NICE recommended that the procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

The Diagnostic Guidance (DG) program focuses on evaluating innovative medical diagnostic technologies to ensure that the NHS can adopt clinically and cost-effective technologies rapidly and consistently.

In May 2023, NICE published two new DGs and made the following conclusions:

Health Technology Evaluations (HTE) are the new type of NICE guidance that uses the Early Value Assessment (EVA) approach to provide rapid conditional recommendations on promising health technologies that have the potential to address the unmet national need. NICE evaluate the available evidence to determine if earlier patient and system access in the NHS is appropriate while further evidence is generated.

In May 2023, NICE published three new HTEs and made the following recommendations:

  • Six digitally enabled therapies for adults with anxiety disorders can be used as treatment options while further evidence is generated on their clinical and cost-effectiveness (once they have appropriate regulatory approval). Recommended technologies are: Beating the Blues (365 Health Solutions), iCT-PTSD (OxCADAT) for post-traumatic stress disorder, iCT-SAD (OxCADAT) for social anxiety disorder, Space from Anxiety (SilverCloud) for generalized anxiety symptoms or unspecified anxiety disorder;
  • Three digitally enabled therapies for adults with depression can be used as treatment options while further evidence is generated on their clinical and cost-effectiveness (once they have appropriate regulatory approval). The therapies should be used with support from a trained practitioner or therapist in NHS Talking Therapies for anxiety and depression services. Recommended technologies are: Beating the Blues (365 Health Solutions), Deprexis (Ethypharm Digital Therapy), Space from Depression (SilverCloud);
  • Two point-of-care tests for urinary tract infections to improve antimicrobial prescribing were not recommended for early routine use in primary or community care settings in the NHS while further evidence is generated: Astrego PA-100 analyzer with the PA AST panel U-0501 (Sysmex Astrego) and Uriscreen (Savyon Diagnostics). NICE made recommendations for further research. Three other assessed culture-based tests were not recommended for early use or further research, as they are not expected to give results quickly enough to improve antimicrobial prescribing in these settings.

Four clinical guidelines were updated in May 2023:

See the full details here.

This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Contact us to get a free, three-month, no-obligation trial.