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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 and clinical guidelines from NICE in January 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 January 2024, NICE published three new IPGs and made the following conclusions:

  • Intravascular lithotripsy for calcified arteries in peripheral arterial disease should only be used with special arrangements for clinical governance, consent, and audit or research;
  • Temperature control as an option to prevent fever and improve neurological outcomes after cardiac arrest is recommended with standard arrangements for clinical governance, consent, and audit. Temperature control to induce therapeutic hypothermia (a temperature of less than 36°C) to improve neurological outcomes after cardiac arrest should only be used in research;
  • Recommendations for pharyngeal electrical stimulation for neurogenic dysphagia depend on clinical conditions: In people who have a tracheostomy after a stroke, pharyngeal electrical stimulation can be used in the NHS while more evidence is generated with special arrangements for clinical governance, consent, and audit or research; For people with neurogenic dysphagia after stroke who do not have a tracheostomy and people with other causes of neurogenic dysphagia, more research is needed on pharyngeal electrical stimulation.

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 January 2024, NICE published one new DG on Artificial intelligence (AI)-derived software to help clinical decision-making in stroke. NICE recommended two AI-derived software (e-Stroke and RapidAI) to be used in the NHS while more evidence is generated to support the review and reporting of CT brain scans for people who have had a suspected stroke. These technologies can only be used once they have appropriate Digital Technology Assessment Criteria (DTAC) approval. Other assessed technologies can only be used in research (Accipio, Aidoc, BioMind, BrainScan CT, Cercare Perfusion, CINA Head, CT Perfusion 4D, icobrain ct, Neuro Solution, and qER). NICE published an evidence generation plan advising how the evidence gaps could be resolved through real-world studies.

In January 2024, NICE updated one DG on devices for remote monitoring of Parkinson’s disease. The evidence generation plan was published, providing further details on the prioritized evidence gaps and outcomes, ongoing studies, and potential real-world data sources. It includes how the evidence gaps could be resolved through real-world evidence studies.

Five clinical guidelines were updated in January 2024, including the following:

  • Early and locally advanced breast cancer: diagnosis and management – NICE reviewed the evidence and updated the recommendations on further surgery after breast-conserving surgery;
  • Caesarean birth – NICE reviewed the evidence and made new and updated recommendations on placenta accreta spectrum.

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.