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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 November 2020

In November, NICE published one new interventional procedures guidance for a swallowable gastric balloon capsule for weight loss.

Interventional Procedure Guidance is developed 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.

Evidence on the safety of the swallowable gastric balloon capsule for weight loss shows infrequent but potentially serious adverse events.

  • For people who need to lose weight in the short term for medical reasons, the evidence of efficacy is adequate to support the use of this procedure provided that special arrangements are in place for clinical governance, consent, and audit
  • For people who are aiming for long-term weight loss, the evidence on efficacy is inadequate in quantity and quality, so the procedure should only be used in the context of research

Further research could be in the form of randomized controlled trials comparing the procedure with current standard therapies or an observational cohort study, including using registry data. Studies should include details of patient selection such as body mass index and other treatments such as diet and lifestyle changes. The studies should also report short- and long-term weight loss, quality of life; metabolic parameters; the need for later surgery.

MedTech Innovation Briefing is the NICE's advice program for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations.

Five MedTech Innovation Briefings were published in November:

Also, one clinical guidance for Acute coronary syndromes was updated in November. This guideline covers the early and longer-term (rehabilitation) management of acute coronary syndromes. This guideline provides new and updated recommendations, including percutaneous coronary intervention, stenting, and coronary angiography

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). First EU issues of both newsletters are available for download free-of-charge.

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