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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 June 2021

In June 2021, NICE published two Interventional Procedures Guidance (IPG):

  • Laser lithotripsy for difficult-to-treat bile duct stones;
  • Percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve.

IPG 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.

NICE concluded that evidence on the efficacy of laser lithotripsy for difficult-to-treat bile duct stones is adequate. However, evidence on long-term safety is limited in quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. The procedure should only be done in specialized centers with experience of managing difficult-to-treat bile duct stones and by clinicians with specific training in bile duct stone visualization and the safe use of laser therapy. Further research should report long-term safety, including biliary stricture.

NICE concluded that evidence on the safety of percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve shows that this procedure can cause potentially serious but well-recognized complications. Evidence on its efficacy is limited in quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. This is a technically challenging procedure, and it should only be done in specialized centers by a multidisciplinary team, including clinicians with training and experience in this procedure.

Medical Technologies Guidance (MTG) evaluates new, innovative medical devices and diagnostics. It looks at medical technologies that deliver treatment, like those implanted during surgical procedures, give greater independence to patients, or detect or monitor medical conditions.

In June 2021, NICE issued one new MTGs on Plus Sutures for preventing surgical site infection. NICE assessed the clinical and cost-effectiveness of three types of Plus Sutures (PDS, MONOCRYL, Coated VICRYL) compared with sutures that did not contain an antibacterial agent and made the following conclusions:

  • Evidence supports the case for adopting Plus Sutures as part of a bundle of care for preventing surgical site infection in the NHS for people who need wound closure after a surgical procedure when absorbable sutures are an appropriate option;
  • Cost modeling shows that Plus Sutures is cost-saving compared with non-triclosan absorbable sutures by an average of £13.62 per patient. These savings are from reduced surgical site infections. Cost savings will vary by surgery type and baseline risk of surgical site infection.

MedTech Innovation Briefing (MIB) is the advice program of NICE 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.

Four new MIBs were published in June 2021:

  • SYNE-COV for predicting COVID-19 outcomes - a cloud-based software developed by the UK company Sensyne Health in collaboration with Chelsea & Westminster Hospitals NHS Foundation Trust that uses a machine-learning algorithm to analyze clinical data in electronic health records to estimate the chance of people with COVID‑19 being admitted for intensive care, having mechanical ventilation, or dying while in hospital;
  • Magtrace and Sentimag for locating sentinel lymph nodes (SLNs) during SLN biopsy (SLNB) procedures for cancer staging. Magtrace is a magnetic liquid tracer that is injected into the body, and Sentimag is a probe that detects the tracer in the lymphatic system during SLNB;
  • WoundExpress to manage lower leg wounds – an advanced wound therapy device, which uses intermittent pneumatic compression to promote lower leg wound healing for people at home;
  • RapidAI for analyzing CT/MRI brain scans in people with suspected acute stroke - a neuroimaging platform that uses artificial intelligence (AI) to process scan images (non-contrast CT, CT angiography, CT perfusion, and MRI diffusion and perfusion) and provides summary maps that help doctors diagnose and treat people with suspected ischemic or hemorrhagic stroke. Processed images are available in five minutes.

Two new clinical guidelines were published in June:

Furthermore, four clinical guidelines were updated in June. However, the updates were not related to Medtech:

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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