Skip to main content
See details

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.
See details

Med Tech-related technology assessments and clinical guidelines from NICE in October 2021

In October 2021, NICE published three Interventional Procedures Guidance (IPG):

  • Genicular artery embolization for pain from knee osteoarthritis;
  • Laparoscopic renal denervation for loin pain hematuria syndrome;
  • Percutaneous endovascular forearm arteriovenous fistula creation for hemodialysis access.

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 safety of genicular artery embolization for pain from knee osteoarthritis shows no major safety concerns in the short term. Evidence on its efficacy and long-term safety is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research.

Laparoscopic renal denervation is a minimally invasive procedure to interrupt the sensorial and sympathetic innervation of the kidney to control pain. NICE concluded that evidence on the safety and efficacy of laparoscopic renal denervation for loin pain hematuria syndrome is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research. Further research should report details of patient selection, a technique used, and long-term follow-up outcomes.

Percutaneous endovascular forearm arteriovenous fistula creation for hemodialysis access is a minimally invasive procedure that uses radiofrequency energy, or heat and pressure, to join an artery and vein in the forearm. NICE concluded that evidence on the safety of the procedure raises no major concerns. However, evidence on its efficacy is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Patient selection should be made by a multidisciplinary team, including a vascular access surgeon, nephrologist, and interventional radiologist. NICE encourages further research, preferably randomized controlled trials, that should report details of patient selection, particularly about vascular anatomy, a technique used, need for training, patency of the fistula and its subsequent ease of use, and quality of life.

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 October 2021, NICE issued one new MTGs on DyeVert Systems for reducing the risk of acute kidney injury in coronary and peripheral angiography. NICE concluded that DyeVert Systems show promise for reducing the risk of acute kidney injury (AKI) in coronary and peripheral angiography after using contrast media. However, there is not enough evidence to support the case for routine adoption. This is because there is not enough good-quality evidence that using the system reduces AKI incidence after having contrast media. A randomized controlled trial is recommended to compare DyeVert Systems with standard care.

Two new clinical guidelines were published in October:

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.

Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks).