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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 2021

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

  • Percutaneous implantation of pulmonary artery pressure sensors for monitoring treatment of chronic heart failure;
  • Coronary sinus narrowing device implantation for refractory angina.

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 made the following conclusions:

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 November 2021, NICE issued one new MTGs on Synergo for non-muscle-invasive bladder cancer. Synergo treats non-muscle-invasive bladder cancer using a radiofrequency-induced thermo-chemotherapeutic effect (RITE). NICE concluded that Synergo shows promise for high-risk non-muscle-invasive bladder cancer that has not responded to or has recurred after Bacillus Calmette-Guerin (BCG) treatment or when people cannot or do not want to have BCG treatment. However, there is not enough good-quality evidence to support the case for routine adoption. Synergo should only be used with special arrangements as outlined by NICE interventional procedures guidance on intravesical microwave hyperthermia and chemotherapy for non-muscle-invasive bladder cancer (IPG628). Further research is recommended.

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 November 2021, NICE published one new DG on SeHCAT (tauroselcholic [75 selenium] acid) for diagnosing bile acid diarrhea. NICE concluded that there is not enough evidence to recommend routine use of SeHCAT for diagnosing bile acid diarrhea in people with 1) chronic diarrhea of unknown cause, suspected or diagnosed diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea; 2) Crohn's disease without ileal resection who have chronic diarrhea. Centers already using SeHCAT for diagnosing bile acid diarrhea may continue to do so but must collect further data or do further research. Further data collection and research are being recommended.

The MedTech Innovation Briefings (MIBs) 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. The four new MIBs published in November 2021 are:

Three new clinical guidelines were published in November 2021:

Six clinical guidelines were updated in November 2021:

See the full details for guidance here. and for MIBs 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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