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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 December 2023

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 December 2023, NICE published one new IPG on Middle meningeal artery embolization for chronic subdural hematomas (CSDH), which recommended the procedure be used only in research. NICE concluded that the evidence was limited in quantity and quality. It included a large number of people with chronic subdural hematomas, but only a small number had this procedure. Also, the procedure was used at different treatment stages and with different aims, including being used alone or with surgery. So, it is uncertain which people may benefit from the procedure. There are no safety concerns from the evidence, although the procedure can have complications. Overall, there is uncertainty about the efficacy of the procedure.

In December 2023, NICE published Technology Appraisal Guidance on Hybrid closed loop (HCL) systems for managing blood glucose levels in type 1 diabetes. This guidance updates and replaces NICE diagnostics guidance on integrated sensor-augmented pump therapy systems for managing blood glucose levels in type 1 diabetes (DG21).

Technology Appraisal is the only NICE program that has a direct link with the acceptance of technologies by payers. Payers need to implement the recommended technologies within three months after the publication of the guidance. Medical devices are very rarely evaluated within the Technology Appraisal program.

NICE recommends HCL systems as an option for managing blood glucose levels in type 1 diabetes in the following cases:

  • For adults who have an HbA1c of 58 mmol/mol (7.5%) or more or have disabling hypoglycemia, despite best possible management with at least one of the following: continuous subcutaneous insulin infusion (CSII), real-time CGM, intermittently scanned CGM ('Flash');
  • For children and young people;
  • For people who are pregnant or planning a pregnancy;

HCL systems are only recommended if they are procured at a cost-effective price agreed upon by the companies and NHS England. Access to HCL systems will be through a 5-year phased roll-out in line with NHS England's and NHS Wales' implementation plans.

One new clinical guideline was published in December 2023 on cardiovascular disease: risk assessment and reduction, including lipid modification.

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.