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Evidence gap analysis

Strategic analysis of the sufficiency of evidence to obtain reimbursement and HTA approval in Europe and recommendations about evidence generation

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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 health technology assessments in Wales in March-April 2025

Health Technology Wales (HTW) is a national body working to improve the quality of care in Wales. It is funded by the Welsh Government and hosted within NHS Wales but is independent of both. HTW covers medical devices, diagnostics, procedures, psychological therapies, models of care, and social care support, excluding pharmaceuticals.

HTW uses a staged process of assessment by developing three types of documents. The topic exploration report (TER) aimed to assess whether there is enough evidence to proceed with a full appraisal and whether the topic meets the appraisal selection criteria. Based on the TER conclusions, HTW's Assessment Group decides whether to progress this topic further. If yes, the following two documents can be developed: Evidence Appraisal Report (EAR) and Guidance (GUI). Recommendations are not mandatory; the status of HTW guidance is "adopt or justify," meaning that the local health board and other relevant bodies are expected to report on how they have considered the appraisal and guidance. If they have chosen not to adopt HTW guidance, they are asked to outline their rationale and justify their decision.

In March-April 2025, HTW accomplished one full appraisal and published an Evidence Appraisal Report and Guidance on Permanent implant brachytherapy devices for unresectable pancreatic cancer, and concluded that current evidence does not support the use of the technology as randomized controlled trials have shown no significant improvements in key clinical outcomes compared to standard chemoradiotherapy. Additionally, the technical challenges and potential adverse events associated with brachytherapy further discourage its use, making it an unsupported treatment option at this time.

Five Med Tech-related Topic Exploration Reports were published in March-April 2025. 

For the following four TERs, HTW decided not to proceed with a full appraisal based on the following conclusions:

For one TER on Tumour-profiling tests to guide adjuvant-bisphosphonate treatment in early breast cancer, HTW decided to proceed with a full appraisal as promising evidence was identified on the MAF Test from randomized controlled trials, indicating improved outcomes in MAF-negative patients and a cost-benefit analysis suggesting potential economic advantages.

Furthermore, four topics were initiated with the publication of TER, for which the decision to proceed with the full appraisal is pending.

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.