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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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Rapid reviews of three health technologies published in Austria in January-March 2024

In January-March 2024, the Austrian Institute for HTA (AIHTA) published Rapid reviews of three health technologies.

On January 31, 2024, a Rapid review, “Liposuction for the removal of subcutaneous (large) lipomas was published. The authors concluded that due to the limited number of studies, there is not enough evidence to evaluate the effectiveness and safety of liposuction treatment for the removal of one or more (large) subcutaneous lipomas compared to surgical excision. The case series suggested that liposuction in combination with the excision of the lipoma capsule was an effective and safe method for lipoma removal. However, randomized, controlled studies with sufficiently long follow-up and a larger number of patients are needed.

On February 7, 2024, a Rapid review, “Biomarkers in Parkinson's disease”. At present, only a few cerebrospinal fluid (CSF) and imaging biomarkers have received CE mark or European Medicines Agency (EMA) approval and are commercially available in Europe. In contrast, the U.S. has seen two recent advancements: an alpha-synuclein (α-Syn)-seeding amplification assay has been designated as a Food and Drug Administration (FDA) breakthrough device, and a tissue-based α-Syn test, which is not subject to FDA approval, received Clinical Laboratory Improvement Amendments (CLIA) approval in 2023. However, blood-based biomarkers have not yet received similar approvals in either Europe or the U.S. The diagnostic accuracy of most biomarkers is not well-established yet, highlighting the need for more research in this field. Harmonization of procedures, certified reference materials, and methods are key for biomarker implementation, and ongoing efforts are aimed at standardization and validation.

On March 8, 2024, a Rapid review, “Use of telepathology in intraoperative frozen section examination” was published. The evidence suggests comparable diagnostic accuracy and turnaround time between telepathological frozen section examination and conventional microscopy. Implementation requires consideration of technology-specific aspects.

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.