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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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MTRC has launched a service of analyzing evidence requirements for reimbursement and HTA submissions

Clinical and economic evidence is essential for obtaining market access for innovative technologies in Europe.

Evidence is required to assist reimbursement (e.g. creation of procedure code in Austria, Belgium, France, the Netherlands) and funding (e.g. obtaining coverage in England, Germany and Switzerland) for hospital and ambulatory technologies.

In some countries, only clinical evidence is required, while in others, economic data is required as well (Belgium, England, the Netherlands, Switzerland).

Companies struggle to understand, what kind of data is required to support reimbursement processes. How many studies are necessary? What should be the duration of follow-up? What outcomes should be considered? What comparator should be selected?

Often, a clinical strategy is developed on the basis on the recommendations of the Clinical Advisory Boards, however, they do not take into account the position of the reimbursement decision-makers. Real decision-makers are almost impossible to get for the meeting about the evidence requirements. They are busy and most importantly, don't have a particular topical knowledge of a specific clinical field. In the projects, they are often replaced by proxies with not enough insights into the real drivers of decision-making.

MTRC is offering a supplemental, fact-based, unbiased approach to determine clinical and economic evidence requirements, on the basis of the benchmarking to the prevision reimbursement decisions of reimbursement authorities and HTA organizations. Recommendations are also based on an in-depth understanding of the reimbursement pathways in individual markets.

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