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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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MTRC has released a White Paper "Co‑Funded Studies for Innovative Medical Devices in Germany (§137e SGB V)"

Germany is emerging as a leading European market for early adoption of medical technologies thanks to its §137e SGB V scheme, which allows temporary reimbursement for promising innovations while generating the clinical evidence required for long‑term statutory coverage. 

Our latest White Paper provides a comprehensive exploration of this pivotal mechanism. It breaks down the strategic rationale, legal framework, and procedural steps required to launch a co‑funded study - whether initiated by manufacturers or triggered by a regulatory assessment.  

A detailed case study illustrates how selected innovators have successfully navigated this pathway, highlighting what differentiates successful applications and the implications for technologies that fail to secure long‑term reimbursement. 

Read more and request a White Paper here.