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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)"

Innovative payment schemes are bilateral or multilateral agreements designed to support medical technologies and procedures that do not align well with, or fail to meet the criteria of, existing reimbursement and funding frameworks. 

Germany’s co-funded clinical study framework, regulated under §137e of the Social Code Book V (SGB V) since 2012, represents one of the “Coverage with Evidence Development” schemes, offering a pathway for temporary, conditional reimbursement and structured evidence development for medical devices in Germany.

The Paper explains strategic rationale, legal framework, procedural steps required to launch a co-funded study and data about the utilization of the scheme. 

Read more and request a White Paper here.