Abstract

Reimbursement for ATMPs in Germany - Prospective for Europe

Matthias Perleth, Department Head Methodological Advice, Federal Joint Committee

Although ATMPs are licensed as drugs in Europe, they are handled as if they were therapeutic procedures within the German health care system. The Federal Joint Committee (G-BA) only decides on the reimbursement of new technologies, including ATMPs, upon proposal of one of its stakeholder organisations. Several examples are available for previous decisions on ATMPs; however, these were complicated by lack of solid evidence on clinical benefit. Regulatory changes on the European level are not likely to affect requirements for licensing of ATMPs in the near future, as these currently concern medical devices. However, there is a move to more collaboration and co-ordination of HTA activities within Europe. In addition, a recent proposal for a new law in Germany (likely to be enacted by spring 2015) will mandate the G-BA to systematically review new high-risk devices introduced in the hospital sector whether further clinical evidence is necessary (apart from data produced during licensing). This will complement the coverage with evidence development procedure which is in place since mid-2013.