On October 11, 2020, the French Ministry of Solidarity and Health published an Order in the French Official Journal relating to the coverage of CARMAT TAH by innovation package for the period of 48 months from the date of the beginning of the trial.
As the innovation package scheme is classified as coverage with the evidence development program, the coverage of the procedure is released within the multicenter clinical study, with direct non-randomized comparators, evaluating the efficacy and safety of CARMAT TAH used in the treatment of biventricular heart failure for patients eligible for transplantation.
The amount of innovation package for CARMAT TAH, including the coverage of the act and the associated hospital costs, is €248,194 per patient. The total number of patients likely to benefit from the procedure is set at 52.
The list of health establishments for which health insurance covers the procedure is provided in the Order and includes five centers in the main list and two centers in the complementary list (all the centers are public).
The full details in French can be found here.
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