France: €20 million turnover to trigger medico-economic evaluation
This article was originally published in SRA
Executive Summary
Catherine Defabianis explains strict new rules for determining whether innovative drugs and medical devices should be reimbursed.
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Medtech sales over €20m? New French rule says medico-economic evaluation needed
Catherine Defabianis explains strict new rules for determining whether innovative medical devices should be reimbursed
France: tough new pricing guidance with HTA focus
The French government has issued guidance to its healthcare products pricing committee (CEPS), requiring that its pricing negotiations take into account the results of medico-economic evaluations – ie health technology assessments (HTAs).
The extremes to which the French are going for ultra high-risk innovative products
Just how far do the French authorities feel it is necessary to go to demonstrate the safety of products considered to be higher risk than all others? Catherine Defabianis, director of information and regulatory intelligence at A.R.C. Pharma (France) , gives details here of the new measures that the French national agency for healthcare product safety ANSM put forward to the country's parliament in late October for those ultra high-risk medical devices