France: tough new pricing guidance with HTA focus
This article was originally published in Clinica
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).
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Catherine Defabianis explains strict new rules for determining whether innovative medical devices should be reimbursed
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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