Well, we didn't get to the U.S
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These are not harmonised in Europe, and there seems to be a significant gap between the marketing authorisation and national reimbursement. While it is not part of a medicine regulators remit to consider cost-effectiveness, the EMA does engage HTA organisations in so-called parallel scientific advice for drug development, and there is ongoing work, including pilots with the European Network for Health Technology Assessment (EUnetHTA), to address concerns that sponsors are not sufficiently addressing the varying evidence needs of payers and healthcare-guidance and HTA bodies in their medicine-development programmes
This is not individual medical advice, just general education
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