[Brakenshire]

> As your source notes, that does not affect "irreplaceable and expensive drugs". Cost-effectiveness concerns are typically about cases such as reimbursement for a generic vs. an equally-effective non-generic medicine.

There is still a cost-effectiveness judgment even for irreplacable drugs (that's the SMR/ASMR category I):

"Two criteria must be met: 1) The ASMR of the drug claimed by the company is major, important, or moderate (ASMR I, II, or III, respectively); and 2) the drug is likely to have a significant impact on the health insurance budget regarding its impact on care organization, professional practices, or patient care and, when applicable, its price. This decree also specifies the medico-economic assessment procedure. The pharmaceutical company, together with its request for inclusion (or renewal of inclusion) of a medicine on the reimbursable drugs formulary, transmits all medico-economic data related to the drug to CEESP and CEPS. CEESP will provide an opinion [reported as a ‘flash opinion’ (14)] (Fig. 1) on the predictable or established efficiency of the drug and its coverage by health insurance. This opinion is based on comparative analysis, between the different therapeutic alternatives, of the ratio of the cost compared to the expected or observed benefit for patient health and quality of life."