France

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Health systems in transition
France
of the technology (intérêt de santé publique), which includes epidemiological
aspects and quality of life. The degree of medical benefit or therapeutic value
is represented by two assessments: SMR for drugs and one for devices and
medical procedures (service attendu). These two are evaluated in absolute terms
for all different types of use. The assessment informs decisions on coverage and
the coverage rate, from 0 to 100% (see section 2.8.4).
Is the technology more effective than the available comparators? An
assessment is made of the relative medical benefit of the technology in
comparison with similar available treatments, termed the improvement in the
relative medical benefit (amélioration du service medical rendu; ASMR) for
medicines or the improvement in expected benefit (amelioration du service
attendu; ASA) for medical devices and procedures. There is an explicit
pricing decision based on the grade given by the drug or the device committee
(Transparency Commission or CNEDIMTS) depending upon the improvement
in medical effectiveness over the existing comparators (rated on a scale from 1
for major improvement, usually assigned to life-saving technologies, to 5 for no
improvement) (see section 2.8.4). Manufacturers have an incentive to provide
sufficient data to assess drugs and devices because of the pricing objective.
Technologies are reassessed every five years based on the documents
provided by the manufacturer and on systematic reviews of the literature.
Starting in October 2013, an economic evaluation has become a part of
the assessment or reassessment of drugs and medical devices under certain
circumstances. The HAS Commission for Economic Evaluation and Public
Health (Commission d’Évaluation Économique et de Santé Publique; CEESP)
undertakes an economic evaluation if:
• the product or technology is being initially assessed or confirmed as
having an ASMR/ASA level 1, 2 or 3; and
• the product or technology may significantly affect SHI expenditure, given
its impact on the organization of health services, professional practices or
conditions of coverage of patients and, if appropriate, its price; or
• if the provisional or actual turnover for the product after two years on the
market is €20 million or higher.
For other technologies, such as the equipment required for a procedure,
reports are commissioned by the Ministry in charge of Health. The HTA
report may recommend waiting until additional information is available or
may commission surveys or observational studies. The manufacturer is usually