Reimbursement of pharmaceutical products in hospital
In order to be used in hospital, any pharmaceutical product should be registered on the list of pharmaceutical products admitted for use in hospitals and other health care organizations (Liste des spécialités agrées aux collectivités). Registration is subject to positive opinion of the HAS and subsequent approval by the Ministry of Health and Social Affairs. Generic pharmaceuticals are not assessed by the HAS and can be registered directly on the basis of the Marketing Authorization.
Most of pharmaceutical products are reimbursed within DRGs (diagnosis-related groups, GHS in French) based on the principle of fixed reimbursement amount paid by the National Health Care Insurance to the hospital for each hospital stay. DRGs are deserved to cover all hospitalization-related costs, with a small supplement to be paid by patient or his complementary private insurance.
DRGs tariff mainly depends on the diagnosis (ICD classification) and the medical procedures provided to patient during the hospital stay. DRGs are assigned by a “grouper” program the PMSI software (Programme de Médicalisation des Systèmes d’Information). The duration of hospital stay has little to no impact on the DRG tariff. The DRGs tariffs are fixed and regularly reviewed by the Ministry of Health and Social Affairs; they are published in the Official Journal.
Prices of pharmaceutical products reimbursed in hospital within DRG tariffs are not regulated; they are freely arranged between manufacturer and hospital, hospital group or hospital procurement platform (tenders).
By way of exception from the above rule, some innovative and particularly expensive pharmaceutical products registered on the special list (Liste “en sus”) are reimbursed on top of DRG tariff. The registration on the list on top of DRG is under the scope of the Ministry of Health and Social Affairs and represents an additional step in the overall market access process. Decision is made with regards to the HAS opinion: in general, at least Important medical value (SMR) and an added value (ASMR) of level I, II or III are required. The list on top of DRG has been created to allow and facilitate the access to new innovative technologies; it is reviewed every year. Some products are withdrawn from the list and subsequently integrated into DRGs, in order to make place for new innovative health technologies.
Price of pharmaceutical products reimbursed on top of DRGs are fixed and regulated by the Economic Committee of Health Products after negotiations with the manufacturer.
Updated on December 15th, 2016