In France, information on cost-effectiveness is utilized for negotiations over the prices of medicines and medical devices. The HTA organization, HAS (Haute Autorité de Santé was founded in 2006. HAS reviews results of cost-effectiveness analysis submitted by manufacturers and provides more appropriate results.
The prices of drugs in France are decided through negotiation between the CEPS (comité économique des produits de santé) and the manufacturers. During price negotiations at CEPS, the 5-level ASMR (Amélioration du Service Médical Rendu) and results of cost-effectiveness analysis are utilized.
When a manufacturer desires reimbursement at higher price, it is required to submit data on the cost-effectiveness analysis to HAS. This obligation is applicable to the cases where the manufacturers desire ASMR I through III (the three highest ratings). If the ASMR rating is III or higher, a price higher than the European average may be set. The annual sales are also selection criteria, anticipated to exceed EUR 20 million. (in the second year of marketing)
In Germany, the IQWiG (Institute for Quality and Efficiency in Healthcare) was founded in 2004 as a HTA organization responsible for evaluation of medicine.
IQWiG has a role to evaluate the cost-effectiveness as well, but no such evaluation has been made to date. Early benefit assessment based on the AMNOG (Arzneimittelmarktneuordnungsgesetz) is performed from the perspective of only effectiveness, safety and HRQOL, not cost-effectiveness. This is intended to evaluate the additional benefit of a new product by IQWiG within one year after its launch. During this process, IQWiG evaluates the presence/absence of additional benefit in comparison to the control. If additional benefit is judged to be present, its magnitude is rated on a four-level scale: major, moderate, minor, and unquantified.
In Germany, manufacturer can set the prices of drugs freely, as a rule. However, on the basis of the results of early benefit assessment (final rating is decided by G-BA based on the evaluation of IQWiG), the association of sickness funds (Spik) holds negotiation with the manufacturers to discount the prices. Although the magnitude of additional benefit is not automatically reflected in the price reduction rate, the rating of higher additional benefit seems to work favorably during price negotiations. If additional benefit is judged to be absent, the price comparable to existing reference group is set for the drug.
3. Other countries
In Scandinavian (e.g., Sweden, Norway, Finland) and other European countries also (Ireland, the Netherlands, Portugal, Poland, etc.), information on cost-effectiveness is used for deciding listing and/or for setting the drug prices. A similar system is also available in Canada, Australia, New Zealand, etc.
In Korea, the negative list system (listing medicines not covered by insurance) was switched to the positive list system (listing medicines covered by insurance) in December 2006. Information on cost-effectiveness is also used in this system as a criterion for deciding the reimbursement of medicines.
In Korea, there is a single payer system which has only one public health insurance. The organization responsible for checking the appropriateness of payment is called HIRA (Health Insurance Review and Assessment Service). Whether or not a medicine is to be reimbursed by public insurance is evaluated by HIRA. If it is not cost-effective, it may not be included in positive list, and such a medicine cannot be used for public healthcare.