|Implemented in this survey?|
The decree of 27 October 1999 reaffirmed the idea to reimburse pharmaceuticals according to their medical service rendered, with two objectives. At first, the idea is to promote the use of the most effective and innovative treatments. Secondly, the expected outcome is the reduction of national health expenditure for medicines.
The decree of 27 October 1999 reaffirmed the idea to reimburse pharmaceuticals according to their medical service rendered. At first, the idea is to promote the use of the most effective and innovative treatments. Secondly, the expected outcome is the reduction of national health expenditure for medicines. The decree had two consequences: the decrease of reimbursement rates of pharmaceuticals having a low or moderate medical service rendered and delisting of pharmaceuticals having an insufficient medical service rendered. Physicians, patients, complementary insurance companies, and pharmaceutical industry are affected by the policy.
Promote the use of effective and innovative treatments.
Reduce national health expenditure for medicines.
Physicians, Patients, complementary insurance companies, Pharmaceutical industries
|Medienpräsenz||sehr gering||sehr hoch|
The revision of the list of medical goods and services reimbursable by public health insurance seems to be a good idea to contain public health expenditure. The use of clinical assessment to
redefine this list is also a good idea, which now applies to medicines, to medical devices, and which is on the political agenda for other types of health services.
We have some difficulties to figure out the impact on this policy:
The economic and political background is made of two main elements. At first, the reduction of national health expenditure is a goal of health policy. Secondly, a wish of developing evidence-based
medicine has been formulated in the 1990's by the Scientific Community.
In order to qualify for reimbursement by the health insurance system, a drug must be included in the positive list of reimbursable drugs established by ministerial ordinance on the advice of the Commission on Transparency and the Economic Committee for Medical Products (CEPS).
Before the decree of 27 October 1999, inclusion on the positive list of reimbursable drugs depended on two factors: the improvement of medical service rendered (ASMR), evaluated in relation to other drugs in the same class, or to a decrease in the cost of treatment.
Since October 1999, in order for a drug to be included on the positive list, evidence must be supplied of it's a valuable medical service rendered (SMR), This is based on five criteria:
The medical service rendered is evaluated in absolute terms, for each indication of the product. If the SMR of a product is 'major or considerable' (A), 'moderate' (B) or 'low but nevertheless justifies reimbursement' (C), it can be included in the positive list for a period of five years, after which it has to be re-evaluated. Then, the level of reimbursement should be determined by the SMR as follows :
The evaluation of the improvement of medical service rendered (ASMR) is used in a second time as a price fixation criterion.
|Implemented in this survey?|
To deal with the necessity of re-defining criteria for reimbursement of pharmaceutical products, the decree of 27 October 1999 introduced the notion of medical service rendered. It has been decided to attribute to each product a rate of reimbursement by social policy related to its medical service rendered. For some products that implies to decrease their reimbursement rate or to exclude them from the positive list. Between 1999 and 2001, the Transparency committee attributed a low or moderate SMR to 840 drugs and an insufficient SMR to 835 drugs and. According to the 1999 decree, the former should no longer figure on the positive list, whereas the later should have a 35 % reimbursement rate. However, until 2003, few of them had been either excluded from reimbursement or had seen their reimbursement rate lowered from 65 % to 35 %.
The approach of the idea is described as:
Two main groups are directly affected by this re-definition of the positive list: pharmaceutical industry and complementary insurance companies.
Moreover, some companies and members of the Scientific Community have hardly criticised both the criteria defined to determine the service rendered and the re-evaluation accomplished by the Commission on transparency.
Until recently only few products having a low or moderate SMR had seen their reimbursement rate lowered from 65% to 35%. In April 2003, a list of 617 drugs for which rate has decreased has been published in a ministerial decree.
Four main actors are implied in the implementation.
There is no foreseen mechanism to review the implementation of this process. But the amounts of units prescribed and reimbursed for pharmaceuticals are regularly measured by the compulsory health insurance and the results are detailed according the service medical rendered of the products, and can be compared among time. Consequently, , it will be possible to measure whether expenditure for pharmaceuticals has decreased.
In the paper "Criteria to be considered in measures in de-reimbursement for drugs" (JEM, October 2002, vol 20 n°6) the authors criticise the perspective retained. They qualify it as very
narrow, since it is essentially based on medical efficiency. It would be convenient to widen the risk-benefit criterion and to introduce the concept of social utility, taking into account the equity
criterion in the study of epidemiological, cultural and economic characteristics of the population affected by these measures.
As far as the effects on costs are considered the same authors are very sceptical, according to the paper "What is the purpose of de-reimbursement ?" (Le Monde, 23/01/03). Uncertainty remains in the change of prescribing practices : it may happen that some alternative treatments, prescribed instead of delisted pharmaceuticals, will have a higher cost.
|Qualität||kaum Einfluss||starker Einfluss|
|Gerechtigkeit||System weniger gerecht||System gerechter|
|Kosteneffizienz||sehr gering||sehr hoch|
The impact on cost-efficiency can not be determined yet because of the uncertainty about the change in prescribing practices and the cost of alternative treatments.
Communiqués de presse du Ministre de la santé, de la famille, et des personnes handicapées (in French)
04/07/03 - Pharmaceuticals having an insufficient service rendered : why a de-reimbursement policy ?
22/04/03 - Decrease of rate of reimbursement for pharmaceuticals having low or moderate service rendered http://www.sante.gouv.fr/ .
Agence française de sécurité sanitaire des produits de santé (AFSSAPS) (in French)
07/06/01 - Re-evaluation of medical service rendered for 4500 special drugs http://agmed.sante.gouv.fr/htm/5/5000.htm .
Journal Officiel (in French)
Décret no 99-915 du 27 octobre 1999
Assurance maladie des professions indépendantes (CANAM) (in French)
March 03 - Drugs expenditure related to medical service rendered
B. Dervaux, T. Lebrun, J.-C. Sailly: What is the purpose of delisting? (in French). In: Le Monde, 23/01/03
C. Debourge, B. Dervaux, J.-C. Sailly: Criteria to be considered in measures in drug delisting. (in French). In: JEM, October 2002, vol 20 n°6.
Florence Naudin, Catherine Sermet