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162 Health systems in transition France be maintained. However, to date there has been no decree authorizing this alternative coverage procedure, and the left-wing government elected in 2012 has not put this measure forward since then. While this cost-containment strategy may be effective in reducing costs in the short term, the long-term effect is less clear. The French Accounts Commission has noted that de-listing drugs in a particular therapeutic class can have effects on prescription of drugs in other covered classes that may reduce or eliminate the cost savings. For example, when the class of expectorants was de-listed, savings of €45 million were anticipated. However, prescriptions were shifted to cough suppressants and bronchodilators, resulting in additional expenditure of €40 million for these drugs (Cour des comptes, 2011b) and highlighting the strong culture in French medical practice of offering prescriptions for every symptom. This underscores the need to address medical practice through, for example, changes in initial training and DPC (see section 4.2.3). Price control Strict control of tariffs was applied, notably to the price of drugs but also to other type of service such hospital remuneration, medical devices and professional tariffs. As a result of tight control of doctors’ tariffs, extra-billing, which is not covered by SHI, was permitted starting in the 1980s for certain categories of doctor (see Sector 2 doctors; section 3.7.2). However, extra-billing in some specialties has significantly increased OOP payments, thereby impairing access in some areas where extra-billing is the rule (e.g. gynaecologists in Paris). For this reason, policies to reduce extra-billing were developed starting in 2013. Drug price control The CEPS (see section 2.7.2) is authorized to reduce previously negotiated drug prices under four circumstances: at the time of renewal of the agreement, particularly if there has been a significant increase in volume following extensions of indications; when the drug’s patent expires and the first generics enter the positive list (generally 85% of the price of the brand name drug); when the evolution of drug expenditure threatens ONDAM targets (see section 3.3.3); or when studies of the drug once it is on the market reveal differences in efficacy or side-effects compared with the clinical trial data that were considered at the time the pricing agreement was made. Drug price reductions, both in the ambulatory and hospital sectors, constitute a significant source of savings in the annual health budget, with a target of €960 million in 2014 (Sécurité sociale, 2013c).
Health systems in transition France 163 Economic evaluation is the newest cost-containment tool. Until recently, coverage and pricing decisions were made following HTA evaluations that were principally based upon clinical efficacy, not on cost–effectiveness or value to broader society. However, since October 2013, economic evaluation has been required for drugs meeting two conditions: having been evaluated as innovative (ASMR level 1, 2 or 3) and likely to have a significant impact on SHI expenditure (annual sales of €20 million or more in the first two years). The CEESP undertakes its assessment simultaneously with the Transparency Commission’s evaluation of the SMR and ASMR of the drug (see section 2.8.4) to avoid undue delay before a drug may be marketed. Based on a file prepared by the manufacturer that includes the data and methodology underlying the modelling of the new drug’s anticipated cost–effectiveness, the CEESP issues an opinion on the drug relative to existing therapeutic strategies, including the benefits expected or observed for patient health and quality of life. Unlike other countries, there is no fixed threshold for cost–utility or cost–effectiveness. The advice of the CEESP should be used by the CEPS in its price negotiations with the manufacturer. The first CEESP opinions were issued in early 2014, and so it is too soon to evaluate the effectiveness and appropriateness of its use. An additional element in the reduction of drug expenditure has been the governmental pressure to expand the generic drug market, starting with the authorization of generic substitution under the 1999 Social Security Finance Act. For a pharmacist to substitute a generic for the brand name drug, the drug must appear on a list of drugs for which substitution is authorized. This list does not include all off-patent medicines. For example, paracetamol is not in this list. Doliprane, the brand name for paracetamol manufactured in northern France by Sanofi-Aventis, was the fourth most reimbursed drug in France in 2013, accounting for €315 million and leading to suspicion of protectionism. While the possibility of generic substitution of paracetamol has been invoked since 2002 and most recently in December 2013 by the ANSM, for the moment the government has chosen instead to reduce the price of the brand name drug (Cour des comptes, 2014b). In terms of market share, generic drugs in France represent a much lower proportion of reimbursable drugs than in other European countries. The generic market’s volume share (drug packages sold) grew from 3.4% in 1999 to 23% in 2011. However, in terms of value, it only accounted for 10.9% of the market. According to IGAS, the list of substitutable drugs in France is much more restrictive than in countries such as the Netherlands and Germany, which have
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Contents Contents Preface
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Preface Preface The Health Systems
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Acknowledgements Acknowledgements T
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Abstract Abstract This analysis of
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