The generic substitution rate in France averaged only 72% during April.
IHS Global Insight Perspective | |
Significance | Sales of generics in France have declined by 3% year-on-year in volume during 2011, due to a lower substitution rate at the pharmacy level and reticence at the physician level. On the positive side, a total of EUR1.4 billion has been saved thanks to generics during 2011. |
Implications | The current substitution rate averages 72%, well below the target of 85% set for 2012. |
Outlook | The French public health insurance seeks to reverse this tendency by the end of 2012, notably thanks to the new conventional agreement signed with pharmacists, which set the 2012 substitution rate target at 85%. |
Generic Market in Decline
The French public health insurer CNAM yesterday (6 June) unveiled figures suggesting a decline in the generics sector in France, as reported by French newspaper Les Echos. According to the CNAM, the current substitution rate averages 72% of the list of substitutable products—known as the répertoire des groupes génériques—well below the 79% substitution rate achieved by the end of 2010. Despite the fact that sales in the generics market declined by about 3% in volume during 2011, savings achieved thanks to generics reached EUR1.4 billion (USD1.76 billion) that year.
"Non-Substitutable" Prescriptions
According to the French generic association GEMME, the decline is due to a development in the use of "non-substitutable" prescriptions, which prevent pharmacists from substituting a generic product for a branded medicine. Contrary to figures published by GEMME, the CNAM estimates that out of 12,000 prescriptions studied, only 4.2% included the mention "non-substitutable". Figures published this week by GEMME suggested that non-substitutable prescriptions account for about 22% of all prescriptions in France (see France: 5 June 2012: Generics Association Deplores Overuse of Non-Substitutable Prescriptions in France). For all that, the CNAM concedes that there is room for manoeuvre to reduce the use of non-substitutable prescriptions. Dominique Maraninchi, general director of the National Agency for Drug Safety, cited the example of anticoagulant Plavix (clopidogrel), for which the mention "non-substitutable" is according to him "unfounded".
Head-to-Head Efficacy Study
The CNAM has in parallel unveiled the results of an efficacy study comparing the originator and generic versions of the cholesterol-lowering drug simvastatin (Zocor/Lodales). Results of the study suggest no difference in terms of death, vascular events, and heart attack between generics and the originator.
Outlook and Implications
The conducting of this study points to the fact that the CNAM is willing to reassure the French population of the efficacy of generic products. France's Medicine Academy in February 2012 expressed its reservations, reminding that generics are not exact copies of the originator and that they have always been subject to controversies relating to their efficacy and tolerability. As such, the Academy has asked pharmacists and physicians to be careful when prescribing or delivering generics with a narrow therapeutic margin, citing anti-epileptics, anticoagulants, hypoglycaemic drugs, and certain cardiovascular treatments as examples. The Academy does not oppose the prescription and dispensing of generics, but nuances guarantees given by official authorities for some of them.
The caution of the Medicine Academy, the difficulties faced by prescribers to find adequate dosing in the list of substitutable products, and the increasing reticence of patients render generic substitution less straightforward than a few years ago. Despite these difficulties, the CNAM is confident that the 85% target substitution rate set as part of the 2012 conventional agreement with pharmacists is achievable (see France: 23 May 2012: New Agreement Signed for 2012 Substitution Rate Targets in France and France: 6 June 2012: Physicians, Pharmacists to Discuss Charter of Good Practice for Generics Use).