Barbarians at the gate

Authors: R J G Peters

Publish Date: 2012/04/03

Volume: 20, Issue: 5, Pages: 191-192

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Abstract

The paper by Liew et al in this issue of the Journal confirms other observations on the consequences of switching from branded to generic statins 1 The common pattern observed is that the staggering costs of lipidlowering therapy lead to national guidelines and policies that recommend or even dictate switching to generic preparations This is associated on average with a reduction in pharmacological potency and an increase in lowdensity lipoprotein LDL plasma levels The net effect is a reduction in costs that comes with a loss of preventive efficacy However this is not an inevitable consequence of these policies Most include the possibility to switch back to branded statins if treatment targets are not reached with generic variantsThe proportion of the observed effects is obviously dependent on the population the drugs involved and the methods and assumptions that were selected for the analysis It is important to note that the calculations are generally based on published observations of cardiovascular event rates during 5 or 10 year followup 2 The impact on lifetime risk may be significantly greater both in relative and absolute event rates 3For a balanced view on the consequences of these observations it may be appropriate to distinguish primary from secondary prevention since the effects of switching are likely greater in secondary prevention where absolute risks of cardiovascular events are generally greater This distinction could not be made in the present study on pharmacy data Similarly no data are available on the selection patterns that led to the 15 of all statin users in whom a switch was apparently considered appropriate by their physician Potentially this could have occurred more frequently in lower risk patients or in those who had LDL levels well below the recommended target plasma LDL level 25 mmol/l In this case the impact of switching may be smaller than was now calculatedIrrespective of the average impact on a population physicians who follow these guidelines need to carefully consider the consequences for their individual patient If a decision is made to switch to a generic preparation the new agent and its dose should at least be equivalent to the drug that is stopped and the LDL plasma level should be checked against previous values and against guidelinerecommended target levelsInterestingly the Pfizer patent on atorvastatin has now expired in Europe and as of 19 March 2012 generic atorvastatin has been admitted to the Dutch market It is available from Ranbaxy and from Pfizer It remains to be established how many patients will now be switched back to atorvastatinImportant as these observations are for lipidlowering therapy they signal a development that may have consequences far beyond cardiovascular prevention Written primarily with the intention to improve the quality of care guidelines in medicine are increasingly used as a basis for legal financial and licensing policies The 2006 Dutch guideline on Cardiovascular Risk Management is a good example where professional recommendations formed the basis for legislation on the reimbursement of lipidlowering therapy This step reduced physicians’ freedom to select drug therapy and in fact reduced professional autonomy The subsequent reductions in preventive therapy as described in the paper by Liew et al represent a serious unintended side effect of the guideline 1This ‘external’ use of our guidelines has important consequences for professional societies that issue guidelines External use should be routinely anticipated This requires explicit attention at multiple levels ranging from the selection of members for the guideline working group to the wording of the final document At each level an inherent conflict needs to be resolved between the responsibility of a physician for the individual patient and our collective responsibility for affordable health careThis article is published under an open access license Please check the Copyright Information section for details of this license and what reuse is permitted If your intended use exceeds what is permitted by the license or if you are unable to locate the licence and reuse information please contact the Rights and Permissions team

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