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In the midst of the high-stakes game to reduce heart attacks, Jackevicius et al. reported in October 2008 that “removal of a [prior authorization (PA)] program led to improvement in timely access to clopidogrel for coronary stenting and improved cardiovascular outcomes.”1 In fact, the PA requirement was replaced with a “limited use” policy for clopidogrel (Plavix) in the Canadian province of Ontario in September 2003, and this policy change was associated with a 4-point decline in major cardiovascular events measured 1 year after hospitalization for acute myocardial infarction and percutaneous coronary intervention (PCI) with stenting among patients aged 65 years or older. Rates of the primary cardiovascular outcome—a composite measure of death, recurrent acute myocardial infarction, repeat PCI, and coronary-artery bypass grafting—were 15% in the 41-month PA period from April 2000 through August 2003 versus 11% in the 19-month limited-use period from September 2003 through March 2005 (P = 0.02). Rates of death during the PA period and the limited-use period did not differ significantly (5% vs. 4%, respectively; P = 0.42). Jackevicius et al. attributed the improvement in cardiovascular outcomes to increased use of clopidogrel following relaxation of the PA requirement. The percentage of patients who used the Ontario Drug Benefit (ODB) program to fill prescriptions for clopidogrel in the first 30 days following hospital discharge for myocardial infarction and PCI with stenting increased from 35% under PA to 88% under the limited-use policy, and the median time from discharge to the first clopidogrel claim declined from 9 days to 0 days.1 Not surprisingly given the morbidity, mortality, and economic cost of heart disease, estimated to have resulted in the deaths of approximately 43,000 Canadians and 514,000 Americans in 2002,2 the report by Jackevicius et al. garnered media attention. The popular press reported that clopidogrel “flowed more freely to stent patients and outcomes improved.”3 One headline stated that “Policy Change Improves Cardiovascular Outcomes,”4 and a press release disseminated by the lead author’s academic institution declared that “Faster Medication = Fewer Heart Attacks.”5 Although the study’s lead author acknowledged that PA policies vary by payer, she contended in an interview conducted shortly after publication of the study that its findings had broad applicability in the United States.6 However, as Fairman and Curtiss pointed out in their March 2008 review of a report on value-based insurance design, press accounts rarely contain the details necessary for a decision-maker to evaluate a study report’s validity, much less its applicability to populations with clinical or demographic characteristics unlike those of the study sample.7 Careful examination of the study’s context, sample and methods is warranted.

Prior Authorization and Clopidogrel Use - The Truth Lies in the Details