Notwithstanding the absence of any data indicating inferior quality or clinical efficacy of generic statins, high-cost, brand-name statins retain a robust share of the market. This trend persists even in the face of increasing pressures to reduce healthcare costs, and despite the recommendations of the National Physicians’ Alliance to initiate lipid-lowering drug therapy with generic statins.
A special article and invited commentary reviewing trends in prescribing generic statins appeared online Jan. 7 in the Journal of the American Medical Association Internal Medicine.
Jonas B. Green, MD, of Cedars-Sinai Health System in Los Angeles, and colleagues surveyed recent published studies involving brand-name and generic statins. They identified three studies that compared the safety and efficacy of various statins at various doses: Incremental Decrease in Endpoints Through Aggressive Lipid Lowering (IDEAL), Study Assessing Goals in the Elderly (SAGE) and Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI22). Although none of these studies compared generic statins with equivalent doses of brand-name statins, none indicated that generic varieties of statins were less effective, or more harmful, than brand-name statins.
According to the study authors, “Head to head statin studies have demonstrated that while a higher dose of a more potent statin (i.e., atorvastatin) reduces lipid levels more than a lower dose of a less potent statin, few differences have been found for any outcomes and none for hard endpoints such as deaths or major coronary events.” In addition, the authors asserted that there are no safety differences between available statins, except that the FDA requires a black-box warning on simvastatin 80mg (Zocor, Merck) because of an increased risk of myopathy at high doses.
The study authors bemoaned the still vigorous sales of brand-name drugs atorvastatin calcium (Lipitor, Pfizer) and rosuvastatin calcium (Crestor, AstraZeneca) despite the availability of much cheaper generic equivalents. They pointed to a survey of physicians which found nearly 25 percent believed that generics are not as effective as brand-name drugs, and nearly 50 percent believed generics are of inferior quality (Ann Pharmacother 2011;45[1]:31-38). “Generic prescribing might be improved by better physician understanding of the[ir] safety and equivalence [of generics],” they wrote.
The article implied that physicians should prescribe generic statins as a matter of course. “Unless Crestor’s and Lipitor’s prices—including out of pocket co-payments and payer costs—fall to meet that of generic atorvastatin, there do not appear to be any appropriate indications for their use,” Green at al concluded.
In an accompanying editorial, Brian K. Alldredge, PharmD, and Steven R. Keyser, PharmD, both of the University of California School of Pharmacy in San Francisco, echoed those sentiments. “The adoption of generic statins to decrease coronary heart disease risk has been slow and disappointingly incomplete, given the equivalence (in terms of clinical efficacy and safety) of generic-available and brand-only statins,” they wrote.
The editorialists attributed physician resistance to generic prescribing to pharmaceutical company marketing efforts, including educational seminars and post-marketing research initiatives, and also to the effect of statin advertising, particularly advertising for Lipitor, on both physicians and patients. Alldredge and Keyser suggested that advertising instilled the notion that Lipitor was a more potent statin than available generic alternatives. But they pointed out that the studies cited in those ads, SAGE, IDEAL and PROVE-IT, did not compare equivalent doses of generic statins and brand-name statins.
Heart disease remains the leading cause of death in the U.S., according to the editorial, and fewer than half of elderly patients who take statins adhere to the therapy for more than a year. The study authors suggested that cost may be a factor in noncompliance.
The editorialists advocated increased evidence-based outreach using noncommercial data sources as a way to increase prescriber comfort with generic statins, and wrote, “massive educational efforts aimed at health professionals and consumers will be needed. A substantial portion of the cost of these efforts should be borne by those who stand to benefit most from the appropriate and optimal use of generic drugs, namely, healthcare payers, the government and consumers.”