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Undressing Brand and Generic Drugs
“Why are these pills a different color?” It’s a common question, and one pharmacists must field nearly every time a patient switches from a branded drug to its generic alternative. Now, a pair of Harvard researchers are asking the same question, but from a health policy perspective: What impact do the variations in physical appearance between generic and branded drugs have on patient outcomes?
In the article “Why Do the Same Drugs Look Different?”, published July 7, 2011, in the New England Journal of Medicine, authors Jeremy A. Greene, MD, PhD, and Aaron S. Kesselheim, MD, JD, MPH, take a critical view of rules that keep generic drugs from looking identical to their pricier equivalents. They argue that these regulations, referred to as “trade dress,” threaten to stunt adherence, increase errors, and discourage generic use.
A drug’s appearance is a critical factor in all 3 areas, according to Drs. Greene and Kesselheim. The authors point to research which shows that direct-to-consumer ads featuring images of pills actually improve adherence to therapies for chronic disease. Given this evidence, they said, “Consistency in appearance between brand-name drugs and generic drugs could help promote patient adherence.”
Visual inconsistencies could have a clinical consequence as well, according to the report. As researchers learn more about the placebo effect, they increasingly find that patients’ beliefs and attitudes about a medication have the power to boost or thwart its therapeutic effect. If appearance impacts the clinical effectiveness of a drug, the authors argue, trade dress regulations may even be at odds with the FDA’s strict standards for bioequivalence.
Although few studies have quantified the effect of trade dress on drug safety, the authors note that “It is clear that the external attributes of pills can have benefits separate from the therapeutic effect of their active ingredients.” They call for an end to outdated policies and “a more consistent and organized system of pill appearance” to ensure that generic drugs are used safely, effectively, and as often as possible.
“The benefit of having similar brandname and generic drug products that range widely in appearance now seems negligible,” concluded Drs. Greene and Kesselheim.
Daily Cost of Therapy Continues to Drop
Patients enrolled in Medicare Part D are paying substantially less for their prescriptions than they were 5 years ago, a new study by IMS Health confirms. Due to the increased availability of more affordable generic drugs, the average daily cost of therapy fell 30%, from $1.50 in January 2006 to $1.00 in December 2010.
The trend will continue through 2015, according to the report by Murray Aitken, MBA, MS, executive director of the IMS Institute for Healthcare Informatics, and colleagues. By the end of 2015, the cost per day of medications in Part D’s top 10 therapeutic classes is projected to drop to $0.65—for a total reduction of 57% since the program’s initiation in 2006.
In 5 of the 10 classes, the average daily cost of therapy is expected to drop by more than 40% between now and December 2015, due largely to the impending expiration of patents on blockbuster drugs. For drugs with generics already on the market, average daily costs are expected to increase, but only modestly, the authors note.
On deck for major patent expirations are some of the Medicare Part D’s heaviest hitters: lipid regulators (Lipitor in December 2012), proton pump inhibitors (Aciphex in May 2013 and Nexium in November 2014), angiotensin II receptor antagonists (Avapro in March 2012 and Diovan in September 2012), and antidepressants (Lexapro in March 2012 and Cymbalta in July 2014).
The report casts a more positive light on federal prescription drug spending than a May 2011 report by the Medicare Board of Trustees, which found that Part D drug costs would grow from $62 billion in 2010 to nearly $157 billion by 2020. However, that number is likely an overestimate, Aitken and coauthors told Reuters. “The 2006-2015 decade is one of steadily decreasing average daily cost of therapy,” they wrote.