With next-generation treatments threatening to break the bank for some payers, drug prices are under more scrutiny than ever. And as people throughout the healthcare chain--physicians, insurers, PBMs, patients--place more emphasis on value, companies may start boasting their meds' bang for the buck. But is that okay with the FDA?
Well, the agency isn't sure yet. Right now, the FDA allows drugmakers to include pricing info in their advertising, whether it's targeted toward patients or physicians. But the agency's concern is that bargain-shopping consumers could be more swayed by lower prices than by other important attributes, like safety and effectiveness.
So it's aiming to find out whether that's the case. According to The Wall Street Journal, the FDA is planning a study to compare healthcare providers' and diabetes patients' responses to three different versions of an ad: one that compares prices between a drug and one competitor, one that includes pricing info only for the advertised drug itself, and one that states actual costs may vary--and also includes the med's safety and efficacy profile.
At present, the agency doesn't have too much to worry about. Very few ads contain pricing info or make cost comparisons, as the Journal notes. But with the debate over high-priced meds heating up--fueled by Gilead Sciences' ($GILD) hepatitis C wonder, Sovaldi, which runs $84,000 per treatment course--that could all change.
"I wouldn't be surprised if they start to appear," John Kamp, director for the Coalition for Healthcare Communication, told the WSJ. Ads for biosimilars, for example, could invoke that strategy when those therapies finally land in the U.S. because they're generic versions of complex, top-selling biologics--rather than easily substitutable small-molecule pills--their makers will need to engage in some serious marketing. And with biotech drugs among the most expensive on the market, biosimilar makers could have a lot to gain from boasting of their cost-effectiveness.
After all, the precedent is already out there with DTC advertising for copay cards, the Journal points out. "This is nicely disguised," Jay Carter, SVP at ad agency AbelsonTaylor, told the paper. "They may not have pricing, but they do say the drug will cost less, which is central to the promotion."
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