Rx Coverage Affects DTC Ad Impact

Consumers who lack pharmacy benefit coverage are more likely to ask physicians about the cost of treatments than those who have coverage, according to data from FDA research on the impact of direct-to-consumer advertising. Moreover, those patients who frequently ask about treatment costs are more aware of DTC ads than others.

A significant factor affecting patient responses is whether the individual pays for medicines out of pocket or has a pharmacy benefit plan, explained Kathryn Aikin of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC). She reported at the Food and Drug Law Institute's marketing conference last month that consumers who recently have seen a DTC ad and have no pharmacy coverage most frequently inquire about treatment cost. The inquiry rate also is higher for individuals who take one or more prescriptions, as opposed to those using only one medicine.

Aikin also noted that women ask about pharmaceutical costs more than men do, and that black people tend to inquire less often than other racial or demographic groups. The findings come from FDA's 2002 national survey of almost 1,000 individuals who visited a doctor in the previous three months. The aim was to learn more about the effect of DTC on the doctor-patient relationship. FDA plans to issue complete survey results later this year when it finishes a parallel study of how physicians respond to DTC ads.

Because the evidence collected to date is inconclusive about DTC's effect on pharmaceutical costs and utilization, FDA and the Agency for Healthcare Research and Quality should collaborate on a series of studies to further define and measure the impact of drug promotion, recommends Steven Findlay, director of research at the National Institute for Health Care Management Research and Educational Foundation. Even though NIHCM has roiled the pharmaceutical industry with studies purporting to document a causal link between rising DTC and spending on prescriptions, Findlay acknowledged at a Federal Trade Commission workshop on healthcare last month that DTC ads are only one element driving increased spending on pharmaceuticals and that the magnitude of the effect of DTC ads "has not yet been accurately quantified."

Findlay noted that expanded drug coverage by health insurers and HMOs, plus easier access to pharmaceuticals through pharmacy benefit managers may be stronger factors driving use than DTC advertising-an observation that agrees with FDA's consumer study. He noted that much evidence describes DTC advertising as a small piece of the drug promotional pie, with physician detailing a stronger force driving the recent growth in prescribing. Although 8-12 million people may have received a prescription last year as a direct result of a DTC ad, Findlay pointed out that this is a tiny portion of some three billion prescriptions written annually. Even NIHCM research that documents increased prescribing of the most heavily advertised drugs fails to prove a direct link between advertising and drug use, Findlay acknowledged, adding that many heavily advertised products might have had soaring sales without consumer ads.

There is "no doubt that DTC ads have some beneficial effect" by prompting doctor visits and leading patients to obtain needed treatment, Findlay concluded. But research fails to clarify how many of such requests are appropriate and necessary-and what portion is excessive. Because the issues raised by such ads are serious, Findlay urges further government study. He also calls for more resources for FDA to review the content of DTC ads and for FTC to monitor how consumer advertising may affect competition for market share between branded and generic drugs.