There has been a lot of discussion about drugs and drug pricing of late, including the idea of value-based purchasing. One element, though, that hasn’t been getting quite enough attention is just how a patient or a pharmacist or a doctor might come to understand what drugs are available and how to make an informed, independent judgment about each drug’s value.
I found myself thinking of this element today as a result of two pronouncements this week. The first was the AMA’s public stance against direct to consumer advertising. This is a good reminder that, as important as it is for patients to be informed about available options, seeing someone drive a cool sports car or frolic in a field with a puppy may not be the best way for them to do that. The second was Janet Woodcock’s assertion at a Politico Pro event that adoption of biosimilars will be tied to acceptance by prescribers. This made me wonder just who would be educating doctors on biosimilars.
Given how much we now spend on biologics, and the potential for biosimilars to save taxpayer dollars while increasing access to vital medication, making sure physicians understand biosimilars seems like a public good. And yet, how will doctors be getting their information on biosimilars? Unfortunately, as with other drugs, doctors have few independent resources for educating themselves (let alone time in which to do it), so, without developing a different solution, the uptake of biosimilars will likely be in the hands of manufacturers.
Brand manufacturers have a long history of using “detailers” to tell doctors about their products, but they are not required to inform doctors how their product compares to others on the market. Generic and biosimilars are newer to “detailing,” and, unfortunately, while they have an incentive to provide information comparing their product to the originator product, the more detailing they pay to do, the less savings they presumably could pass on to consumers. Academic detailing, in which an academic or at least non-commercial institution leads the effort, typically provides comparative information but is not widely available.
Where does that leave us? There is widespread misunderstanding about biosimilars in the U.S. While we must take great care in all things related to prescribing medication, few prescribers know how stringent the FDA’s standards are on biosimilars, let alone the success they have had abroad. It seems likely that manufacturer efforts, whether of originator or biosimilars products, will be too targeted to specific products to address this concern. How then can we remedy this? Should the FDA have an educational role here? If not the FDA, then who?