Commentary
Prescription drug coupons: Evolution and need for regulation in direct-to-consumer advertising

https://doi.org/10.1016/j.sapharm.2013.08.002Get rights and content

Summary

Pharmaceutical marketing in the United States had undergone a shift from largely exclusively targeting physicians to considerable efforts in targeting patients through various forms of direct-to-consumer advertising (“DTCA”). This includes the use of DTCA in prescription drug coupons (“PDCs”), a new form of DTCA that offers discounts and rebates directly to consumers to lower costs of drug purchasing. Our examination of PDCs reveals that the use and types of PDC programs is expanding and includes promotion of the vast majority of top grossing pharmaceuticals. However, controversy regarding this emerging form of DTCA has given rise to health policy concerns about their overall impact on prescription drug expenditures for consumers, payers, and the health care system, and whether they lead to optimal long-term utilization of pharmaceuticals. In response to these concerns and the growing popularity of PDCs, what we propose here are clearer regulation and regulatory guidance for PDC DTCA use. This would include review for appropriate disclosure of marketing claims, increased transparency in PDC use for pharmaceutical pricing, and leveraging potential positive benefits of PDC use for vulnerable or underserved patient populations.

Section snippets

Background

The practice of US pharmaceutical marketing has undergone significant changes since the 1990s when promotional spending focused primarily on detailing directly to physicians through pharmaceutical sales representatives.1, 2, 3 This form of promotion focused on fostering physician–industry relationships and interactions, comprised of financial and non-financial transfers of payments and benefits such as pharmaceutical product detailing, provisioning of gifts and entertainment, consulting

Expansion and forms of PDCs

PDCs, also known as prescription drug discount cards and prescription drug co-pay subsidy programs, are a relatively new and innovative phenomenon in pharmaceutical marketing. This form of DTCA advertises co-payment discounts to lower the cost of brand name drugs for patients with private insurance or those paying out-of-pocket.18 While PDCs often enable short-term savings for consumers on expensive brand name prescription drugs, a critical question is whether they represent an appropriate way

Examples of PDCs

PDCs are typically used for top-selling branded drugs and may be associated with products with impending patent expiry that can enable continued sales following loss of market exclusivity. For example, in a simple online search using Google search engine conducted from Nov 2011–Nov 2012 using the keywords “prescription drug coupon” and a specific blockbuster drug name, we found nine of the top-10 selling drugs (90%) of 2010, which include Lipitor, Nexium, Plavix, Advair Diskus, Abilify,

Controversy regarding PDC DTCA

PDCs may have the potential to provide substantial discounts directly and conveniently to patients to offset co-pays and out-of-pocket expenses, reduce financial burden of prescription drug expenditures, and even improve medication adherence, especially for newer pharmaceuticals with no other therapeutic alternative or generic formulation.18, 19 However, a key health policy concern regarding PDCs is whether they will materialize into actual short-term or long-term cost savings for individuals

Legal considerations

Federal government programs ban PDC usage because they regard these remuneration schemes to be in potential violation of the federal Anti-Kickback statute. Similarly, Massachusetts was the only state that specifically banned PDC usage; however, recently Massachusetts passed legislation amending its state anti-kickback law allowing PDC programs to be used by consumers only in circumstances where there is no generic equivalent medication available.33

Yet, despite legal prohibitions, PDCs may be

Policy reform

The growing popularity and increasing presence of DTCA-based PDCs in various physical and digital mediums requires careful consideration regarding potential benefits and negative impacts on health policy and prescription drug expenditures. Though PDC programs may enable cost savings to individual consumers, consumers may nevertheless not be fully cognizant of the true cost of purchasing branded drugs through PDC programs when other clinically appropriate options are available.

In response, the

Conclusion

PDCs represent a new and emerging form of DTCA that has yet to be adequately studied or assessed for potential impact on consumer perception and influence, prescription drug utilization, or effect on overall health care related expenditures. However, researchers, consumer advocacy groups, and insurers have already expressed concern over this form of DTCA that may incentivize consumers to purchase expensive drugs. Health care professionals, regulators and policymakers must partner to

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    Competing interests: The authors declare no potential conflicts of interest, competing interests, or funding sources associated with this manuscript.

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