As the industry waits for the FDA’s implementation plan for comparative effectiveness research, the senior executives of The Core Nation (Core-Create/Brandkarma/Alpha & Omega) offer a multifaceted perspective on the brand implications of this new regulatory mandate. Ken Kramer, Ph.D. Senior Vice President, Medical Director According to the U.S. Department of Health and Human Services, comparative effectiveness is defined as “the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in ‘real world’ settings." The clear intent of the FDA is to create mandates for comparative effectiveness to influence reimbursement decisions. The challenge for comparative effectiveness research is to determine the length of its reach. It makes perfect sense to evaluate treatments for dyslipidemia and hypertension based on a cadre of validated outcomes. But, as with all medicine, one approach is unlikely to best serve every circumstance. For example, with today’s cancer therapies, the value of comparative effectiveness is questionable as the effectiveness of treatment is often determined by an individual’s genetics and medical needs. It is easy to foresee the potential conflict between the ideas of comparative effectiveness and personalized medicine. Both have been top-of-mind for pharma marketers for some time and each can be used as an approach to drive a brand’s success. Some therapeutic areas are not going to benefit from comparative effectiveness research as much as others. Regardless, sound branding practices that reinforce a product’s ability to stand apart from the crowd and serve the specific patient’s needs remains the hallmark of market success. Ken Ribotsky President and Chief Executive Officer The advent of comparative effectiveness will certainly affect the marketing of new drugs and indications. Currently, in competitive and crowded drug classes (e.g., NSAIDS, statins, oral contraceptives) where little clinically differentiates, doctors make treatment choices based upon more than the data. If this weren’t the case, clinical inertia — the failure to initiate or adjust therapy when it is appropriate and available — wouldn’t exist. Looking at the emotional and intellectual factors that play a role in these decision-making processes provides critical insights that often lead to brand opportunities. With the advent of comparative effectiveness, marketers will likely have new measurables with which to position their brands. Softer metrics such as quality of life will come into play to provide a fresh perspective on a product. But marketers beware: Soon we will all have even more data points to compete against. Ultimately, the fight for data supremacy is a never-ending battle; spending money on clinical trials for the mere purpose of one-upmanship is unlikely to be the best use of funds. A more effective investment could be made in educating patients on medication usage and lifestyle modifications when appropriate, in support of better outcomes. Better outcomes are the most compelling point of differentiation for any brand. Dorene Weisenstein Executive Vice President and Chief Creative Officer Regulation of message is a reality. Many marketers fall into the trap of regulatory fear—something that the advent of comparative effectiveness will help address, eventually. But today the result of regulatory anxiety is clearly expressed in the sea of sameness among pharma brands trying hard not to stand out for fear of unwanted FDA attention. Until the effects of comparative data begin to truly have an impact on the commercialization of products, brands can and should leverage distinctive creative and design to establish their differentiated value with physicians and patients. One constant remains: the visual realm offers much more expressive leeway than the written word. n Dorene Weisenstein Executive Vice ­President and Chief Creative Officer Ken Kramer, Ph.D. Senior Vice President, Medical Director Ken Ribotsky President and Chief Executive Officer The Core Nation is dedicated to providing clients with the highest level of service and creative healthcare marketing through its member companies, Core-Create, Brandkarma, and Alpha & Omega. For more information, visit thecorenation.com.

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