Specialty drugs accounted for most new product launches in the past decade. Why do we know so little about how clinical studies influence their diffusion?

Newswise — A fresh Journal of Marketing publication by scholars from McGill University and Ontario Tech University delves into the factors behind the spread of specialized medications.

The upcoming article in the Journal of Marketing, entitled "Scientific Evidence Production and Diffusion of Specialty Drugs," is authored by Demetrios Vakratsas and Wei-Lin Wang.

Within the pharmaceutical sector, a prominent pattern involves the creation of specialty medications tailored for intricate, severe ailments, typically affecting a small patient population. Out of the 219 newly introduced drugs or new active substances (NASs) in the United States from 2014 to 2018, a significant majority of 136 (62%) fell under the category of specialty drugs. Notably, in 2017 alone, 32 out of 42 NASs were designated as specialty drugs.

Advanced biotechnology serves as the foundation for the production of specialty drugs, which serve the purpose of addressing unmet needs among patients. These medications are specifically designed to tackle intricate and critical diseases; however, they also carry a significant risk of adverse events and are accompanied by exorbitant costs. A striking example of their financial impact is evident in the United States, where in 2018, specialty drugs accounted for a substantial 49.5% of the total net spending on medicines, amounting to $344 billion. It is noteworthy that despite representing only 2.2% of the 5.8 billion prescriptions, they commanded such a significant portion of expenditure. Due to their high costs, the prescription of specialty drugs requires prior authorization from insurance providers, necessitating thorough documentation demonstrating the appropriateness of the treatment for the individual patient.

Despite the increasing prevalence of specialty drugs, there remains a scarcity of knowledge regarding the factors that drive their dissemination. This study explores the role of scientific evidence in this context, as well as the potential influence of marketing activities on prescriptions issued by physicians, who are predominantly specialists. The research reveals that the diffusion of new specialty drugs is influenced by clinical studies, which play a pivotal role in a multi-stage scientific evidence production process.

The researchers put forth a specialized framework for the diffusion of specialty drugs, driven by two fundamental principles:

1. The unique nature of specialty drugs, characterized by their novelty, complexity, and criticality in treating specific conditions, demands that physicians who prescribe them rapidly acquire a comprehensive knowledge base. This enables them to make informed decisions based on the available evidence in a timely manner.
2. Specialist physicians, who primarily serve as prescribers of specialty drugs, possess the motivation, opportunity, and capability to directly access and evaluate scientific information. As a result, the emergence of evidence from clinical studies plays a crucial role in influencing the diffusion of specialty drugs, given that it directly informs their decision-making process.

The Importance of Scientific Evidence

The production of scientific evidence involves three main stages: (1) unpublished clinical studies, (2) publication of evidence in medical journals, and (3) development of clinical guidelines. Due to the significant potential advantages of specialty drugs and the seriousness of the diseases they treat, researchers anticipate that prescribers of these drugs will extensively utilize information from all stages of scientific evidence production to assess their usefulness and overall benefit for patients. Additionally, they believe that direct-to-physician marketing, such as personal selling and journal advertising, will have a diminished or possibly insignificant impact since physicians can access information directly from the scientific evidence production process.

According to Vakratsas' research, their findings substantiate the notion that the impact of scientific evidence production on the adoption of specialty drugs can be observed across all three stages of the production process. Additionally, their study reveals that both journal advertising and personal selling do not have a noteworthy effect on the diffusion of these drugs, which aligns with their initial expectations.

To further reinforce their findings, the researchers conducted a study on the diffusion of a non-specialty drug. Their investigation revealed that, in terms of scientific evidence production, only uncited publications (i.e., medical journal publications that are not referenced in clinical guidelines) and clinical guidelines have an impact on prescribing behavior, while unpublished clinical studies do not. Moreover, when they analyzed the data based on physician specialty status, they discovered that clinical guidelines solely influenced specialty physician prescribers, while detailing (i.e., personal selling) had a substantial influence only on prescribers who were general practitioners. These additional analyses provide additional support for their initial findings and shed light on the differential effects of scientific evidence production and marketing strategies based on physician specialty.

Wang emphasizes that their study provides a valuable framework for pharmaceutical companies to assess the effectiveness of their scientific evidence production efforts. They highlight the importance of shifting the focus from solely relying on published clinical results to considering all three stages of the scientific evidence production process. According to their findings, solely concentrating on publications would result in an underestimation of the returns on scientific evidence. By recognizing the significance of each stage, pharmaceutical firms can gain a more comprehensive understanding of the impact and value of their scientific evidence production initiatives.

Lessons for Chief Marketing Officers

These findings indicate that scientific evidence plays a significant role in driving the diffusion of specialty drugs. This presents several opportunities for Chief Marketing Officers (CMOs) in the pharmaceutical industry:

1. Engaging physicians and patients in clinical study protocol design: By involving physicians and patients in the design of clinical study protocols, CMOs can promote customer-led innovation. This approach not only increases patient enrollment and reduces protocol amendment costs but also enhances the relevance of the drug to the target patient population.
2. Systematically monitoring patient and physician input: CMOs should establish processes to systematically gather and assess input from patients and physicians. Shifting the focus towards engaging with these stakeholders can optimize marketing efforts by leveraging customer insights and aligning them with scientific evidence production.
3. Increasing involvement in innovation production: CMOs can seek closer involvement in the production of innovation within their organizations. This deeper engagement can potentially enhance the influence of marketing within the firm and facilitate a more integrated approach to product development and marketing strategies.
4. Committing to innovation and quality: Pharmaceutical firms can prioritize innovation and quality, driven by the prospect of a high return on investment (ROI) from scientific evidence for specialty drugs. This commitment to scientific evidence production can improve patients' quality of life, enhance productivity, and alleviate the burden of diseases.

By capitalizing on these opportunities, CMOs can align marketing efforts with the dominant driving force of scientific evidence, ultimately leading to improved patient outcomes, business success, and societal benefits.