This blog post includes key takeaways from the opening session of Certara’s first Strategic Evidence and Value Communications Symposium. This session featured the following four speakers: Shawn W. Bates is vice president of US sales and business development, Maximilian Vargas is senior director of US access strategy and account management, and Alex Solis is a senior consultant at Certara. Andre Carvalho is cofounder and data specialist at Mindbeat.
Conveying a new drug’s intrinsic value effectively in a payer presentation takes careful planning and preparation because stakeholder time and attention are scarce resources.
Developing a Value Story
As illustrated in Figure 1 – the best value statements start to take shape at the beginning of the new product development cycle.
The first step is to understand fully the unmet medical needs, and the clinical and competitive landscape for a particular disease. That is especially important with rare diseases or when addressing underserved populations in a well-established, highly competitive market.
Then, products and trials need to be developed to meet those value drivers that the market requires. Thoughtfully designed clinical trials need to satisfy two objectives: they must achieve health authority approval and demonstrate quality-of-life improvements and clinical outcomes to show payers the value the product will deliver. Those data will comprise the evidence package that will be used to substantiate the product’s price at launch.
The final step is to demonstrate value through thoughtful pricing and contracting. That is the stage at which value propositions are developed and message testing occurs to determine the best way to explain the innovation’s anticipated economic impact to the payer community. Ideally, payer communications begin early in the development cycle, so they are aware of clinical advances on an ongoing basis.
As the product launch gets closer, draft/final labeling is usually known, and the conversation focuses more on the baseline clinical data.
Head-to-head clinical trials produce powerful results that are well received by payers. But those trials are not always undertaken because they involve an element of risk for the manufacturer. That said, in the absence of direct data, payers will endeavor to create their own indirect comparisons. Giving them evidence to support those comparisons is important just before launch. Helping them to identify high unmet needs and cost mitigation strategies is also necessary because they will be thinking about current spend and how that will increase or decrease with the innovation’s introduction. Ideally, the new product will deliver savings in terms of pharmacy spend or another broader economic benefit, perhaps a quality-of-life impact.
Preparing a Powerful Presentation
Payers have limited time available, so they tend to focus on therapeutic areas that have a high budget impact, such as oncology, diabetes, and cardiovascular disease. To capture their attention for less budget-intensive diseases, a presentation needs to be highly targeted and relevant, featuring real-world evidence, localized data, and comparative effectiveness data. The presentation needs to be clear, eloquent, and able to pull data from multiple sources, so that it can be used to illustrate a point or answer a question promptly in real time. Software-as-a-service (SaaS) is proving to be a potent approach because it allows large quantities of information to be integrated, producing an all-in-one solution. It allows representatives to be well prepared, to control the conversation, and removes some of the uncertainty from their meetings.