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.
Take example 1 – This message grabs one’s attention, but using Certara’s BaseCase digital platform, representatives can add further layers of interactivity to better demonstrate the product’s value and achieve their desired outcome – a contract and listing on the formularies. BaseCase allows representatives to customize their presentation and simulate specific models. For example, during a cost-effectiveness conversation, they can create budget impact simulations using default data from institutions, and countries, and then refine them to demonstrate what the scenario would look like for a public or private payer. BaseCase is an interactive solution, which integrates with economic models, calculators, complex datasets, and other types of information.
This approach also enhances in-house training because it allows each representative to adapt the presentation to reflect their own style, while maintaining version control so that the entire sales team has the latest approved materials, messaging, data, and models. BaseCase enables this efficient knowledge sharing across teams and affiliates because it allows staff without technical knowledge (other than Word, PowerPoint, and Excel) to build apps that can be easily adapted to different markets and quickly distributed.
The need for personalized presentations has been particularly acute during the COVID-19 pandemic because most meetings have been digital engagements, with all the inherent distractions from texts and emails, instead of face-to-face meetings. Capturing a payer’s attention online is far more challenging than in person.
Trying to present two Excel spreadsheets with calculations, a PowerPoint document with multiple screenshots, and 10 PDFs with peer-reviewed data simultaneously during a 30–45-minute meeting is not going to create a succinct value message.
Furthermore, if the payer asks for the data source for a particular slide, and the representative cannot download that asset with one click, it could derail the conversation. BaseCase empowers the presenter to control the conversation and achieve the required outcome.
Keeping it Simple
The best way to deliver a value proposition and value story is to keep it simple visually. But that is harder to achieve than it sounds because there are so many data sources available – clinical, real-world evidence, PDFs, graphics, Excel spreadsheets, and videos – to support the message.
Ideally, the presenter needs to highlight an outcome and have two or three lines to support it, and then use the platform resources to keep all the data in the background. Some payers, those with an academic or medical background, will be more concerned with study details. Others will be more focused on the cost of the change. The value story needs to be framed differently for each payer; presented in the way that resonates best with them. Having a platform that can deliver the right data for each payer situation is powerful and something that cannot be achieved with a mere PowerPoint deck. The golden rules are: Make it simple, show what is important, and emphasize what you want them to remember.
Payers see a lot of presentations every day, so it is worth spending a little time and some design resources to make the presentation beautiful and ensure the value story stands out.
The goal is to be transparent, have all the data accessible via interactive tools, and tailor the conversation to head in the direction that the payer is guiding it.
Global Variations in Market Access
Risk distribution is one of the biggest differences between market access in the U.S. and Europe.
Even though the government is the largest payer in the U.S, it is still a distributed, third-party system with many different risk holders. In contrast, most European countries have some form of single-payer system, and they implement it.
Risk distribution in the U.S. creates a communications issue because there are distinct geographies with quite different practice and prescribing patterns. That impacts what the payer sees from a population view. As a result, stakeholders have quite different frames of reference depending on the area of the country they are from and their local population. National data may not resonate with payers who represent a specific state or set of employers due to their own experience. Those differences may be in cost of services, cost of drugs, or utilization; the numbers can be vastly different. Therefore, the presentation needs to be dynamic, and able to pivot in whatever direction the payer needs it to go.
It is crucial to understand a payer’s mandate and frame of reference. Consider how things are going to change in their therapeutic area from a cost and treatment perspective. They are ultimately responsible for providing insurance against costs relating to healthcare utilization. They want to make services, drugs, and diagnostics available that are beneficial to their membership because that will enhance enrollments.
That perspective is especially important when considering outcome-based or evidence-based schemes for unmet medical needs, such as cell and gene therapies for rare diseases, where the clinical data can be a little less robust, and regulatory approvals and labeling are often based on surrogate biomarkers. In those cases, it is vital to communicate what that specific change in enzyme level means in terms of a clinical outcome or benefits for the patient, their caregiver, or physician.
Data from patient registries and real-world evidence patient arms in clinical trials can provide crucial insights, even prior to product launch. Many payers are not aware of the disease burden because they may see only one or two patients with that condition, and they do not track those patients closely in their institution. Patients tend to be clustered around a center of excellence based on referral patterns.
It is essential to be able to connect with payers and demonstrate awareness of the struggles that each one of them is facing. Using a platform that can capture feedback and create customized experiences is key.
Remember to establish new product value drivers early because that will set up all the messaging components and suggest effective ways to present them. Also, don’t expect them to be static. New clinical data and real-world evidence will emerge. Practice patterns will change as the market changes. Therefore, presentations will need to be updated and refined to ensure that the right points are being communicated as the brand lifecycle continues.
To learn more about our “no-code” platform for demonstrating the value of products to key decision-makers, check out our BaseCase page.