How to Make a PIE That Sets the Table for Your Launch

FDA approval lets a new product enter the marketplace, but successful access can be influenced well before PDUFA with thoughtful preapproval communications. Preapproval information exchange, or PIE, is an important approach for setting a launch up for success. 

The FDA has provided guidance aimed at clarifying how drug and medical device manufacturers can communicate health care economic information (HCEI) to payers, formulary committees, and similar entities. This guidance addresses the nuances of sharing economic analyses related to both approved and unapproved products, and emphasizes the importance of providing truthful, non-misleading, and scientifically reliable information to those who play a critical role in determining coverage and reimbursement decisions. It outlines the types of HCEI that can be shared, including cost-effectiveness analyses, budget-impact models, and patient utilization projections, while stressing the need for transparency in study design, methodology, and limitations.

With so many high-cost innovative therapies entering the market, payers are looking for early information on products’ clinical and economic impact so they can forecast budgets and prepare to make coverage decisions. PIE allows market access teams to lead the way in meeting this need. At SAKS Health, PIE helps us enable Better Healthcare Tomorrow™ by building product value for our clients today.

What’s in the PIE?

The rule of PIE is that clinical data may be presented but not characterized. Even so, the most effective PIEs are not indiscriminate dumps of dry data. They tell a compelling story by carefully selecting the data that resonates with a payer audience. They find dramatic tension in a situation—a problem for a product to solve. They anticipate the concerns of decision makers and highlight the data that speak to them. They engage interest with data visualizations. They flow.

PIE is not a static “one and done” presentation. It’s important for manufacturers to update their PIE materials as clinical data becomes available and evolves during the prelaunch period. These updates provide opportunities for market access teams to have multiple touchpoints with payers in the years and months leading up to product launch.

Corporate awareness

Pharmaceutical and device manufacturers, particularly startups, often include an introduction of the company. Manufacturers need to tread lightly here and remember this is not a presentation to investors—PIE audiences are primarily interested in the product. A one-slide summary is usually enough to introduce the company and assure the audience that you are worth giving their time and attention to. Additional content about an innovative proprietary platform or a robust pipeline may help decision makers see the expected approval as the start of something more impactful in the future (so long as it doesn’t distract from the value of the launch product).

Disease state awareness

Next comes the disease state. It is strategically important to identify the problem that your product may be able to solve, especially for rare or less common conditions. This helps create the tension necessary for a strong narrative. Disease awareness for payers should go beyond just the clinical issues to demonstrate health economic costs such as emergency room utilization or hospitalizations. Impacts on quality of life hold less interest for a payer audience.

Product awareness

And then, the product. PIE audiences want to know the indication sought, the study design---especially inclusion/exclusion criteria---and clinical results. They are interested in information that can help them start to project the population of expected users. Payers are often very eager to know what the price of the product will be; manufacturers may disclose it in PIE, but they often choose not to. Pricing strategy is a sensitive topic and internal debates over product value and the competitive landscape usually continue right up until launch.

Take more bites

As noted above, the PIE story will evolve over time, and multiple preapproval meetings may be an option. If payers are interested, a disease awareness presentation may be followed up with a pipeline presentation, then presentations of various stages of clinical development. As you build relationships and align decision makers to your value proposition, you’ll set the table for favorable, timely market access at launch.

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