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US pre-approval information exchange: building a pre-approval information exchange strategy in 3 steps


As payers’ evidence needs continue to evolve and formulary and US budgetary decision-making becomes more complex, biopharma manufacturers have a prime opportunity to create added value by engaging with payer customers earlier and more often through pre-approval information exchange (PIE) programs.

What is pre-approval Information exchange?

PIE is the exchange of clinical and healthcare economic information on assets that are in development (before regulatory approval) between US healthcare decision-makers and biopharma manufacturers.

3 steps for building a pre-approval information exchange strategy

The manufacturer team involved in the PIE engagement typically comprises multiple stakeholders, including scientific and pricing experts. This is not a requirement, as well-trained individuals can likely speak to all aspects, but often provides for a more robust discussion overall.

We suggest the team follows these three steps when developing their PIE strategy.

Step 1: Ask the right questions.

As building a PIE communication is a lot of work, can involve multiple consultants and vendors, and is an investment, it’s imperative for manufacturers to understand:

  • Is PIE the best approach? Can market research solve the issue or question?
  • Would a PIE bring value to payers?
  • Is this a new MOA, a new class, or a rare therapeutic area that payers may need to better understand?
  • Is there a potential for a large budget impact that payers and HCDMs should be aware of prior to launch for planning purposes?
  • What information do payers want to see in a PIE?
  • How do we create value in the PIE interaction with payers and not overload with too much data or too many touch points?
  • What accounts are best suited to receive the PIE?

Step 2: Figure out resources needed to support the PIE activity.

Whether it’s creating a segmented target list of accounts, internal documents that provide context and legal guidance, FAQ’s, outreach tools such as emails and trackers, and trainings, all support resources for your PIE initiative should be carefully vetted and included in your tactical plan.

Step 3. Create and deliver a tailored PIE communication.

While payers may be your primary audience, other healthcare decision makers (HCDMs), such as integrated delivery networks, group purchasing organizations, healthcare policymaking organizations, and healthcare ecosystem organizations, may have an interest in your PIE data.

It’s important to tailor your medical and commercial content to the specific needs and interests of your audience; this can include topics such as commercial models, market and disease landscape, pricing strategy, launch timing, cost burden studies, and pivotal trials. Where possible, it might also be beneficial to include information specific to the member or patient population relevant the payer or HCDM.

Typically, a PIE presentation is between 45 and 60 minutes in length, so it’s important to be highly specific about what you want to communicate and seek to present the material in a simple and compelling manner. Also make sure to include a list of discussion questions, as this is a prime opportunity to gather feedback about your data or model; prioritize your questions by order of importance, and weave them through your presentation.

Ultimately, gauge the interest level of your audience throughout the presentation and hone in on topics of high importance—these will be the questions and feedback that will have the most impact on your follow-up/through strategies and help to guide development of your post-approval medical and commercial communications plans.

What US market access professionals need to know about pre-approval information exchange

For a deeper dive into PIE, our free article discusses:

  • Why, historically, manufacturers have been limited in what information they were permitted to share with payers and similar entities prior to FDA approval of a drug
  • How legislation and FDA guidance has now created useful communication pathways and safe harbor for manufacturers to share much-needed pre-approval product information with payers
  • The opportunities for payers to gain valuable insights about new products and therapy areas well in advance of FDA approval and make earlier and more informed coverage and reimbursement decisions

Get in touch for expert support with your pre-approval information exchange

To learn more about how we can help you develop PIE strategies and communications, reach out to us for an introductory conversation.

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