
PIE is Good for You: Drive Patient Access by Embracing FDA's Final Guidance
R&D organizations can leverage FDA’s final guidance on pre-approval information exchange, otherwise known as PIE, to engage with payers prior to regulatory approval and commercial launch.
Market dynamics are changing rapidly. Cost pressures are driving pharmaceutical manufacturers to generate evidence that demonstrates product value. While we’re
The final guidance addresses scientific and health economic information exchange between pharmaceutical manufacturers and payers (which includes formulary committees and similar entities) regarding their unapproved products and unapproved uses of approved products (i.e. PIE). This information could help payers plan for, budget for and ultimately drive future coverage or reimbursement decisions on a population health basis prior to FDA approval. Pharmaceutical manufacturers, on the other hand, have an opportunity to enhance their evidence generation strategy through increased dialogue with payers.
Achieving these benefits, however, isn’t as easy as pie. Risk-averse payers and pharma companies remain uncertain about compliance and the
Instead of nibbling around the edges of PIE, R&D organizations can embrace FDA’s final guidance by working hand in hand with payers earlier in the development process (ideally prior to a drug’s phase 2 clinical trials) with the overarching goal of favorable coverage and reimbursement decisions. There are three critical steps to achieving this:
• Assemble the right team to engage. Payers are a sophisticated market force, and with industry consolidation on the rise, they possess stronger controls on patient access than ever before. Early interactions prior to product approval are high-stakes and high-reward, with the potential to reap downstream benefits for patients. The right mix of expertise from development, medical and commercial organizations can
• Leverage clinical trial and value frameworks to incorporate payer feedback. The disparity between regulatory approval and successful reimbursement is widening as the R&D and value and access organizations are unable to integrate payer needs into Phase 2-3 trial design. As a result, these organizations pass the baton to medical affairs, health economics and outcomes research organizations, to design phase 3b-4, IITs and RWE strategies, including patient registries. The
• Lay the foundation for RWE partnerships. FDA has embarked on the journey to include the use of RWE as part of the regulatory paradigm. FDA leverages advancements in analytics as well as the explosion of disparate data sets that span electronic health records, laboratory tests, wearable devices and insurance claims data via its new
At the current pace of change, organizations face an imperative to improve patient access. It’s understandable that the current regulatory environment might leave some nervous about adopting a framework like PIE; however, with the right strategy and approach, embracing FDA’s final guidance is a key to adapting to the age of value and affordability.
Dean Hakanson is a Principal in the R&D Excellence practice; Jon Gonzales is a Manager in the Medical Affairs practice; and Tara Alire is a â¨Strategy Insights & Planning Associate Consultant, all at
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