ADVERTISEMENT
Preapproval Information Exchange Act Introduced in Congress
Congressman Brett Guthrie (R-KY-02) introduced the Preapproval Information Exchange (PIE) Act of 2022 (HR 7008) earlier this week in an effort to improve patient access to emerging therapies by improving the communication exchange between manufacturers and payers ahead of US Food & Drug Administration (FDA) approval.
The purpose of this new legislation is “to improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes.”
According to the Academy of Managed Care Pharmacy (AMCP), an organization that has long supported initiatives to improve preapproval communication, “The need for proactive PIE communication is especially important as the health care system continues to evolve from a fee-for-service payment system to a value-based system rewarding quality, improved patient outcomes, and cost efficiency.”
In 2018, the FDA shared guidance permitting PIE but it was unclear whether manufacturers could proactively share information with payers or if payers needed to request the data. AMCP noted the guidance also defined communicable health care economic information differently than the relevant statutory law, creating legal grey areas and uncertainty for both parties.
Under the act, payers would be able to better anticipate new indications and in turn, increase the speed of coverage decisions, granting access to patients in need.
Following its introduction, AMCP issued a statement naming the bipartisan PIE act is one of its top federal priorities.
“The PIE Act will help patients receive swift access to new treatments by empowering pharmaceutical manufacturers to provide truthful and non-misleading evidence to health payers ahead of FDA approval,” said AMCP CEO Susan Cantrell in a statement. “This allows payers to incorporate new therapies into their formularies for the plan year in which approval is anticipated. Public payers like Medicare and Medicaid will especially benefit from PIE due to their limited authority to modify formularies during a plan year.”
First Report Managed Care will be following the development of this legislation.
