The Pre-approval Information Exchange Act of 2022 Passes in the House
AMCP is celebrating a win for patients! On June 8, 2022, the U.S. House of Representatives passed the Pre-approval Information Exchange (PIE) Act of 2022. PIE enables enhanced patient access to emerging pharmaceuticals and devices by authorizing pharmaceutical manufacturers to proactively share certain health care economic and scientific information about products with health payers ahead of Food and Drug Administration (FDA) approval. In short, PIE can help speed up patient access to new, potentially lifesaving treatments by reducing the time between FDA approval and the beginning of coverage for that treatment.
Recognizing its vital importance to patients, AMCP made PIE a legislative priority starting in 2016. These efforts included connecting with and educating elected officials. AMCP found an ally in Representative Brett Guthrie from Kentucky, who introduced the PIE Act of 2022 in March. After receiving and incorporating technical assistance from FDA, the PIE Act of 2022 was advanced favorably and unanimously by the House Energy & Commerce Committee on May 18, 2022, as part of H.R.7667. On June 8, the act passed the full House 392-28.
Helping Patients Get the Medications They Need…
Sharing information earlier in the approval process will benefit more than 100 million Americans covered under Medicare and Medicaid, which have limited ability to modify formularies during a plan year. This can create disparities in treatment for millions of patients. PIE will help Medicare and Medicaid plan more efficiently, leveling the playing field for beneficiaries while also promoting the shift from fee-for-service to value-based care.
In addition to PIE’s bipartisan support, a diverse and growing coalition of stakeholders representing the entirety of the healthcare continuum also back the legislation. Together, we share our gratitude to Representative Guthrie for his leadership. We also look forward to working with the Senate, through continued outreach, education, and coalition efforts, to pass this important bipartisan legislation.
To learn more about PIE and our work on behalf of the legislation, I encourage you to visit AMCP’s PIE Resource Center.