Manufacturers and payers will now be allowed to exchange information before a drug is approved by FDA.
Although all eyes are current on the dramatic stalemate over who will become the next House speaker, the Academy of Managed Care Pharmacy (AMCP) is savoring a legislative victory that occurred in the end of last year in the previous Congress.
The Pre-Approval Information Exchange (PIE) Act was folded into the $1.7 trillion Consolidated Appropriations Act of 2023 that Congress passed just before Christmas and that President Joe Biden signed on Dec. 29.
The PIE Act will allow drug manufacturers to share information about their products with payers prior to the products gaining FDA approval.
AMCP pushed for the legislation to hasten coverage decisions and speed access to new therapies, said Susan A. Cantrell, the organization’s CEO, in an email responding to questions from Managed Healthcare Executive.®
Cantrell said the law will allow payers and manufacturers to communicate continuously coverage and purchasing. “It doesn’t fundamentally change the nature of the decision-making process for payers,” Cantrell wrote. “Rather, it safely accelerates patient access to covered medicines by enabling the payer’s review to run in parallel with the FDA’s.”
Cantrell said the definition of “information” that manufacturers and payers can share in the law is deliberately broad, including but also has some limits. Manufacturers remain prohibited from making “conclusory statements” that comparisons of efficacy, safety and overall cost to products. She said the PIE law requires manufacturers to include prominent statements that the product has not been approved by the FDA.
Under the law, payers are any entity that makes decisions about covering drugs and devices, she said, and will include insurers, pharmacy benefit managers and consultants who work on formulary development.
She said existing rules guarding the confidentiality of information will apply.
“(The PIE Act) will allow payers to conduct rigorous reviews of life-saving treatments concurrently with the FDA, helping them reach patients faster without sacrificing safety or review quality.”
AMCP says it initially introduced the concept of pre-approval information exchange between manufacturers and healthcare payers and plans in 2016.
In 2018, the FDA released guidance permitting pre-approval information exchange, but the guidance was unclear on some points, including the kind of information that could be exchanged.
The PIE Act of 2022 closely followed the FDA guidance, but spelled out the clinical trial information and economic information could be exchanged. It also specificed who the data can be shared with.