From pipeline to patient: How PIE streamlines biopharma and payer communication

The Consolidated Appropriations Act of 2023 codified US Food and Drug Administration (FDA) guidance, establishing a safe harbor for biopharma companies to engage in PIE with HCDMs.² “The regs and legs have been very explicit that these must be truthful, non-misleading communications between biopharma companies and population health decision-makers,” said Andrew Gaiser, Director, Digital Solutions, Cencora. 

Appropriate types of information include disease burden, such as epidemiology, product and pricing information, indication sought, presentation of study results, and anticipated FDA approval timeline. Eligible PIE recipients include public or private sector payers and formulary committees, drug information centers, technology assessment committees, and pharmacy benefit managers. Payers, formulary committees, and pharmacy benefit managers are among the HCDMs concerned with PIE. 

“PIE isn’t meant to be a one-way street, where the biopharma company delivers information to the payer, and that’s it. It’s a conversation, an exchange of insights,” Gaiser said. 

HCDMs want pre-approval information earlier, according to a Cencora survey of 41 advisors representing national and regional health plans, integrated delivery networks, and pharmacy benefit managers. However, over half (56%) of payers received pre-approval information on few or none of the products that were FDA-approved in 2023.³ 

Advisors also indicated that PIE can help speed patient access to new therapies, particularly for critical areas like oncology, rare diseases, and cell and gene therapies. “Delays in formulary additions in these types of spaces can literally mean patient lives,” said Bridgette Schroader, Director, Medical Affairs Strategy & Publications, Cencora.  

Payers who are focused on diseases with the most patients and highest costs, like diabetes and cardiovascular disease, may not otherwise know of a rare disease or a biopharma’s product for treating it, noted Kristy Cantrell, Director, Commercial Consulting, Cencora.  

“Having that education and providing that information not only helps you move forward in your formulary status but also allows you to control your narrative. It’s important if there are other products in the space—that your competitor is not controlling your narrative in the disease and with your product,” she said. 

The most common myth around PIE is that biopharma companies do not provide pricing information. However, not only does the law allow biopharma companies to share pricing, but many do so confidentially, often providing a range. 

Similarly, biopharma companies often wrongly believe that only clinical data or peer-reviewed manuscripts are allowed or wanted and that posters and abstracts do not meet PIE guidelines. “It’s very clear that the FDA did not specify particular documents, data sets, or references that could be used when delivering PIE,” Schroader said. 

“What they did state is the information has to be truthful and non-misleading. And I think we all know that our posters and abstracts meet that,” she continued. 

Other common myths include that a pre-approval dossier cannot be proactively disseminated because it is a dossier and only medical teams may present PIE information to HCDMs. While approved product dossiers require an unsolicited request, this isn’t the case for pre-approval dossiers. Biopharma companies have discretion to provide these resources proactively or reactively.

Regulations do not specify who can deliver PIE for a biopharma company. “What we hear from payers is that for clinical information that’s a part of PIE, they like to hear from medical science liaisons (MSLs) or health economic and outcomes liaisons (HEOLs). For the commercially aligned topics like pricing, if the company decides to include it, they like to hear from non-MSLs, account directors, and other more commercially aligned individuals at the biopharma company,” Gaiser said. 

In some instances, it may not be a matter of preference: MSLs and HEOLs may be firewalled from discussing certain information such as pricing. Therefore, identifying the most appropriate biopharma representatives to present specific information—and preparing clear answers to key questions in advance—is essential for successful interactions with payers. 

“Payers don’t like sudden changes; you will build trust with them if you are consistent with your messaging and communications and are as transparent as you possibly can be,” Cantrell said.  

When preparing PIE presentations, the person responsible for putting them together should include as much information as the biopharma company is willing to share. “You should go in with content that’s as robust as possible,” Chianta said. 

If payers don’t get the information they want, they will look for it elsewhere, she noted. “I’ve heard payers say, ‘We will be scouring the internet and looking for this information on our own in the absence of you providing it to us.’ So, if biopharma companies aren’t doing it, it’s a missed opportunity.”   

Given the bidirectional nature of PIE, pre-approval communications can make the process of preparing and delivering post-approval resources like payer value propositions more efficient.  

“As a biopharma company, you're talking to a payer about pre-approval information while also gathering insights for post-approval, to help build your value story, once you have a label. That’s why it should be a two-way conversation, not just dumping a bunch of information and then saying, ‘I'll see you after approval,’” Cantrell said. 

By approaching PIE as a bidirectional exchange, the biopharma company can learn what payers want. “You’ll also have data in your label that can help mold your marketing messages post-approval,” Cantrell said. 

With so much to gain for biopharma companies and HCDMs, access to pre-approval information is crucial for both stakeholders.