The Preapproval Information Exchange (PIE) is an evolving concept within the pharmaceutical industry that facilitates early exchange of healthcare economic information and preliminary scientific data across manufacturers, payers and health systems before a new therapy receives U.S. Food and Drug Administration (FDA) approval. This early exchange allows stakeholders to collaboratively make informed decisions about potential coverage, reimbursement and patient access strategies with the goal of improving patient access to new therapies immediately upon approval. Many key health systems as part of receiving PIE presentations are deciding how they may use a new drug and how to configure their electronic health record (EHR) to allow ordering and administration of the new medication. We term these discussions “EHR Readiness.”
Although PIE was initially met with caution due to regulatory concerns about misinformation and off-label promotion, frameworks like the FDA’s guidance on PIE have clarified the pathways for these interactions. This has helped transform PIE into a more structured component of the healthcare ecosystem, enabling manufacturers, payers and providers to align their efforts toward enhancing patient outcomes. In this article, we will explore the opportunities PIE and EHR Readiness discussions present for pharmaceutical manufacturers, how they can leverage discussions and follow-up questions on EHR Readiness for mutual benefit with health systems, and how Point-of-Care Partners (POCP) can support these efforts.
Opportunities for Pharmaceutical Manufacturers in the PIE Process
For pharmaceutical manufacturers, PIE presents a unique opportunity to engage with payers and health systems before a product is approved. This engagement offers several advantages.
- Showcasing the value of therapies: PIE allows manufacturers to present clinical trials data, economic benefits and the anticipated impact of their therapies on patient care. This early exposure helps payers understand the potential value of new treatments and prepares them for future negotiations.
- Influencing coverage and reimbursement policies: By sharing detailed information about the clinical and economic value of a therapy, manufacturers can influence payer decisions regarding coverage and reimbursement. This is particularly important in a competitive market where new drugs need to demonstrate clear benefits over existing treatments.
- Preparing health systems for integration: Health systems require significant time to integrate new therapies into clinical practice. PIE and EHR Readiness discussions allow manufacturers to engage with health systems early, ensuring they are prepared to incorporate new treatments into their workflows, EHRs and treatment protocols.
- Establishing treatment protocols: Before a drug is approved, EHR Readiness discussions enable dialogue about establishing treatment protocols. This is crucial for ensuring a smooth transition from clinical trial mode to standard treatment protocols, especially for clinical trial sites that need to adapt their processes accordingly.
Leveraging PIE to Collaborate with Payers and Health Systems
Effective collaboration among pharmaceutical manufacturers, payers and health systems through PIE can lead to such mutual benefits as accelerated patient access to new treatments and optimized resource allocation. Here are some strategies for leveraging PIE to achieve these outcomes.
- Preparing to integrate EHRs with new therapies: EHRs can play a critical role integrating new therapies into treatment protocols. EHR Readiness discussions assist health systems in planning new treatment protocols before drug approval. We have heard these discussions are especially important for sites where clinical trials occur as they transition from clinical trial protocols to traditional coverage.
- Developing post-approval strategies: EHR Readiness within PIE discussions provides benefits beyond a drug’s approval. Experience and feedback in EHR Readiness discussions confirm assumptions on how health systems may establish initial treatment protocols. This feedback and experience will help pharmaceutical companies become savvier about EHR treatment protocols after approval. Also, health systems share EHR configurations that work. The earlier health systems establish working protocols to identify and treat patients, the sooner these organizations can share these protocols with others.?
- Breaking down silos: Manufacturers and health systems can use PIE to break down traditional silos and work together on shared goals, such as improving patient outcomes and reducing healthcare costs. By fostering a collaborative environment, stakeholders can develop comprehensive strategies that consider the needs of all parties involved.
How POCP Can Assist Life Sciences Manufacturers with PIE
Point-of-Care Partners (POCP) has extensive experience assisting life sciences manufacturers in navigating the complexities of EHR Readiness as part of the PIE discussion process. POCP can provide valuable support in several ways.
- Facilitating conversations between stakeholders: POCP helps manufacturers follow up on initial discussion questions about configuring the EHR for site readiness upon approval. This ensures a seamless transition from clinical trial activity to the establishment of new drug protocols within health systems.
- Providing educational presentations and materials: POCP can develop presentations and educational materials for account and medical teams to use with customers. These materials can cover topics such as EHR options for establishing treatment protocols, patient testing requirements, appropriate handling of adverse events (before discontinuing therapy) and integration of genomic results into EHRs.
- Planning to establish new treatment protocols: For some new medications, treatment protocols can be multifaceted with more complex treatment regimens than a simple prescription. There may also be a need for testing, additional companion treatments, tracking side effects to appropriately reduce dosages, and educating patients about their treatment and support. All these elements should be considered when planning EHR Readiness discussions as part of PIE.
- Supporting genomic data integration: With the increasing importance of genomic data in personalized medicine, POCP offers expertise in integrating genomic results into EHRs. This ensures healthcare providers have access to comprehensive genomic information, which can be critical in clinical decision making and improving patient outcomes.
- Advising on rare disease testing and referrals: For manufacturers developing therapies for rare diseases, POCP provides guidance on rare disease testing and referral processes. This support is crucial toward ensuring patients with rare diseases have access to appropriate therapies as quickly as possible.
The EHR Readiness as part of Preapproval Information Exchange represents a significant opportunity for pharmaceutical manufacturers to collaborate with health systems for mutual benefit. By engaging in early information exchange, manufacturers can showcase the value of their therapies and ensure health systems are prepared for integration of new treatments upon approval.
POCP is well positioned to assist life sciences manufacturers in navigating EHR Readiness as part of the PIE process. With expertise in facilitating stakeholder conversations, providing educational materials, integrating genomic data into EHRs, establishing new treatment protocols and advising on rare disease testing, POCP can help manufacturers maximize the benefits of PIE and achieve their strategic goals. As the healthcare landscape continues to evolve, adding EHR Readiness to PIE discussions will be essential for bringing safe, effective and cost-efficient therapies to patients as quickly and efficiently as possible. Contact us
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