Increased Opportunities to Accelerate Patient Access To Life-Saving Treatments

Where are you in your Journey?

Chad Patel and Ashik Jayakumar

Legislation provisions known as the Preapproval Information Exchange (PIE) Act was recently passed in conjunction with Congress’s omnibus funding bill. Once signed into law, this legislation will amend the Federal Food, Drug, and Cosmetic Act’s (FD&C) Title 21, Section 502 (a) on misbranded drugs and devices to formally allow drug and medical device manufacturers to proactively share investigational drug and device information, including health care economic information, with payors, health plans, formulary committees, and other similar entities prior to the clearance or approval of the drug or device.  

Who are appropriate audiences within this scope?

Section 502 (a) specifies that HCEI can be provided to “a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement.”  

What constitutes payer and similar entities in today’s healthcare business model?

The dynamics of the US healthcare system has created the emergence of organized customers-which are large, sophisticated, and complex healthcare provider and payer systems and groups with broad influence and footprint in the US healthcare systemLet’s review a couple of examples:  


These include vertical business relationships among insurers, PBMs, specialty pharmacies, and providers.  


Integrated Delivery Networks (IDNs) represent another entity that include a healthcare system that owns and operates a network of one or more healthcare facilities with goals to provide care coordination to maximize revenue and access across geographies. who IDNs are often categorized by their degree of integration with the most integrated ones having common electronic health record (EHR), financial platform and formularies across facilities. One example include Advocate Health—the organization formed in 2022 through the merger of Advocate Aurora Health and Atrium Health—cites among its goals an intent to address root causes of health inequities and increase the speed with which medical innovations reach patients.1  


Oncology Pathway Entities- payers are increasing linking quality patient care and cost savings based on value-based care. Value Pathways powered by NCCNTM  are treatment pathways that highlight evidence-based treatment options based on efficacy, toxicity, and an evaluation of financial impact to patient and payor (Medicare reimbursement). 


Institute for Clinical and Economic Review (ICER) is a nonprofit research organization that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices, and health system delivery innovations. US payers among other stakeholders use ICER’s reports an independent input into their considerations around pricing and coverage decisions.  

Given the evolution of these different types of entities making population-based decisions for health care organizations, pharmaceutical and device manufacturers should feel more comfortable about proactively exchanging information now that legislation formalizing the practice has passed in the US Congress. 

From a pharmaceutical and device manufacturer perspective, it is critical to have the following principals set in place to ensure these appropriate entities have the data needed for population-based decision making.   

  • To have strong understanding on the spirit of FDA guidance and statutes around payer communications 
  • To define governance and evidence standard for pre-approval information exchange and healthcare economic information. For PIE alignment on what types of economics information are permissible to communicate.    

This requires clear roles and responsibility within review committees to enable a successful pathway for the generation and communication of timely evidence to accelerate patient access to newer therapies.

Contact us if you would like our help to brainstorm and share pitfalls and best practices to developing internal ways for HEOR materials approval and development.  



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