BIO International Convention Insights: Patient Assistance and Digital Therapeutics

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At the 2024 BIO International Convention, Avalere led discussions on post-IRA patient access and affordability and reimbursement pathways for digital therapeutics.

The 2024 BIO International Convention drew over 18,500 healthcare industry leaders from across the world to learn about the latest therapies and innovation in biotechnology.  The agenda was packed with four days of over 100 sessions, including two sessions on patient assistance and digital health therapeutics that were moderated by Avalere experts. Below is a recap of Avalere’s presentations from the event.

A New Era for Access and Affordability: Considerations for Patients and Manufacturers in a Post-IRA World

Moderator: Mark Gooding

Panelists: Anna Hyde, Arthritis Foundation; Valerie Reynolds, Genentech; and Eric Gascho, National Health Council

As Inflation Reduction Act (IRA) provisions are implemented in 2024 and 2025, manufacturers are rethinking how they approach patient support programs. The IRA has already transformed the landscape of Medicare Part D, including shifts in stakeholder financial liability throughout the benefit. The environment will continue to change in 2025 with the implementation of a $2,000 out-of-pocket (OOP) cap and introduction of the optional Medicare Prescription Payment Plan (MPPP) to help beneficiaries manage OOP costs throughout the year. As these changes are implemented, patients’ ability to access and pay for Part D products may shift.

The MPPP and OOP cap are expected to support Part D beneficiaries’ ability to pay for—and access—drugs. The MPPP will enable Part D beneficiaries who opt into the program to spread their OOP costs throughout the year. Decreased cost sharing via the cap will likely lead to higher utilization of Part D drugs and possibly improved medication adherence. However, despite these policies offering opportunity for greater affordability for some enrollees, new liabilities for plans may create additional pressures and hurdles for patients accessing and adhering to their treatments.

The panel discussion focused on both the challenges and opportunities that the evolving Part D landscape represents for beneficiaries. Panelists spoke about the need to educate patients and providers on the new Part D environment. While panelists acknowledged the efforts by advocacy groups and other stakeholders to prepare patients, there was agreement that additional work must be done across all stakeholder types to support access and affordability in 2025 and beyond.

Forging New Pathways to Reimbursement for Digital Therapeutics: Considerations for Payer Coverage

Moderator: Brigit Kyei-Baffour

Panelists: John Campbell, National Pharmaceutical Council; Dirk Soenksen, Ceresti Health; Beth Rogozinski, Oncoustics; Chris Koch, LeGen Medical Devices

Digital therapeutics are evidence-based therapeutic interventions that are often developed in combination with a device and/or therapeutic agent. They are designed to prevent, manage, or treat a variety of medical conditions and address challenges such as medication adherence and poor disease control. These products—which can be prescription or non-prescription—can help maximize the value of an asset by differentiating it, promoting clinical trial efficacy, efficiently collecting data,  and maximizing therapeutic potential, among other benefits.

Despite the unique benefits of digital therapeutics in disease management and prevention, these products face significant reimbursement barriers. There is no clear reimbursement policy for Medicaid or Medicare, and private payers have only just begun developing evaluation frameworks for digital products and services. With a variety of reimbursement routes applied across markets, it may be difficult for manufacturers to identify the optimal path. Further, digital technologies that demonstrate equivalence to the standard of care may not be reimbursed at a preferred price, as comparator technology may be relatively low-cost. Given this dynamic, demonstrating value is key for favorable reimbursement.

During the panel, experts discussed the current landscape of digital therapeutics, challenges to obtaining access from both coverage and reimbursement perspectives, regulatory considerations, and opportunities with regards to payment pathways. Panelists used examples of leveraging shared savings models and quality care programs such as accountable care organizations (ACOs). A major theme was the importance of education and awareness for all stakeholders involved—and particularly patients, providers, and payers—of digital therapeutics and their clinical and economic benefits.

Dive Deeper

Avalere works closely with manufacturers and payers to evaluate, develop, and refine patient support programs that are finely attuned to the current policy and market landscape. We also work closely with digital therapeutics and digital health stakeholders to maximalize patient access and affordability. To learn more about Avalere’s work, connect with us.

Webinar | A Closer Look at Patient Support Avalere experts explored how potential implications of the Inflation Reduction Act (IRA)’s out-of-pocket cap, in addition to other key regulatory and policy activities shaping benefit design and patient cost-share (e.g., EHB), could impact patient commercial and foundation assistance. Learn More
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