Webinar Insights: Navigating the changing landscape of Inflation Reduction Act (IRA) negotiations 

Understanding the regulatory implementations of IRA to date

The IRA has significantly reshaped healthcare regulations, incorporating the redesign of Medicare Part D, provisions for drug pricing with penalties for inflation-exceeding increases, and the introduction of Medicare drug price negotiation starting in 2026.

The implementation timeline extends from 2023 to 2028, with ongoing regulatory activities since enactment. Biopharma manufacturers are advised to focus on navigating negotiations with the Centers for Medicare and Medicaid Services (CMS), and leveraging data for submissions.

In the increasingly competitive Part D landscape, effective communication of value propositions to payer audiences through enhanced digital engagement is of paramount importance. Adjusting patient assistance programs and exploring changes to eligibility criteria are key strategic considerations. Stakeholder education takes center stage, with a particular emphasis on patients, healthcare providers (HCPs), and caregivers. These programs serve as pivotal touchpoints for information and engagement, making proactive preparation essential for industry stakeholders to adeptly navigate the evolving regulatory terrain.

Focusing your medical communications to prepare for negotiations

Primary Manufacturers, when identified for negotiation, can submit key information to the CMS through the Information Collection Request (ICR), covering diverse elements outlined in IRA sections. Despite uncertainties surrounding interested parties, competitor impacts, evolving ICR components, and the next list of affected drugs, the emphasis is on proactive preparation.

The recommendation is to establish an internal IRA team, adapting existing strategic planning processes for IRA considerations. Leveraging existing data sources, such as AMCP dossiers and real-world evidence, is essential for addressing ICR requirements. Creating a standalone document for ICR Section I’s needs using available data sources ensures readiness for negotiations.

Integration of IRA into strategic planning is pivotal, involving the identification of evidence gaps, use of existing value demonstration assets, and the inclusion of comparative effectiveness in the value story. This comprehensive approach enables companies to navigate uncertainties, emphasizing the need for ongoing preparation for the evolving regulatory landscape. Ultimately, the focus is on aligning medical communications with strategic planning to effectively navigate and prepare for IRA negotiations.

Deploying best practices for disseminating your value messages in a digital world amid greater payer scrutiny

Effectively communicating a product’s value story is now more critical than ever due to both negotiation aspects and the Medicare Part D redesign components of IRA. Payers, especially for products selected for negotiation, seek similar deals for their commercial lines of business. With competitors likely making concessions, Part D plans facing higher liabilities, and formulary narrowing, the need for a top-notch value story is evident.

Amidst these changes, there has been an accelerated shift to a digital world. Payers now prefer digital communication to supplement traditional face-to-face engagements. In this evolving landscape, asynchronous information is key, considering the transition from in-office to remote work environments. To maximize impact, leveraging the IRA-informed value story is essential, but effective communication is equally vital. A digital channel, such as FormularyDecisions, becomes crucial. With one of the largest audiences of healthcare decision makers, it offers a platform for sharing valuable tools, resources, and evidence to justify a product’s value.

Having a top-notch value story and an IRA strategy is not enough; timely and consistent communication through digital channels is essential. By meeting payer information needs in their current digital environment, the goal is to saturate the market with the product’s message, thereby maximizing impact and minimizing the impact of IRA scrutiny.

Assessing your patient support services to ensure you're meeting the needs of your populations

The IRA will distinctly impact manufacturer-sponsored patient assistance programs catering to significant Part D populations. Despite the positive improvements brought by IRA to the Medicare population, the Part D patient population, being the largest group affected, continues to face financial burdens, particularly concerning the anticipated $2,000 out-of-pocket costs. Manufacturer-sponsored patient assistance programs remain crucial in providing support to this population. Navigating through the various components of IRA and identifying their specific impact on patient assistance programs is essential for manufacturers.

Key considerations include redirecting Low-Income Subsidy (LIS)-eligible patients, reassessing out-of-pocket spend requirements in alignment with the out-of-pocket cap, and conducting impact analyses to inform necessary changes. As 2025 approaches, strategic planning becomes imperative, considering the time-consuming legal and compliance review processes. Manufacturers need to swiftly initiate a comprehensive roadmap that encompasses operational changes, updates to materials and CRM systems, policy adjustments, and effective communication strategies to ensure a seamless transition in line with the impending IRA changes.

Strategic considerations

Moving forward, consider practical strategies for navigating the evolving landscape. Firstly, leverage existing resources, especially medical communications, when negotiating with CMS. Avoid reinventing the wheel. Given the heightened competition in Part D, engage payers digitally to ensure your value messages reach decision-makers effectively. If your patient assistance program serves a significant part D population, seize the opportunity to reassess criteria for potential adjustments. Lastly, take a proactive stance in educating key stakeholders, particularly through patient support programs, to equip them for the anticipated changes in 2025.

Staying ahead of regulatory changes in the healthcare landscape is crucial for pharmaceutical companies. The IRA has significantly reshaped healthcare regulations, and navigating its implementation requires strategic considerations. To gain a comprehensive understanding of effectively preparing for negotiations and navigating the evolving regulatory landscape, watch our webinar on-demand now.

Our panelists:

Corey Ford, Vice President, Reimbursement Strategy, Cencora

As the Vice President of Reimbursement Strategy, Corey has been closely monitoring the Inflation Reduction Act (IRA) long before its enactment. His perspective and expertise on healthcare components and the subsequent developments since enactment provide valuable insights for understanding the regulatory implementations of IRA.

Kati Hale, Senior Director, Biopharma Services, Cencora

As the Senior Director of Biopharma Services, Kati Hale possesses deep industry knowledge and expertise in navigating the ever-changing healthcare landscape as it pertains to patient assistance program (PAP) operations. Her insights bring focus toward PAP operations and how manufacturers can evolve their programs to better support patient needs.

Bridgette Schroader, Associate Director, Medical Affairs Strategy and Publications, Cencora

As the Associate Director of Medical Affairs Strategy and Publications, Bridgette Schroader brings a unique perspective on strategic considerations for preparing organizations for future challenges. Her expertise in leveraging existing resources and educating key stakeholders is instrumental in helping attendees navigate changes brought about by IRA implementation.

Derek Swiger, Assistant Director, Digital Solutions Market Access and Healthcare Consulting, Cencora

Derek Swiger serves as the Assistant Director of Digital Solutions Market Access and Healthcare Consulting. His deep understanding of digital platforms' critical role in engaging payers after the COVID-19 pandemic provides valuable insights into adapting to a more digital environment while delivering impactful value messages.

The contents of this article may contain marketing statements and do not contain any legal advice. Cencora strongly encourages readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto.