Practice Makes Perfect: Preparing for IRA Negotiations
Dan Gratie, Jaymin Patel, Chad Patel
With the 2026 drug list revealed, pharmaceutical companies must now prepare themselves for a negotiation process with CMS. Pricing justification in the era of the inflation reduction act is novel and not a straightforward process. Following a detailed submission process and initial offer from CMS, pharmaceutical clients only have 30 days to coordinate and submit their best counteroffer. If an agreement on a maximum fair price is not reached through the initial offer or counteroffer, CMS will invite companies to up to three negotiation meetings during spring and summer 2024 before the negotiation period ends on 1st August 2024.1
To ensure that all 2,500 words of the counteroffer are utilized in the most impactful, succinct narrative, pharmaceutical companies need to start preparing now for that eventual sprint. Entering negotiations unprepared can lead to multiple downstream impacts in reimbursement, and even future research and development initiatives.2
This is where AESARA steps in, offering invaluable assistance to their clients in the form of a mock negotiation workstream by leveraging our current IRA experience with multiple pharmaceutical companies, significant industry experience, expert payer panel, and commitment to novel solutions for complex challenges. Our expertise lies in understanding the intricacies of the CMS reimbursement landscape and devising effective strategies to put forward the optimal counteroffer.
Benefits of AESARA’s Approach to Mock Negotiations
Mock negotiations create a controlled environment that provide CMS perspectives to your teams’ workflow. This allows companies to anticipate challenges, identify weaknesses, and fine-tune their negotiation strategies while pressure-testing narratives from our stand-in CMS representatives.
AESARA leverages data analytics to provide evidence-backed arguments during negotiations from both a Market Access and Actuarial perspective. By simulating negotiation outcomes, we can identify the types of data that have the most persuasive impact on CMS decision-makers.
Mock negotiations involve cross-functional teams within the organization, including regulatory, clinical, and marketing teams. This fosters collaboration and alignment among various stakeholders, leading to a more cohesive negotiation strategy.
Not all negotiations follow the same trajectory. Through mock negotiations, companies can develop adaptable strategies to respond to varying scenarios and counterarguments put forth by CMS and prepare for future submissions.
This is a novel process for the industry, which can be intimidating regardless of the preparation process. Mock negotiations build confidence in the negotiating team by allowing them to practice and refine their communication and negotiation skills.
Debrief and Analysis
Post-simulation, the consulting team provides an in-depth analysis of the negotiation’s outcomes. This includes identifying strengths, weaknesses, and areas for improvement.
Securing optimal reimbursement from CMS is a critical step for companies looking to make their innovations accessible to a wider population. Leveraging AESARA’s domain expertise and strategic insights can provide an invaluable service by conducting mock negotiations. These simulations empower companies to approach CMS negotiations with confidence, data-driven strategies, and the ability to adapt to dynamic scenarios. With the aid of AESARA, pharmaceutical companies can enhance their chances of securing favorable reimbursement, ultimately benefiting patients, and advancing healthcare innovation.
Contact us to learn more and how we can help you prepare.
1. Accessed online August 30, 2023 https://www.cms.gov/files/document/fact-sheet-medicare-selected-drug-negotiation-list-ipay-2026.pdf
2. Government Price Controls Limit Access to Medicine and Stifle American Innovation. Accessed online June 29, 2023: https://www.uschamber.com/health-care/government-price-controls-limit-access-to-medicine-and-stifle-american-innovation