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Register for this insightful webinar today to understand the impact of the IRA on pricing negotiations in the pharmaceutical industry.

The signing of the Inflation Reduction Act (IRA) in 2022 represented one of the most significant landscape changes to the US healthcare ecosystem over the past decade. In particular, the provision authorizing Centers for Medicare and Medicaid Services (CMS) to negotiate drug prices has had a major impact on pharmaceutical manufacturers.

On August 15, 2024, CMS released the maximum fair price (MFP) for the first 10 drugs selected for price negotiations. However, the detailed explanation of the rationale for the negotiated prices will not be released until March 1, 2025.

The expert panel has investigated the CMS policy guidance around evidence considered while determining MFPs and will offer perspectives around evidence strategies that could help manufacturers demonstrate true product value during Medicare price negotiations.

By attending this webinar, attendees will:

• Gain an understanding of CMS’ initial policy guidance on evidence leveraged for supporting negotiations with manufacturers and determining MFP
• Explore strategies for developing robust evidence packages to be prepared for future Medicare price negotiations

Discover the power of in-trial qualitative interviews in drug development and decision making.

REGISTER NOW!

Join a free webinar on Wednesday, September 11, 2024 at 10:00am EDT to explore the value of these supplementary data to enhance clinical trial design, interpret findings and demonstrate value for payers while addressing unmet patient needs. You’ll gain a greater understanding of:

• The utilization of qualitative evidence in drug development
• How this evidence is valorized during evaluation by regulators and health technology assessment (HTA) bodies
• Implications for reimbursement decision-makers

Expert speakers from Evidera, part of the PPD clinical research business of Thermo Fisher Scientific, will explore the added value of in-trial interview data in drug development and its pivotal role as a driver in decision making for regulatory and HTA decisions. The discussion will draw from case studies from multiple data sources, including FDA and EMA labels, HTA reports, and guidance documents. Attendees are invited to participate in a pre-survey about their experience using in-trial data in regulatory and HTA submissions, the results of which will be presented during the webinar with key points addressed for knowledge sharing.

SPEAKERS:

Carla Dias-Barbosa, MSc, Senior Research Leader & In-trial Research Lead, Patient-Centered Research, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Miriam Kimel, PhD, Senior Research Scientist, Patient-Centered Research, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Karen Bailey, PhD, Research Scientist, Patient-Centered Research, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Paulina Rolska-Wójcik, PhD, Director, Value & Access Consulting, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific