Navigating the Inflation Reduction Act: Reassessing Evidence and Value Needs for Price Negotiations

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

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

Speakers

Dr. A. Mark Fendrick, MD, Director, University of Michigan Center for Value-Based Insurance Design

Dr. A. Mark Fendrick, MD, is a Professor of Internal Medicine and Health Management and Policy at the University of Michigan. He currently directs the V-BID Center at the University of Michigan, the leading advocate for development, implementation and evaluation of innovative health benefit plans.

His research focuses on how clinician payment and consumer engagement initiatives impact access to care, quality of care and health care costs. His perspective and understanding of clinical and economic issues have fostered collaborations with numerous government agencies, health plans, professional societies and health care companies.

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Dr. Fendrick is an elected member of the Institute of Medicine of the National Academy of Sciences, previously served on the Medicare Coverage Advisory Committee and has been invited to present testimony before the US Senate and the US House of Representatives. He is the Co-Editor-in-Chief of the American Journal of Managed Care.

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Manasee Shah, Director, Value, Evidence & Outcomes, GSK

With nearly 20 years’ experience in the pharmaceutical industry, Ms. Shah has a wide range of outcomes research, health economics and data generation expertise. She currently focuses on supporting the launch of products in the oncology space by designing and implementing innovative real-world data generation studies.

Over the last eight years, Manasee has authored several publications with the aim of disseminating the study results to wider clinical and non-clinical audiences. She has an MS from the University of Michigan, School of Public Health, Department of Health Management and Policy, where she regularly engages with current students as a guest panelist and occasional lecturer.

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Priya Jain, MS, MBA, Executive Director, Value and Access, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Ms. Jain is a seasoned life sciences strategy consultant with over 17 years of biotech and pharmaceuticals experience, with specialization in the areas of market access and product commercialization. She is an Executive Director on Evidera’s Value & Access Consulting team and is based in San Francisco, California.

A scientist by training, Priya leverages her strong technical background and problem-solving abilities to help clients address pressing strategic challenges. Her market access experience ranges across payer market research, pricing strategy, evidence generation, patient access and affordability and distribution and dispensing, with a goal of addressing needs of various stakeholders (patient, payer, provider) in a product’s access and reimbursement journey.

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She has worked across diverse disease areas, including immunology, oncology, cell and gene and orphan rare diseases and advised Top 25 pharma clients on defining and executing commercial and market access strategies for in-line and pipeline products.

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Ariel Berger, MPH, Executive Director, Integrated Solutions, Real World Evidence, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Mr. Berger, MPH, is the Executive Director of Integrated Solutions, US Database Analytics at Evidera in Massachusetts. He leads the Database Analytics Business Unit, focusing on internal processes, staff development and new customer offerings.

He designs and advises on RWE and health economics studies, involving complex methodologies and strategic initiatives. Previously, he was a senior consultant at Policy Analysis Inc. for 13 years, leading outcomes research studies and developing health economic models.

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Mr. Berger has experience in various therapeutic areas, including pulmonary arterial hypertension, infectious diseases, oncology and cardiovascular disease. His work is published in journals like Surgical Infections and Pain Practice and presented at conferences such as ATS and ISPOR. He holds an MPH in Epidemiology and Biostatistics from Boston University and a BA from Syracuse University.

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Sarah Ronnebaum, PhD, Research Scientist: Evidence Synthesis, Modeling & Communication, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Dr. Ronnebaum leads the development of systematic and targeted literature reviews within Evidera’s Evidence Synthesis practice to convey disease burden, review treatment landscapes, support value propositions, provide evidence for indirect treatment comparisons and identify economic model inputs.

Her areas of expertise include oncology, inflammatory and autoimmune diseases, neurological disorders, cardiovascular disease, infectious diseases and hematological diseases. She has written numerous HTA-ready systematic reviews and her work has been used in submissions to NICE, SMC, CADTH and other HTA bodies.

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Her work has also been published in peer-reviewed articles and presented at international symposia. She was previously a Senior Consultant at Deloitte Consulting and has served clients at the National Institutes of Health, Military Health Services and the Veterans Administration.

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