The Inflation Reduction Act (enacted in August 2022) contains profound changes for the healthcare and pharmaceutical industries, shifting responsibility for drug costs away from beneficiaries and onto plans and manufacturers. The law affects provider reimbursement, changes AMP and ASP calculations, and, perhaps most significantly, allows the federal government to negotiate prices for the first time—all of which present challenges to even the most experienced companies. Join our experts as we break down the Inflation Reduction Act, including how it will be implemented and who is most affected.
- Gain an understanding of the law’s components affecting the pharmaceutical industry and the implementation timeline.
- Understand manufacturers’ new responsibilities.
- Identify which drugs may be eligible for government price negotiation, and which will be exempt.
Derek van Amerongen, MD, served for 20 years as Vice President and Medical Officer for Humana Health Plans of Ohio in Cincinnati. In this role, he oversaw the medical management and strategy for one of the nation’s most innovative health plans. Before joining Humana, Dr. van Amerongen was National Medical Director for Anthem Blue Cross and Blue Shield, responsible for working with Anthem’s national accounts, as well as creating and directing the company’s women’s health initiative. His experience also includes over six years as Chief of Obstetrics and Gynecology for the Johns Hopkins Medical Services Corporation in Baltimore and as a faculty member in the Department of Gynecology and Obstetrics of the Johns Hopkins School of Medicine.
Maximilian Vargas, PhD MBA, is a Senior Director, US Access Strategy and Account Management within Certara’s Evidence and Access Group since 2012. He brings both scientific training and experience in healthcare product development that are important for evidence-based value and access strategies for pipeline and marketed products.
Leading a team of analysts and focusing on projects involving late stage, launch, and due diligence efforts, Max’ experience cuts across all major therapeutic areas and care settings with special emphasis on CV / metabolics, oncology, gene therapies, ophthalmology, GI, and dermatology. Max and team have designed successful pricing and contracting strategies for products at launch and throughout the life cycle. He also leads projects focusing on managed markets communications strategies.
Caitlin Verrilli, MBA, is an Associate Director, US Access Strategy. She joined Certara in 2021 and brings experience from across the healthcare industry, including pricing and contracting, market access planning, value-based care, and advanced modelling skills.
Caitlin’s specialties include data presentation and visualization, Medicaid and Medicare policy and innovation, reimbursement strategies, multi-channel analytics, budget impact modeling, financial forecasting, and ROI metrics. She is also a trained workshop facilitator and CQI (continuous quality improvement) coach.
Steve Sibley is the Vice President, Global Submissions and Submission Leadership. 医薬品業界での 30 年余にわたるキャリアを持つ、Steveは、レギュラトリーライティング、コンサルティング、プロジェクトリーダーシップの職務において、豊富な経験を有しています。彼は創薬から薬事承認まで、またライフサイクル管理において、多くのプロジェクトの成功を支えてきました。具体的には、75件以上の薬事申請において重要な役割に就き、いくつかの事例では薬事申請チーム全体を指揮し、モジュール1から5までのすべての書類作成、文書公開、規制当局への送信を監督してきました。