Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury (see EMA ATMPs page.)

However, ATMPs also bring challenges. The introduction of these new treatments requires high upfront costs for the public healthcare providers because of new logistical and infrastructural demands including necessary investments in infrastructure (e.g. equipment, storage and treatment capacity), more complex procedures for quality control and a high price per dose compared to other kinds of medicine. Often, clinical effects - particularly long-term - and adverse effects are very uncertain. Public decision-makers are therefore faced with challenging issues related to the use of adequate evaluation methods, sustainable payment models and organizational conditions to enable the uptake of these treatments. These challenges put pressure on pharmaceutical companies, public authorities, healthcare payers and other stakeholders to develop joint solutions.

Join us for the Signal event on September 27, 2022 to learn about the Danish experience with ATMP valuation approach and development of an innovative outcomes-based pricing agreement between pharma and payers. You will gain insight into the practicalities of stakeholder involvement and data requirements, and overall learnings from the outcomes-based pricing agreement experience from a multistakeholder perspective.

Learning Objectives

  • Learn about valuation criteria and challenges for the advanced therapeutic medicinal products (ATMPs)
  • Gain insights into the practicalities of stakeholder involvement and data requirements of the innovative outcomes-based pricing agreements on a specific example
  • Learn about ongoing experience of implementing and managing an outcomes-based pricing agreement

Speakers

Pia Krogsgaard Villadsen, Head, Market Access, Novartis Healthcare, Copenhagen, Denmark

Dorthe Bartels, Senior Strategic Advisor - New Medicines, AMGROS, Copenhagen, Denmark

Sarah Wadmann, PhD, Senior Researcher, VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark

Julia Chamova, MBA, Senior Director, Content Strategies, ISPOR — The Professional Society for Health Economics and Outcomes Research, Lawrenceville, NJ, USA