Navigating the CAR-T Reimbursement Landscape

ABOUT THE WEBINAR

Join the International Society for Cell & Gene Therapy (ISCT) for an in-depth webinar on the evolving reimbursement landscape for CAR-T therapy. This session is essential for professionals navigating the complexities of cost, coverage, and regulatory considerations associated with CAR-T treatments.

Led by industry experts and policymakers, the webinar will delve into recent developments in CAR-T reimbursement, explore regional differences, and outline strategies to optimize reimbursement pathways for this innovative therapy.

KEY LEARNING OBJECTIVES

Understanding the Evolving Reimbursement Landscape for CAR-T Therapy:

  • Gain insight into the current challenges and opportunities within the reimbursement process for CAR-T treatments.
  • Understand the role of cost, coverage, and regulatory factors in determining reimbursement eligibility and rates.

Exploring Recent Developments in CAR-T Reimbursement:

  • Stay updated on the latest regulatory changes and advancements affecting CAR-T therapy reimbursement.
  • Learn about policy shifts that may impact pricing and reimbursement strategies for CAR-T treatments.

Navigating Regional Differences in CAR-T Reimbursement:

  • Analyze how CAR-T reimbursement policies vary across regions, including country-specific guidelines and payer practices.
  • Identify key geographical challenges and opportunities for reimbursement in CAR-T therapy.

Optimizing Reimbursement Pathways for CAR-T Therapy:

  • Explore strategies for improving reimbursement pathways and ensuring timely access to CAR-T treatments for patients.
  • Learn from best practices and industry experts' insights on enhancing reimbursement processes and reducing barriers.

Addressing the Regulatory Considerations:

  • Understand the regulatory hurdles associated with CAR-T therapies and how they influence reimbursement decisions.
  • Learn about key stakeholders involved in CAR-T therapy reimbursement and how to collaborate effectively with them.

Engaging with Policymakers and Stakeholders:

  • Gain practical knowledge on engaging policymakers and key stakeholders to advocate for favorable reimbursement outcomes.
  • Understand the importance of data-driven approaches and real-world evidence in shaping reimbursement policies.
 WEBINAR CHAIR

Karla Villa
Market Access Specialist
Terumo Blood and Cell Technologies
United States

 WEBINAR SPEAKERS

Susan Leppke, MPH
Sr, Director, Public Policy & Strategic Partnerships
AABB
United States

Ms. Leppke is the senior director of public policy and strategic partnerships for the Association for the Advancement of Blood and Biotherapies (AABB) where she is responsible for advancing advocacy and driving public policy initiatives on improving access to transfusion medicine and biotherapies.  Ms. Leppke has over 15 years of experience in health care management, reimbursement, access-to-care policy and analysis, and stakeholder engagement.

Prior to her role at AABB, Ms. Leppke served as the Director of Public and Payer Policy at the National Marrow Donor Program where she led multi-stakeholder teams to successfully pass federal and state policies to protect access to cellular therapies for patients with blood cancer and other blood diseases and disorders.  Prior to that, Ms. Leppke managed and led efforts in organ transplant policy where she provided strategic leadership and direction on organ allocation policy, transplant research, and payment analysis, strategically engaging with external stakeholders. Her experience includes leading government affairs and policy teams to drive change in the federal, state, and local legislative and regulatory settings. Ms. Leppke has her master’s degree in public health administration and policy from the University of Minnesota.


Richard Maziarz, MD
Medical Director, Blood & Marrow Transplant & Cellular Therapy Program
OHSU
United States

Dr. Maziarz has been involved in clinical investigation and translational research, for over three decades, beginning with research and clinical training at the Dana-Farber Cancer Institute and the Brigham & Women’s Hospital and continuing in 1991 when he moved to OHSU to develop a transplantation immunology program and served as the medical director of the adult OHSU stem cell transplant program since 1994.

His research involved the immunology of transplantation or its complications, particularly in studying the immunopathophysiology of GVHD. He has served as principal investigator or co-investigator on over 100 clinical trials including multiple initiatives sponsored by numerous national transplant organizations including SWOG, CIBMTR, ISCT, NMDP and BMT CTN. Within the BMT CTN, he serves on the Steering committee, chaired the Regimen Related Toxicity Committee, was a member of the GVHD Committee and served as the principal investigator for the BMT CTN on the first multicenter, stem cell transplant trial for patients with advanced chronic lymphocytic leukemia (BMT CTN 0804).

He also served on the writing committee for the first national multicenter, randomized trial between conventional and reduced intensity transplantation (BMT CTN 0901) and for transplantation for HIV associated malignancies. He currently serves as Chair of the Regimen Related Toxicity Strategic Planning Committee of the BMT CTN for the planned State of the Science Symposium, to define cell therapy and transplant clinical trials over the next 5 years.

A special interest has been the intersection of transplantation and health policy; he has served as consultant to the Oregon Health Resource Commission assessing indications for autologous transplantation and analyzing efficacy of reduced intensity allogeneic transplantation as a standard of care for adults with hematologic malignancies. He also has been an active member of the Health Policy working committee of the CIBMTR, served as a member of the ASBMT reimbursement committee and served as Chair of the NMDP financial working group for their system capacity initiative regarding transplantation expansion and most recently is Chair of the Health Economics SIG for ASTCT. At OHSU, he had maintained a laboratory focused on basic and preclinical models focused on how to reduce the risks for morbidity and mortality associated with graft versus host disease.

Most recently, his focus has been on the toxicity and efficacy of immune effector cell therapy. He has opened IEC multiple trials, assisted in the generation/ writing of new emerging trials utilizing CART and NK cells for a variety of disease indications and was the Chair of the Scientific Steering Committee for the Juliet trial that led to the approval of tisagenlecleucel for advanced diffuse large B cell lymphoma.


Kenny Hodge
Vice President, Government Affairs
Jeffrey J. Kimbell & Associates, Inc.
United States

Kenny Hodge currently serves as the Vice President of Government Affairs for Kimbell & Associates. In this role he works with the government affairs team to develop client-specific strategies and then executes them on Capitol Hill.

Coming from a long line of healthcare professionals in his family, Kenny has spent his entire professional career at the intersection of healthcare and politics. Since first joining the firm in 2010, Kenny has taken a lead role translating coding, coverage, and payment issues in the Medicare payment rules into Capitol Hill advocacy efforts supporting access for innovative technologies; and he is proud to serve as the Director of Government Affairs for the Institute for Gene Therapies (IGT), an advocacy organization launched in 2020 specifically to help address access challenges surrounding the development and adoption of gene therapy products.


Kenny has volunteered time working for over a half-dozen Republican Senate and Congressional campaigns during his time in Washington; assisting in data collection, data analysis, policy research, and other field activities. Kenny has also been utilized as a public speaker for various events, including courses at Columbia University’s School of Public Health.


Kenny was raised in Louisville, Kentucky and graduated from the University of Kentucky with a BS in Biology, where he was a member of the varsity men’s tennis team. In his spare time, Kenny can be seen in the surrounding states with his dog, a fly fishing rod, or a set of downhill skis. On occasion, he'll still pick up a racket and hit the courts.