State-Only Webinar: The Cost of Speed – Accelerated Drug Approvals and Medicaid

Medicaid programs are required to cover all Food and Drug Administration-approved drugs, including those approved through its Accelerated Approval Pathway. The Accelerated Approval pathway allows drugs to be approved on the basis of surrogate endpoints (e.g., lowering cholesterol), which may not be representative of the true clinical outcomes of interest (e.g., reducing mortality), and depend on the completion of post-approval follow-on studies. As a result, states can devote scarce financial resources to pay for expensive drugs with uncertain clinical benefits. 

This webinar, designed for state officials only, will explore: 

• How the Accelerated Approval program has grown and changed over time;
• How much state Medicaid programs are spending on drugs approved through the accelerated pathway;
• How accelerated pathway spending compares to their overall state Medicaid drug expenditures; and
• Medicaid and CHIP Payment and Access Commission (MACPAC) recommendations to require higher rebates from manufacturers for drugs with Accelerated Approval.

Moderator: Trish Riley, Executive Director, National Academy for State Health Policy

Speakers:

• Rachel Sachs, JD, MPH, Associate Professor, Washington University School of Law
• Stacie Dusetzina, PhD, Associate Professor of Health Policy, Vanderbilt University School of Medicine
• Julie Donohue, PhD, Professor and Chair of Health Policy and Management, University of Pittsburgh Graduate School of Public Health

State Reactant: Donna Sullivan, MS, PharmD, Chief Pharmacy Officer, Washington Health Care Authority