Revisiting Accelerated Approval: A Provocative Rebate Proposal
Formal MACPAC proposal to US Congress to consider enhanced rebates for drugs approved via the Accelerated Approval pathway could have a long shelf life in the context of debates over drug pricing – and over FDA regulatory reforms.
You may also be interested in...
Medicaid Spending On Accelerated Approvals ‘Outsized’ Relative To Use
A new study highlights a subset of high-cost drugs in Medicaid for which legal and policy tools may be available to manage spending growth.
MedPAC’s Part B Options Include ‘Value-Based’ Payment During Accelerated Approval
Medicare Payment Advisory Commission also considering reviving least costly alternative policy in some way, but remains relatively hesitant about changes to ASP+6%.
Lower Reimbursement For Accelerated Approval Drugs May Get Push From ICER
ICER President Steve Pearson expresses interest in setting drug costs for accelerated approval drugs low with price increases based on confirmatory evidence ahead of upcoming white paper from the group.