Accelerated Approval Reforms Complicated Because Most Drugs Have Regular Indications Too

Efforts to develop reimbursement-based policy reforms to address concerns about drugs approved through the US Food and Drug Administration’s accelerated approval pathway will be complicated by the fact that the majority of drugs with accelerated approvals in Medicaid and Medicare also have regular approvals for other indications, according to two recent studies by researchers at Brigham and Women’s Hospital.

One study published in the December issue of Health Affairs by Benjamin Rome and Aaron Kesselheim looked at accelerated approvals in Medicaid to assess a proposal by the Medicaid and CHIP Payment and Access Commission (MACPAC) on a new payment approach for accelerated approval drugs