Drug Makers To Congress: Reject Accelerated Approval Pay Reforms

By: Gabrielle Wanneh / August 2, 2021

Drug makers researching rare disease treatments are urging congressional health committees to reject calls by Medicaid payment advisers to update reimbursement policies for drugs granted accelerated approval by FDA. Patient advocates also are pressing lawmakers to reject the proposals, saying they would curtail access to innovative products and stifle development of rare disease treatments.

At issue are proposals by the Medicaid and CHIP Payment and Access Commission (MACPAC) and some state Medicaid programs to limit the amount public and private insurers pay for costly accelerated approval drugs until drug makers can prove their efficacy.

The Rare Disease Company Coalition, like the patient advocates, argues the proposals would decrease access to new innovative medications, particularly those meant to treat rare and life-threatening diseases that might be too difficult to study using the traditional pathway for approval.