Accelerated Approval Drugs contained in Oregon’s 1115(a) Demonstration Waiver
MNRDAC believes that the restrictions on drugs approved through the FDA’s Accelerated Approval Pathway in this proposal will significantly impede access to medically necessary treatments for rare disease patients who are enrolled in Oregon’s Medicaid program and exacerbate inequities that already exist for the rare disease community related to the availability of treatments.
We strongly urge CMS to reject the proposal to exclude Accelerated Approval Drugs contained in Oregon’s 1115(a) Demonstration Waiver.