Ontology highlight
ABSTRACT: Importance
State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on state Medicaid programs.Objective
To identify the number and class of drugs approved through the FDA
SUBMITTER: Sachs RE
PROVIDER: S-EPMC8727037 | biostudies-literature | 2021 Oct
REPOSITORIES: biostudies-literature