MACPAC ‘Undeterred’ By Lukewarm Reception Of Accelerated Drug Approval Recommendation
Executive director Schwartz suggests Congress may turn its attention to the advisory commission’s proposal to revise Medicaid coverage for drugs approved under the accelerated approval pathway in the next year or two.
You may also be interested in...
Accelerated Approvals In Medicaid: Drug Coverage Exclusion Authority Sought In Oregon
If approved, Oregon would be the first state granted the authority to exclude coverage of accelerated approval drugs, even if manufacturers provide the statutory rebates required for Medicaid.
Reforming Accelerated Approval: Three Ideas For Congress
Ideas to reform Accelerated Approval are likely to be debated during the reauthorization of the key US FDA user fee funding authority in 2022. Here are three suggestions for Congress to consider.
Accelerated Approval Reforms Complicated Because Most Drugs Have Regular Indications Too
Because Medicare and Medicaid do not reimburse based on indication, it would be hard to target specific accelerated approvals for pricing discounts. This could penalize drug manufacturers even if the accelerated indication represents a minor share of the drug’s use, researchers say.