In a bid to lower prescription drug costs, a federal agency is recommending pharmaceutical companies pay higher Medicaid rebates if they have not completed required trials to confirm the effectiveness of medicines that received accelerated approval.
Specifically, the Medicaid and CHIP Payment and Access Commission, or MACPAC, on Friday voted 16-to-1 to boost two different types of rebates that drug makers would have to offer Medicaid if they fail to complete so-called confirmatory trials. Although Congress has to act on the recommendation, the agency hopes that drug makers will be moved to complete these trials rather than take a hit on revenue.
The suggestion comes as the Food and Drug Administration increasingly endorses treatments under the accelerated approval process. This was created three decades ago to hasten access to medicines for serious conditions and fill an unmet medical need based on a surrogate endpoint, which are used to predict a clinical benefit. An example would be shrinking a tumor.
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