The Commission is looking at how states can better manage the high costs of specialty drugs, focusing this meeting on one type: those approved through the U.S. Food and Drug Administration’s (FDA) accelerated approval pathway. As a part of receiving accelerated approval, the manufacturer must conduct post-market clinical trials to confirm that the drug achieves a clinical benefit. Accelerated approval drugs have extremely high costs. A prior MACPAC analysis found that Medicaid spent $686 million before rebates in FY 2017 for 27 drugs approved under the accelerated approval pathway since 2014.
This presentation built on the findings from MACPAC’s technical advisory panel presented in January and takes the next step toward a recommendation on changing payment policy for drugs receiving accelerated approval. The technical advisory panel proposed a differential rebate where the manufacturer would pay higher rebates on accelerated approval drugs until it has completed the required post-market confirmatory trial. Once the FDA has granted traditional approval, the rebates would revert back to typical amount. The presentation provided the rationale and options for recommendations to implement a differential rebate on accelerated approval drugs.