Pacira’s Exparel Will Get Separate Medicare Payment; CMS Still Wants Better Opioid-Sparing Data
US Centers for Medicare and Medicaid Services proposes a change to its reimbursement policies for non-opioid pain therapies which will benefit a single product: Pacira’s Exparel. However, the broader message for that company is mixed.
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Inclusion of failed studies in US label for Pacira’s Exparel label is unusual but appropriate given regulatory history with that application. Could FDA take that approach with other products to address unapproved uses in the context of uncertainty about prohibitions against 'off-label' promotion?
Administration also plans to roll out slate of proposals to decrease drug prices and bring discounts to patients.
US FDA advisory committee to weigh whether efficacy data support an expanded label for the local anesthetic; despite Pacira's completion of two new studies following a complete response letter, FDA continues to harbor concerns about adequacy of the data to support a broad nerve block claim.