Higher Medicaid Rebates For Expedited Approvals Offer Modest Savings But Target Growing Concern
As MACPAC moves toward formal recommendations, a CBO analysis finds that differential Medicaid rebates for drugs approved through the accelerated pathway could save the federal government up to $1bn over five years.
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Formal MACPAC proposal to US Congress to consider enhanced rebates for drugs approved via the Accelerated Approval pathway could have a long shelf life in the context of debates over drug pricing – and over FDA regulatory reforms.
Oncologic Drugs Advisory Committee will meet for three days in April to consider whether indications for Tecentriq, Keytruda and Opdivo should remain on label despite failure to confirm clinical benefit; review is part of the Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals, which has led to withdrawals of four other PD-1/L-1 inhibitor claims.
Some manufacturers may have to start essentially paying Medicaid programs to cover their drugs beginning in 2024 under a provision in the US economic relief bill headed to President Biden.