Gottlieb slams ‘Kabuki’ biosimilar pricing schemes

FDA Commissioner Scott Gottlieb Wednesday criticized PBMs and payers for creating “Kabuki” drug pricing schemes “that obscure profit taking across the supply chain that drives up costs; that expose consumers to high out-of-pocket spending; and that actively discourage competition.” We are “living in a world where financial toxicity is a real concern for patients and every member of the drug supply chain needs to take responsibility for addressing it,” he said.

In a speech to America’s Health Insurance Plans (AHIP), an insurance industry trade association, Gottlieb said that the combination of PBM consolidation and market concentration, along with drug rebating and contracting schemes, are “pernicious.” He singled out biologics reimbursement practices, warning that they are undermining the biosimilars industry. The biosimilars pathway has not created sufficient savings, Gottlieb said. He noted that FDA has approved nine biosimilars, but only three are on the market...