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In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. Between December 1, 2018 and January 31, 2019, 65% of erectile dysfunction prescriptionsfilled were for Viagra or its generic version 12. Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively.
Timely implementation is particularly critical for beneficiaries requiring immediate mental health or substance use treatment, where delays can lead to worsening health outcomes, increased hospitalization rates, and preventable mortality. 38 Furthermore, CMS should include manufacturer rebates in the definition of “negotiated price.”
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