ICER’s Final NASH Report Urges Step Therapy, Specialist Prescribing, Equitable Access
When the first non-alcoholic steatohepatitis drugs reach market, the health cost watchdog says payers will be justified in setting step-therapy including weight-management efforts, while early prescribing should be by specialists.
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With a 14 March FDA action date and no advisory panel scheduled, Madrigal is looking ahead to resmetirom becoming the first approved NASH therapy, following stumbles by competitors.
Company tells advisory committee it is unsure of continuing on to collect Phase III outcomes data in NASH without accelerated approval, which the panel voted against.
Competing with Madrigal in the THRβ agonist class in non-alcoholic steatohepatitis, Viking’s VK2809 reports stronger efficacy and better safety and tolerability than resmetirom at that stage.