Intercept's Pricing Of Ocaliva Anticipates Outcomes Data
This article was originally published in The Pink Sheet Daily
Executive Summary
With OCA approved for primary biliary cholangitis, Intercept anticipates a potentially slow ramp of sales, but has priced product at $69,350 a year based on need in second-line treatment and in anticipation of survival benefit data.
You may also be interested in...
Intercept’s Ocaliva: ‘Dangling’ PBC Indication At Risk As Near-Term NASH Approval Looks Unlikely
Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.
Is ICER Too NICE? A Comparison Of Drug Assessments Programs
Drug companies are accusing the US Institute for Clinical and Economic Review of approaching cost effectiveness assessments in the same way as the UK National Health Service gatekeeper, the National Institute for Health and Care Excellence.
Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending
However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.