'Disruption' In Action: Lilly Tries To Upend PD1 Pricing – But Instead Upsets US FDA
Executive Summary
Lilly set out to “disrupt” US pricing models for checkpoint inhibitors by working with Innovent to seek US FDA approval of sintilimab. Did it end up disrupting its own relationship with the FDA?
You may also be interested in...
Casualty Of Change? Innovent/Lilly’s Chinese PD-1 Inhibitor Sintilimab Falls Hard At US FDA Panel
Advisory committee says additional trials needed to demonstrate applicability of ORIENT-11 results to US population; in opting to seek approval only with Chinese data, Innovent said it relied on 2019 comments by FDA’s Richard Pazdur, but the oncology center head said therapeutic and societal changes have caused an evolution in the agency’s thinking.
The $4 Million NDA: US FDA User Fees After 30 Years
The cost of filing a New Drug Application with the US FDA has pushed above the $4 million mark. That is a remarkable rate of increase from the original $100,000 fee set in 1992 – but it does buy a lot more.
Medicare Copay ‘Smoothing’ Plan Shows Nothing Is Simple In Part D
Guidance on how to implement a new policy to permit Part D beneficiaries to pay high copays in monthly installments (rather than all at once at the pharmacy counter) shows that there is no such thing as a straight-forward change in the drug benefit program.