A New Drug Price Milestone
Much like Genzyme’s Ceredase did two decades ago, Novartis’ Zolgensma is setting a new pricing benchmark. The first million-dollar product is launching in the US and it will actually cost more than $2 million.
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Data Manipulation Not Common, But Happens "More Than I Would Have Expected," US FDA's Sharpless Says
As fallout from the Novartis Zolgensma data manipulation incident continues, US FDA acting commissioner Norman Sharpless notes that "at some level we have to trust the sponsors."
News and views from day two of the BIO International Convention: US FDA's Sharpless decries the focus on the price of "medical miracle" Zolgensma; CBER Director Marks talks about how his division will staff up to review cell and gene therapy candidates; and Takeda explains why its business development philosophy leads to the valuation seen in the Ariad buyout.
The total cost of Zolgensma is more than $2m – in line with estimates – or $425,000 annually for five years if payers choose an annuity-like payment plan. Novartis is also negotiating value-based reimbursement agreements for infants treated with the one-time infusion.