Oliver Leatham, vice president and global head of value and access at Certara, writes about the complex issues that surrounds assigning a value to new drugs.
How do you assign a value to saving someone’s life? Then, how do you pay the bill? Those are questions that manufacturers and health authorities are increasingly being asked to answer as pharmaceutical companies attempt to gain regulatory approval and subsequent reimbursement for innovative and, in some cases, curative new therapies; products with limited evidence and small patient populations.
On 24 May, the US Food and Drug Administration (FDA) approved Novartis' Zolgensma, the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), a leading genetic cause of infant mortality. Zolgensma is a one-time treatment, which is designed to be curative, but it will cost more than $2 million, making it the most expensive drug ever brought to market in the US.