Janssen Seeking Medicare Add-On Payments For CAR-T Carvykti, But CMS May Be Skeptical
Executive Summary
J&J will need to convince the Centers for Medicare and Medicaid Services that its treatment is not substantially similar to existing CAR-T’s in order to qualify for supplemental Medicare reimbursement.
You may also be interested in...
When FDA Changes Your Payment Plans
Five sponsors withdrew their applications for new technology add-on payments from CMS – all due to regulatory reasons happening at the US FDA.
Medicare And CAR-Ts: Breyanzi Denied Add-On Payments But Tecartus, Abecma Approved
CMS shows willingness to continue approving new technology add-on payments for CAR-T treatments despite suggestions they are no longer needed.
Medicare Alzheimer’s Coverage Policy Advancing Clinical Trial Diversity Efforts
Medicare national coverage determination for Alzheimer’s drugs has been a ‘game changer’ in terms of motivating industry to boost diversity in clinical studies in the disease, trial expert says.