CMS Strayed From Its Lane With Alzheimer’s Drugs Decision, US Congressional Republicans Say
Recent congressional reactions to the Medicare national coverage determination offers insight into policies around CMS decision-making that could advance if Republicans gain more control in Congress in 2023.
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New safety information may help defense of CMS's coverage restrictions. FDA updated the prescribing information for Biogen’s Alzheimer's therapy after four cases of seizures were reported in a trial.
Roche Pharma India CEO and managing director, V Simpson Emmanuel, outlines the company's multi-forked approach, including collaborating with a crowdfunding platform, to move the access and treatment needle for Evrysdi in India. The Swiss firm, along with industry associations, also suggests the need for a formal accelerated regulatory pathway in India for rare diseases.
Final Medicare national coverage determination aims to set up a ‘nimble’ system to allow for broad and rapid patient access to drugs for Alzheimer’s disease following traditional approval while retaining a more restrictive approach for accelerated approvals.