CMS Strayed From Its Lane With Alzheimer’s Drugs Decision, US Congressional Republicans Say
Executive Summary
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.
You may also be interested in...
Aduhelm Label Update Includes Seizure Risk And Recommends More MRIs
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.
It Takes A Village: Roche’s India Rare Disease Approach, Crowdfunding Support
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.
Medicare Alzheimer’s Decision Varies Evidence Mandate For Accelerated vs. Traditional Approvals
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.