Biogen Inc.’s plan to seek US Food and Drug Administration approval for its aducanumab for Alzheimer’s disease is putting a spotlight on the many obstacles standing in the way of coverage and access for such treatments.
Alzheimer’s Drug Coverage Issues Move To Forefront With Biogen’s Plan To Seek Approval
Any product would be mostly covered by Medicare, but because the potential patient population will likely be 'substantial,' payers will likely 'closely scrutinize' these drugs, Duke Margolis white paper observes.
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.
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Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.
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Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
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The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.
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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.