Medicare could require Biogen, Inc. and Eisai Co., Ltd. to collect clinical data on the use and effectiveness of aducanumab in Alzheimer’s disease as a condition of coverage if the drug is approved by the US Food and Drug Administration.
Is Aducanumab In Alzheimer’s A Candidate For Medicare ‘Coverage With Evidence Development’?
Medicare may look to bolster evidence on Biogen’s potential Alzheimer’s treatment, if approved, with a national coverage decision requiring the collection of clinical data in the postmarket setting.
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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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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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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.