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Public opinion regarding U.S. Food and Drug Administration approval of aducanumab and potential policy responses: A nationally representative survey

BACKGROUND: Despite controversy among experts regarding aducanumab's approval by the U.S. Food and Drug Administration, little is known about public opinion on this matter. METHODS: We conducted a representative survey of U.S. adults ages 35 and older to (1) determine opinions regarding aducanu...

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Autores principales: DiStefano, Michael J., Alexander, G. Caleb, Polsky, Daniel, Anderson, Gerard F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9177789/
https://www.ncbi.nlm.nih.gov/pubmed/35129210
http://dx.doi.org/10.1111/jgs.17692
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author DiStefano, Michael J.
Alexander, G. Caleb
Polsky, Daniel
Anderson, Gerard F.
author_facet DiStefano, Michael J.
Alexander, G. Caleb
Polsky, Daniel
Anderson, Gerard F.
author_sort DiStefano, Michael J.
collection PubMed
description BACKGROUND: Despite controversy among experts regarding aducanumab's approval by the U.S. Food and Drug Administration, little is known about public opinion on this matter. METHODS: We conducted a representative survey of U.S. adults ages 35 and older to (1) determine opinions regarding aducanumab's approval, (2) identify any evidence of reputational injury to the Food and Drug Administration, and (3) explore opinions regarding policy responses available to policymakers, such as those relating to a national coverage determination by the Centers for Medicare and Medicaid Services. The survey was administered online and in English and Spanish using a probability‐based sample derived from the National Opinion Research Center's AmeriSpeak® panel. Selection probabilities in the panel and survey design account for differences in population distribution and expected response rates by demographic. The survey was analyzed using survey weights to adjust for selection probabilities and non‐response. RESULTS: A total of 1025 respondents completed the survey. While approximately three‐quarters of respondents were initially unfamiliar with aducanumab, respondents were less supportive of the drug's approval once given information about the drug's potential clinical and economic impact. Sixty‐three percent of respondents support restricting aducanumab access to patients most likely to benefit. Seventy‐one percent indicated a willingness to enroll a family member with mild Alzheimer's disease in a “waitlist”‐style trial to further study aducanumab; sixty percent indicated a willingness to enroll a family member in a randomized placebo‐controlled trial. Eighty‐one percent agree aducanumab should be withdrawn from the market if confirmatory trials fail. The median respondent was willing to pay $1–5 in higher Part B premiums to cover aducanumab. CONCLUSION: These findings demonstrate support for a range of proposed policies in response to aducanumab's approval. The opinions of an informed public ought to be considered when developing policies in response to aducanumab's approval.
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spelling pubmed-91777892022-06-09 Public opinion regarding U.S. Food and Drug Administration approval of aducanumab and potential policy responses: A nationally representative survey DiStefano, Michael J. Alexander, G. Caleb Polsky, Daniel Anderson, Gerard F. J Am Geriatr Soc Regular Issue Content BACKGROUND: Despite controversy among experts regarding aducanumab's approval by the U.S. Food and Drug Administration, little is known about public opinion on this matter. METHODS: We conducted a representative survey of U.S. adults ages 35 and older to (1) determine opinions regarding aducanumab's approval, (2) identify any evidence of reputational injury to the Food and Drug Administration, and (3) explore opinions regarding policy responses available to policymakers, such as those relating to a national coverage determination by the Centers for Medicare and Medicaid Services. The survey was administered online and in English and Spanish using a probability‐based sample derived from the National Opinion Research Center's AmeriSpeak® panel. Selection probabilities in the panel and survey design account for differences in population distribution and expected response rates by demographic. The survey was analyzed using survey weights to adjust for selection probabilities and non‐response. RESULTS: A total of 1025 respondents completed the survey. While approximately three‐quarters of respondents were initially unfamiliar with aducanumab, respondents were less supportive of the drug's approval once given information about the drug's potential clinical and economic impact. Sixty‐three percent of respondents support restricting aducanumab access to patients most likely to benefit. Seventy‐one percent indicated a willingness to enroll a family member with mild Alzheimer's disease in a “waitlist”‐style trial to further study aducanumab; sixty percent indicated a willingness to enroll a family member in a randomized placebo‐controlled trial. Eighty‐one percent agree aducanumab should be withdrawn from the market if confirmatory trials fail. The median respondent was willing to pay $1–5 in higher Part B premiums to cover aducanumab. CONCLUSION: These findings demonstrate support for a range of proposed policies in response to aducanumab's approval. The opinions of an informed public ought to be considered when developing policies in response to aducanumab's approval. John Wiley & Sons, Inc. 2022-02-07 2022-06 /pmc/articles/PMC9177789/ /pubmed/35129210 http://dx.doi.org/10.1111/jgs.17692 Text en © 2022 The Authors. Journal of the American Geriatrics Society published by Wiley Periodicals LLC on behalf of The American Geriatrics Society. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Regular Issue Content
DiStefano, Michael J.
Alexander, G. Caleb
Polsky, Daniel
Anderson, Gerard F.
Public opinion regarding U.S. Food and Drug Administration approval of aducanumab and potential policy responses: A nationally representative survey
title Public opinion regarding U.S. Food and Drug Administration approval of aducanumab and potential policy responses: A nationally representative survey
title_full Public opinion regarding U.S. Food and Drug Administration approval of aducanumab and potential policy responses: A nationally representative survey
title_fullStr Public opinion regarding U.S. Food and Drug Administration approval of aducanumab and potential policy responses: A nationally representative survey
title_full_unstemmed Public opinion regarding U.S. Food and Drug Administration approval of aducanumab and potential policy responses: A nationally representative survey
title_short Public opinion regarding U.S. Food and Drug Administration approval of aducanumab and potential policy responses: A nationally representative survey
title_sort public opinion regarding u.s. food and drug administration approval of aducanumab and potential policy responses: a nationally representative survey
topic Regular Issue Content
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9177789/
https://www.ncbi.nlm.nih.gov/pubmed/35129210
http://dx.doi.org/10.1111/jgs.17692
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