Biomarker tests for the diagnosis of Alzheimer's disease : Generating evidence to inform insurance coverage determinations
Copyright © 2013 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved..
Outside of their uses in drug development and clinical research trials, the current clinical value of performing any type of formal biomarker testing for the diagnosis or exclusion of Alzheimer's disease (AD) is controversial, and most biomarker tests for AD are not covered by public or private insurers. This situation raises the issue of how insurers determine whether there is "adequate" evidence to justify a positive coverage determination in this area. This article, a focused condensation of a larger white paper, is the product of an initiative led by the Institute for Clinical and Economic Review to convene a multiple-stakeholder AD Diagnostics Policy Development Group composed of patient advocates, clinicians, clinical researchers, manufacturers, and insurers. The larger white paper was the basis for the evidence review presented to the Medicare Evidence Development and Coverage Advisory Committee meeting on January 30, 2013, as part of its deliberations on positron emission tomography-amyloid imaging. Herein we focus on the description of the core elements of what insurers will be looking for in evidence on all potential diagnostic tests for AD. Corresponding research recommendations are also included, framed to serve as a guide for future AD diagnostics research.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2013 |
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| Erschienen: |
2013 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
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| Enthalten in: |
Alzheimer's & dementia : the journal of the Alzheimer's Association - 9(2013), 6 vom: 15. Nov., Seite 745-52 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pearson, Steven D [VerfasserIn] |
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| Links: |
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| Themen: |
Alzheimer's disease |
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| Anmerkungen: |
Date Completed 20.06.2014 Date Revised 19.11.2015 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jalz.2013.06.002 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM23141398X |
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| 520 | |a Copyright © 2013 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a Outside of their uses in drug development and clinical research trials, the current clinical value of performing any type of formal biomarker testing for the diagnosis or exclusion of Alzheimer's disease (AD) is controversial, and most biomarker tests for AD are not covered by public or private insurers. This situation raises the issue of how insurers determine whether there is "adequate" evidence to justify a positive coverage determination in this area. This article, a focused condensation of a larger white paper, is the product of an initiative led by the Institute for Clinical and Economic Review to convene a multiple-stakeholder AD Diagnostics Policy Development Group composed of patient advocates, clinicians, clinical researchers, manufacturers, and insurers. The larger white paper was the basis for the evidence review presented to the Medicare Evidence Development and Coverage Advisory Committee meeting on January 30, 2013, as part of its deliberations on positron emission tomography-amyloid imaging. Herein we focus on the description of the core elements of what insurers will be looking for in evidence on all potential diagnostic tests for AD. Corresponding research recommendations are also included, framed to serve as a guide for future AD diagnostics research | ||
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