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Alzheimer's disease blood-based biomarker testing: A stakeholder-informed assessment of coverage considerations
Deverka Patricia A, Arias Jalayne J, Lin Grace A, Zwerling Jessica, Phillips Kathryn A. Journal of Alzheimer's disease : JAD, 2025-04-02
Topic: Amyloid, tau and blood-test diagnosis
BackgroundRecently published clinical studies suggest that blood-based biomarker tests (BBMTs) for Alzheimer's disease (AD) provide value, but in the U.S., neither public nor private payers currently cover these tests.ObjectiveTo describe considerations for payer coverage of AD BBMTs that would need to be addressed to facilitate timely diagnosis and equitable patient access if clinical utility is demonstrated.MethodsWe performed a targeted literature review to characterize predictable coverage barriers for BBMTs and inform the development of an interview guide. We conducted semi-structured interviews with clinicians, researchers, test developers, and a patient advocate and former payer (N = 12) to assess the barriers and refine the proposed key considerations for obtaining payer coverage.ResultsStakeholders noted that payers will require evidence of clinical validity and utility of BBMTs as part of their coverage determinations contingent on the specific indication for testing, with insufficient evidence for screening applications currently. Stakeholders also agreed that there are evidence gaps for use of BBMTs in patients from ethnic and racial minority communities that must be addressed. Given the shortage of memory specialists, stakeholders noted that limiting testing coverage authorization to specialists could be harmful to patients, particularly the underserved. Interviewees also agreed that patients with mild cognitive impairment or early-stage AD could benefit from earlier diagnosis to avoid progressing to moderate disease and limiting eligibility for new disease-modifying therapies.ConclusionsIf BBMTs meet criteria for clinical utility, anticipating and planning for coverage and reimbursement before widespread implementation will be critical to ensuring broad, equitable access to BBMTs.
Key findings
- BackgroundRecently published clinical studies suggest that blood-based biomarker tests (BBMTs) for Alzheimer's disease (AD) provide value, but in the U.S., neither public nor private payers currently cover these tests.ObjectiveTo describe considerations for payer coverage of AD BBMTs that would need to be addressed to facilitate timely diagnosis and equitable patient access if clinical utility is demonstrated.MethodsWe performed a targeted literature review to characterize predictable coverage barriers for BBMTs and inform the development of an interview guide.
Why it matters
This assessment describes what payers would need to cover blood-based biomarker tests for Alzheimer's disease, noting that neither public nor private payers in the U.S. currently cover them. It reports insufficient evidence for screening applications and evidence gaps for use in ethnic and racial minority communities.
Study details
- Participants12
- Evidence strengthLow
How this study scored 37/100
Published in a peer-reviewed journal. Scored zero for study design, effect reported and randomised / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Journal of Alzheimer's disease : JAD) |
| Journal's citation record | 2 / 4 | Journal of Alzheimer s Disease: journal h-index 218 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 1 / 4 | 12 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 1 / 7 | Cited 1 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.3 citations a year over 3 year(s) since 2025 |
| Impact for its field and year | 1 / 6 | Cited 0.6× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 0 / 4 | Cited 1 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 1 / 4 | Last-listed author Kathryn A. Phillips: h-index 18 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | University of California, San Francisco: institution h-index 1,915 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 5 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 40170393) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 37 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1177/13872877251329394
- PubMed: 40170393
- Original source →
- Free full text: Journal of Alzheimer s Disease →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
APA 7th
Deverka Patricia, A., Arias Jalayne, J., Lin Grace, A., Jessica, Z., & Phillips Kathryn, A. (2025). Alzheimer's disease blood-based biomarker testing: A stakeholder-informed assessment of coverage considerations. Journal of Alzheimer's disease : JAD. https://doi.org/10.1177/13872877251329394
Vancouver
Deverka Patricia A, Arias Jalayne J, Lin Grace A, Jessica Z, Phillips Kathryn A. Alzheimer's disease blood-based biomarker testing: A stakeholder-informed assessment of coverage considerations. Journal of Alzheimer's disease : JAD. 2025. doi:10.1177/13872877251329394. PMID: 40170393.
BibTeX
@article{deverkapatricia2025-40170393,
author = {Deverka Patricia, A. and Arias Jalayne, J. and Lin Grace, A. and Jessica, Zwerling and Phillips Kathryn, A.},
title = {{Alzheimer's disease blood-based biomarker testing: A stakeholder-informed assessment of coverage considerations}},
journal = {Journal of Alzheimer's disease : JAD},
year = {2025},
doi = {10.1177/13872877251329394},
pmid = {40170393},
url = {https://doi.org/10.1177/13872877251329394}
}
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