BlueCross BlueShield of Tennessee Medical Policy Manual

Biochemical Markers for Alzheimer’s Disease

DESCRIPTION

The clinical diagnosis of Alzheimer’s disease (AD) focuses on the exclusion of other causes of dementia. Because diagnosis of AD can be difficult, there has been considerable interest in identifying an accurate laboratory test for AD, particularly for use early in the course of the disease.

Several cerebrospinal fluid (CSF) peptide markers and urine markers have been investigated as possible predictors of AD and include the following:

ADmark® CSF Analysis tests can be used to detect phosphorylated tau protein, total tau protein and amyloid-β peptide 1-42 peptide in cerebrospinal fluid. AlzheimAlert™ tests can be used to detect neural thread protein in urine or cerebrospinal fluid.

POLICY

IMPORTANT REMINDERS

Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION  

Evidence for the use of biochemical markers to diagnose Alzheimer’s disease does not demonstrate incremental improvement in diagnostic accuracy over clinical testing.

SOURCES

Alzheimer’s Association. (2019). Earlier diagnosis. Retrieved June 4, 2019 from https://www.alz.org/alzheimers-dementia/research_progress/earlier-diagnosis.

BlueCross BlueShield Association. Evidence Positioning System. (1:2021). Evaluation of biomarkers of Alzheimer disease (2.04.14). Retrieved February 5, 2021 from https://www.evidencepositioningsystem.com/. (36 articles and/or guidelines reviewed)

Herukka, S.K., Simonsen, A.H., Andreasen, N., Baldeiras, I., Bjerke, M., Blennow, K., et al. (2017). Recommendations for cerebrospinal fluid Alzheimer’s disease biomarkers in the diagnostic evaluation of mild cognitive impairment. Alzheimer’s & Dementia, 13, 285-295. (Level 1 evidence)

McKhann, G., Knopman, D., Chertkow, H., Hyman, B., Jack, C., Kawas, C., et al. (2011). The diagnosis of dementia due to Alzheimer’s disease: Recommendations from the National Institute on Aging and the Alzheimer’s Association workgroup. Alzheimer’s and Dementia: The Journal of the Alzheimer’s Association, 7 (3), 263-269. (Level 2 evidence)

Mroczko, B., Groblewska, M., & Litman-Zawadzka, A. (2019). The role of protein misfolding and Tau oligomers (TauOs) in Alzheimer’s disease (AD). International Journal of Molecular Sciences, 20 (19), 4661. (Level 3 evidence)

National Institutes of Health. National Institute on Aging. (2019). Biomarkers for dementia detection and research. Retrieved June 4, 2019 from https://www.nia.nih.gov/health/biomarkers-dementia-detection-and-research#future.

Olsson, B., Schott, J., Blennow, K., & Zetterberg, H. (2017). The use of cerebrospinal fluid biomarkers to measure change in neurodegeneration in Alzheimer’s disease clinical trials. Expert Review of Neurotherapeutics, 17 (8), 767-775. Abstract retrieved June 26, 2017 from PubMed database.

Rosa, M.I., Perucchi, J., Medeiros, L.R., Fernandes, B., Fernandes, D., & Silva, B.R. (2014). Accuracy of cerebrospinal fluid (Aβ(1-42) for Alzheimer’s disease diagnosis: a systematic review and meta-analysis. Journal of Alzheimer’s Disease, 40 (2), 443-454. Abstract retrieved June 5, 2018 from PubMed database.

United States Preventive Services Task Force. (2020). Screening for cognitive impairment in older adults. Retrieved February 5, 2021 from https://uspreventiveservicestaskforce.org/uspstf/recommendation/cognitive-impairment-in-older-adults-screening.

Zhang, J., Zhang, C.H., Li, R.J., Lin, X.L., Chen, Y.D., Gao, H.Q., & Shi, S.L. (2014). Accuracy of urinary AD7c-NTP for diagnosing Alzheimer’s disease: a systematic review and meta-analysis. Journal of Alzheimer’s Disease, 40 (1), 153-159. Abstract retrieved June 5, 2018 from PubMed database.

ORIGINAL EFFECTIVE DATE:  12/10/2011

MOST RECENT REVIEW DATE:  4/8/2021

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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