DESCRIPTION
Assessment of disease activity in rheumatoid arthritis is an important component of management to maintain low disease activity or achieve remission. A multi-biomarker disease activity (MBDA) instrument (e.g., Vectra®) comprised entirely of serum biomarkers is proposed as a disease activity measure. The Vectra test measures 12 biomarkers to construct a disease activity score. Concentrations of these 12 biomarkers are entered into a proprietary formula which, after adjustment by age, gender, and adiposity (i.e., leptin) levels, generates a disease activity score ("adjusted MBDA score") that ranges from 1 (low disease activity) to 100 (high disease activity).
Assessment of disease activity in rheumatoid arthritis (RA) is an important component of treatment management, as one of the main goals of treatment is to maintain a state of low disease activity and/or remission. There are a variety of available instruments for measuring RA disease activity. The most widely used and validated in clinical research is the Disease Activity Score (DAS) 28 score; a composite measure that includes examination of 28 joints for swelling and tenderness, combined with individual reported symptoms and measurement of C-reactive protein or erythrocyte sedimentation rate. The DAS 28 along with 5 other disease activity measurement tools (Clinical Disease Activity Index, Patient Activity Scale, Patient Activity Scale II, Routine Assessment of Patient Index, and the Simplified Disease Activity Index) are endorsed by the American College of Rheumatology (ACR) as the most useful and feasible tools for point-of-care assessment.
NOTE: The policy statement only applies to the panel tests performed in determining a multi-biomarker disease score and is not relevant to any of these tests when performed alone (i.e., not part of a panel test).
POLICY
The use of a multi-biomarker disease activity score for rheumatoid arthritis (e.g., Vectra®) is considered investigational in all situations.
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
There is insufficient evidence to determine whether an adjusted multi-biomarker disease activity score is as good as other more established disease activity measures in improving outcomes.
SOURCES
American College of Rheumatology. (2021, July). Guideline for the treatment of rheumatoid arthritis. Retrieved October 19, 2023 from www.rheumatology.org.
American College of Rheumatology. (December, 2019). 2019 update of the American College of Rheumatology recommended rheumatoid arthritis disease measures. Retrieved August 21, 2020 from www.rheumatology.org.
BlueCross BlueShield Association. Evidence Positioning System. (7:2023). Multibiomarker disease activity blood test for rheumatoid arthritis (2.04.119). Retrieved October 19, 2023 from www.bcbsaoca.com/eps/. (28 articles and/or guidelines reviewed)
Brahe, C.H., Østergaard, M., Johansen, J.S., Defranoux, N., Bolce, R., et al. (2019). Predictive value of a multi-biomarker disease activity score for clinical remission and radiographic progression in patients with early rheumatoid arthritis: a post-hoc study of the OPERA trial. Scandinavian Journal of Rheumatology, 48 (1), 9-16. Abstract retrieved August 21, 2020 from PubMed database.
Curtis, J.R., Flake, D.D., Weinblatt, M.E., Shadick, N., Østergaard, M., Hetland, M.L., et al. (2019). Adjustment of the multi-biomarker disease activity score to account for age, sex and adiposity in patients with rheumatoid arthritis. Rheumatology (Oxford), 58 (5), 874-883. Abstract retrieved August 21, 2020 from PubMed database.
Hambardzumyan, K., Bolce, R., Saevarsdottir, S., Forslind, K., Wallman, J., Cruickshank, S., et al. (2016). Association of a multibiomarker disease activity score at multiple time-points with radiographic progression in rheumatoid arthritis: results from the SWEFOT trial. Rheumatic & Musculoskeletal Diseases. 2016, e000197. Doi: 10.1136/rmdopen-2015-000197. (Level 4 evidence)
Li, W., Sasso, E., van der Helm-van Mil, A., & Huizinga, T. (2015). Relationship of multi-biomarker disease activity score and other risk factors with radiographic progression in an observational study of patients with rheumatoid arthritis. Rheumatology, 55, 357-366. (Level 4 evidence)
Meznerics, F.A., Kemény, L.V., Gunther, E., Bakó, E., Dembrovszky, F., Szabó, B., et al. (2023). Multibiomarker disease activity score: an objective tool for monitoring rheumatoid arthritis? A systematic review and meta-analysis. Rheumatology, 62 (6), 2048-2059. (Level 1 evidence)
National Institute for Health and Care Excellence (NICE). (2018, July; last update search October 2020). Rheumatoid arthritis in adults: management. Retrieved September 29, 2022 from https://www.nice.org.uk.
Rech, J., Hueber, A., Finzel, S., Englbrecht, M. Haschka, J., Manger, B. et al. (2015). Prediction of disease relapses by multibiomarker disease activity and autoantibody status in patients with rheumatoid arthritis on tapering DMARD treatment. Annals of Rheumatic Disease, 75, 1637-1644. (Level 4 evidence)
Winifred S. Hayes, Inc. Medical Technology Directory. (2018, January; last update search March 2022). Vectra DA test (Crescendo Bioscience Inc.) for management of patients with rheumatoid arthritis. Retrieved September 28, 2022 from www.Hayesinc.com/subscribers. (39 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 11/8/2014
MOST RECENT REVIEW DATE: 12/14/2023
ID_BA
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.
This document has been classified as public information.