Metabolites of some direct-acting antiviral (DAA) medications can be measured in the urine. Measurement of urine drug levels reflects serum levels. This measurement has the potential component of a therapeutic intervention for hepatitis C, with the intent of improving treatment response by monitoring adherence.
The evidence for monitoring adherence to DAAs by measuring urinary metabolites in individuals who have hepatitis C and are receiving DAA medications includes no published studies that evaluate the impact on adherence to DAA agents.
Measurement of urinary metabolites from direct-acting antiviral medications for the purpose of monitoring adherence to treatment for hepatitis C infection is considered investigational.
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.
The evidence is insufficient to determine the impact of the technology on health outcomes.
American Association for the Study of Liver Diseases / Infectious Disease Society of America. (2016, July). Recommendations for testing, managing, and treating hepatitis C. Retrieved November 17, 2016 from www.hcvguidelines.org.
American Association for the Study of Liver Diseases. (2015). HCV guidance: A summary of recommendations for when and in whom to initiate HCV therapy. Retrieved September 14, 2015 from www.hcvguidelines.org.
American College of Gastroenterology. (2013). Diagnosis, management, and treatment of hepatitis C: An update. Retrieved September 14, 2015 from www.gi.org/guideline.
Department of Veteran’s Affairs. (2016, September). Chronic hepatitis C virus (HCV) infection: treatment considerations. Retrieved November 17, 2016 from firstname.lastname@example.org.
Larrey, D., Ripault, M., & Pageaux, G. (2014). Patient adherence issues in the treatment of hepatitis C. DovePress Review, 2014 (8), 763-773. (Level 5 evidence)
ORIGINAL EFFECTIVE DATE: 1/9/2016
MOST RECENT REVIEW DATE: 12/13/2018
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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