BlueCross BlueShield of Tennessee Medical Policy Manual

Urinary Metabolite Tests for Adherence to Direct-Acting Antiviral Medications for Hepatitis C

DESCRIPTION

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.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

The evidence is insufficient to determine the impact of the technology on health outcomes. Therefore this technology remains investigational.  American Association for the Study of Liver Diseases and Infectious Disease Society of America’s 2015 recommendations for medication adherence are regular clinic visits and telephone contact.

SOURCES

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: vhvhhphp@va.gov.

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)

Younossi, Z., & Henry, L. (2015). Systematic review: patient-reported outcomes in chronic hepatitis C--the impact of liver disease and new treatment regimens. Alimentary Pharmacology & Therapeutics, 41 (6), 497-520. Abstract retrieved September 14, 2015 from PubMed database.

ORIGINAL EFFECTIVE DATE:  1/9/2016

MOST RECENT REVIEW DATE:  12/14/2017

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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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