Clinical UM Guideline


Subject:HCV and HIV-AIDS Anti-Viral Drug Treatment Regimens **NOTE: At this time, this guideline is not implemented for medical benefit determinations
Guideline #:  CG-DRUG-32Current Effective Date:  04/15/2014
Status:RevisedLast Review Date:  02/13/2014

Description

NOTE: At this time, this guideline is not implemented for medical benefit determinations.

This Clinical UM Guideline addresses chronic Hepatitis C virus infection and human immunodeficiency virus – acquired immunodeficiency syndrome (HIV-AIDS) anti-viral drug treatment regimens which may include (whether oral or injectable) drugs, antiretrovirals, biologics and other targeted therapies utilized to treat HIV-AIDS (collectively, "agents").  A regimen may consist of a single agent or include two or more agents.  The agent(s) in a treatment regimen may be utilized in an off-label indication.  This guideline does not address any agents used to treat complications (for example, nausea), toxicities (for example, cytopenias), or adverse events (for example, rash) that occur as a consequence of the treatment regimen. 

The U.S. Food and Drug Administration (FDA) approves drugs for specific use(s) that are listed in the drug's product information label. Off-label or "unlabeled" drug use is the utilization of an FDA approved drug for uses other than those listed in the FDA approved labeling or in treatment regimens or populations that are not included in approved labeling. Many off-label uses are effective, well documented in the peer-reviewed literature and widely used.

Note: For additional information specific to off-label drug use or Hepatitis C virus anti-viral treatment regimens, please see:

Clinical Indications

MedicallyNecessary:

I.  Hepatitis C Drug Treatment Regimens 

Medically Necessary:

A chronic Hepatitis C virus infection drug treatment regimen may be medical necessary when all of the following criteria are met:

  1. The agents(s) in the drug treatment regimen are approved by the FDA for use in humans; and
  2. The chronic Hepatitis C drug treatment regimen is supported by one or more of the following for the specific clinical situation under review (for example, but not limited to, prior treatment, comorbid conditions, or absence of contraindications):
    1. As found in the most recent update of the combined American Association for the Study of Liver Diseases (AASLD) and Infectious Disease Society of America (IDSA) Hepatitis C practice guideline specific to the clinical situation with a classification of Class I or IIa* and a level of evidence A or B*; or
    2. Two articles are identified which meet all of the following:
      1. The articles were published in major scientific or medical peer-reviewed journals including, but not limited to: Annals of Internal Medicine, Gastroenterology, Journal of American Medical Association, Journal of Hepatology, Lancet, or New England Journal of Medicine; and
      2. The articles used appropriate study designs including, but are not limited to, randomized, double blind, placebo-controlled clinical trials; and
      3. The articles are not case reports, letters, posters or abstracts; and
    3. The data published in the articles supports the proposed chronic Hepatitis C drug treatment regimen for the specific clinical situation as safe and effective.

*Note: See Attachment A for additional details.

Not Medically Necessary:

A chronic Hepatitis C virus infection drug treatment regimen is considered not medically necessary when the above criteria are not met.

II.  HIV-AIDS Drug Treatment Regimens

Medically Necessary:

A HIV-AIDS drug treatment regimen may be medical necessary when all of the following criteria are met:

  1. The agents(s) in the drug treatment regimen are approved by the FDA for use in humans; and
  2. The drug treatment regimen is being prescribed to treat an individual with HIV-AIDS for whom treatment is medically appropriate according to the most recent update of either the World Health Organization (WHO) Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV infection or U.S. Department of Health and Human Services guidelines; and
  3. The HIV-AIDS drug treatment regimen is supported by one or more of the following for the specific clinical situation under review (for example, but not limited to, stage of disease, prior treatment, performance status, comorbid conditions, or absence of contraindications):
    1. As found in the most recent update of the U.S. Department of Health and Human Services guidelines on antiretroviral drugs specific to the clinical situation; or
    2. World Health Organization (WHO) Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection; or
    3. Two articles are identified which meet all of the following:
      1. The articles were published in major scientific or medical peer-reviewed journals including, but not limited to: Journal of American Medical Association, New England Journal of Medicine or Lancet; and
      2. The articles used appropriate study designs including, but are not limited to, randomized, double blind, placebo-controlled clinical trials; and
    4. The articles are not case reports, letters, posters or abstracts; and
    5. The data published in the articles supports the proposed HIV-AIDS drug treatment regimen for the specific clinical situation as safe and effective.

If the off-label use of an agent within a drug treatment regimen is determined to be medically necessary, its use shall also be determined to be "non-investigational" for the purposes of benefit determination.

Not Medically Necessary:

A HIV-AIDS drug treatment regimen is considered not medically necessary when the above criteria are not met.

Discussion/General Information

The U.S. Food and Drug Administration (FDA) approves drugs for specific use(s) that are listed in the drug's product information label.  Off-label or "unlabeled" drug use is the utilization of an FDA approved drug for uses other than those listed in the FDA approved labeling or in treatment regimens or populations that are not included in approved labeling.  Many off-label uses are effective, well documented in the peer-reviewed literature and widely used.

The drug's product information label approved by the FDA "is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the individual.  Labels are often found inside drug product packaging" (FDA, 2012).  The terms "off-label drug" or "unlabeled drug" refer to the prescription and use of a drug for an indication that is not stated in the approved FDA labeling.

Hepatitis C
The American Association for the Study of Liver Diseases (AASLD) is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease.  Their "Recommendations for Testing, Managing, and Treating Hepatitis C," (2014) "An Update on Treatment of Genotype 1 Chronic Hepatitis C Infection: 2011 Practice Guideline," (Ghany, 2011) and "Diagnosis, Management and Treatment of Hepatitis C" (Ghany, 2009) are based on a formal review and analysis of the most recently published literature and the experience of the authors. The recommendations are based on the level of evidence and the strength of the recommendation which incorporates expert opinion (See Attachment A). The guidelines are endorsed by the American College of Gastroenterology and the Infectious Diseases Society of America.

HIV-AIDS
The U.S. Department of Health and Human Services (HHS) provides AIDSInfo, a service offering access to the most recent federally approved HIV/AIDS medical practice guidelines, HIV treatment and prevention clinical trials, and other research information for health care providers, researchers, people affected by HIV/AIDS, and the general public.  There are multiple guidelines produced by HHS regarding the use of antiretroviral therapy in HIV-infected individuals.  These include:

These guidelines are produced by the HHS Panels that are working groups of the Office of AIDS Research Advisory Council (OARAC).  The Panels' primary goal is to provide HIV care practitioners with recommendations based on current knowledge of antiretroviral drugs (ARV) used to treat HIV-infected individuals in the United States.  The guidelines include recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health and the HIV Medicine Association of the Infectious Diseases Society of America.

The World Health Organization is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.

Definitions

Antiretroviral therapy (ART): Therapy regimens consisting of anti-viral drugs used to treat people infected with HIV.

Drug: A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; a substance (other than food) intended to affect the structure or any function of the body; biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process).

Hepatitis C therapy:  Therapy regimens consisting of anti-viral drugs used to treat people chronically infected with the Hepatitis C virus.

HIV: Refers to human immunodeficiency virus. There are two types of HIV: HIV-1 and HIV-2.

References

Government Agency, Medical Society, and Other Authoritative Publications: 

  1. American Association for the Study of Liver Diseases (AASLD). Practice Guidelines. Available at: http://www.aasld.org/practiceguidelines/Pages/default.aspx. Accessed on February 4, 2014.
  2. Department of Health and Human Services. HIV/AIDS medical practice guidelines. Available at: http://aidsinfo.nih.gov/guidelines. Accessed on February 4, 2013.
  3. World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. June 2013. Available at: http://www.who.int/hiv/pub/guidelines/arv2013/en/index.html. Accessed on February 4, 2014.
Web Sites for Additional Information
  1. AIDSinfo Drug Database. Available at: http://aidsinfo.nih.gov/drugs. Accessed on February 4, 2014.
Index

Antiretroviral
Biologic agents
Prescription Drugs, Unlabeled Use of
Targeted therapy
Unlabeled Use of Drug

The use of specific product names is illustrative 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.

History

Status

Date

Action

Revised02/13/2014Medical Policy & Technology Assessment Committee (MPTAC) review.  Added level of evidence and strength of recommendation to medically necessary criteria for hepatitis C.  Added Attachment A to the document.
 01/31/2014Added website information for American Association for the Study of Liver Diseases (AASLD) guidelines.  Updated references.
New11/14/2013MPTAC review.  Initial document development.

 

Attachment A

Hepatitis C

ClassificationDescription
Class IConditions for which there is evidence and/or general agreement that a given diagnostic evaluation, procedure, or treatment is beneficial, useful and effective
Class IIConditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness and efficacy of a diagnostic evaluation, procedure or treatment
Class IIaWeight of evidence and/or opinion is in favor of usefulness and efficacy
Class IIbUsefulness and efficacy are less well established by evidence and/or opinion
Class IIIConditions for which there is evidence and/or general agreement that a diagnostic evaluation, procedure, or treatment is not useful and effective or if it in some cases may be harmful

 

Level of EvidenceDescription
Level AData derived from multiple randomized clinical trials or meta-analyses
Level BData derived from a single randomized trial, or nonrandomized studies
Level CConsensus opinion of experts, case studies, or standard of care

AASLD and IDSA grading system used to rate the level of evidence and strength of the recommendation for each recommendation. 2014. Available at: http://www.hcvguidelines.org/full-report/methods-table-2-grading-system-used-rate-level-evidence-and-strength-recommendation-each.  Accessed on February 4, 2014.