Pharmaceutical Management of Chronic Hepatitis C
DESCRIPTION
Interferon alfa is a family of highly homologous, species-specific proteins and, occasionally, glycoproteins with antiviral, antineoplastic, and immunomodulating activities. Pegylated interferon is interferon that has been chemically joined to polyethylene alcohol. The coupling form of these two agents dramatically increases the half-life of the drug. Ribavirin is a synthetic nucleoside antiviral agent that has a broad spectrum of antiviral activity against both RNA and DNA viruses.
In the United States, two different regimens have been approved for the pharmaceutical management of chronic hepatitis C virus (HCV). These drug treatment regimens are: monotherapy (interferon alfa) and combination therapy (interferon alfa and ribavirin).
Examples of preparations of monotherapy (interferon alfa) are: interferon alfa-2b (e.g., Intron® A), interferon alfa-2a, interferon alfacon-1 (e.g., Infergen®), pegylated interferon alfa-2b (e.g., Peg-Intron®), and pegylated interferon alfa-2a (e.g., Pegasys®).
Examples of preparations of combination therapy (interferon alfa and ribavirin) are: pegylated interferon alfa-2b plus ribavirin (e.g., Peg-Intron® / Rebetol®) and pegylated interferon alfa-2a plus ribavirin (Pegasys® / Copegus®).
REFER TO DECISION SUPPORT TREE
POLICY
Interferon alfa (pegylated or non-pegylated) as monotherapy for the treatment of chronic hepatitis C is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Interferon alfa (pegylated or non-pegylated) with ribavirin as combination therapy for the treatment of chronic hepatitis C is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Ribavirin as monotherapy for the treatment of chronic hepatitis C is considered not medically necessary.
MEDICAL APPROPRIATENESS
Interferon alfa (pegylated or non-pegylated) as monotherapy for the treatment of chronic hepatitis C is considered medically appropriate if ALL of the following criteria are met:
The individual is 18 years of age or older
Has a documented diagnosis of chronic hepatitis C
Has a documented quantitative lab value for HCV RNA
Has compensated liver disease (absence of other hepatitis complications - e.g., ascites, active gastrointestinal bleeding or encephalopathy)
The following monitoring occurs once therapy begins:
Prior to or at the end of week 12 of the initial 16 weeks of therapy, a quantitative lab value for HCV RNA is obtained
If the HCV RNA result is less than a 2 log decrease from baseline - therapy should be discontinued, or if the HCV RNA result is a minimum 2 log decrease from baseline, early viral response (EVR) is achieved - therapy should continue:
A total of 24 weeks for genotypes not determined to be types 1 or 4; or a total of 48 weeks for genotypes 1 and 4.
Interferon alfa (pegylated or non-pegylated) with ribavirin as combination therapy for the treatment of chronic hepatitis C is considered medically appropriate if ALL of the following criteria are met:
The individual has a documented diagnosis of chronic hepatitis C
Has a documented quantitative lab value for HCV RNA
Has compensated liver disease (absence of other hepatitis complications - e.g., ascites, active gastrointestinal bleeding or encephalopathy)
The following monitoring occurs once therapy begins:
Prior to or at the end of week 12 of the initial 16 weeks of therapy, a quantitative lab value for HCV RNA is obtained
If the HCV RNA result is less than a 2 log decrease from baseline - therapy should be discontinued, or If the HCV RNA result is a minimum 2 log decrease from baseline, early viral response (EVR) is achieved - therapy should continue:
A total of 24 weeks for genotypes not determined to be types 1 or 4; or a total of 48 weeks for genotypes 1 and 4.
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
SOURCES
109th Congress: 1st Session: H. R. 2552: (2005, March). Hepatitis C epidemic control and prevention act of 2007. Retrieved January 31, 2008 from http://thomas.loc.gov.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2005). Treatment of hepatitis C with interferon and / or ribavirin (5.01.11). Retrieved March 27, 2009 from BlueWeb.
Chevaliez, S., & Pawlotsky, J.M. (2006). Review: Hepatitis C virus serologic and virologic tests and clinical diagnosis of HCV related liver disease. International Journal of Medical Sciences, 3 (2), 35-40.
Drugs for non-HIV viral infections. (2007, July). Treatment Guidelines from The Medical Letter, 5 (Issue 59), 59-70.
Lexi-Comp Online. (2009). AHFS DI. Interferon alfa (antiviral). Retrieved March 31, 2009 from Lexi-Comp Online with AHFS.
Lexi-Comp Online. (2009). AHFS DI. Peginterferon alfa. Retrieved March 31, 2009 from Lexi-Comp Online with AHFS.
Lexi-Comp Online. (2009). AHFS DI. Ribavirin. Retrieved March 30, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Interferon alfa-2a. Retrieved March 31, 2009 from MICROMEDEX Healthcare Series.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Interferon alfa-2b. Retrieved March 31, 2009 from MICROMEDEX Healthcare Series.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Peginterferon alfa-2a. Retrieved March 31, 2009 from MICROMEDEX Healthcare Series.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Peginterferon alfa-2b. Retrieved March 31, 2009 from MICROMEDEX Healthcare Series.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Ribavirin. Retrieved March 30, 2009 from MICROMEDEX Healthcare Series.
National Institutes of Health. (2006, November). National Institutes of Diabetes and Digestive and Kidney Diseases. Chronic hepatitis C: Current disease management. Retrieved March 30, 2009 from http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/chronichepc.pdf.
Roche Pharmaceuticals. (2007, September). Copegus®. . Retrieved March 30, 2009 from http://www.rocheusa.com/products/copegus/pi.pdf.
Schering-Plough. (2009, January). Intron® A (interferon alfa-2b, recombinant). Retrieved March 31, 2009 from http://www.spfiles.com/piintrona.pdf.
Three Rivers Pharmaceuticals. (2006, July). Infergen (interferon alfacon-1. Retrieved April 9, 2009 from http://www.infergen.com/pdf/Infergen_PI_Master_Final_090106.pdf.
U. S. Food and Drug Administration. (2004, April). Center for Drug Evaluation and Research. Label Information. Ribavirin. Retrieved March 30, 2009 from http://www.fda.gov/cder/foi/label/2004/76192lbl_Ribavarin_Sandoz.pdf.
U. S. Food and Drug Administration. (2006, August). Center for Drug Evaluation and Research. Label Information. Roferon® A (interferon alfa-2a, recombinant). Retrieved March 31, 2009 from http://www.fda.gov/cder/foi/label/2006/103145s5060LBL.pdf.
U. S. Food and Drug Administration. (2007, December). Center for Drug Evaluation and Research. Label and Approval History. Rebetol. Retrieved April 14, 2009 from http://www.fda.gov/cder/foi/label/2007/020903s040lbl.pdf.
U. S. Food and Drug Administration. (2008, April). Center for Drug Evaluation and Research. Approval Letter NDA 21-511/5-015. Copegus®. Retrieved March 30, 2009 from http://www.fda.gov/cder/foi/appletter/2008/021511s015ltr.pdf.
U. S. Food and Drug Administration. (2008, June). Center for Drug Evaluation and Research. Label and Approval History. Peglntron/Rebetol Combo Pack. Retrieved March 31, 2009 from http://www.fda.gov/cder/foi/label/2008/125196s000lbl.pdf.
U. S. Food and Drug Administration. (2008, May). Center for Drug Evaluation and Research. Approval Letter. Retrieved March 31, 2009 from http://www.fda.gov/cder/foi/appletter/2008/103132s5108ltr.pdf.
U. S. Food and Drug Administration. (2008, October). Center for Drug Evaluation and Research. Label Information. Pegasys® (peginterferon alfa-2a). Retrieved March 31, 2009 from http://www.fda.gov/cder/foi/label/2008/103964s5133lbl.pdf.
U. S. Food and Drug Administration. (2009, March). Center for Drug Evaluation and Research. Label Information. PegIntron® (peginterferon alfa-2b). Retrieved March 31, 2009 from http://www.fda.gov/cder/foi/label/2009/103949s5125lbl.pdf.
ORIGINAL EFFECTIVE DATE: 1/1/2005
MOST RECENT REVIEW DATE: 6/24/2009
ID_BT
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.
Pharmaceutical Decision Support Tree
Pharmaceutical Management of Chronic Hepatitis C
Is the request for ribavirin as monotherapy for the treatment of chronic hepatitis C?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Interferon Alfa (pegylated or non-pegylated) as Monotherapy
Is interferon alfa (pegylated or non-pegylated) being used as monotherapy for the treatment of chronic hepatitis C and does the individual show evidence of ALL of the following:
The individual is 18 years of age or older
Has a documented diagnosis of chronic hepatitis C
Has a documented quantitative lab value for HCV RNA
Has compensated liver disease (absence of other hepatitis complications - e.g., ascites, active gastrointestinal bleeding or encephalopathy)
The following monitoring occurs once therapy begins:
Prior to or at the end of week 12 of the initial 16 weeks of therapy, a quantitative lab value for HCV RNA is obtained
If the HCV RNA result is less than a 2 log decrease from baseline - therapy should be discontinued, or if the HCV RNA result is a minimum 2 log decrease from baseline, early viral response (EVR) is achieved - therapy should continue:
A total of 24 weeks for genotypes not determined to be types 1 or 4; or a total of 48 weeks for genotypes 1 and 4.
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Interferon Alfa (pegylated or non-pegylated) with Ribavirin as Combination Therapy
Interferon alfa (pegylated or non-pegylated) with ribavirin as combination therapy for the treatment of chronic hepatitis C does and the individual show evidence of ALL of the following:
The individual has a documented diagnosis of chronic hepatitis C
Has a documented quantitative lab value for HCV RNA
Has compensated liver disease (absence of other hepatitis complications - e.g., ascites, active gastrointestinal bleeding or encephalopathy)
The following monitoring occurs once therapy begins:
Prior to or at the end of week 12 of the initial 16 weeks of therapy, a quantitative lab value for HCV RNA is obtained
If the HCV RNA result is less than a 2 log decrease from baseline - therapy should be discontinued, or If the HCV RNA result is a minimum 2 log decrease from baseline, early viral response (EVR) is achieved - therapy should continue:
A total of 24 weeks for genotypes not determined to be types 1 or 4; or a total of 48 weeks for genotypes 1 and 4.
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.