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HCV is an RNA virus that has 6 genotypes and over 50 subtypes. Genotype 1 accounts for 70 to 75 percent of all HCV infections in the United States and is associated with a lower rate of response to treatment.
Hepatitis C is a common cause of chronic liver disease, cirrhosis and hepatocellular carcinoma, and is the most common cause of liver transplantation. Chronic HCV infection is diagnosed by the detection of HCV RNA in the blood for at least six months. It is estimated that 60 to 85 percent of HCV infected persons develop chronic infection.
Approximately 3 million Americans have chronic hepatitis C infection, and 35,000 new HCV infections are estimated to occur each year. However, because the majority of people infected with HCV have yet to be diagnosed, the NIH estimates a fourfold increase in the number of adults diagnosed with chronic HCV from 1990 to 2015.
HCV transmission occurs primarily through exposure to infected blood. Increased risk for exposure exist through injectable drug use, blood transfusion before 1992, solid organ transplantation from infected donors, unsafe medical practices, occupational exposure to infected blood, birth to an infected mother, sex with an infected person, and high-risk sexual practices.
A number of agents have been used in the treatment of chronic viral hepatitis, including corticosteroids, NSAIDs, and antiviral agents. Combination therapy with a pegylated interferon and ribavirin achieve the highest response rates. The best indicator of effective treatment is sustained viral response (SVR), defined as the absence of detectable HCV RNA in the serum as shown by qualitative HCV RNA assay with lower limit of detection of 50 IU/ml or less at 24 weeks after the end of treatment. Early viral response (EVR) is a predictor of SVR and should be a routine part of monitoring patients. EVR is defined as a minimum 2 log drop in viral load during the first 12 weeks of therapy.
Pegasys® (peginterferon alfa-2a)
Prior authorization is required.
The following guidelines should be followed for the treatment of patients who are infected with chronic hepatitis C:
Treatment of Naïve Patients with Pegylated Interferon and Ribavirin
Genotype 2 and 3:
Retreatment of Patients
Nonresponders (no EVR or SVR) and relapsers (no SVR) treated with standard interferon-ribavirin combinations may be considered for retreatment using pegylated interferon (Pegasys® or Peg-Intron®) and ribavirin. Preliminary studies showed that 15-20% of non-responders achieved an SVR with retreatment.
Most patients relapse again when retreated with the same regimen that was used originally. It has not been proven that extending the duration of retreatment reduces relapse rates.
Nonresponders and relapsers treated with pegylated interferon (Pegasys® or Peg-Intron®)-ribavirin combinations may be considered for retreatment with one additional course (48 weeks for Genotype 1 or 24 weeks for Genotype 2 or 3) of pegylated interferon (Pegasys® or Peg-Intron®) and ribavirin.
Treatment with Sovaldi®
Sovaldi® is a once daily 400mg oral tablet.
^Peg-Intron® may be considered medically necessary only after failed treatment with Pegasys®.
For patients who are Genotype 1 and interferon ineligible, Sovaldi® can be used in combination with ribavirin for 24 weeks.
For patients with hepatocellular carcinoma awaiting liver transplantation, Sovaldi® can be used in combination with ribavirin for up to 48 weeks or until liver transplantation, whichever occurs first.
Treatment with Triple Therapy
Treatment with a 48 week course of pegylated interferon and ribavirin along with a 12 week course of telaprevir (Incivek®). The patient must not be receiving a contraindicated medication nor attempted a prior course of therapy with a treatment regimen that includes an HCV NS3/4A protease inhibitor. Viral load less than 1000 IU/mL should be detected at treatment week 4 for approval of continuation of triple therapy past treatment week 8. Viral load less than 1000 IU/mL should be detected at treatment week 12 for approval of continuation of triple therapy past treatment week 16. Peg-Intron® may be considered medically necessary only after failed treatment (nonresponder or relapser) with Pegasys®.
Treatment with a 48 week course of pegylated interferon and ribavirin along with a 44 week course of boceprevir (Victrelis®). The patient must not be receiving a contraindicated medication nor attempted a prior course of therapy with a treatment regimen that includes an HCV NS3/4A protease inhibitor. Viral load less than 100 IU/mL should be detected at treatment week 12 for approval of continuation of triple therapy past treatment week 16. Viral load less than 100 IU/mL should be detected at treatment week 24 for approval of continuation of triple therapy past treatment week 28. Peg-Intron® may be considered medically necessary only after failed treatment (nonresponder or relapser) with Pegasys®.
Treatment with Infergen
Infergen 9 mcg three times per week for 24 weeks is may be considered for monotherapy of naïve patients with chronic HCV infection (at least 48 hours should elapse between doses of Infergen).
Patients who tolerated previous interferon therapy and did not respond or relapsed following its discontinuation may be considered for retreatment with 15 mcg of Infergen monotherapy three times per week for up to 48 weeks.
Infergen 15mcg daily in combination with weight based ribavirin at 1,000 mg 1200 mg may be considered medically necessary for relapsers or nonresponsders for up to 48 weeks. EVR should be detected at week 12 of treatment for continuation of therapy past 12 weeks.
Alcohol abuse should be treated before consideration of treatment for chronic hepatitis C.
Depression in Patients
Depression and suicidal behavior including suicidal ideation, suicidal attempts, and suicides are strongly associated with alfa interferon therapy. Patients should be informed that depression and suicidal ideation may be side effects of treatment and advise them to report these side effects immediately to the prescribing physician. In some cases, the treating physician should consider prophylaxis with antidepressant therapy.
Ribavirin may cause birth defects and/or death of the exposed fetus. Ribavirin capsules are contraindicated in women who are pregnant and in men whose female partners are pregnant. Advise patients (male and female) to practice adequate contraception (2 reliable forms) during combination therapy and to notify the physician in the event of pregnancy. Advise female patients of the need to perform a pregnancy test monthly during therapy and for 6 months post-therapy due to the extended half-life.
Ribavirin is contraindicated in patients with hemoglobinopathies (eg, thalassemia major or sickle-cell anemia).
Interferon alfa therapy (standard and pegylated) is contraindicated in patients with autoimmune hepatitis and hepatic decompensation (Child-Pugh class B and C) before or during treatment.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
11/19/2003: Approved by external gastroenterology consultants
12/18/2003: Code Reference section completed
11/02/2005: Description section updated, Off Label Uses and Renal carcinoma deleted. Policy section updated; changed preferred provider to CuraScript.
11/4/2005: Code Reference section updated, HCPCS codes J8499, J9213, J9214 moved from the CPT4 code section in the table to the HCPCS code section, a deletion date of 6/30/2005 was added to codes J9213 and J9214; HCPCS codes S0145 and S0146 added with an effective date of 7/1/2005; the Non-Covered Codes table was deleted from the policy.
11/2005: Approved by Pharmacy & Therapeutic (P & T) Committee.
6/29/2006: CuraScript fax number changed from 1-877-462-6234 to 1-866-239-5502
5/5/2008: Ribavirin dosing information updated
01/01/2009: CuraScript preferred provider information removed. BCBSMS information added
12/29/2008: Code Reference section updated per 2009 CPT/HCPCS revisions
4/14/2009: Policy statement updated to reflect retreatment guidelines
8/18/2009: Policy updated: Policy statement updated to include statement Peg-Intron® may be considered medically necessary only after failed treatment (nonresponder or relapser) with Pegasys®. Dosing Genotype 1, 2 and 3 deleted.
10/21/2010: Policy description unchanged. Policy statement updated regarding Infergen dosing.
09/15/2011: Policy revised to add Incivek® and Victrelis® and criteria for treatment with triple therapy.
04/01/2014: Policy statement updated regarding treatment with Sovaldi®. Removed deleted HCPCS codes J9213 and J9214 from the Code Reference section.
National Institutes of Health Concensus Development Conference Statement: Management of Hepatitis C: 2002. June 10-12, 2002. [On Line] Available at http://consensus.nih.gov/cons/116/116cdc_intro.htm Accessed: October 29, 2003.
Wickersham RM, Novak KK, Schweain SL, et al. Drug Facts and Comparisons. St.Louis, Wolters Kluwer, 2003. [On Line] Available at www.drugfacts.com
Infergen® Prescribing Information
PegIntron® Prescribing Information
Incivek® Prescribing Information
Victrelis® Prescribing Information
Sovaldi® Prescribing Information
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.