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Blue Cross Blue Shield of Vermont and The Vermont Health Plan
Rebetrol
 (Ribavirin)
Prior Approval Guidelines
Description:
Ribavirin is a nucleoside analog that prevents a virus from multiplying.
Indications:
1)
Ribavirin capsules in combination with interferon alfa-2b for the treatment of chronic hepatitis C
in patients with compensated liver disease previously untreated with alpha-interferon or who
have relapsed following alpha-interferon therapy.
Ribavirin capsules in combination with pegylated interferon-alfa-2b for the treatment of chronic
hepatitis C in patients with compensated liver disease previously untreated with alphainterferon.
2)
Reasons for PA:
Criteria for Approval:
Cost
1)
2)
3)
4)
5)
6)
Reasons for Denial
of Benefit:
1)
2)
3)
4)
Potential for misuse
Toxicity
Diagnosis is chronic hepatitis C with compensated liver disease and patient does not have any
contraindications listed below.
Patient is 18 years of age or older.
Must be used in combination with an interferon product such as interferon alfa-2b (Intron-A), or
pegylated interferon alfa-2b (Peg-Intron)
Viral load and genotype have been determined.
Patient is under the close supervision of a gastroenterologist, infectious disease specialist, or
physician highly experienced in treating Hepatitis C.
Patient must maintain sobriety and have been sober for the last 6 months.
Patient has any of the following contraindications
a) Woman is pregnant or woman may become pregnant during therapy
b) Males whose partner is pregnant and/or using < 2 appropriate forms of contraception.
c) Patient has decompensated liver disease as diagnosed by liver biopsy
d) History of hemoglobinopathies (i.e., sickle cell anemia, thalassemia)
Patient does not meet criteria for approval
Rebetol (ribavirin) is being prescribed alone as monotherapy.
Patient has history of severe kidney impairment such that Clcr is <50mL/min.
Renewal Criteria:
In order to allow renewal of this medication, the patient must have an HCV RNA viral load
performed at 12 and 24 weeks after treatment to determine response to therapy. Requests for
renewal should be denied in patients who have not achieved HCV RNA below the limit of detection
after 24 weeks of therapy or in patients who have not demonstrated a decrease in HCV RNA
(response) after 12 weeks.
Benefit Approval:
Approval will be for a total 6 months in relapse patients subject to virologic test results to determine
response. For previously untreated patients, approval will be for 6 months in patients with
genotypes 2/3 and 12 months in patients with genotype 1, again subject to virological testing.
Quantity limits applied to Rebetol Capsules:
References:
•
•
In combination with Peg-Intron: #112 capsules/28 days (4wks)
In combination with Intron-A: #140 capsules for patients ≤75kg and #168 capsules for patients
> 75kg per 28 days.
1.
2.
3.
Olin BR, ed. Drug Facts and Comparisons. St. Louis, 1999.
Schering Corporation. Rebetol Prescribing Information. Rev8/01. Available from: www.rebetol.com
McHutchison JG, Gordon SC, Schiff ER, et al. Interferon alfa-2b alone or in combination with ribavirin as
initial treatment for chronic hepatitis C. N Engl J Med. 1998;339:1485-92.
Poynard T, Marcellin P, Lee SS, et al. Randomized trial of interferon alpha-2b plus ribavirin for 48 weeks
or for 24 weeks versus interferon alpha-2b plus placebo for 48 weeks for treatment of chronic infection with
hepatitis C. Lancet. 352:1426-32.
Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a Plus Ribavirin For Chronic Hepatitis C
Virus Infection. NEJM 2002; 347:975-82.
4.
5.
BCBCVT/TVHP Rebetol PA guidelines
Created: July 2003