Aetna considers ribavirin (Virazole) medically necessary for the treatment of respiratory syncytial virus (RSV) infection in immunosuppressed and high risk children and adults, and for the treatment of viral hemorrhagic fever (Crimean-Congo, Ebola, Lassa, and Marburg), Rift valley fever and Hantaan, a hanta virus.
Aetna considers ribavirin in combination with interferon alpha or pegylated interferon alpha medically necessary for persons with chronic hepatitis C according to the criteria set forth in CPB 0404 - Interferons. Clinical research suggests that there are synergistic effects of ribavirin and interferon alpha in the treatment of chronic hepatitis.
Aetna considers ribavirin monotherapy for the treatment of persons with chronic hepatitis C infection experimental and investigational because there is insufficient evidence to support the effectiveness of this approach.
Aetna considers ribavirin experimental and investigational for all other indications (e.g., acute myeloid leukemia, hepatitis E infection, multiple sclerosis) because its effectiveness for indications other than the ones listed above has not been established.
Ribavirin is indicated for use in the treatment and prevention of certain viral infections in selected patients. Ribavirin is marketed as a inhalation solution (Virazole), oral capsule (Rebetol) and tablet (Copegus), but can also be prepared for intravenous administration.
Mallet et al (2010) reported 2 patients in whom ribavirin therapy seemed to alter the natural history of chronic hepatitis E virus (HEV) infection. A kidney and pancreas transplant recipient and a patient with idiopathic CD4(+) T lymphocytopenia, both with biopsy-proven chronic HEV infection were included in this study. Patients received oral ribavirin, 12 mg/kg of body weight daily for 12 weeks. Liver function tests, detection of HEV RNA (viremia and stool shedding) by reverse transcriptase polymerase chain reaction, and anti-HEV IgM and IgG antibodies wer performed. Both patients had normalized liver function test results after 2 weeks of treatment and cleared HEV after 4 weeks of treatment. Hepatitis E virus RNA remained undetectable in the serum and stools throughout follow-up (3 months and 2 months for the 1st and 2nd patient, respectively). Side effects were considered mild. The authors concluded that ribavirin is a potentially effective treatment of HEV infection and should be evaluated in patients with chronic HEV infection. The main drawback of this study was that given the relatively short follow-up, the achievement of HEV eradication could not be claimed.
In a pilot study, Kamar and colleagues (2010) evaluated the ant-iviral effect of ribavirin monotherapy in patients with chronic HEV infection following kidney transplantation. A total of 6 patients who received kidney transplants and were positive for HEV RNA (infected with HEV for 36.5 months; [range of 11 to 46 months]) were given ribavirin monotherapy for 3 months. Ribavirin was given at 600 to 800 mg/day in 2 separate doses, based on the patient's ability to clear creatinine. Median serum concentration of HEV RNA at baseline was 5.77 log copies/mL (range of 4.35 to 7.35 log copies/ml). Three months after ribavirin therapy commenced, HEV RNA was undetectable in serum samples from all patients. A sustained virologic response was observed in 4 patients; the other 2 patients relapsed at 1 and 2 months after ribavirin therapy ended. At the end of the study, all patients had normal levels of alanine and aspartate aminotransferase. Anemia was the main side effect caused by ribavirin therapy. The authors concluded that ribavirin monotherapy inhibits the replication of HEV in vivo and might induce a sustained virological response in patients with chronic HEV infections. They stated that further studies are needed to determine the optimal duration of ribavirin therapy.
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
Other HCPCS codes related to the CPB:
J9213, J9214, J2915
Interferon alpha-2a, 2b, and n3
ICD-9 codes covered if selection criteria are met:
Crimean hemorrhagic fever [CHF Congo virus]
Other specified arthropod-borne hemorrhagic fever (e.g., mite-borne hemorrhagic fever)
Other mosquito-borne fever (e.g., Rift valley)
Chronic hepatitis C without mention of hepatic coma [not covered for ribavirin monotherapy]
Other specified diseases due to viruses (e.g., Marburg disease, Tanapox)
Respiratory syncytial virus (RSV)
Acute bronchiolitis due to respiratory syncytial virus (RSV)
ICD-9 codes not covered for indications listed in the CPB:
Hepatitis E with hepatic coma
Hepatitis E without mention of hepatic coma
205.00 - 205.92
Acute myeloid leukemia
The above policy is based on the following references:
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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.