Infergen in peg interferon failures

[sdpharmd]

Are there studies which would support covering Infergen in Hep C patients who failed pegylated interferons?

[diana.papshev]

A Medline search revealed one uncontrolled study which evaluated the effectiveness of interferon alfacon-1 in 137 non-responders to pegylated interferon alfa-2b. Daily therapy with interferon alfacon-1 (15 mcg SC) and ribavirin (weight-based) for 48 weeks resulted in a 37% sustained virologic response (SVR) rate. The investigators noted that further studies are warranted.

Latest treatment guidelines from the American Gastroenterological Association (AGA) and the American Association for the Study of Liver Diseases (AASLD) do not provide specific recommendations for the management of pegylated interferon non-responders due to the lack of sufficient evidence.

Use of Infergen in non-responders to pegylated interferon is considered investigational by many national and regional plans; however, Wellpoint as well as the VA have developed criteria for coverage in these cases.

Sources:

Leevy CB.Consensus Interferon and Ribavirin in Patients with Chronic Hepatitis C Who Were Nonresponders to Pegylated Interferon alfa-2b and Ribavirin. Dig Dis Sci. 2008;53:1961-6.

Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004;39:1147-1171. Available in full-text at AASLD website

Dienstag JL and McHutchison. American Gastroenterological Association medical position statement on the management of hepatitis C. Gastroenterology. 2006;130:225-230. Available in full-text from the publisher

Wellpoint Pharmacy Management. Prior authorization criteria for Infergen

VA Pharmacy Benefit Management Services. Criteria for use of Infergen posted on 3/4/08 .

[jeff.dunn]

Agreed. There is a lack of quality literature evaluating Infergen in pegylated interferon failures. That, however, is the marketing message of the manufacturer. My plan has chosen to hold to the guidelines and evidence - we do not cover Infergen without a strenuous clinical review after other options have been tried.