Re-treatment with pegylated interferons in hepatitis C

[chantell.reagan]

In March 2009, Schering received an expanded indication for the combination of PegIntron and Rebetol for treating chronic hepatitis C in patients 3 years of age and older with compensated liver disease. At that time, the company touted that it was the only pegylated interferon which was not restricted to treatment-naïve patients. So, what are the implications of this labeling change? In reality, it translates into minimal coverage policy changes since the label states that “patients with the following characteristics are less likely to benefit from retreatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.”

Current treatment guidelines issued by the American Gastroenterological Association (AGA) and the American Association for the Study of Liver Diseases (AASLD) already recognize that non-responders/relpasers of non-pegylated interferons should try the pegylated combination. Additionally, relapsers are more likely to benefit from subsequent pegylated interferon therapy, while non-responders are not likely to benefit. This is consistent with recent publications regarding peginterferon alpha-2a. A study sponsored by Roche evaluated the use of peginterferon-alpha2a plus ribavirin in the re-treatment of nonresponders to peginterferon-alpha2b plus ribavirin. Authors concluded that re-treating nonresponders to therapy with peginterferon-alpha2b plus ribavirin for 72 weeks significantly increases SVR rates compared with re-treating them for 48 weeks, but SVR rates were still low (16% for 72 weeks and 8% for 48weeks). Also of note, peginterferon-alpha 2a + ribavirin was not evaluated in this study. In a separate post-hoc analysis evaluating re-treatment with peginterferon alpha2a, researchers concluded that relapsers have a “strong probability of treatment success”, while non-responders do not have a strong probability of success with subsequent pegylated interferon alfa-2a. Of the relapsers, 60% of Peg interferon monotherapy relapsers achieved an SVR, while 77% of Peg interferon+ribavirin relapsers achieved an SVR. In previous nonresponders, only 33% of Peg interferon monotherapy non-responsders and 14% Peg interferon+ribavirin nonresponders achieved an SVR.

The bigger question is how are plans addressing non-responders/failures of pegylated interferons in Hepatitis C. In an informal analysis of 6 regional and national health plans, no plans are covering repeat use of pegylated interferons for failures in non-responders. We would love to hear your thoughts of how your plan is covering (or not covering) retreatment with pegylated interferon for those members who have already failed treatment.

Sources:

Nelson DR et al. Clin Gastroenterol Hepatol. 2009 Feb;7(2):212-8. Safety and antiviral activity of albinterferon alfa-2b in prior interferon nonresponders with chronic hepatitis C. (Pubmed abstract)

Poynard T et al. Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy. Gastroenterology. 2009 May;136(5):1618-28.e2. (Pubmed abstract)

Aetna Clinical Policy Bulletin: Interferons

BCBS of Alabama:Pegasys policy and BCBS of Alabama: PegIntron policy

BCBS of Florida Medical Policies (search Pegasys)

Cigna: Pegasys policy and Cigna: PegIntron policy

The Regence Group: Pegasys policy and The Regence Group: PegIntron policy

Wellpoint Pharmacy Management: PegIntron policy and Wellpoint Pharmacy Management: Pegasys policy

Related links:

Infergen in peg-interferon failures

Expanded indications/labeling changes for March 2009