Download PEGASYS (peginterferon alfa-2b)

PEGASYS
(peginterferon alfa-2b)
RATIONALE FOR INCLUSION IN PA PROGRAM
Hepatitis B
Pegasys is an antiviral indicated, as monotherapy, for the treatment of adult patients with
HBeAg positive and HBeAg negative chronic hepatitis B infection who have compensated liver
disease and evidence of viral replication or as either a monotherapy or part of a combination
regimen, for the treatment of chronic hepatitis C in patients with compensated liver disease (1).
Hepatitis C
Pegasys is indicated for the treatment of chronic hepatitis C in patients 5 years of age and older
with a detectable viral load in the serum. Patients must have compensated liver disease and
not previously treated with an interferon alpha. Pegasys monotherapy is indicated for chronic
hepatitis only if patient has contraindication to or significant intolerance to other hepatitis C
antiviral drugs. Pegasys used in combination with Ribavirin therapy is recommended unless
patient has contraindication to or significant intolerance to ribavirin (1,2).
Boxed Warning: Risk of Serious Disorders
Pegasys may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune,
ischemic, and infectious disorders. Physicians should monitor patients closely and withdraw
therapy with persistently severe or worsening signs or symptoms of the above disorders (1).
Pegasys alone or in combination with ribavirin without additional hepatitis antiviral drugs is not
recommended for treatment of patients with chronic hepatitis C who previously failed therapy
with an interferon-alfa (1).
Pegasys is not recommended for treatment of patients with chronic hepatitis C who have had
solid organ transplantation (1).
Ribavirin may cause birth defects and fetal death: avoid pregnancy in female patients and
female partners of male patients (1, 3).
Summary
Hepatitis C is a viral disease caused by the hepatitis C virus (HCV) that leads to inflammation of
the liver. Untreated, chronic infection can lead to liver cirrhosis and/or liver cancer. The most
common treatment regimens are based on combinations of pegylated interferon alfa, ribavirin,
and a protease inhibitor (1,2).
Pegasys FEP Clinical Rationale
PEGASYS
(peginterferon alfa-2b)
Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of
Pegasys while maintaining optimal therapeutic outcomes.
References
1. Pegasys. Prescribing Information. South San Francisco, CA. Genentech USA, Inc. March
2015.
2. Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of
hepatitis C: an update. Hepatology. 2009; 49(4):1335-1374.
3. Ribavirin capsules [package insert]. Sellersville, PA: Teva Pharmaceuticals USA; March
2011.
Pegasys FEP Clinical Rationale