Pegasys Hepatitis B. Pegasys (peginterferon alfa-2a) Description

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Pegasys Hepatitis B Page: 1 of 5 Last Review Date: September 18, 2015 Pegasys Hepatitis B Description Pegasys (peginterferon alfa-2a) Background Chronic hepatitis B virus (HBV) infection is a growing health problem affecting over a million people in the United States and at least 350 million people worldwide (1). Patients with chronic hepatitis B are at an increased risk to develop cirrhosis, liver failure, and liver cancer. The goal of chronic hepatitis B therapy is to prevent these complications by decreasing the patient s hepatitis B viral level and maintaining it at low levels for as long as possible (2). The management of chronic hepatitis B infection remains a controversial issue. Hepatitis B e antigen (HBeAg) and Hepatitis B viral DNA (HBV DNA) are both markers of HBV replication and their presence provides a rationale for initiating therapy to stop the progression of liver disease. In the past, the ability to detect HBV DNA in the serum by hybridization assays was a major factor in determining which patients should be treated. This assay is sensitive enough to detect viral DNA when it is present in amounts 10 5 copies/ml and consequently this viral level became an important benchmark in treatment algorithms. As improvements in viral detection have advanced it has become apparent that it is not possible to designate a single HBV DNA value that can differentiate between inactive hepatitis B carriers and patients suffering from chronic hepatitis B. Recent practice guidelines have recommended that alanine aminotransferase (ALT) levels and liver biopsies can be used to determine which patients with low HBV DNA levels require treatment (2).

2 Subject: Pegasys Hepatitis B Page: 2 of 5 There are currently seven FDA-approved treatments for chronic HBV infection in the United States, these include interferon alfa-2b (Intron-A), peginterferon alpha-2a (Pegasys), lamivudine (Epivir-HBV), entecavir (Baraclude), adefovir dipivoxil (Hepsera) and tenofovir (Viread) (3). Pegasys works by both stimulating the immune system and inhibiting viral replication. It also has a longer half-life than conventional interferon which allows for once-weekly dosing (6). Pegasys has been shown to produce superior clinical outcomes in patients with HBeAg-positive chronic HBV and significantly higher response rates in chronic HBV patients that are HBeAg-negative (4). For patients with compensated cirrhosis the goal is to prevent the progression to decompensated cirrhosis and to prevent the development of liver cancer. Interferon therapy is not recommended in patients with decompensated cirrhosis because it increases their risk for developing bacterial infections and it can potentially worsen their condition (5). Regulatory Status FDA-approved indication: Pegasys is an antiviral indicated for treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation (6). Pegasys is also indicated for hepatitis C. This policy is limited to the use of Pegasys for hepatitis B. Limitations of use: Pegasys may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders (6). The safety and effectiveness of Pegasys in patients below the age of 5 years have not been established (6). Related policies Intron A Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims.

3 Subject: Pegasys Hepatitis B Page: 3 of 5 Pegasys may be considered medically necessary for the treatment of chronic hepatitis B in patients age 5 years or older with compensated liver disease and evidence of viral replication. Pegasys is considered investigational in patients under 5 years of age for the treatment of hepatis B and in patients who do not meet the criteria for medical necessity. Prior-Approval Requirements Age 5 years of age or older Diagnosis Patient must have the following: 1. Chronic hepatitis B AND ALL of the following: a. Compensated liver disease b. Evidence of viral replication Prior Approval Renewal Requirements None Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Duration 12 months Rationale Summary Pegasys is an antiviral indicated 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 (6). Pegasys is also indicated for hepatitis C. This policy is limited to the use of Pegasys for hepatitis B.

4 Subject: Pegasys Hepatitis B Page: 4 of 5 Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Pegasys while maintaining optimal therapeutic outcomes. References 1. Kanwal F, Gralnek IM, Martin P, Dulai GS, Farid M, Spiegel BM. Treatment alternatives for chronic hepatitis B virus infection: a cost-effectiveness analysis. Ann Intern Med May 17; 142(10): Keeffe EB, Dieterich DT, Han SH, Jacobson IM, Martin P, Schiff ER, et al. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States. Clin Gastroenterol Hepatol. 2004; 2: Hepatitis B Foundation web site. Accessed September Marcellin P, Lau GK, Bonino F, Farci P, Hadziyannis S, Jin R, Lu ZM, Piratvisuth T, Germanidis G, Yurdaydin C, Diago M, Gurel S, Lai MY, Button P, Pluck N; Peginterferon Alfa-2a HBeAg-Negative Chronic Hepatitis B Study Group. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med Sep 16; 351(12): Fung SK, Lok AS. Management of patients with hepatitis B virus-induced cirrhosis. J Hepatol. 2005; 42 Suppl(1):S54-S Pegasys [package insert]. South San Francisco, CA: Genentech USA, Inc; 2015 Policy History Date December 2011 March 2010 Action Original Policy Prior approval criteria reorganized by drug rather than disease state to improve functionality and work flow.

5 Subject: Pegasys Hepatitis B Page: 5 of 5 September 2011 September 2012 June 2014 September 2015 Per the current package insert Pegasys is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation (6). Adult age requirement of 18 and older was added to the criteria and the requirement for a positive HBeAg was removed. The criteria wording was changed to match the current package insert guidelines. The current recommended duration of treatment is 48 weeks. The manufacturer has not studied treatment beyond 48 weeks and no current literature supports treatment beyond 48 weeks. The manufacturer goes on to state that the safety and efficacy of Pegasys has not been established in patients with a liver or any other organ transplantation (6). All mention of liver transplant removed from criteria. With the advent of newer treatment modalities for the maintenance therapy of hepatitis B, renewal can no longer be recommended at this time for Pegasys (3). Annual editorial and reference update. Requirement for "liver inflammation removed from prior approval requirements. Annual editorial and reference update Limitations of use added to Regulatory Status section Age limitation of 5 years of age and older Annual editorial review and reference update Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on September 18, 2015 and is effective October 1, Deborah M. Smith, MD, MPH