Pegasys – NC Standard

Restricted Products:

• Pegasys® (Peginterferon alfa-2a)

FDA Approved Use:

• For the treatment of pediatric patients ≥5 years of age with chronic hepatitis C and compensated liver disease in combination with ribavirin.
• For the treatment of adults with hepatitis B e antigen (HBeAg)-positive and HBeAg-negative chronic hepatitis B virus (HBV) infection who have compensated liver disease and evidence of viral replication and liver inflammation; treatment of pediatric patients 3 years and older with HBeAg-positive chronic HBV infection who are noncirrhotic and have evidence of viral replication and elevations of serum alanine aminotransferase.

Criteria for Approval of Restricted Product(s):

1. The patient has been diagnosed with chronic Hepatitis B; AND
   1. The patient does not have cirrhosis (medical record documentation required]; OR
2. The patient has been diagnosed with chronic Hepatitis C; AND
   1. Has a diagnosis of chronic hepatitis C (CHC) infection with confirmed genotypes 1, 2, 3, 4, 5, or 6, AND
   2. Medical record documentation including genotype, fibrosis score, and HCV RNA (within the last 6 months), Child-Pugh score, and as specified within the criteria is provided; AND
   3. Will be used in combination with ribavirin unless patient has a contraindication to or cannot tolerate ribavirin, AND
   4. Pegasys is prescribed by or in consultation with a physician with expertise and experience in the management of infectious hepatitis, AND
   5. Pegasys plus ribavirin used without protease inhibitor; AND
      1. For Genotype 1,4,5,6 or unknown: initial approval for 28 weeks. At 24 weeks, the viral titer must have decreased by ≥ 2 log₁₀ (or virus undetectable) before authorization for an additional 20 weeks of therapy (48 weeks total) will be given; OR
      2. Genotype 2 or 3: Approval for 24 weeks will be given. Patients who are being re-treated for HCV, those co-infected with HCV and HIV, and those using peginterferon as monotherapy: approval for 48 weeks will be given.
         1. Patients with chronic hepatitis C viral genotype 3 who have a high level (as determined by the prescribing physician) of HCV RNA or advanced fibrosis may be approved for 48 weeks. (High viral load usually is considered to be > 600,000 or 800,000 IU/mL.); OR
3. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. [Medical records and references / evidence must be provided].

Duration of Approval:

• Hepatitis B: 48 weeks
• Hepatitis C: 24 to 48 weeks, depending on genotype
• Other: 365 days

References:

All information referenced is from FDA package insert unless otherwise noted below.

Pegasys (peginterferon alfa-2a) product labeling. Genentech. San Francisco, CA. 2011.

http://www.gene.com/gene/products/information/pegasys/pdf/pi.pdf

Incivek (telaprevir) product labeling.Vertex Pharmaceuticals Incorporated. Cambridge, MA. 2011. http://pi.vrtx.com/files/uspi_telaprevir.pdf

Victrelis (boceprevir) product labeling. Schering Corporation, a subsidiary of Merck & Co. Whitehouse Station, NJ. 2011.

http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf

Policy Implementation/Update Information:

March 2022: Criteria update: Annual criteria review. Removal of Peg-Intron (obsolete product). Updated FDA indication section.

Mar 2018: Reformatting; indication review; added criteria for indications outside of FDA labeling

Nov 2013: Original utilization management criteria issued