Pharmacy Prior Authorization Criteria

Alfa Interferons

Indications for Prior Authorization

Pegasys (peginterferon alfa-2a)

• For diagnosis of Chronic Hepatitis C
  1) Indicated for the treatment of Chronic Hepatitis C (CHC) in combination therapy with other hepatitis C virus drugs for adults with compensated liver disease. PEGASYS monotherapy is indicated only if patient has contraindication or significant intolerance to other HCV drugs. 2) indicated for the treatment of Chronic Hepatitis C (CHC) in combination with ribavirin for pediatric patients 5 years of age and older with compensated liver disease.

  Limitations of use: Pegasys alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa. - Pegasys is not recommended for treatment of patients with CHC who have had solid organ transplantation.

• For diagnosis of Chronic Hepatitis B
  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 and liver inflammation.

  Indicated for the treatment of HBeAg-positive CHB in non-cirrhotic pediatric patients 3 years of age and older with evidence of viral replication and elevations in serum alanine aminotransferase (ALT).

Criteria

Pegasys

**Defined as Child-Pugh Class B or C

Prior Authorization (Initial Authorization)

Length of Approval: 28 Week(s)
For diagnosis of Chronic Hepatitis C

• Diagnosis of chronic hepatitis C infection
AND
• Patient without decompensated liver disease**
AND
• One of the following:
• Used in combination with one of the following:
• Sovaldi (sofosbuvir)
• Ribavirin
OR
• Contraindication or intolerance to all other HCV agents (e.g., Sovaldi [sofosbuvir], ribavirin)
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• HIV specialist certified through the American Academy of HIV Medicine

Pegasys

Prior Authorization (Reauthorization)

Length of Approval: 20 Week(s)
For diagnosis of Chronic Hepatitis C

• Patient has an undetectable HCV RNA at week 24
AND
• Additional treatment weeks of peginterferon are required to complete treatment regimen
AND
• Patient has not exceeded 48 weeks of therapy with peginterferon
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• HIV specialist certified through the American Academy of HIV Medicine

Pegasys

**Defined as Child-Pugh Class B or C

Prior Authorization

Length of Approval: 48 Week(s)
For diagnosis of Chronic Hepatitis B

• Diagnosis of chronic hepatitis B infection
AND
• Patients without decompensated liver disease**

P & T Revisions

2025-08-05, 2024-07-03, 2023-06-22, 2023-06-08, 2022-06-08, 2021-09-30, 2021-08-02, 2021-05-10, 2020-05-14

References

1. Pegasys Prescribing Information. Genentech, Inc. South San Francisco, CA. December 2023.

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Revision History

• 2025-08-05: 2025 Annual Review - no criteria changes. Removed obsolete GPIs for interferon alfa-2B and associated criteria. Updated background and references.
• 2024-07-03: Annual Review - GPI update
• 2023-06-22: Removed Oncology specialist requirement
• 2023-06-08: Annual Review - no criteria changes. PegIntron removed from criteria as product is obsolete.
• 2022-06-08: Annual Review
• 2021-09-30: GPI replication update for Pegasys. No changes to clinical criteria.
• 2021-08-02: 2021 UM Annual Review.
• 2021-05-10: 2021 UM Annual Review.
• 2020-05-14: Annual Review

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