Limited Coverage Drugs - Ribavirin with Pegylated Interferon

Generic Name / Strength / Form

ribavirin in combination with pegylated interferon alfa-2a (Pegasys RBV®) / 200 mg / tablet, 180 mcg / pre-filled syringe

ribavirin in combination with pegylated interferon alfa-2a (Pegasys RBV® ProClick™ Autoinjector) / 200 mg / tablet, 180 mcg / pre-filled injection pen
ribavirin in combination with pegylated interferon alfa-2b (Pegetron®) / 200 mg / capsule, 50 mcg / 150 mcg / single-dose vial
ribavirin in combination with pegylated interferon alfa-2b (Pegetron Redipen®) / 200 mg / capsule, 80 mcg / 100 mcg / 120 mcg / 150 mcg / injection pen

Special Authority Criteria

Approval Period

For the treatment of chronic hepatitis C genotype 2, 3, 4, 5 or 6 in:

  • treatment-naïve patients with no cirrhosis or with compensated cirrhosis. Compensated cirrhosis is defined as cirrhosis with a Child Pugh Score=A (5-6).

AND

Who meet ALL of the following:

  1. Prescribed by a gastroenterologist or an infectious disease specialist or other physicians experienced with treating hepatitis C
  2. Lab-confirmed hepatitis C genotype 2, 3, 4, 5 or 6
  3. Patient has a quantitative HCV RNA value within the last 6 months
  4. Fibrosis stage F2 or greater (Metavir scale or equivalent). Acceptable methods include liver biopsy, transient elastography (FibroScan®) and serum biomarker panels (such as AST-to-Platelet Ratio Index (APRI) or Fibrosis-4 (FIB-4) score) either alone or in combination.
  5. Re-treatment requests will NOT be considered.

First approval: 14 or 24 weeks according to genotype.

 

Renewals: According to established protocols for the specific drug product as noted on the request form

For treatment of chronic hepatitis C genotype 1, please see Limited Coverage criteria for simeprevir in combination with peginterferon/ribavirin or sofosbuvir in combination with peginterferon/ribavirin.

 

Practitioner Exemptions

  • None

Special Notes

  • In exceptional cases, requests that do not meet established criteria may receive special consideration for coverage if the physician provides additional documentation of disease progression and/or for other patient-specific considerations. The Hepatitis Drug Benefit Adjudication Advisory Committee reviews exceptional case submissions.

Additional Information:

Special Authority Request Form(s)