Elbasvir and Grazoprevir (Zepatier®)

ORAL ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of chronic hepatitis C, genotypes  1 and 4 in adults (with or without concomitant medications per FDA approved dosing.

All of the following must be met as a condition for coverage:

  • Patient must have compensated liver disease by fibroscan ultrasound or biopsy, documenting stage 2, 3 or stage 4.  Acitest-Fibrotest is not accepted as documentation.
  • Resistance testing must be included with the prior authorization request for genotype 1.
    • Treatment failure associated with HCV resistance to newly developed direct-acting antiviral agents is not an uncommon occurrence and poses a substantial problem to clinicians trying to re-treat patients who have failed available interferon-free treatments.
  • Trial and failure of preferred agent(s) Epclusa, Harvoni, Vosevi

This Medication is Not Approvable for the following condition(s):

  • Patients with Stage 0 or Stage 1 fibrosis
  • Any condition not listed above as an approved indication

Dosing:  

  • One tablet once daily.  For ribavirin dosing regimen, see FDA prescribing information for Ribavirin.

Duration of Therapy:

  • Genotype 1a:  Treatment naïve or peg interferon alfa/ribavirin experienced:  without baseline NS5A polymorphisms:  12 weeks
  • Genotype 1a with baseline Ns5A polymorphisms:  16 weeks with Ribavirin. 
  • G1b treatment naïve or peginterferon alpha/ribavirin-experienced:  12 weeks. 
  • Genotype 1a or 1b:  Peginterferon alfa/ribavirin/PI experienced:  12 weeks with Ribavirin
  • Genotype 4:  Treatment naive:  12 weeks
  • Genotype 4:  Peginterferon alfa/ribavirin-experienced:  16 weeks with Ribavirin.

Last review date: September 12, 2018