Elbasvir and Grazoprevir (Zepatier®)
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.
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
- 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: December 26, 2016