Glecaprevir/Pibrentasvir (Mavyret)

SELF ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of adult patients with chronic hepatitis C (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
  • Treatment of Genotype 1 patients previously treated with an HCV NS5A inhibitor regimen or an NS3/4A protease inhibitor regimen, but not both

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

  • Patients must have a fibrosis stage 2, 3, or 4 by fibroscan ultrasound or biopsy.  Actitest-Fibrotest is not accepted as documentation, AND
  • Resistance testing must be included with the prior authorization request for genotype 1 and 3.
    • 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, AND
  • Trial and failure of preferred agent(s) Epclusa, Harvoni, Vosevi

This medication is not approvable for the following condition(s):

  • Hepatitis C Virus (HCV)  with Child-Pugh Class C Liver Disease
  • Hepatitis C Virus (HCV) [any genotype], combination with any other Direct-Acting Antivirals (DAAs)
  • Pediatric patients (<18 years old)

Dosing:

  • Glecaprevir 300mg/Pibrentasvir 120mg (3 tablets) taken once daily

Duration of Therapy:

  • HCV Genotype 1, 2, 3, 4, 5, 6, Treatment Naive without Cirrhosis: 8 weeks
  • HCV Genotype 1, 2, 3, 4, 5, 6, Treatment Naive with Compensated Cirrhosis: 12 weeks
  • HCV Genotype 1, Previously Treated with NS5A inhibitor  without prior treatment with an NS3/4A protease inhibitor without Cirrhosis or with compensated Cirrhosis (Child-Pugh A): 16 weeks
  • HCV Genotype 1, Previously Treated with NS3/4 Protease inhibitor (PI) without prior treatment with an NS5A inhibitor without Cirrhosis or with compensated Cirrhosis (Child-Pugh A): 12 weeks
  • HCV Genotype 1, 2, 4, 5, 6, Previously Treated with regiments containing (peg) interferon, ribavirin, and/or sofosbuvir, but not prior treatment experience with an HCV NS3/4 PI or NS5A inhibitor without Cirrhosis: 8 weeks, OR with compensated Cirrhosis (Child-Pugh A): 12 weeks
  • HCV Genotype 3, Previously Treated with regiments containing (peg) interferon, ribavirin, and/or sofosbuvir, but not prior treatment experience with an HCV NS3/4 PI or NS5A inhibitor without Cirrhosis or with compensated Cirrhosis (Child-Pugh A): 16 weeks

Approval:

  • Approval for 8, 12, or 16 weeks depending on treatment experience, genotype, and cirrhosis

Last review date: September 12, 2018