WHA

MAVYRET (glecaprevir/pibrentasvir)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

  • Chronic Hepatitis C Virus (HCV) - Indicated for the treatment of adult and pediatric patients 3 years and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). Indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

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

1. Request for chronic HCV - genotype 1, 2, 3, 4, 5, or 6 - treatment-naïve, without decompensated cirrhosis (8 weeks):

  • Dose does not exceed three tablets/packets (100 mg of glecaprevir, 40 mg of pibrentasvir per tablet) once daily; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document ALL of the following:

    • HCV genotype 1, 2, 3, 4, 5, or 6

    • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

    • Patient is treatment-naïve

    • Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C); AND

  • Patient is not receiving Mavyret in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)

 

2. Request for chronic HCV - genotype 1- treatment-experienced (prior failure to an NS3/4A Protease Inhibitor), without decompensated cirrhosis (12 weeks):

  • Dose does not exceed three tablets/packets (100 mg of glecaprevir, 40 mg of pibrentasvir per tablet) once daily; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document ALL of the following:

    • HCV genotype 1

    • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

    • Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C)

    • Patient has experienced failure with a previous treatment regimen that included an HCV NS3/4A protease inhibitor; AND

  • Patient has had no previous treatment experience with a treatment regimen that included an NS5A inhibitor (see additional information for examples); AND

  • Patient is not receiving Mavyret in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)

 

3. Request for chronic HCV - genotype 1- treatment-experienced (prior failure to an NS5A inhibitor), without decompensated cirrhosis (16 weeks):

  • Dose does not exceed three tablets/packets (100 mg of glecaprevir, 40 mg of pibrentasvir per tablet) once daily; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document ALL of the following:

    • HCV genotype 1

    • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

    • Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C)

    • Patient has experienced failure with a previous treatment regimen that included an NS5A inhibitor; AND

  • Patient has had no previous treatment experience with a treatment regimen that included an HCV NS3/4A protease inhibitor (see additional information for examples); AND

  • Patient is not receiving Mavyret in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)

 

4. Request for chronic HCV, genotype 3, treatment-experienced (Interferon – or Sovaldi based regimen), without decompensated cirrhosis (16 weeks):

  • Dose does not exceed three tablets/packets (100 mg of glecaprevir, 40 mg of pibrentasvir per tablet) once daily; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document ALL of the following:

    • HCV genotype 3

    • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

    • Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C)

    • Patient has experienced treatment failure with a previous treatment regimen that included interferon, peginterferon, ribavirin, and/or Sovaldi (sofosbuvir); AND

  • Patient has had no previous treatment experience with a treatment regimen that included an HCV NS3/4A protease inhibitor or an NS5A inhibitor (see additional information for examples); AND

  • Patient is not receiving Mavyret in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)

 

5. Request for chronic HCV - genotype 1, 2, 4, 5, or 6 - treatment-experienced (interferon-based regimen), without cirrhosis (8 weeks):

  • Dose does not exceed three tablets/packets (100 mg of glecaprevir, 40 mg of pibrentasvir per tablet) once daily; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document ALL of the following:

    • HCV genotype 1, 2, 4, 5, or 6

    • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

    • Patient does not have cirrhosis

    • Patient has experienced treatment failure with a previous interferon-based treatment regimen; AND

  •  

  • Patient has had no previous treatment experience with a treatment regimen that included an HCV NS3/4A protease inhibitor or an NS5A inhibitor (see additional information for examples); AND

  • Patient is not receiving Mavyret in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)

 

6. Request for chronic HCV - genotype 1, 2, 4, 5, or 6 - treatment-experienced (interferon-based regimen), with compensated cirrhosis (12 weeks):

  • Dose does not exceed three tablets/packets (100 mg of glecaprevir, 40 mg of pibrentasvir per tablet) once daily; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document ALL of the following:

    • HCV genotype 1, 2, 4, 5, or 6

    • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

    • Patient has compensated cirrhosis (i.e., Child-Pugh Class A)

    • Patient has experienced treatment failure with a previous interferon-based treatment regimen; AND

  • Patient has had no previous treatment experience with a treatment regimen that included an HCV NS3/4A protease inhibitor or an NS5A inhibitor (see additional information for examples); AND

  • Patient is not receiving Mavyret in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)

 

7. Request for chronic HCV - genotype 1, 2, 4, 5, or 6 - treatment-experienced (Sovaldi-based regimen), without decompensated cirrhosis (16 weeks):

  • Dose does not exceed three tablets/packets (100 mg of glecaprevir, 40 mg of pibrentasvir per tablet) once daily; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document ALL of the following:

    • HCV genotype 1, 2, 4, 5, or 6

    • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

    • Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C)

    • Patient has experienced treatment failure with a previous treatment regimen that included Sovaldi (sofosbuvir); AND

  • Patient has had no previous treatment experience with an HCV NS3/4A protease inhibitor inclusive combination direct-acting antiviral regimen (see additional information for examples); AND

  • Patient is not receiving Mavyret in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)

 

8. Request for chronic HCV - genotype 1, 2, 3, 4, 5, or 6 - treatment-experienced (prior failure of Vosevi), without decompensated cirrhosis (16 weeks):

  • Dose does not exceed three tablets/packets (100 mg of glecaprevir, 40 mg of pibrentasvir per tablet) once daily; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document ALL of the following:

    • HCV genotype 1, 2, 3, 4, 5, or 6

    • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

    • Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C)

    • Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to Vosevi (sofosbuvir/velpatasvir/voxilaprevir); AND

    • Used in combination with Sovaldi (sofosbuvir) and ribavirin; AND

  • Patient is not receiving Mavyret in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)

 

9. Request for HCV-uninfected recipient of a liver transplant from an HCV-Viremic donor (12 weeks):

  • Dose does not exceed three tablets/packets (100 mg of glecaprevir, 40 mg of pibrentasvir per tablet) once daily; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document ALL of the following:

    • Patient has recently received a liver transplant from a donor with a diagnosis of HCV genotype 1, 2, 3, 4, 5, or 6

    • Patient was not infected with HCV prior to receiving a liver transplant; AND

  •  

  • Patient is not receiving Mavyret in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)

 

10. Request for chronic HCV - genotype 1, 2, 3, 4, 5, or 6 – post-liver or kidney transplant, treatment naïve or non-direct acting antiviral (DAA) experienced,  without decompensated cirrhosis (12 weeks):

  • Dose does not exceed three tablets/packets (100 mg of glecaprevir, 40 mg of pibrentasvir per tablet) once daily; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document ALL of the following:

    • Patient received a liver or kidney transplant

    • HCV genotype 1, 2, 3, 4, 5, or 6

    • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

    • Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C); AND

  • Patient is not receiving Mavyret in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)

 
Coverage Duration:

  • 8 weeks, 12 weeks, or 16 weeks as determined to be medically necessary (see above).

Authorization is not covered for the following:

  • The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

  • Child-Pugh (CP) score calculation = sum of points from 5 categories:

    • Encephalopathy: None = 1 point; Grade 1 and 2 = 2 points; Grade 3 and 4 = 3 points

    • Ascites:  None = 1 point; slight = 2 points; moderate = 3 points

    • Bilirubin: under 2 mg/ml = 1 point; 2 to 3 mg/ml = 2 points; over 3 mg/ml = 3 points

    • Albumin: greater than 3.5mg/ml = 1 point; 2.8 to 3.5mg/ml = 2 points; less than 2.8mg/ml = 3 points

    • Prothrombin Time* (sec prolonged): less than 4 sec = 1 point; 4 to 6 sec = 2 points; over 6 sec = 3 points

  • Severity of cirrhosis classification using Child-Pugh (CP) calculation:

    • Child-Pugh A: 5 to 6 points - good hepatic function

    • Child-Pugh B: 7 to 9 points - moderately impaired hepatic function

    • Child-Pugh C: 10 to 15 points - advanced hepatic dysfunction

  • Examples of drug classes:

    • NS5A protein inhibitors include:

      • daclatasvir (Daklinza)

      • elbasvir (component of Zepatier)

      • ledipasvir (component of Harvoni)

      • ombitasvir (component of Viekira Pak)

      • pibrentasvir (component of Mavyret)

      • velpatasvir (component of Epclusa, component of Vosevi).

    • NS3/4A protease inhibitors include:

      • glecaprevir (component of Mavyret)

      • grazoprevir (component of Zepatier)

      • paritaprevir (component of Viekira Pak)

      • simeprevir (Olysio)

      • voxilaprevir (component of Vosevi)

    • NS5B polymerase inhibitors include:

      • sofosbuvir (Sovaldi, component of Harvoni, component of Epclusa, component of Vosevi)

      • dasabuvir (component of Technivie)

  • Warnings and precautions:

    • Risk of Hepatitis B Virus Reactivation: test all patients for evidence of current or prior HBV infection before initiation of HCV treatment.  Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up.

    • Risk of Hepatic Decompensation/Failure in patients with evidence of advanced liver disease: monitor for clinical and laboratory evidence of hepatic decompensation.  Discontinue Mavyret in patients who develop evidence of hepatic decompensation/failure

  • Contraindication:

    • Patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation

    • Coadministration with atazanavir or rifampin

  • Drug interactions

    • Carbamazepine, efavirenz, and St. John’s wort may decrease concentrations of glecaprevir and pibrentasvir. Coadministration of carbamazepine, efavirenz containing regimens, and St. John’s wort with MAVYRET is not recommended.

    • Clearance of HCV infection with direct-acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary.

    • Medication-Assisted Treatment (MAT) for Opioid Use Disorder.

    • Consult the full prescribing information prior to and during treatment for potential drug interactions.

Policy Updates:
  • 02/15/2022 – Updated policy approved by P&T.
  • 09/12/2018 – Last reviewed
References:
  1. Tsoris A, Marlar CA. Use Of The Child Pugh Score In Liver Disease. [Updated 2021 Mar 22]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK542308/
  2. Mavyret Prescribing Information. Abbvie Inc. North Chicago, IL. June 2021.
  3. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. March 2021. http://www.hcvguidelines.org/full-report-view. Accessed May 13, 2021.

Last review date: February 15, 2022