Limited Coverage Drugs – glecaprevir-pibrentasvir

Generic Name

glecaprevir-pibrentasvir                                                                       

Strength

100 mg-40 mg

Form

tablet
 
Special Authority Criteria

For the treatment of treatment-naïve or treatment-experiencedi adult patients with chronic hepatitis C (CHC) genotype 1, 2, 3, 4, 5, or 6 infection who meet all the following criteria,

    OR

For the treatment of direct acting antivirals (DAA)-experiencedii adult patients with CHC genotype 1 infection, who meet all the following criteria:

  1. Fibrosis stage of F0 or greater (Metavir scale or equivalent)iii.
    AND
  2. Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or other physician experienced with treating CHC.
    AND
  3. Laboratory confirmediv hepatitis C genotype 1, 2, 3, 4, 5 or 6.
    AND
  4. Laboratory confirmed quantitative HCV RNA test from within the previous 12 monthsv.
    AND
  5. The patient is not currently being treated with another hepatitis C DAA drug.
 

Treatment regimens for genotype 1, 2, 3, 4, 5 or 6 CHC adult patients

Genotype 1, 2, 3, 4, 5 or 6 treatment-naïve or genotype 1, 2, 4, 5 or 6 treatment-experiencedi with no cirrhosis. 

8 weeks

Genotype 1, 2, 3, 4, 5 or 6 treatment-naive or genotype 1, 2, 4, 5 or 6 treatment-experiencedi with compensated cirrhosisvi.

12 weeks

Genotype 3 treatment-experiencedi with no cirrhosis or with compensated cirrhosisvi.

16 weeks            

Treatment regimens for genotype1 DAA-experiencedii adult patients

Genotype 1 NS3/4A protease inhibitor-experienced, but NS5A inhibitor-naïve, with no cirrhosis or with compensated cirrhosisvi.

12 weeks

Genotype 1 NS5A inhibitor treatment-experienced, but NS3/4A inhibitor treatment-naïve, with no cirrhosis or with compensated cirrhosisvi.

16 weeks

Special Notes

  1. Treatment-experienced is defined as a patient who has been previously treated with interferon, peginterferon-ribavirin (PR), ribavirin (RBV), and/or sofosbuvir (SOF), (PR, SOF + PR, SOF + RBV), but no prior treatment experience with an HCV NS3/4A protease Inhibitor or NS5A inhibitor, and who has relapsed or not responded to treatment.
  2. DAA Treatment-experienced is defined as a patient who has been previously treated with DAA regimens containing daclatasvir (DCV) + SOF, DCV + PR or ledipasvir-sofosbuvir (Harvoni®), with no prior treatment experience with NS3/4A protease inhibitors, and who has relapsed or not responded to treatment OR prior treatments with NS3/4A protease inhibitors (simeprevir [SMV] +SOF or SMV + PR or boceprevir + PR or telaprevir + PR) with no prior treatment experience with NS5A inhibitors, and who has relapsed or not responded to treatment.
  3. Special Authority requests must include a fibrosis score test performed within the previous 12 months. Acceptable methods include liver biopsy, transient elastography (FibroScan®) and serum biomarker panels (AST-to-Platelet Ratio Index) either alone or in combination. Supporting documentation must be submitted.
  4. Special Authority requests must include the most recent genotyping test report. For treatment-experienced patients, Special Authority requests must include the genotype report from the latest post-treatment course.
  5. Special Authority requests for patients must include the most recent HCV RNA test performed within the previous 12 months. For genotype 1 DAA-experienced patients, HCV RNA detectable levels must be confirmed at SVR12 or SVR24 post-DAA treatment.
  6. Compensated cirrhosis is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6).

Practitioner Exemptions

  • None

Special Authority Request Form