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Limited coverage drugs – glecaprevir-pibrentasvir

Publication date: January 29, 2019

Generic name

 glecaprevir-pibrentasvir

Strength

100 mg/40 mg

Form

tablet
 

Special Authority criteria

For the treatment of treatment-naïve or treatment-experienced1 adult patients with chronic hepatitis C (CHC) genotype (GT) 1, 2, 3, 4, 5 or 6 infection, who meet all the following criteria:

OR

For the treatment of direct-acting antivirals (DAA)-experienced2 adult patients with CHC genotype 1 infection, who meet all the following criteria:

  1. Fibrosis stage of F0 or greater (Metavir scale or equivalent)3;

AND

  1. Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or other prescriber experienced with treating CHC;

AND

  1. Laboratory-confirmed4 hepatitis C genotype 1, 2, 3, 4, 5 or 6;

AND

  1. Laboratory-confirmed quantitative HCV RNA test from within the previous 12 months5;

AND

  1. 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

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

Approval period

Genotype 1, 2, 3, 4, 5 or 6 treatment-naïve with no cirrhosis or with compensated cirrhosis6

8 weeks

Genotype 1, 2, 4, 5 or 6 (Non-GT 3) treatment-experienced1 with no cirrhosis

Genotype 1, 2, 4, 5 or 6 (Non- GT 3) treatment-experienced1 with compensated cirrhosis6

12 weeks

Genotype 3 treatment-experienced1 with no cirrhosis or with compensated cirrhosis6

16 weeks
Treatment regimens for genotype 1 DAA-experienced adult patients

Treatment regimens for genotype 1 DAA-experienced2 adult patients

Approval period

Genotype 1 NS3/4A protease inhibitor-experienced, but NS5A inhibitor-naïve, with no cirrhosis or with compensated cirrhosis6

12 weeks

Genotype 1 NS5A inhibitor treatment-experienced, but NS3/4A inhibitor treatment-naïve, with no cirrhosis or with compensated cirrhosis6

16 weeks

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). Maviret is not recommended in patients with moderate hepatic impairment (CPS = B) and is contraindicated in patients with severe hepatic impairment (CPS = C).

Practitioner exemptions

  • None

Special notes

  • None

Additional information

Special Authority request form