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Limited coverage criteria – glecaprevir-pibrentasvir

Publication date: January 29, 2019

 

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Generic name

 glecaprevir-pibrentasvir

Strength & form

100 mg/40 mg tablet
50 mg/20 mg granules in sachet7

Special Authority criteria

For the treatment of treatment-naïve or treatment-experienced1 patients 3 years of age or older 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:

  • Fibrosis stage of F0 or greater (Metavir scale or equivalent)3

AND

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

AND

  • Laboratory-confirmed quantitative HCV RNA or dried blood spot test within the previous 12 months5

AND

  • Laboratory-confirmed4 hepatitis C genotype 1, 2, 3, 4, 5, or 6 for treatment-experienced1 patients only

AND

  • 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 patients 3 years of age and older with:

Approval period

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

 8 weeks

Genotype 1, 2, 3, 4, 5, or 6 (non-GT3) treatment-experienced1 with no cirrhosis

Genotype 1, 2, 3, 4, 5, or 6 (non-GT3) 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-experienced2 CHC adult patients with:

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 inhibitor-naïve, with no cirrhosis or compensated cirrhosis6

 16 weeks

Practitioner exemptions

  • None

Special notes

  • 1Treatment-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
  • 2DAA 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
  • 3Special 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 [APRI] or fibrosis-4 [FIB-4]) either alone or in combination. Supporting documentation must be submitted
  • 4For treatment-experienced patients, Special Authority requests must include the genotype report from the latest HCV post-treatment course
  • 5Special 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
  • 6Compensated 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)
  • 7For glecaprevir-pibrentasvir oral granules, the patient must be:​
    • ​3 to less than 12 years of age, and
    • Weigh between 12 kg to less than 45 kg

Additional information

Special Authority request form(s)