Limited Use Note(s)

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ELBASVIR & GRAZOPREVIR50mg & 100mg Tab
Reason For Use CodeClinical Criteria
489For treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND (ii) Laboratory confirmed hepatitis C genotype 1 or genotype 4; AND (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). Treatment regimens for Zepatier (elbasvir-grazoprevir) for genotype 1: I. Treatment-naive with or without compensated cirrhosis (2) Approved duration: 12 weeks Note: As approved by Health Canada, 8 weeks may be considered in treatment-naive genotype 1b patients without significant fibrosis or cirrhosis as determined by liver biopsy (i.e., Metavir F0-F2) or by non-invasive tests. II. Treatment-experienced genotype 1b patients and genotype 1a relapsers, with or without compensated cirrhosis (2) Approved duration: 12 weeks Treatment regimens for Zepatier (elbasvir-grazoprevir) for genotype 4: I. Treatment-naive patients, treatment-experienced relapsers, with or without compensated cirrhosis (2) Approved duration: 12 weeks Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program.
LU Authorization Period: 12 Weeks.
490For treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND (ii) Laboratory confirmed hepatitis C genotype 1 or genotype 4 AND (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). Treatment-experienced genotype 1a or genotype 4 who have had on-treatment virologic failures (3) Approved regimen: 16 weeks in combination with ribavirin (Ibavyr) Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program.
LU Authorization Period: 16 Weeks.
NOTE: 1. Treatment-experienced for patients with genotype 1 is defined as patients who have been previously treated with a pegylated interferon + ribavirin regimen or a protease inhibitor + pegylated interferon + ribavirin regimen and have not experienced adequate response. Treatment-experienced for patients with genotype 4 is defined as patients who have been previously treated with a pegylated interferon + ribavirin regimen and have not experienced adequate response. 2. Treatment may be considered for patients with compensated cirrhosis (Child-Turcotte-Pugh A [i.e. Score 5 to 6]) 3. On-treatment virologic failures are patients who have had a null response, partial response, virologic breakthrough or rebound, or intolerance to prior treatment. 4. Combination therapy with Sovaldi (sofosbuvir) will not be considered for funding for any genotypes. 5. Health care professionals are advised to refer to the product monograph and prescribing guidelines for appropriate use of the selected drug, including use in special populations.