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ANTI-INFECTIVE AGENTS › ANTIVIRALS

SOFOSBUVIR & VELPATASVIR (Epclusa)

400mg & 100mgTab
LU488
QUICK SCAN

For 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…

LU Authorization Period: 12 Weeks.
Complete Ontario criteria

For 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, 2, 3, 4, 5, 6 or mixed genotypes; 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 Epclusa (sofosbuvir-velpatasvir): I. Treatment-naive or treatment-experienced (1) non-cirrhotic or compensated cirrhosis (2) Approved duration: 12 weeks II. Treatment-naive or treatment-experienced patients with decompensated cirrhosis (2) Approved regimen: 12 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. 1. Treatment-experienced are those who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor. 2. Compensated cirrhosis (Child-Turcotte-Pugh A [i.e. Scores 5 to 6]) and decompensated cirrhosis (Child-Turcotte-Pugh B or C [i.e. Score 7 or above]) may be considered. 3. Health care professionals are advised to refer to the product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations.

Clinical verification required

Quick summaries support scanning only. Confirm eligibility against the complete Ontario criteria and current Ontario e-Formulary before billing.

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