| 550 | 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.
(ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, or 6;
(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).
Exclusion criteria:
- Patients with genotype 1 who have relapsed but are treatment experienced on both an NS3/4A protease inhibitor and an NS5A inhibitor
- For use in combination with other hepatitis C antiviral agents
- Patients with decompensated cirrhosis or severe hepatic impairment (Child-Pugh C)
Retreatment is not funded. Retreatment for re-infection in patients who have received an adequate prior course of Maviret will be considered on a case-by-case basis through the Exceptional Access Program.
Treatment regimens for Maviret:
I. Treatment-naive, non-cirrhotic genotype 1, 2, 3, 4, 5, or 6.
Approved duration: 8 weeks
II. Treatment-naive genotype 1, 2, 3, 4, 5, or 6 with compensated cirrhosis.
Approved duration: 8 weeks
III. Treatment-experienced, non-cirrhotic genotype 1, 2, 4, 5, or 6 who have failed peginterferon/ribavirin and/or sofosbuvir ONLY.
Approved duration: 8 weeks
Notes:
(1) Treatment-experienced definitions vary by the genotype being treated. Health care professionals are advised to refer to the Maviret product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations.
(2) NS3/4A Pls include simeprevir, boceprevir, and telepravir.
(3) NS5A inhibitors include daclatasvir and ledipasvir. |
| | LU Authorization Period: 8 Weeks |
| 551 | 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;
(ii) Laboratory confirmed hepatitis C genotype 1, 2, 4, 5, or 6;
(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).
Exclusion criteria:
- Patients with genotype 1 who have relapsed but are treatment experienced on both an NS3/4A protease inhibitor and an NS5A inhibitor
- For use in combination with other hepatitis C antiviral agents
- Patients with decompensated cirrhosis or severe hepatic impairment (Child-Pugh C)
Retreatment is not funded. Retreatment for re-infection in patients who have received an adequate prior course of Maviret will be considered on a case-by-case basis through the Exceptional Access Program.
Treatment regimens for Maviret:
I. Treatment-experienced, genotype 1, 2, 4, 5, or 6 with compensated cirrhosis who have failed peginterferon/ribavirin and/or sofosbuvir ONLY.
Approved duration: 12 weeks
II. Treatment-experienced genotype 1 non-cirrhotic or compensated cirrhosis who have failed an NS3/4A protease inhibitor (2) but are NS5A inhibitor naive.
Approved duration: 12 weeks
Notes:
(1) Treatment-experienced definitions vary by the genotype being treated. Health care professionals are advised to refer to the Maviret product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations.
(2) NS3/4A PIs include simeprevir, boceprevir, and telepravir.
(3) NS5A inhibitors include daclatasvir and ledipasvir. |
| | LU Authorization Period: 12 Weeks. |
| 552 | 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;
(ii) Laboratory confirmed hepatitis C genotype 1 or 3;
(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).
Exclusion criteria:
- Patients with genotype 1 who have relapsed but are treatment experienced on both an NS3/4A protease inhibitor and an NS5A inhibitor
- For use in combination with other hepatitis C antiviral agents
- Patients with decompensated cirrhosis or severe hepatic impairment (Child-Pugh C)
Retreatment is not funded. Retreatment for re-infection in patients who have received an adequate prior course of Maviret will be considered on a case-by-case basis through the Exceptional Access Program.
Treatment regimens for Maviret:
I. Treatment-experienced genotype 1 non-cirrhotic or compensated cirrhosis who have failed an NS5A inhibitor (3) but is NS3/4A protease inhibitor naive.
Approved duration: 16 weeks
II. Treatment-experienced genotype 3 non-cirrhotic or compensated cirrhosis who have failed peginterferon/ribavirin and/or sofosbuvir ONLY.
Approved duration: 16 weeks
Notes:
(1) Treatment-experienced definitions vary by the genotype being treated. Health care professionals are advised to refer to the Maviret product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations.
(2) NS3/4A PIs include simeprevir, boceprevir, and telepravir.
(3) NS5A inhibitors include daclatasvir and ledipasvir. |
| | LU Authorization Period: 16 Weeks. |
