Product Details

Maviret

Glecaprevir + Pibrentasvir
100 mg + 40 mg
Tablet


DIN/PIN/NPN

02467550

Manufacturer

AbbVie Corporation

Formulary Listing Date

2019-02-28  

Unit Price

238.0952

Amount MOH Pays

238.0952

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

J05AP57

Interchangeable Products

NO  

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
550 8 weeks

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.

551 12 weeks

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.

552 16 weeks

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.

 

EAP Criteria

Therapeutic Class Reimbursement Criteria
Hepatology Drugs

HEPATITIS C DRUGS 

The following drugs are reimbursed on the Ontario drug benefit formulary as limited use benefits for patients with Chronic Hepatitis C Infection upon meeting the LU criteria:

  1. Epclusa (sofosbuvir/velpatasvir) 400mg/100mg Tab 

  1. Harvoni (ledipasvir/sofosbuvir) 90mg/400mg Tab (GIL) 

  1. Ibavyr (ribavirin) 200mg, 400mg, 600mg Tab 

  1. Maviret (glecaprevir/pibrentasvir) 100 mg/40 mg Tab 

  1. Sovaldi (sofosbuvir) 400mg Tab 

  1. Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 400 mg/100 mg/100 mg Tab 

  1. Zepatier (elbasvir/grazoprevir) 50mg/100mg Tab 

The Ministry only considers funding of patient with Chronic Hepatitis C infection. 

Please refer to the Limited Use Criteria in the Ontario Drug Benefit Formulary for provincial reimbursement criteria for these products which are part of Ontario’s hepatitis C framework. 

Patients not meeting limited use criteria may be considered on a case-by-case basis through the Exceptional Access Program.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph