Product Details
Harvoni
Ledipasvir + Sofosbuvir90 mg + 400 mg
Tablet
DIN/PIN/NPN
02432226
Manufacturer
Gilead Sciences Canada, Inc.
Formulary Listing Date
2017-02-28
Unit Price
797.6190
Amount MOH Pays
797.6190
Coverage Status
Limited Use Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
J05AP51
Interchangeable Products
NOLU Clinical Criteria
| LU Code | Auth. Period | Clinical Criteria |
|---|---|---|
| Note: 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. | ||
| 482 | 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; AND (ii) Laboratory confirmed hepatitis C genotype 1; 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-naive, non-cirrhotic, recent quantitative hepatitis C viral load less than 6 M IU/mL Approved duration: 8 weeks 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. |
| 483 | 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; AND (ii) Laboratory confirmed hepatitis C genotype 1; 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: I. Treatment-naive, without cirrhosis, viral load greater than or equal to 6 M IU/mL; or treatment-naive with cirrhosis; or treatment-experienced without cirrhosis Approved duration: 12 weeks II. Treatment-naive or treatment-experienced with decompensated cirrhosis (2) Approved regimen: 12 weeks in combination with ribavirin (Ibavyr) III. Treatment-naive or treatment-experienced liver transplant recipients without cirrhosis or with compensated 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. |
| 484 | 24 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; AND (ii) Laboratory confirmed hepatitis C genotype 1; 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 regimen: - Treatment-experienced, cirrhotic: Approved duration: 24 weeks 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. |
EAP Criteria
| Therapeutic Class | Reimbursement Criteria |
|---|---|
| Hepatology Drugs | HEPATITIS C DRUGSThe 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:
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: |