Product Details
Vosevi
Sofosbuvir + Velpatasvir + Voxilaprevir400 mg + 100 mg + 100 mg
Tablet
DIN/PIN/NPN
02467542
Manufacturer
Gilead Sciences Canada, Inc.
Formulary Listing Date
2018-02-28
Unit Price
714.2857
Amount MOH Pays
714.2857
Coverage Status
Limited Use Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
J05AP56
Interchangeable Products
NOLU Clinical Criteria
| LU Code | Auth. Period | Clinical Criteria |
|---|---|---|
| Note: 1. Treatment-experienced are those who failed prior therapy with a HCV regimen containing: i. NS5A inhibitor* for genotype 1, 2, 3, 4, 5, or 6; OR ii. Sofosbuvir (Sovaldi) without an NS5A inhibitor for genotype 1, 2, 3, or 4 *NS5A inhibitors include: daclatasvir (Daklinza), elbasvir (as part of Zepatier), ledipasvir (as part of Harvoni), ombitasvir (as part of Holkira Pak), velpatasvir (as part of Epclusa), pibrentasvir (as part of Maviret) 2. Compensated cirrhosis (Child-Turcotte-Pugh A [i.e. Scores 5 to 6]) 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. | ||
| 524 | 12 weeks | For 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 regimen for Vosevi (sofosbuvir-velpatasvir-voxilaprevir): Treatment-experienced, non-cirrhotic or compensated cirrhosis (2) Approved duration: 12 weeks Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of Vosevi 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: |