Vosevi · DIN 02467542 · 400mg & 100mg & 100mg · tablet
Limited Use — Reason for Use code 524 requiredMarketed · checked 2026-09-20
StatusLimited Use — Reason for Use code 524 required
Write on scriptLU code 524 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 524
Reason for Use code 524
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.
Coverage limit:
LU Authorization Period: 12 Weeks.
Coverage limit:
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.
No interchangeable product listed in the Ontario extract
Vosevi · DIN 02467542
Manufacturer: Gilead Sciences Canada, Inc.; listing date 2018-02-28
Health Canada: Marketed since 2017-09-18 · brand VOSEVI · ATC J05AP56 SOFOSBUVIR, VELPATASVIR AND VOXILAPREVIR · form Tablet · route Oral · ingredients SOFOSBUVIR 400 MG, VELPATASVIR 100 MG, VOXILAPREVIR 100 MG · company Gilead sciences canada inc · schedule Prescription
Vosevi: Formulary list price $714.2857/unit (unit not stated in source; not the patient's cost)
Ministry pays: $714.2857 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95590 · Verify on the e-Formulary ↗ (DIN 02467542)
Source record
DIN 02467542: Vosevi
Raw flags: sec12=Y, sec3=Y
Item: 081800389; group id 111; item number 0193; lccId 00298; manufacturer id GIL
Source form: Tab; strength: 400mg & 100mg & 100mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $714.2857; ministry $714.2857
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02467542
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95590
Shortage status: not checked (no credentials)