Harvoni · DIN 02432226 · 90mg & 400mg · tablet
Limited Use — Reason for Use code 482, 483, 484 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 482, 483, 484 required
Write on scriptLU code 482, 483, 484 (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 482, 483, 484
Reason for Use code 482
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:
- 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.
Coverage limit:
LU Authorization Period: 8 Weeks
Reason for Use code 483
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.
Coverage limit:
LU Authorization Period: 12 Weeks.
Reason for Use code 484
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.
Coverage limit:
LU Authorization Period: 24 Weeks.
Coverage limit:
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.
No interchangeable product listed in the Ontario extract
Harvoni · DIN 02432226
Manufacturer: Gilead Sciences Canada, Inc.; listing date 2017-02-28
Health Canada: Marketed since 2014-10-16 · brand HARVONI · ATC J05AP51 SOFOSBUVIR AND LEDIPASVIR, J05AP51 SOFOSBUVIR AND LEDIPASVIR · form Tablet · route Oral · ingredients SOFOSBUVIR 400 MG, LEDIPASVIR 90 MG · company Gilead sciences canada inc · schedule Prescription
Harvoni: Formulary list price $797.6190/unit (unit not stated in source; not the patient's cost)
Ministry pays: $797.6190 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=91668 · Verify on the e-Formulary ↗ (DIN 02432226)
Source record
DIN 02432226: Harvoni
Raw flags: sec12=Y, sec3=Y
Item: 081800370; group id 96; item number 0168; lccId 00276; manufacturer id GIL
Source form: Tab; strength: 90mg & 400mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $797.6190; ministry $797.6190
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02432226
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=91668
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02432226
Shortage record checked 2026-09-13T08:10:21.292534+00:00