Leqvio · DIN 02518376 · 284mg/1.5mL · injection solution-1.5mL pre-filled syringe
Limited Use — Reason for Use code 732 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 732 required
Write on scriptLU code 732 (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 732
Reason for Use code 732
For the treatment of Heterozygous Familial Hypercholesterolemia (HeFH) in patients 18 years of age or older who meet the following criteria:
1. Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing;
AND
2. Unable to reach Low Density Lipoprotein Cholesterol (LDL-C) target (i.e., LDL-C less than 2.0 mmol/L for secondary prevention) or at least a 50% reduction in LDL-C from untreated baseline for primary prevention despite:
A) Confirmed adherence to ezetimibe for at least a total of 3 months in combination with high dose statin (e.g., atorvastatin 80mg or rosuvastatin 40mg);
OR
B) Confirmed adherence to ezetimibe for at least a total of 3 months and inability to tolerate high dose statin defined as:
(i) Inability to tolerate at least 2 statins with at least one started at the lowest starting dose; AND
(ii) For each statin (two statins in total), dose reduction is attempted for intolerable symptom (myopathy) or biomarker abnormality (creatine kinase (CK) greater than 5 times the upper limit of normal) resolution rather than discontinuation of statin altogether; AND
(iii) For each statin (two statins in total), intolerable symptoms (myopathy) or abnormal biomarker (creatine kinase (CK) greater than 5 times the upper limit of normal) changes are reversible upon statin discontinuation but reproducible by re-challenge of statins where clinically appropriate; AND
(iv) One of the following:
(I.) Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out;
(II.) Patient developed confirmed and documented rhabdomyolysis;
(III.) Patient is statin contraindicated i.e. active liver disease, unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal.
Inclisiran will not be funded when used in combination with proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies.
Treatment with inclisiran should be discontinued if the patient does not meet all of the following:
1. Patient is adherent to therapy.
2. Patient has achieved a reduction in LDL-C of at least 40% from baseline (4-8 weeks after initiation of inclisiran).
3. Patient continues to have a significant reduction in LDL-C (with continuation of inclisiran) of at least 40% from baseline since initiation of PCSK9 inhibitor. LDL-C should be checked periodically with continued treatment with PCSK9 inhibitors (e.g., every 6 months).
Dosing: 284mg administered as a single subcutaneous injection: initially, again at 3 months, followed by every 6 months
Coverage limit:
LU Authorization Period: 1 year
No interchangeable product listed in the Ontario extract
Leqvio · DIN 02518376
Manufacturer: Novartis Pharma Canada Inc.; listing date 2025-10-31
Health Canada: Marketed since 2022-09-26 · brand LEQVIO · ATC C10AX16 INCLISIRAN · form Solution · route Subcutaneous · ingredients INCLISIRAN (INCLISIRAN) 284 MG/1.5ML · company Novartis pharmaceuticals canada inc · schedule Prescription
Leqvio: Formulary list price $2898.9048/unit (unit not stated in source; not the patient's cost)
Ministry pays: $2898.9048 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=100766 · Verify on the e-Formulary ↗ (DIN 02518376)
Source record
DIN 02518376: Leqvio
Raw flags: sec12=Y, sec3=Y
Item: 240692003; group id 311; item number 0686; lccId 00418; manufacturer id NOV
Source form: Inj Sol-1.5mL Pref Syr; strength: 284mg/1.5mL
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $2898.9048; ministry $2898.9048
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02518376
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100766
Shortage status: not checked (no credentials)