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ALIROCUMAB

All injection strengths: Limited Use (codes 555)

Praluent · DIN 02547732 · 300mg/2mL · injection solution-pre-filled pen 2mL Pk (Preservative-Free)

Limited Use — Reason for Use code 555 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 555 required
Write on scriptLU code 555 (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 555
Reason for Use code 555 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; (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; (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. Treatment with alirocumab 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 alirocumab). 3. Patient continues to have a significant reduction in LDL-C (with continuation of alirocumab) 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). Patients prescribed alirocumab 75mg every two weeks must use the 75mg/mL dosage strength and are limited to 26 pre-filled pens (PFP) per year. Patients prescribed alirocumab 150mg every two weeks must use the 150mg/mL dosage strength and are limited to 26 PFP per year. Patients prescribed alirocumab 300mg every four weeks may use either the 150mg/mL dosage strength (limited to 26 PFP per year) or the 300mg/2mL dosage strength (limited to 13 PFP per year). Coverage limit: LU Authorization Period: 1 year
No interchangeable product listed in the Ontario extract
Praluent · DIN 02547732 Manufacturer: Sanofi-Aventis Canada Inc.; listing date 2024-11-29 Health Canada: Marketed since 2024-09-16 · brand PRALUENT · ATC C10AX14 ALIROCUMAB · form Solution · route Subcutaneous · ingredients ALIROCUMAB 300 MG/2ML · company Sanofi-aventis canada inc · schedule Prescription, Schedule d
Check this DIN again · Health Canada product record

Praluent: Formulary list price $546.9000/unit (unit not stated in source; not the patient's cost)

Ministry pays: $546.9000 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=103666 · Verify on the e-Formulary ↗ (DIN 02547732)

Source record
DIN 02547732: Praluent Raw flags: sec12=Y, sec3=Y Item: 240624005; group id 310; item number 0685; lccId 00315; manufacturer id SAC Source form: Inj Sol-Pref Pen 2mL Pk (Preservative-Free); strength: 300mg/2mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $546.9000; ministry $546.9000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02547732 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103666
Shortage status: resolved shortage (ended 2026-08-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02547732
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (24:06:24 PCSK9 Inhibitors) and how they are covered
No products matched this class search: “24:06:24”. This is a search result, not a decision about coverage. Try a different class name, abbreviation or class code. Search this as a medication name or DIN
Full class listing Related classes: 24:08:16 Central Alpha-Agonists, 24:32:08 Angiotensin II Receptor Antagonists Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1. Indications Prevention of Cardiovascular Events PRALUENT (alirocumab injection) is indicated in combination with a maximum tolerated dose of a statin, with or without other lipid lowering therapies, to reduce the risk of myocardial infarction, ischemic stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. Primary Hyperlipidemia PRALUENT (alirocumab injection) is indicated for the reduction of low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (heterozygous familial and non-familial): • As an adjunct to diet and statin therapy, with or without other lipid-lowering therapies; • As an adjunct to diet, as monotherapy or in combination with other non-statin lipid-modifying therapies, in patients for whom a statin is contraindicated. 1.1. Pediatrics The efficacy and safety of PRALUENT in these patients have not been established; therefore, Health Canada has not authorized an indication for pediatric use. 1.2. Geriatrics In primary hypercholesterolemia controlled studies, 1158 patients (34.7 %) treated with PRALUENT were ≥ 65 years of age, including 241 patients (7.2 %) ≥ 75 years … https://pdf.hres.ca/dpd_pm/00085406.PDF PM date: 2026-07-20 Source product: PRALUENT; DIN 02453819; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.