Product Details
Praluent
Alirocumab300 mg/2 mL
Solution for Injection
Single-Use 2-mL Prefilled Pen (Preservative-Free)
DIN/PIN/NPN
02547732
Manufacturer
Sanofi-Aventis Canada Inc.
Formulary Listing Date
2024-11-29
Unit Price
535.6600
Amount MOH Pays
535.6600
Coverage Status
Limited Use Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
C10AX14
Interchangeable Products
NOLU Clinical Criteria
LU Code | Auth. Period | Clinical Criteria |
---|---|---|
555 | 1 year | 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). |