Product Details

Praluent

Alirocumab
75 mg/mL
Solution for Injection
Single-Use 1-mL Prefilled Pen (Preservative-Free)

DIN/PIN/NPN

02453819

Manufacturer

Sanofi-Aventis Canada Inc.

Formulary Listing Date

2019-03-28  

Unit Price

267.8300

Amount MOH Pays

267.8300

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

C10AX14

Interchangeable Products

NO  

LU 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).

 

EAP Criteria

NO

Product Monograph

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