Interactive Drug Benefit List
DIN/NPN/PIN 02453835 PRALUENT 150 MG / ML INJECTION ALIROCUMAB
240000 CARDIOVASCULAR DRUGS
240600 ANTILIPEMIC AGENTS
240624 PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE
Date Listed/Coverage Update: 01-Feb-2019
Unit Price: 256.2100
LCA Price: N/A
MAC Price:

N/A

Unit of Issue: Millilitre
Manufacturer: SANOFI - AVENTIS (SAV)
ATC: C10AX14
1
Interchangeable Products: No

Coverage Status: SPECIAL AUTHORIZATION
Applies to Clients of: Non-Group Coverage (Group 1)
Coverage for Seniors (Group 66)
Palliative Coverage (Group 20514, Please note:Your client may have Group 1 or Group 66 coverage)
Child and Family Services (Group 20403)
Alberta Child Health Benefit (Group 20400)
Children and Youth Services (Group 19824)
Income Support (Group 19823)
Learners Program (Group 22128)
Alberta Human Services (AISH) (Group 19823)
Alberta Adult Health Benefit (AAHB) (Group 23609)

Special Authorization Request Form:

Alirocumab/Evolocumab for HeFH Special Authorization Form (ABC 60060)

SPECIAL AUTHORIZATION

"Special authorization coverage may be provided for the reduction of Low Density Lipoprotein Cholesterol (LDL-C) if the following clinical criteria and conditions are met:

I) Patient has a definite or probable diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH) using the Simon Broome or Dutch Lipid Network criteria or genetic testing

AND

II) Patient is unable to reach LDL-C target (i.e., LDL-C < 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 high dose statin (e.g., atorvastatin 80 mg or rosuvastatin 40 mg) in combination with ezetimibe for at least 3 months.

OR

b) Confirmed adherence to ezetimibe for at least 3 months.
AND
Patient is unable to tolerate high dose statin, defined as meeting all of the following:
i) Inability to tolerate at least two statins with at least one started at the lowest starting daily dose,
AND
ii) For each statin (two statins in total), dose reduction is attempted for intolerable symptom (myopathy) or biomarker abnormality (creatine kinase (CK) > 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 biomarkers (CK > 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 either:
- Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out,
OR
- Patient developed confirmed and documented rhabdomyolysis.

OR

c) Confirmed adherence to ezetimibe for at least 3 months.
AND
Patient is statin contraindicated, i.e., active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal.

Initial coverage may be approved for either 75 mg once every two weeks or 300 mg once every 4 weeks for a period of 12 weeks.

- Patients prescribed alirocumab 300 mg once every 4 weeks must use the 150 mg/dose formulation.
- Patients will be limited to receiving a 4 week supply of alirocumab per prescription at their pharmacy.

For continued coverage beyond 12 weeks, the patient must meet the following criteria:
- Patient is adherent to therapy.
- Patient has achieved a reduction in LDL-C of at least 40% from baseline (4-8 weeks after initiation of alirocumab).

Continued coverage may be approved for either 75 mg once every 2 weeks or 300 mg once every 4 weeks for a period 12 months. The dosage may be adjusted to the maximum dosage of 150 mg administered every 2 weeks, depending on patient response.
- Patients are limited to 26 syringes/pens per year.

Ongoing coverage may be considered only if the following criteria are met at the end of each 12-month period:
- Patient is adherent to therapy.
- 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)."

All requests (including renewal requests) for alirocumab for Heterozygous Familial Hypercholesterolemia must be completed using the Alirocumab/Evolocumab for HeFH Special Authorization Request Form (ABC 60060).

Review Status / Past Decisions

Indication Reviewing
Body
Submission
Completion
Date
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
Review
Status
PRIMARY HYPERCHOLESTEROLEMIA (NON-FAMILIAL & HETEROZYGOUS FAMILIAL) Common Drug Review 2016/01/26 2019/02/01 Special Authorization
PRIMARY HYPERCHOLESTEROLEMIA (NON-FAMILIAL & HETEROZYGOUS FAMILIAL) Common Drug Review 2016/01/26 2016/07/20 View CDR - List with clinical criteria and/or conditions
Indication PRIMARY HYPERCHOLESTEROLEMIA (NON-FAMILIAL & HETEROZYGOUS FAMILIAL)
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2016/01/26
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2019/02/01
CDR
Recommendation
Review
Status
Special Authorization
Indication PRIMARY HYPERCHOLESTEROLEMIA (NON-FAMILIAL & HETEROZYGOUS FAMILIAL)
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2016/01/26
CDR
Recommendation
Date
2016/07/20
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with clinical criteria and/or conditions
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