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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).