Area map will cover the Alberta, British Columbia, Manitoba, New Brunswick, Nova Scotia, Ontario, Quebec, Saskatchewan

Repatha® is covered by most Canadian provincial formularies for HeFH

Area map will cover the Alberta, British Columbia, Manitoba, New Brunswick, Nova Scotia, Ontario, Quebec, Saskatchewan

Do you have coverage questions? Connect with the Amgen Canada Medical Information team for help.

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Province icon with checkmark and Repatha® logo

REPATHA® IS COVERED BY THE ALBERTA DRUG BENEFIT LIST FOR HeFH (SPECIAL AUTHORIZATION) and by most private drug plans for HeFH and ASCVD11,13

Repatha® is indicated for the reduction of elevated LDL-C in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH] and ASCVD):

  • as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C
  • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated.

CLINICAL CRITERIA FOR SPECIAL AUTHORIZATION

For the treatment of HeFH in patients who meet the following criteria: Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing

AND

LDL-C target and treatment: 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 confirmed adherence to high-dose statin (i.e., atorvastatin 80 mg or rosuvastatin 40 mg) in combination with ezetimibe for at least a total of 3 months

OR

Confirmed adherence to ezetimibe for at least a total of 3 months and the inability to tolerate high-dose statin defined as:

Inability to tolerate at least two statins with at least one started at the lowest starting daily dose

AND

For each statin (two statins in total), dose reduction is attempted for intolerable symptom (myopathy) or biomarker abnormality (CK > 5x ULN) resolution rather than discontinuation of statin altogether

AND

For each statin (two statins in total), intolerable symptoms (myopathy) or abnormal biomarkers (CK > 5x ULN) changes are reversible upon statin discontinuation but reproducible by rechallenge of statins where clinically appropriate

AND one of the following:

Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out

OR

Patient developed confirmed and documented rhabdomyolysis

OR

Confirmed adherence to ezetimibe for at least 3 months
AND
Patient is statin-contraindicated, i.e., active liver disease, unexplained persistent elevations of serum transaminases exceeding 3x ULN

See additional criteria

Initial coverage may be approved for either 140 mg every 2 weeks or 420 mg every month for a period of 3 months. Patients prescribed evolocumab 420 mg every month must use the 420 mg/dose formulation. Patients will be limited to receiving a one-month supply of evolocumab per prescription at their pharmacy.

For continued coverage beyond 3 months, 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 evolocumab)

Continued coverage may be approved for 140 mg every 2 weeks or 420 mg every month for a period of 12 months. Patients prescribed evolocumab 140 mg every 2 weeks are limited to 26 doses per year. Patients prescribed evolocumab 420 mg every month are limited to 12 doses 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 evolocumab) of at least 40% from baseline since initiation of PCSK9 inhibitor. LDL-C should be checked periodically with continued treatment with PCSK9 inhibitors (i.e., every 6 months)

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

ASCVD=atherosclerotic cardiovascular disease; CK=creatine kinase; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol; PCSK9=proprotein convertase subtilisin/kexin type 9; ULN=upper limit of normal.

REPATHA® IS COVERED BY BRITISH COLUMBIA PHARMACARE (SPECIAL AUTHORITY) FOR HeFH and by most private drug plans for HeFH and ASCVD11,12

Repatha® is indicated for the reduction of elevated LDL-C in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH] and ASCVD):

  • as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C
  • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated.

SPECIAL AUTHORITY: INITIAL APPROVAL CRITERIA (12 WEEKS)

For the treatment of HeFH* as an adjunct to maximally tolerated HMG-CoA Reductase Inhibitors (statins) therapy in adult patients who are unable to reach target LDL-C levels† when:

  • The patient has confirmed adherence to treatment with atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 6 months.
    • OR
  • The patient is unable to tolerate at least two HMG-CoA Reductase Inhibitors (statins)‡.
    • OR
  • The patient has confirmed rhabdomyolysis.
    • OR
  • Treatment with HMG-CoA Reductase Inhibitors (statins) is contraindicated.
    • AND
  • The patient has confirmed adherence to treatment with ezetimibe for a minimum of 3 months.

Special Notes

* Definite or probable diagnosis of HeFH is determined using the Simon Broome or Dutch Lipid Network criteria or genetic testing.
† Target LDL-C levels are: For primary prevention, a ≥ 50% reduction in LDL-C from untreated baseline; For secondary prevention, an LDL-C < 2.0 mmol/L.
‡ Inability to tolerate at least two HMG-CoA Reductase Inhibitors (statins): Dose reduction and re-challenge of each HMG-CoA Reductase Inhibitor (statin) must be attempted to resolve intolerable symptoms or biomarker abnormality (CK > 5 times the ULN) before discontinuing a treatment.

See additional criteria

SPECIAL AUTHORITY: RENEWAL CRITERIA (1 YEAR)§¶

Approval will be granted if the following criteria are met:

  • The patient is adherent to therapy.
    • AND
  • The patient has achieved a reduction in LDL-C of at least 40% from baseline within 4–8 weeks after initiation of evolocumab.
    • AND
  • The patient maintains a significant reduction in LDL-C (with continuation of evolocumab) of at least 40% from baseline since initiation of evolocumab.

Special Notes

§ Patients prescribed evolocumab 140 mg every 2 weeks are limited to 26 of 140 mg prefilled autoinjectors per year.
¶ Patients prescribed evolocumab 420 mg monthly are limited to 12 prefilled cartridges per year.

ASCVD=atherosclerotic cardiovascular disease; CK=creatine kinase; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol; ULN=upper limit of normal.

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REPATHA® IS LISTED BY MANITOBA DRUG BENEFITS AND INTERCHANGEABILITY FORMULARY UNDER EXCEPTION DRUG STATUS FOR HeFH (criteria exists)

Repatha® is listed for the treatment of HeFH. Full prescribing criteria are available from the EDS Office.

Please address request to:
Provincial Drug Programs Review Committee
300 Carlton Street
Winnipeg MB, R3B 3M9
Or
Fax at 204 942-2030 or 1-877-208-3588

Repatha® is covered by the majority of private drug plans for HeFH and ASCVD.

ASCVD=atherosclerotic cardiovascular disease; EDS=Exception Drug Status. HeFH=heterozygous familial hypercholesterolemia.
Reference: Manitoba Drug Benefits and Interchangeability Formulary, www.gov.mb.ca/health/mdbif/bulletin96.pdf. Bulletin #96. Accessed November 15, 2022.

Province icon with checkmark and Repatha® logo

REPATHA® IS COVERED BY THE NEW BRUNSWICK DRUG PLAN FORMULARY FOR HeFH (EXCEPTION DRUG STATUS) and by most private drug plans for HeFH and ASCVD11,18

Repatha® is indicated for the reduction of elevated LDL-C in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH] and ASCVD):

  • as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C
  • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated.

CLINICAL CRITERIA FOR EXCEPTION DRUG STATUS

For the treatment of heterozygous familial hypercholesterolemia (HeFH) in adult patients who require additional lowering of low-density lipoprotein cholesterol (LDL-C) if the following criteria are met:

  • Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing; AND
  • Patient is unable to reach LDL-C target (< 2.0 mmol/L or at least a 50% reduction in LDL-C from untreated baseline) despite confirmed adherence to at least 3 months of continuous treatment with:
    • high-dose statin (e.g., atorvastatin 80 mg, rosuvastatin 40 mg) in combination with ezetimibe; or
    • ezetimibe alone, if high dose statin is not possible due to rhabdomyolysis, contraindication, or intolerance

Initial renewal criteria:

  • A reduction in LDL-C of at least 40% from baseline or has reached a target LDL-C < 2.0 mmol/L

Subsequent renewal criteria:

  • The patient continues to maintain a reduction in LDL-C of at least 40% from baseline or has reached a target LDL-C < 2.0 mmol/L

See additional criteria

Clinical notes:

  1. LDL-C levels must be provided.
  2. Intolerance to high-dose statin will be considered if patient has developed documented rhabdomyolysis, myopathy or abnormal biomarkers (i.e., creatine kinase > 5 times the upper limit of normal) after trial of at least two statins; and
    • for each statin, dose reduction was attempted rather than statin discontinuation, and intolerance was reversible upon statin discontinuation, but reoccurred with statin re-challenge where clinically appropriate; and
    • at least one statin was initiated at the lowest daily starting dose; and
    • other known causes of intolerance have been ruled out.
  3. For patients who cannot take ezetimibe due to an intolerance or contraindication, details must be provided.

Claim notes:

  • Approvals will be for a maximum of 140 mg every 2 weeks or 420 mg monthly
  • Initial approval: 6 months
  • Renewal approval: 1 year

ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol
Province icon with checkmark and Repatha® logo

REPATHA® IS COVERED BY THE NOVA SCOTIA PHARMACARE FORMULARY (EXCEPTION DRUG STATUS) FOR HeFH and by most private drug plans for HeFH and ASCVD11,19

Repatha® is indicated for the reduction of elevated LDL-C in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH] and ASCVD):

  • as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C
  • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated.

CLINICAL ELIGIBILITY CRITERIA

For the treatment of HeFH in adult patients who require additional lowering of LDL-C if the following criteria are met:

  • Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing;
    • AND
  • Patient is unable to reach LDL-C target (< 2.0 mmol/L or at least a 50% reduction in LDL-C from untreated baseline) despite confirmed adherence to at least 3 months of continuous treatment with:
    • high-dose statin (e.g., atorvastatin 80 mg, rosuvastatin 40 mg) in combination with ezetimibe;
      • OR
    • ezetimibe alone if high-dose statin is not possible due to rhabdomyolysis, contraindication or intolerance.

Initial renewal criteria:

A reduction in LDL-C of at least 40% from baseline or has reached a target LDL-C < 2.0 mmol/L.

Subsequent renewal criteria:

The patient continues to maintain a reduction in LDL-C of at least 40% from baseline or has reached a target LDL-C < 2.0 mmol/L.

See additional criteria

Clinical notes:

  1. LDL-C levels must be provided.
  2. Intolerance to high-dose statin will be considered if patient has developed documented myopathy or abnormal biomarkers (i.e., CK >5xULN) after trial of at least two statins; AND
    • for each statin, dose reduction was attempted rather than statin discontinuation, and intolerance was reversible upon statin discontinuation, but reoccurred with statin re-challenge where clinically appropriate; AND
    • at least one statin was initiated at the lowest daily starting dose; AND
    • other known causes of intolerance or abnormal biomarkers have been ruled out.
  3. For patients who cannot take a statin due to an intolerance or contraindication, details must be provided (i.e., confirmed rhabdomyolysis, active liver disease, unexplained persistent elevations of serum transaminases exceeding 3xULN).
  4. For patients who cannot take ezetimibe due to an intolerance or contraindication, details must be provided.

Claim notes:

  • Maximum dose approved: 140 mg every 2 weeks or 420 mg monthly
  • Initial approval: 6 months
  • Renewal approval: 1 year

ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; CK=creatinine kinase; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol; ULN=upper limit of normal.

Province icon with checkmark and Repatha® logo

REPATHA® IS COVERED BY ONTARIO DRUG BENEFIT PROGRAM FOR HeFH (LU CODE 527) and by most private drug plans for HeFH and ASCVD11,16

Repatha® is indicated for the reduction of elevated LDL-C in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH] and ASCVD):

  • as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C
  • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated.

LU CODE 527 CLINICAL CRITERIA

For the treatment of HeFH in patients 18 years of age or older who meet the following criteria: Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing;

AND

LDL-C target and treatment: Unable to reach 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 despite confirmed adherence to high-dose statin (i.e., atorvastatin 80 mg or rosuvastatin 40 mg) in combination with ezetimibe for at least a total of 3 months

OR

Confirmed adherence to ezetimibe for at least a total of 3 months and inability to tolerate high-dose statin defined as:

  • Inability to tolerate at least two statins with at least one started at the lowest starting daily dose
    • AND
  • 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 [ULN]) resolution rather than discontinuation of statin altogether
    • AND
  • For each statin (two statins in total), intolerable symptoms (myopathy) or abnormal biomarker (CK >5xULN) changes are reversible upon statin discontinuation but reproducible by rechallenge of statins where clinically appropriate
AND one of the following:

Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out

OR

Patient developed confirmed and documented rhabdomyolysis

OR

Patient is statin-contraindicated, i.e., active liver disease, unexplained persistent elevations of serum transaminases exceeding 3x ULN

See additional criteria

Treatment with Repatha® should be discontinued if the patient does not meet all of the following:

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 Repatha®).
Patient continues to have a significant reduction in LDL-C (with continuation of Repatha®) of at least 40% from baseline since initiation of PCSK9 inhibitor. LDL-C should be checked periodically with continued treatment with PCSK9 inhibitors (i.e., every 6 months).

Patients prescribed Repatha® 140 mg every two weeks are limited to 26 prefilled syringes per year. Patients prescribed Repatha® 420 mg every month must use the automated mini-doser and are limited to 12 per year.

LU Authorization Period: 1 year

ASCVD=atherosclerotic cardiovascular disease; CK=creatine kinase; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol; LU=limited use; PCSK9=proprotein convertase subtilisin/kexin type 9.

Province icon with checkmark and Repatha® logo

REPATHA® IS COVERED BY RAMQ (EXCEPTIONAL MEDICATION) FOR HeFH and by most private drug plans for HeFH and ASCVD 11,17

Repatha® is indicated for the reduction of elevated LDL-C in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH] and ASCVD):

  • as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C
  • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated.

RAMQ (EXCEPTIONAL MEDICATION) CRITERIA FOR HeFH PATIENTS

Diagnosis: HeFH in adults, confirmed by genotyping or phenotyping

Phenotyping defined as LDL-C > 4.9 mmol/L in adults prior to initiation of treatment and at least one of the following:

  • Family history of HeFH confirmed by genotyping in a first-degree relative
  • Presence in a first-degree relative of an LDLR, ApoB or PCSK9 gene mutation that causes familial hypercholesterolemia
  • Presence of xanthomas in the patient or in a first- or second-degree relative
  • Presence of corneal arcus before the age of 45 years in a first-degree relative
  • Family history of LDL-C > 4.9 mmol/L in a first-degree adult relative or ≥ 4 mmol/L in a first-degree relative under 18 years
  • Family history of total cholesterol > 7.5 mmol/L in a first- or second-degree adult relative or > 6.7 mmol/L in a first-degree relative under 16 years

Current treatment: On optimal dose of statin plus ezetimibe, which has not allowed for adequate control of the cholesterolemia, unless there is a serious intolerance or a contraindication.

Adequate control of cholesterol defined as:

  • In patients with no ASCVD, at least 50% reduction in LDL-C from baseline, i.e., prior to any lipid-lowering therapy
  • In patients with ASCVD, an LDL-C < 2.0 mmol/L

The initial request is authorized for a maximum period of 4 months.

For subsequent requests, the physician must provide evidence showing the treatment’s beneficial effects, i.e., reduction ≥ 40% in LDL-C level versus baseline value prior to initiating treatment with evolocumab. Subsequent requests are authorized for a maximum duration of 12 months.

Authorizations for evolocumab are given for a maximum dose of 140 mg every 2 weeks or 420 mg every month.

ApoB=apolipoproteinB; ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol; LDLR=low-density lipoprotein receptor; PCSK9=proprotein convertase subtilisin/kexin type 9.

Province icon with checkmark and Repatha® logo

REPATHA® IS COVERED BY THE SASKATCHEWAN DRUG BENEFIT LIST FOR HeFH (EXCEPTION DRUG STATUS) and by most private drug plans for HeFH and ASCVD11,14

Repatha® is indicated for the reduction of elevated LDL-C in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH] and ASCVD):

  • as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C
  • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated.

CLINICAL CRITERIA FOR EXCEPTION DRUG STATUS

For the treatment of HeFH in patients who meet the following criteria: Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing

AND

Who are 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 despite confirmed adherence to high-dose statin (i.e., atorvastatin 80 mg or rosuvastatin 40 mg) in combination with ezetimibe for at least a total of 3 months

OR

Unable to tolerate high-dose statin defined as all of the following:

Confirmed adherence to ezetimibe for at least a total of 3 months

AND

Inability to tolerate at least two statins with at least one started at the lowest starting daily dose

AND

For each statin (two statins in total), dose reduction is attempted for intolerable symptom (myopathy) or biomarker abnormality (CK > 5x ULN) resolution rather than discontinuation of statin altogether

AND

For each statin (two statins in total), intolerable symptoms (myopathy) or abnormal biomarkers (CK > 5x ULN) changes are reversible upon statin discontinuation but reproducible by rechallenge of statins where clinically appropriate

AND one of the following:

Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out

OR

Patient developed confirmed and documented rhabdomyolysis

OR

Patient is statin-contraindicated, i.e., active liver disease, unexplained persistent elevations of serum transaminases exceeding 3xULN

See additional criteria

Quantity limits

  • Patients prescribed Repatha® 140 mg every 2 weeks are limited to 26 prefilled syringes per year
  • Patients prescribed Repatha® 420 mg every month must use the automated mini doser (AMD) and are limited to 12 AMDs per year

Discontinuation criteria

Treatment with Repatha® should be discontinued if the patient does not meet all of the following:

  • Adherent to therapy
  • Achieved a reduction in LDL-C of at least 40% from baseline (4-8 weeks after initiation of Repatha®)
  • Continues to have a significant reduction in LDL-C (with continuation of Repatha®) of at least 40% from baseline since initiation of PCSK9 inhibitor. LDL-C should be checked periodically with continued treatment with PCSK9 inhibitors (i.e., every 6 months)

AMD=automated mini doser; ASCVD=atherosclerotic cardiovascular disease; CK=creatine kinase; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol; PCSK9=proprotein convertase subtilisin/kexin type 9; ULN=upper limit of normal.

Province icon with checkmark and Repatha® logo

REPATHA® is covered by the PEI Pharmacare Formulary for HeFH (Special Authorization) and by the majority of private drug plans for HeFH and ASCVD11,20

Repatha® is indicated for the reduction of elevated LDL-C in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH] and ASCVD):

  • as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C
  • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated.

CLINICAL CRITERIA FOR SPECIAL AUTHORIZATION

For the treatment of HeFH in adult patients who require additional lowering of LDL-C, if the following criteria are met:

  • Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing; AND
  • Patient is unable to reach LDL-C target (less than 2.0 mmol/L or at least a 50% reduction in LDL-C from untreated baseline) despite confirmed adherence to at least 3 months of continuous treatment with:
    • high-dose statin (e.g., atorvastatin 80 mg, rosuvastatin 40 mg) in combination with ezetimibe; OR
    • ezetimibe alone, if high-dose statin is not possible due to rhabdomyolysis, contraindication or intolerance

Initial renewal criteria:

  • A reduction in LDL-C of at least 40% from baseline or has reached a target LDL-C less than 2.0 mmol/L

Subsequent renewal criteria:

  • The patient continues to maintain a reduction in LDL-C of at least 40% from baseline or has reached a target LDL-C less than 2.0 mmol/L

Clinical notes:

  1. LDL-C levels must be provided.
  2. Intolerance to high-dose statin will be considered if patient has developed documented myopathy or abnormal biomarkers (i.e., creatinine kinase greater than 5 times the upper limit of normal) after trial of at least two statins AND
    • for each statin, dose reduction was attempted rather than statin discontinuation, and intolerance was reversible upon statin discontinuation, but reoccurred with statin re-challenge where clinically appropriate; AND
    • at least one statin was initiated at the lowest daily starting dose; AND
    • other known causes of intolerance have been ruled out.
  3. For patients who cannot take ezetimibe due to an intolerance or contraindication, details must be provided.

Claim notes:

  • Approvals will be for a maximum of 140 mg every 2 weeks or 420 mg monthly
  • Initial approval period: 6 months
  • Renewal approval period: 1 year

ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol; PEI = Prince Edward Island.
Province icon with checkmark and Repatha® logo

REPATHA® is covered by the Newfoundland and Labrador Prescription Drug Program for HeFH (Special Authorization) and by the majority of private drug plans for HeFH and ASCVD11,21

Repatha® is indicated for the reduction of elevated LDL-C in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH] and ASCVD):

  • as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C
  • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated.

CLINICAL CRITERIA FOR SPECIAL AUTHORIZATION

For the treatment of HeFH in adult patients who require additional lowering of LDL-C if the following criteria are met:

  • Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing AND
  • Patient is unable to reach LDL-C target (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:
    • confirmed adherence to high-dose statin (e.g., atorvastatin 80 mg or rosuvastatin 40 mg) in combination with ezetimibe for at least 3 months of continuous treatment OR
    • Confirmed adherence to ezetimibe for at least a total of 3 months and inability to tolerate high-dose statin as defined:
  • Inability to tolerate at least 2 statins with at least one started at the lowest starting daily dose, AND
    • For each statin (2 statins in total), dose reduction is attempted for intolerable symptom (myopathy) or biomarker abnormality CK >5 times the upper limit of normal) resolution rather than discontinuation of statin altogether, AND
    • For each statin (2 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
    • One of the following:
      • Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out OR
      • Patient developed confirmed and documented rhabdomyolysis OR
      • Patient is statin contraindicated i.e., active liver disease, unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal

ASCVD=atherosclerotic cardiovascular disease; CK=creatine kinase; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol.

Most private drug plans in Canada cover Repatha® for HeFH and ASCVD11*

Tips for completing special authorization forms for patients with private insurance

To assist your clinic in completing private insurance special authorization forms for your patients who have been prescribed Repatha®, the following suggestions and tips have been compiled. You may find these tips useful for filling in reimbursement criteria and history as requested, according to your individual patient’s diagnosis and treatment history.

Please ensure that the primary indication for treatment is specified:

  • Adult patients with ASCVD: prevention of cardiovascular events: adjunct to diet and standard of care therapy to reduce risk of MI, stroke and coronary revascularization; or
  • Primary hyperlipidemia including HeFH: reduction of elevated LDL-C. See below for Repatha® indications.

Forward completed special authorization forms to RepathaREADY®

If the patient is diagnosed with both HeFH and ASCVD, HeFH is documented more often as the underlying reason for their ASCVD. Most insurers accept probable diagnosis of HeFH through Simon Broome assessment or the Dutch Lipid Clinic Network criteria.

Clinical documentation to include recent lipid panel (within 3 months) confirming an LDL-C level above threshold of 1.8 mmol/L; some patients may require bloodwork within one month of the first Repatha® dose.

Please provide complete history of lipid-lowering treatments.

Please provide your patient's history with lipid-lowering medication(s).

  • Remember to document intolerance, different trials, as well as re-challenges or contraindications to prior lipid-lowering medication(s) such as statins and ezetimibe.

Many insurers require LDL-C level verification prior to renewal.

Ensure the patient has their LDL-C level checked 1 to 3 months prior to the insurance expiry date, which varies depending on the patient’s insurance plan (most are 6 months or 1 year).

Repatha® Special Authorization Forms Guidance

RepathaREADY® Assist co-pay card

front and back cover of co-pay card front and back cover of co-pay card

Designed to provide an option for eligible patients to access financial assistance for their Repatha® prescription, including those with:

  • Private insurance
    • Up to 100% of the drug cost is covered for all eligible Repatha® patients with private insurance deductibles11†
  • Public insurance
  • No insurance coverage

Requesting cards

Please contact your Repatha® representative for additional details about the RepathaREADY® Assist card and to request the number of cards you would like to receive. Details on card activation will be provided directly to patients by RepathaREADY®.

RepathaREADY® Assist Card: Providing up to 50% copay support11‡

* 90% of the top private insurance companies currently cover Repatha®; 20% of private insurance plans are “Open Plans” and do not require special authorization forms.
†Coverage support does not include pharmacy acquisition cost mark-up or dispensing fee.
‡ Restrictions apply for some British Columbia patients. Contact RepathaREADY® for details.
ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol.

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