Pharmacy Policy Bulletin
PCSK9 Inhibitors – Commercial and Healthcare Reform
Number: J-0434 Category: Prior Authorization
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial:

Prior Authorization (1.):

1.  PCSK-9 = Yes w/ Prior Authorization

 

Healthcare Reform: Not Applicable
Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

None


Drugs Products
  • Praluent (alirocumab)
  • Repatha (evolocumab)
  • Repatha (evolocumab) SureClick
  • Repatha (evolocumab) Pushtronex
FDA-Approved Indications:
  • Praluent
    • To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
    • As adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol LDL-C.
  • Repatha
    • To reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.
    • As an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe) for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C).
    • As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional LDL-C lowering.


Background:
  • The PCSK9 enzyme binds to LDL receptors present on the surface of hepatocytes and degrades the receptors. This results in fewer LDL receptors available on hepatocytes to remove excess LDL-C from the blood. Therefore, PCSK9 inhibitors hinder this process and lower LDL levels.
  • Clinical atherosclerotic cardiovascular disease (ASCVD) includes acute coronary syndromes, or a history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin. Repatha (evolocumab) and Praluent (alirocumab) are indicated in patients with established ASCVD and hyperlipidemia and thus should only be used as secondary prophylaxis to prevent an additional cardiovascular event.
  • Guideline based treatment options that should be considered for the management of blood cholesterol including the following:
    • All individuals encouraged to live a heart-healthy lifestyle throughout their life.
    • In patients with clinical ASCVD, reduce LDL-C with high-intensity statin therapy or maximally tolerated statin therapy. Use a maximally tolerated statin to lower LDL-C levels by ≥ 50%.
    • If very high-risk ASCVD, use a LDL-C threshold of 70 mg/dL and consider addition of non-statins to statin therapy. It is reasonable to add ezetimibe to maximally tolerated statin therapy when the LDL-C level remains ≥ 70 mg/dL. If LDL-C remains ≥ 70 mg/dL while on maximally tolerated statin and ezetimibe, add PCSK9 inhibitor.
    • In patients with severe primary hypercholesterolemia (LDL-C level ≥ 190 mg/dL), without calculating 10-year ASCVD risk, begin high-intensity statin therapy. If LDL-C levels remain ≥ 100 mg/dL, add ezetimibe. If LDL-C continues to be above goal while on statin plus ezetimibe and has risk of ASCVD events, a PCSK9 inhibitor can be considered.
    • In patients 40 to 75 years of age with diabetes mellitus and LDL-C ≥ 70 mg/dL, start moderate-intensity statin therapy without calculating 10-year ASCVD risk.
    • In adults 40 to 75 years of age without diabetes mellitus and with LDL-C levels ≥ 70 mg/dL at a 10-year ASCVD risk of ≥ 7.5%, start a moderate-intensity statin if a discussion of treatment options favors statin therapy.
    • In patients 30 to 75 years of age with HeFH of ≥ 100 mg/dL while taking maximally tolerated statin and ezetimibe therapy, the addition of a PCSK9 inhibitor may be considered.
    • HoFH treatment is recommended to be managed by a lipid specialist as care is beyond the scope of the guideline as it is harder to treat and more rare than HeFH.
  • The Simon Broom Criteria and Dutch Lipid Clinic Criteria are accepted resources for FH diagnosis. Dutch Lipid Clinic Network assigns points based on low density lipoprotein cholesterol levels, personal history of early ASCVD, family history of early ASCVD, or high cholesterol in a first-degree relative, and personal and physical examination findings. A score > 8 indicates a definitive familial hypercholesterolemia diagnosis. Simon Broom Criteria is based on the lipid profile in familial hypercholesterolemia, a family history of hypercholesterolemia and/or premature ischemic heart disease, or the presence of tendon xanthomata.
  • Prescribing Considerations:
    • In clinical trials, PCSK9 inhibitors were used in conjunction with statins. ACC/AHA guidelines continue to promote the use of statins for secondary prevention of cardiovascular events. As such, the importance of continued statin therapy should not be minimized.

 

Low-Intensity Statin Therapy

Moderate-Intensity Statin Therapy

High-Intensity Statin Therapy

Daily dose lowers LDL-C by < 30% on average

Daily dose lowers LDL-C by 30% to <50%, on average

Daily dose lowers LDL-C by ≥ 50%, on average
  • Simvastatin 10 mg
  • Pravastatin 10-20 mg
  • Lovastatin 20 mg
  • Fluvastatin 20-40 mg
  • Pitavastatin (Livalo) 1 mg

 

 

  
  • Atorvastatin 10-20 mg
  • Rosuvastatin 5-10 mg
  • Simvastatin 20-40 mg
  • Pravastatin 40-80 mg
  • Lovastatin 40 mg
  • Fluvastatin XL (Lescol XL) 80 mg
  • Fluvastatin 40 mg twice daily
  • Pitavastatin (Livalo) 2-4 mg

 

  
  • Atorvastatin 40-80 mg
  • Rosuvastatin 20-40 mg

 

 

 

 


Approval Criteria

I.      Homozygous Familial Hypercholesterolemia (HoFH) (Repatha only)

 

A.    Initiation (< 6 months of therapy)

When a benefit, coverage of Repatha may be approved when all of the following criteria are met (1. through 5.):

1.     The member is 13 years of age or older.

2.     Repatha is being prescribed by or in consultation with one (1) of the following specialties (a., b., or c.):

a.     Cardiologist

b.    Lipid Specialist

c.     Endocrinologist

3.     There is clinical documentation supporting the HoFH diagnosis including one (1) of the following (a. or b.):

a.     There is genetic confirmation of two (2) mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus.

b.    The member meets all of the following criteria (i. and ii.):

i.      The member meets one (1) of the following criteria [A) or B)]:

A)    The member has a documented untreated LDL-C level > 500 mg/dL

B)    The member has a documented treated LDL-C level ≥ 300 mg/dL prior to treatment with a PCSK9 inhibitor

ii.    The member meets one (1) of the following criteria [A) or B)]:

A)    The member has experienced documented cutaneous or tendon xanthoma before 10 years of age.

B)    There is evidence that both of the member’s parents have a diagnosis of heterozygous familial hypercholesterolemia.

4.     The prescriber attests that the member will be using Repatha in combination with a maximally-tolerated statin unless all statins are contraindicated or not tolerated.

5.     The prescriber attests that the member will not be using Repatha in combination with Juxtapid or another PCSK9 inhibitor. 

 

B.    Maintenance (≥ 6 months of therapy)

When a benefit, reauthorization of Repatha may be approved when all of the following criteria are met (1. Through 7.):

1.     The member is 13 years of age or older.

2.     Repatha is being prescribed by or in consultation with one (1) of the following specialties (a., b., or c.):

a.     Cardiologist

b.    Lipid Specialist

c.     Endocrinologist

3.     Prior to the start of therapy, there is clinical documentation supporting the HoFH diagnosis including one (1) of the following (a. or b.):

a.     There is genetic confirmation of two (2) mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus.

b.    The member meets all of the following criteria (i. and i.):

i.      The member meets one (1) of the following criteria [A) or B)]:

A)    The member has a documented untreated LDL-C level > 500 mg/dL

B)    The member has a documented treated LDL-C level ≥ 300 mg/dL prior to treatment with a PCSK9 inhibitor

ii.    The member meets one (1) of the following criteria [A) or B)]:

A)    The member has experienced documented cutaneous or tendon xanthoma before 10 years of age.

B)    There is evidence that both of the member’s parents have a diagnosis of heterozygous familial hypercholesterolemia.

4.     The prescriber attests that the member will be using Repatha in combination with a maximally-tolerated statin unless all statins are contraindicated or not tolerated.

5.     The prescriber attests that the member will not be using Repatha in combination with Juxtapid or another PCSK9 inhibitor. 

6.     The member has experienced a reduction in LDL-C from baseline.

7.     The member has been adherent to Repatha therapy as evidenced by pharmacy claims.

 

II.    Heterozygous Familial Hypercholesterolemia (HeFH)

 

A.    Initiation (< 6 months of therapy)

When a benefit, coverage of Praluent or Repatha may be approved when all of the following criteria are met (1. through 6.):

1.     The member is 18 years of age or older.

2.     Repatha or Praluent is being prescribed by or in consultation with one of the following specialties (a., b., or c.):

a.     Cardiologist

b.    Lipid Specialist

c.     Endocrinologist

3.     There is clinical documentation supporting the HeFH diagnosis including one (1) of the following (a., b., or c.):

a.     There is genetic confirmation of one (1) mutant allele at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus.

b.    The member has experienced one (1) of the following physical signs of familial hypercholesterolemia (i. through iv.):

i.      tendon xanthoma

ii.    corneal arcus prior to age 45 years

iii.   tuberous xanthoma

iv.   xanthelasma

c.     The member meets one (1) of the following criteria (i. or ii.):

i.      WHO criteria/Dutch Lipid Clinical Network score > 8 points

ii.    Definite familial hypercholesterolemia based on the Simon Broome register

4.     The member meets one (1) of the following criteria (a., b. or c.):

a.     Untreated LDL-C ≥ 190 mg/dL

b.    Untreated LDL-C ≥ 160 mg/dL before age 20 years

c.     Treated LDL-C ≥ 160 mg/dL prior to treatment with a PCSK9 inhibitor

5.     The member meets one (1) of the following criteria (a. or b.):

a.     The member meets all of the following criteria (i., ii, and iii.):

i.      The member has been previously treated with one (1) of the following [A) or B)]:

A)    The highest dose of a high intensity statin atorvastatin 80 mg or rosuvastatin 40 mg) for at least 8 consecutive weeks.

B)    A maximally tolerated dose of a high intensity statin (atorvastatin 40 mg or rosuvastatin 20 mg) for at least 8 consecutive weeks with documentation demonstrating why higher strengths of the statin could not be tolerated, would not be tolerated (e.g., exacerbate existing skeletal muscle symptoms) or would not enable member to achieve LDL-C goal.

ii.    Previous treatment has been ineffective as defined by one (1) of the following [A), B), or C)]:

A)    Failure to achieve ≥ 50% reduction in LDL-C

B)    LDL-C ≥ 130 mg/dL

C)    LDL-C ≥ 70 mg/dL in patients with one (1) of the following [1) through 6)]:

1)     Clinically evident coronary heart disease (CHD)

2)     Atherosclerotic cardiovascular disease

3)     Diabetes

4)     Family history of very early CHD defined as one (1) of the following [a) or b)]:

a)     Event in men less than 45 years

b)    Event in women less than 55 years

5)     Current smoker

6)     Lipoprotein(a) ≥ 50 mg/dL

iii.   The prescriber attests that the member will be using Praluent or Repatha in combination with a maximally-tolerated, high intensity statin.

b.    The member is statin intolerant defined as one (1) of the following criteria (i. or ii.):

i.      There is clinical documentation of statin related rhabdomyolysis or skeletal-related muscle symptoms while receiving a trial of at least 2 separate trials of different chemically-distinct high intensity statins, which resolved upon discontinuation of the statin.

ii.    There is clinical documentation of one (1) of the following during any course of statin therapy [A), B), or C)]:

A)    Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN)

B)    Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN)

C)    Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis

6.     If the request is for Praluent, the member has experienced therapeutic failure or intolerance to Repatha. 

 

B.    Maintenance (≥ 6 months of therapy)

When a benefit, reauthorization of Praluent or Repatha may be approved when all of the following criteria are met (1. through 7.):

1.     The member is 18 years of age or older.

2.     Repatha or Praluent is being prescribed by or in consultation with one of the following specialties (a., b., or c.):

a.     Cardiologist

b.    Lipid Specialist

c.     Endocrinologist

3.     There is clinical documentation supporting the HeFH diagnosis including one (1) of the following (a., b., or c.):

a.     There is genetic confirmation of one (1) mutant allele at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus.

b.    The member has experienced one (1) of the following physical signs of familial hypercholesterolemia (i. through iv.):

i.      tendon xanthoma

ii.    corneal arcus prior to age 45 years

iii.   tuberous xanthoma

iv.   xanthelasma

c.     The member meets one (1) of the following criteria (i. or ii.):

i.      WHO criteria/Dutch Lipid Clinical Network score > 8 points

ii.    Definite familial hypercholesterolemia based on the Simon Broome register

4.     The member meets one (1) of the following criteria (a., b. or c.):

a.     Untreated LDL-C ≥ 190 mg/dL

b.    Untreated LDL-C ≥ 160 mg/dL before age 20 years

c.     Treated LDL-C ≥ 160 mg/dL prior to treatment with a PCSK9 inhibitor

5.     The member meets one (1) of the following criteria (a. or b.):

a.     The member meets all of the following criteria (i., ii, and iii.):

i.      The member has been previously treated with one (1) of the following [A) or B)]:

A)    The highest dose of a high intensity statin atorvastatin 80 mg or rosuvastatin 40 mg) for at least 8 consecutive weeks.

B)    A maximally tolerated dose of a high intensity statin (atorvastatin 40 mg or rosuvastatin 20 mg) for at least 8 consecutive weeks with documentation demonstrating why higher strengths of the statin could not be tolerated, would not be tolerated (e.g., exacerbate existing skeletal muscle symptoms) or would not enable member to achieve LDL-C goal.

ii.    Previous treatment has been ineffective as defined by one (1) of the following [A), B), or C)]:

A)    Failure to achieve ≥ 50% reduction in LDL-C

B)    LDL-C ≥ 130 mg/dL

C)    LDL-C ≥ 70 mg/dL in patients with one (1) of the following [1) through 6)]:

1)     Clinically evident coronary heart disease (CHD)

2)     Atherosclerotic cardiovascular disease

3)     Diabetes

4)     Family history of very early CHD defined as one (1) of the following [a) or b)]:

a)     Event in men less than 45 years

b)    Event in women less than 55 years

5)     Current smoker

6)     Lipoprotein(a) ≥ 50 mg/dL

iii.   The prescriber attests that the member will be using Praluent or Repatha in combination with a maximally-tolerated, high intensity statin.

b.    The member is statin intolerant defined as one (1) of the following criteria (i. or ii.):

i.      There is clinical documentation of statin related rhabdomyolysis or skeletal-related muscle symptoms while receiving a trial of at least 2 separate trials of different chemically-distinct high intensity statins, which resolved upon discontinuation of the statin.

ii.    There is clinical documentation of one (1) of the following during any course of statin therapy [A), B), or C)]:

A)    Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN)

B)    Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN)

C)    Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis

6.     The member meets one (1) of the following criteria (a. or b.):

a.     The member has experienced at least a 50% reduction in LDL-C from baseline.

b.    If the member had a baseline LDL-C of > 130 mg/dL then the member has a LDL-C ≤ 130 mg/dL.

7.     The member has been adherent to Praluent or Repatha therapy as evidenced by pharmacy claims.

 

III.   Hypercholesterolemia with ASCVD

           

A.    Initiation (< 6 months of therapy)

When a benefit, coverage of Praluent or Repatha may be approved when all of the following criteria are met (1. through 4.):

1.     The member is 18 years of age or older.

2.     There is clinical documentation supporting the clinical ASCVD diagnosis including one (1) of the following (a. through g.):

a.     Acute coronary syndrome

b.    History of myocardial infarction

c.     Stable or unstable angina

d.    Coronary or other arterial revascularization

e.     History of stroke

f.      History of transient ischemic attack

g.    Peripheral arterial disease presumed to be of atherosclerotic origin

3.     The member has been unable to achieve a LDL-C < 70 mg/dL and meets one (1) of the following (a. or b.):

a.     The member meets all of the following criteria (i. and ii.):  

i.      The member has been previously treated with one (1) of the following [A). or B)]:

A)    The highest dose of a high intensity statin (atorvastatin 80 mg or rosuvastatin 40 mg) for at least 8 consecutive weeks.

B)   A maximally tolerated dose of a high intensity statin (atorvastatin 40mg or rosuvastatin 20mg) for at least 8 consecutive weeks with documentation demonstrating why higher strengths of the statin could not be tolerated, would not be tolerated (e.g., exacerbate existing skeletal muscle symptoms) or would not enable member to achieve LDL-C goal.

ii.    The prescriber attests that the member will be using Praluent or Repatha in combination with a maximally-tolerated, high intensity statin.

b.    The member is statin intolerant defined as one (1) of the following criteria (i. or ii.):

i.      There is clinical documentation of statin related rhabdomyolysis or skeletal-related muscle symptoms while receiving a trial of at least 2 separate trials of different chemically-distinct high intensity statins, which resolved upon discontinuation of the statin

ii.    There is clinical documentation of one (1) of the following during any course of statin therapy [A), B), or C]):

A)    Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN)

B)    Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN)

C)    Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis

4.     If the request is for Praluent, the member has experienced therapeutic failure or intolerance to Repatha.

 

B.    Maintenance (≥ 6 months of therapy)

When a benefit, reauthorization of Praluent or Repatha may be approved when all of the following criteria are met (1. through 5.):

1.     The member is 18 years of age or older.

2.     There is clinical documentation supporting the clinical ASCVD diagnosis including one (1) of the following (a. through g.):

a.     Acute coronary syndrome

b.    History of myocardial infarction

c.     Stable or unstable angina

d.    Coronary or other arterial revascularization

e.     History of stroke

f.      History of transient ischemic attack

g.    Peripheral arterial disease presumed to be of atherosclerotic origin

3.     The member has been unable to achieve a LDL-C < 70 mg/dL and meets one (1) of the following (a. or b.):

a.     The member meets all of the following criteria (i. and ii.):  

i.      The member has been previously treated with one (1) of the following [A). or B)]:

A)    The highest dose of a high intensity statin (atorvastatin 80 mg or rosuvastatin 40 mg) for at least 8 consecutive weeks.

B)   A maximally tolerated dose of a high intensity statin (atorvastatin 40mg or rosuvastatin 20mg) for at least 8 consecutive weeks with documentation demonstrating why higher strengths of the statin could not be tolerated, would not be tolerated (e.g., exacerbate existing skeletal muscle symptoms) or would not enable member to achieve LDL-C goal.

ii.    The prescriber attests that the member will be using Praluent or Repatha in combination with a maximally-tolerated, high intensity statin.

b.    The member is statin intolerant defined as one (1) of the following criteria (i. or ii.):

i.      There is clinical documentation of statin related rhabdomyolysis or skeletal-related muscle symptoms while receiving a trial of at least 2 separate trials of different chemically-distinct high intensity statins, which resolved upon discontinuation of the statin

ii.    There is clinical documentation of one (1) of the following during any course of statin therapy [A), B), or C]):

A)    Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN)

B)    Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN)

C)    Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis

4.     The member meets one (1) of the following criteria (a. or b.):

a.     The member has experienced at least a 40% reduction in LDL-C from baseline.

b.    The member has a documented LDL-C < 70 mg/dL.

5.     The member has been adherent to Praluent or Repatha therapy as evidenced by pharmacy claims.

 

IV.   Primary Hyperlipidemia, Not Associated with ASCVD, HeFH, or HoFH

A.    Initiation (< 6 months of therapy)

When a benefit, initial authorization of Praluent and Repatha may be approved when all of the following criteria are met (1. through 5.):

1.     The member is 18 years of age or older.

2.     There is clinical documentation the member has a diagnosis of primary hyperlipidemia not associated with ASCVD, HeFH or HoFH.

3.     The member has a coronary artery calcium or calcification (CAC) score ≥ 300 Agatston units.

4.     The member has been unable to achieve a LDL-C < 70 mg/dL and meets one (1) of the following (a. or b.):

a.     The member meets all of the following criteria (i. and ii.):  

i.      The member has been previously treated with one (1) of the following [A), or B)]:

A)    The highest dose of a high intensity statin (atorvastatin 80 mg or rosuvastatin 40 mg) plus ezetimibe for at least 8 consecutive weeks.

B)    A maximally tolerated dose of a high intensity statin (atorvastatin 40mg or rosuvastatin 20mg) plus ezetimibe for at least 8 consecutive weeks with documentation demonstrating why higher strengths of the statin could not be tolerated, would not be tolerated (e.g., exacerbate existing skeletal muscle symptoms) or would not enable member to achieve LDL-C goal.

ii.    The prescriber attests that the member will be using Praluent or Repatha in combination with a maximally-tolerated, high intensity statin.

b.    The member is statin intolerant defined as one (1) of the following criteria (i. or ii.):

i.      There is clinical documentation of statin related rhabdomyolysis or skeletal-related muscle symptoms while receiving a trial of at least 2 separate trials of different chemically-distinct high intensity statins, which resolved upon discontinuation of the statin

ii.    There is clinical documentation of one (1) of the following during any course of statin therapy [A), B), or C)]:

A)    Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN).

B)    Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN)

C)   Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis.

5.     If the request is for Praluent, the member has experienced therapeutic failure or intolerance to Repatha.

 

B.    Maintenance (≥ 6 months of therapy)

When a benefit, reauthorization of Praluent or Repatha may be approved when all of the following criteria are met (1. through 6.):

1.     The member is 18 years of age or older.

2.     There is clinical documentation the member has a diagnosis of primary hyperlipidemia not associated with ASCVD, HeFH or HoFH.

3.     The member has a coronary artery calcium or calcification (CAC) score ≥ 300 Agatston units.

4.     The member has been unable to achieve a LDL-C < 70 mg/dL and meets one (1) of the following (a. or b.):

a.     The member meets all of the following criteria (i. and ii.):  

i.      The member has been previously treated with one (1) of the following [A), or B)]:

A)    The highest dose of a high intensity statin (atorvastatin 80 mg or rosuvastatin 40 mg) plus ezetimibe for at least 8 consecutive weeks.

B)    A maximally tolerated dose of a high intensity statin (atorvastatin 40mg or rosuvastatin 20mg) plus ezetimibe for at least 8 consecutive weeks with documentation demonstrating why higher strengths of the statin could not be tolerated, would not be tolerated (e.g., exacerbate existing skeletal muscle symptoms) or would not enable member to achieve LDL-C goal.

ii.    The prescriber attests that the member will be using Praluent or Repatha in combination with a maximally-tolerated, high intensity statin.

b.    The member is statin intolerant defined as one (1) of the following criteria (i. or ii.):

i.      There is clinical documentation of statin related rhabdomyolysis or skeletal-related muscle symptoms while receiving a trial of at least 2 separate trials of different chemically-distinct high intensity statins, which resolved upon discontinuation of the statin

ii.    There is clinical documentation of one (1) of the following during any course of statin therapy [A), B), or C)]:

A)    Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN).

B)    Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN)

C)    Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis.

5.     The member meets one (1) of the following criteria (a. or b.):

a.     The member has experienced at least a 40% reduction in LDL-C from baseline.

b.    The member has a LDL-C < 70 mg/dL.

6.     The member has been adherent to Praluent or Repatha therapy as evidenced by pharmacy claims.

 

V.    An exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations.


Limitations of Coverage

I.      Coverage of Praluent or Repatha for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.

II.    For Commercial or HCR members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.


Authorization Duration

Initial Authorization

 

  • Commercial and HCR Plans: If approved, up to a 6 month authorization may be granted.

 

Reauthorization

 

  • Commercial and HCR Plans: If approved, up to a 12 month authorization may be granted.


Automatic Approval Criteria

None.


Version: J-0434-013
Effective Date Begin: 09/03/2020
Effective End Begin: 03/03/2021
Original Date: 07/09/2015
Review Date: 08/05/2020


References:

  1. Praluent [package insert]. Bridgewater, NJ: Sanofi-Aventis and Regeneron Pharmaceuticals, Inc.; May 2020.
  2. Repatha [package insert]. Thousand Oaks, CA: Amgen Inc.; May 2020.
  3. Grundy SM, Stone NJ, Bailey AL, Beam C, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73(24):e285-350.
  4. Raala FL, Hovinghb GK, Catapano AL. Familial hypercholesterolemia treatments: Guidelines and new therapies. 2018;277:483–492.
  5. Lloyd-Jones, D. M., Morris, P.M., et al. 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk. JACC Volume 68, Number 1.
  6. Orringer C, Jacobson T, Saseen J, et al. Update on the use of PCSK9 inhibitors in adults: Recommendations from an Expert Panel of the National Lipid Association. J Clin Lipid 2017. Volume 11, Issue 4.
  7. Nordestgaard BG, Chapman MJ, Humphries SE, et al. Familial hypercholesterolaemia is underdiagnosed and undertreated in the general population: guidance for clinicians to prevent coronary heart disease: consensus statement of the European Atherosclerosis Society. Eur Heart J. 2013; 34:3478.
  8. National Institute for Health and Care Excellence. Identification and management of familial hypercholesterolaemia. Available at: www.nice.org.uk/guidance/CG71/NICEGuidance/pdf/English. Accessed June 29, 2020.

 

 




Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.