Pharmacy Policy Bulletin
PCSK9 Inhibitors – Commercial
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
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.
  • The AHA and ACC guidelines recommend the following:
    • In very high-risk ASCVD, use a LDL-C threshold of 70 mg/dL (1.8 mmol/L) to consider addition of nonstatins to statin therapy. Very high-risk includes a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions. In very high-risk ASCVD patients, it is reasonable to add ezetimibe to maximally tolerated statin therapy when the LDL-C level remains ≥70 mg/dL. In patients at very high risk whose LDL-C level remains ≥70 mg/dL on maximally tolerated statin and ezetimibe therapy, adding a PCSK9 inhibitor is reasonable, although the long-term safety (>3 years) is uncertain.
    • In patients with severe primary hypercholesterolemia (LDL-C level ≥190 mg/dL [≥4.9 mmol/L]) begin high-intensity statin therapy. If the LDL-C level remains ≥100 mg/dL (≥2.6 mmol/L), consider adding ezetimibe. If the LDL-C level on statin plus ezetimibe remains ≥100 mg/dL (≥2.6 mmol/L) and the patient has multiple factors that increase subsequent risk of ASCVD events, a PCSK9 inhibitor may be considered, although the long-term safety (>3 years) is uncertain.
  • Guidelines for familial hypercholesterolemia recommend PCSK9 inhibitors in patients at very high risk such as those with CVD or having additional CV risk factors with elevated LDL-C levels (>180 mg/dL) despite maximal dose of statin plus ezetimibe.
  • The Simon Broom Criteria and Dutch Lipid Clinic Criteria are accepted resources for FH diagnosis.
  • The following is a summary of the 2017 National Lipid Association Expert Panel Update On The Use Of PCSK9 Inhibitors in Adults for PCSK9 inhibitor considerations:
    • For ASCVD risk reduction in patients with stable ASCVD, particularly in those with additional ASCVD risk factors, on maximally-tolerated statin therapy ± ezetimibe, with on-treatment LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL.
    • To further reduce LDL-C in patients with progressive ASCVD on maximally-tolerated statin therapy ± ezetimibe, and on-treatment LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL.
    • To further reduce LDL-C in patients aged 40 to 79 years with pre-treatment LDL-C ≥190 mg/dL, no uncontrolled ASCVD risk factors, or other key additional-high risk markers, and on-treatment LDL-C≥100 mg/dL or non-HDL-C ≥130 mg/dL on maximally tolerated statin therapy ± ezetimibe.
    • To further reduce LDL-C in patients aged 40 to 79 years with pre-treatment LDL-C ≥190 mg/dL, and the presence of either uncontrolled ASCVD risk factors, key additional-high risk markers, or genetic confirmation of FH, and on-treatment LDL-C≥70 mg/dL or non-HDL-C ≥100 mg/dL on maximally tolerated statin therapy ± ezetimibe.
    • To further reduce LDL-C in patients aged 18 to 39 years with pre-treatment LDL-C ≥190 mg/dL, and the presence of either uncontrolled ASCVD risk factors, key additional-high risk markers, or genetic confirmation of FH, and on-treatment LDL-C≥100 mg/dL or non-HDL-C ≥130 mg/dL on maximally tolerated statin therapy ± ezetimibe.
    • To further reduce LDL-C in members with HoFH, either of unknown genotype, or those known to be LDLR defective, on maximally-tolerated statin therapy ± ezetimibe with LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL.
    • To further reduce LDL-C in selected very-high-risk patients who meet the definition of statin intolerance (as previously define by the NLA Statin Expert Panel) who require substantial additional atherogenic cholesterol lowering, despite use of other lipid-lowering therapies.
  • 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

Initial and Reauthorization

 

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

 

Initiation (< 6 months of therapy)

When a benefit, initial authorization of Repatha may be approved when all of the following criteria are met (A. through E.):

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

B.    Repatha is being prescribed by or in consultation with one of the following specialties (1., 2., or 3.):

1.     Cardiologist

2.     Lipid Specialist

3.     Endocrinologist

C.    There is clinical documentation supporting the homozygous familial hypercholesterolemia diagnosis including one (1) of the following (1. or 2.):

1.     Genetic confirmation of two mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus.

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

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

i.      The member has a documented untreated LDL-C level > 500 mg/dL

ii.    The member has a documented treated LDL-C level > 300 mg/dL prior to treatment with a PCSK9 inhibitor

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

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

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

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

E.    The prescriber documents that the member will not be using Repatha in combination with Juxtapid (lomitapide), Kynamro (mipomersen), or another PCSK9 inhibitor. 

 

 

Maintenance (≥ 6 months of therapy)

When a benefit, reauthorization of Repatha may be approved when all of the following criteria are met (A. through G.):

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

B.    Repatha is being prescribed by or in consultation with one of the following specialties (1., 2., or 3.):

1.     Cardiologist

2.     Lipid Specialist

3.     Endocrinologist

C.    Prior to the start of therapy, there is clinical documentation supporting the homozygous familial hypercholesterolemia diagnosis including one (1) of the following (1. or 2.):

1.     Genetic confirmation of two mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus.

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

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

i.      The member has a documented untreated LDL-C level > 500 mg/dL

ii.    The member has a documented treated LDL-C level > 300 mg/dL prior to treatment with a PCSK9 inhibitor

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

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

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

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

E.    The prescriber documents that the member will not be using Repatha in combination with Juxtapid (lomitapide), Kynamro (mipomersen), or another PCSK9 inhibitor. 

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

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

 

II.    Heterozygous Familial Hypercholesterolemia (HeFH)

 

Initiation (< 6 months of therapy)

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

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

B.    Repatha or Praluent is being prescribed by or in consultation with one of the following specialties (1., 2., or 3.):

1.     Cardiologist

2.     Lipid Specialist

3.     Endocrinologist

C.    There is clinical documentation supporting the heterozygous familial hypercholesterolemia diagnosis including one (1) of the following (1., 2., or 3.):

1.     Genetic confirmation of one mutant allele at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus.

2.     The member has experienced one (1) of the following physical signs of familial hypercholesterolemia (a. through d.):

a.     tendon xanthoma

b.    corneal arcus prior to age 45 years

c.     tuberous xanthoma

d.    xanthelasma

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

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

b.    Definite familial hypercholesterolemia based on the Simon Broome register

D.    The member meets one (1) of the following criteria (1., 2. or 3.):

1.     Untreated LDL-C ≥ 190 mg/dL

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

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

E.    The member meets one (1) of the following criteria (1. or 2.):

1.     The member meets all of the following criteria (a. through c.):

a.     The member has been previously treated with one (1) of the following (i. or ii.):

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

ii.    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.

b.    Previous treatment (see II.E.1.a.) has been ineffective as defined by one (1) of the following (i., ii., or iii.):

i.      Failure to achieve ≥ 50% reduction in LDL-C

ii.    LDL-C ≥ 130 mg/dL

iii.   LDL-C ≥ 70 mg/dL in patients with one (1) of the following (A. through F.):

A.    Clinically evident coronary heart disease (CHD)

B.    Atherosclerotic cardiovascular disease

C.    Diabetes

D.    Family history of very early CHD defined as one (1) of the following (1. or 2.):

1.     Event in men less than 45 years

2.     Event in women less than 55 years

E.    Current smoker

F.    Lipoprotein(a) ≥ 50 mg/dL

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

2.     The member is determined to be statin intolerant defined as one (1) of the following criteria (a. or b.):

a.     A trial of at least two chemically-distinct statins and documentation of severe and intolerable skeletal-muscle related symptoms with each of the two statins that resolved upon statin discontinuation.

b.    Documentation of one (1) of the following during any course of statin therapy (i., ii., or iii.):

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

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

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

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

 

Maintenance (≥ 6 months of therapy)

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

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

B.    Repatha or Praluent is being prescribed by or in consultation with one of the following specialties (1., 2., or 3.):

1.     Cardiologist

2.     Lipid Specialist

3.     Endocrinologist

C.    Prior to the start of therapy, there is clinical documentation supporting the heterozygous familial hypercholesterolemia diagnosis including one (1) of the following (1., 2., or 3.):

1.     Genetic confirmation of one mutant allele at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus.

2.     The member has experienced one (1) of the following physical signs of familial hypercholesterolemia (a. through d.):

a.     tendon xanthoma

b.    corneal arcus prior to age 45 years

c.     tuberous xanthoma

d.    xanthelasma

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

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

b.    Definite familial hypercholesterolemia based on the Simon Broome register

D.    Prior to the start of therapy, the member meets one (1) of the following criteria (1., 2. or 3.):

1.     Untreated LDL-C ≥ 190 mg/dL

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

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

E.    Prior to the start of therapy, the member meets one (1) of the following criteria (1. or 2.):

1.     The member meets all of the following criteria (a. through c.):

a.     The member has been previously treated with one (1) of the following (i. or ii.):

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

ii.    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.

b.    Previous treatment (see II.E.1.a.) has been ineffective as defined by one (1) of the following (i., ii., or iii.):

i.      Failure to achieve ≥ 50% reduction in LDL-C

ii.    LDL-C ≥ 130 mg/dL

iii.   LDL-C ≥ 70 mg/dL in patients with one (1) of the following (A. through F.):

A.    Clinically evident coronary heart disease (CHD)

B.    Atherosclerotic cardiovascular disease

C.    Diabetes

D.    Family history of very early CHD defined as one (1) of the following (1. or 2.):

1.     Event in men less than 45 years

2.     Event in women less than 55 years

E.    Current smoker

F.    Lipoprotein(a) ≥ 50 mg/dL

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

2.     The member is determined to be statin intolerant defined as one (1) of the following criteria (a. or b.):

a.     A trial of at least two chemically-distinct statins and documentation of severe and intolerable skeletal-muscle related symptoms with each of the two statins that resolved upon statin discontinuation.

b.    Documentation of one (1) of the following during any course of statin therapy (i., ii., or iii.):

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

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

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

F.    The member meets one (1) of the following criteria (1. or 2.):

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

2.     If the member had a baseline LDL-C of > 130 mg/dL, the member has a documented LDL-C ≤ 130 mg/dL.

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

 

III.   Hypercholesterolemia with ASCVD

           

Initiation (< 6 months of therapy)

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

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

B.    There is clinical documentation supporting the clinical atherosclerotic cardiovascular disease (ASCVD) diagnosis including one (1) of the following (1. through 7.):

1.     Acute coronary syndrome

2.     History of myocardial infarction

3.     Stable or unstable angina

4.     Coronary or other arterial revascularization

5.     History of stroke

6.     History of transient ischemic attack

7.     Peripheral arterial disease presumed to be of atherosclerotic origin

C.    The member has been unable to achieve a LDL-C < 70 mg/dL and meets one (1) of the following (1. or 2.):

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

a.     The member has been previously treated with one (1) of the following (i. or ii.):

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

ii.      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.

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

2.     The member is determined to be statin intolerant defined as one (1) of the following criteria (a. or b.):

a.     A trial of at least two (2) chemically-distinct statins and documentation of severe and intolerable skeletal-muscle related symptoms with each of the two statins that resolved upon statin discontinuation.

b.    Documentation of one (1) of the following during any course of statin therapy (i., ii., or iii.):

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

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

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

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

 

Maintenance (≥ 6 months of therapy)

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

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

B.    Prior to the start of therapy, there is clinical documentation supporting the clinical atherosclerotic cardiovascular disease (ASCVD) diagnosis including one (1) of the following (1. through 7.):

1.     Acute coronary syndrome

2.     History of myocardial infarction

3.     Stable or unstable angina

4.     Coronary or other arterial revascularization

5.     History of stroke

6.     History of transient ischemic attack

7.     Peripheral arterial disease presumed to be of atherosclerotic origin

C.    Prior to the start of therapy, the member has been unable to achieve a LDL-C < 70 mg/dL and meets one (1) of the following (1. or 2.):

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

a.     The member has been previously treated with one (1) of the following (i. or ii.):

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

ii.      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.

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

2.     The member is determined to be statin intolerant defined as one (1) of the following criteria (a. or b.):

a.     A trial of at least two (2) chemically-distinct statins and documentation of severe and intolerable skeletal-muscle related symptoms with each of the two statins that resolved upon statin discontinuation.

b.    Documentation of one (1) of the following during any course of statin therapy (i., ii., or iii.):

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

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

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

D.    The member meets one (1) of the following criteria (1. or 2.):

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

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

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

 

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

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 (A. through E.):

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

B.    The member has a documented diagnosis of primary hyperlipidemia not associated with ASCVD, HeFH or HoFH.

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

D.    The member has been unable to achieve a LDL-C < 70 mg/dL and meets one (1) of the following (1. or 2.):

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

a.     The member has been previously treated with one (1) of the following (i. or ii.):

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

ii.    A maximally tolerated dose of a high intensity statin (atorvastatin 40mg or rosuvastatin 20mg) and 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.

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

2.     The member is determined to be statin intolerant defined as one (1) of the following criteria (a. or b.):

a.     A trial of at least two (2) chemically-distinct statins and documentation of severe and intolerable skeletal-muscle related symptoms with each of the two statins that resolved upon statin discontinuation.

b.    Documentation of one (1) of the following during any course of statin therapy (i., ii., or iii.):

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

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

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

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

 

Maintenance (≥ 6 months of therapy)

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

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

B.    Prior to the start of therapy, the member has a documented diagnosis of primary hyperlipidemia not associated with ASCVD, HeFH or HoFH.

C.    Prior to the start of therapy, the member has a coronary artery calcium or calcification (CAC) score ≥300 Agatston units.

D.    Prior to the start of therapy, the member has been unable to achieve a LDL-C < 70 mg/dL and meets one (1) of the following (1. or 2.):

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

a.     The member has been previously treated with one (1) of the following (i. or ii.):

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

ii.    A maximally tolerated dose of a high intensity statin (atorvastatin 40mg or rosuvastatin 20mg) and 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.

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

2.     The member is determined to be statin intolerant defined as one (1) of the following criteria (a. or b.):

a.     A trial of at least two (2) chemically-distinct statins and documentation of severe and intolerable skeletal-muscle related symptoms with each of the two statins that resolved upon statin discontinuation.

b.    Documentation of one (1) of the following during any course of statin therapy (i., ii., or iii.):

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

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

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

E.    The member meets one of the following criteria (1. or 2.):

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

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

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

   

V.    Quantity Level Limits

A.    Members who meet the above clinical criteria will be eligible for approval of 2 syringes/autoinjectors per 28 days or 6 syringes/autoinjectors per 84 days (if benefit allows).

B.    For members who meet the above clinical criteria with a diagnosis of homozygous familial hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH), hypercholesterolemia with ASCVD, or primary hyperlipidemia Repatha Pushtronex (evolocumab) will be eligible for approval of one package/Pushtronex per 30 days or 3 packages/Pushtronex per 90 days (if benefit allows). 

 

VI.   For Commercial members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made base on Policy J-513 – West Virginia – Step Therapy Override Exception – Commercial and Healthcare Reform.


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 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-0434-012
Effective Date Begin: 08/27/2019
Effective End Begin: 09/02/2020
Original Date: 07/09/2015
Review Date: 08/07/2019


References:

1.     Praluent [package insert]. Bridgewater, NJ: Sanofi-Aventis and Regeneron Pharmaceuticals, Inc.; April 2019.

2.     Repatha [package insert]. Thousand Oaks, CA: Amgen Inc.; February 2019.

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. 2018;S0735-1097(18):39033-8.

4.     Raala FL, Hovinghb GK, Catapano AL. Familial hypercholesterolemia treatments: Guidelines and new therapies. Atherosclerosis. 2018;277:483–492.

5.     Stone, N. J., Robinson, J., Lichtenstein, A. H., et al. 2013 ACC/AHA Guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. Circulation 2013. Retrieved from: http://circ.ahajournals.org.

6.     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.  2016. Volume 68, Number 1.

7.     Lloyd-Jones D.M., Morris P.B., et al. 2017 Focused Update of the 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: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol 2017. Volume 70, Issue 14.

8.     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.

9.     Hect HS, Cronin P, Blaha M, et al.  2016 SCCT/STR guidelines for coronary artery calcium scoring of noncontrast noncardiac chest CT scans:  A report of the Society of Cardiovascular Computed Tomography and Society of Thoracic Radiology.  J Thorac Imaging 2017;32(5): W54-S66. 

10.  Blaha MJ, Mortensen MB, Kianoush S, et al.  Coronary artery calcium scoring.  Is it time for a change in methodology.  J Am Coll Cardiol Imag 2017;10: 923-937.

11.  Burge MR, Eaton RP, Comerci G, et al.  Management of asymptomatic patients with positive coronary artery calcium scans.  J Endocr Soc 2017; 1(6): 588-599.

 




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