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| PCSK9 Inhibitors - Commercial | |
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| Number: J-0434 | Category: Prior Authorization |
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Line(s) of Business:
Commercial |
Benefit(s):
Prior Authorization (1.)
Quantity Limits (1., 2., 3., or 4.)
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Region(s):
All |
Additional Restriction(s):
None |
| Drugs Products |
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| FDA-Approved Indications: |
· Praluent o As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-cholesterol (LDL-C) · Repatha o To reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease o 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) o 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: | · 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. · In 2017, a Focused Update of the 2016 American College of Cardiology (ACC) Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for Low-Density Lipoprotein (LDL)-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease (ASCVD) was published. The update includes revised recommendations for patients with clinical ASCVD with or without comorbidities on statin therapy for secondary prevention. Recommendations include: o Addition of non-statin therapies to maximally tolerated statin therapy is recommended to be considered among patients with clinical ASCVD when additional LDL lowering is desired. o Addition of either ezetimibe or a PCSK9 inhibitor should also factor in patient preferences, costs, and route of administration in addition to percent of LDL lowering desired. · For <25% of additional LDL lowering, ezetimibe may be preferred. · For patients who require >25% additional LDL lowering, a PCSK9 inhibitor may be preferred. · The following is a summary of the 2017 National Lipid Association Expert Panel Update On The Use Of PCSK9 Inhibitors in Adults: o PCSK9 inhibitor therapy should be considered: · 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 (Strength: A, Quality: High) · 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 (Strength: B, Quality: Moderate) · 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 (Strength: B, Quality: Moderate) · 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 (Strength: B, Quality: Moderate) · 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 (Strength: E, Quality: Low) · 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 (Strength: B, Quality: Moderate) · 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 (Strength: C, Quality: Low) · 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.
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| Approval Criteria |
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I. Homozygous Familial Hypercholesterolemia (evolocumab only) A. Initiation (< 6 months of therapy) When a benefit, initial authorization of evolocumab 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. Evolocumab is being prescribed by or in consultation with one of the following specialties (a. through c.): a. Cardiologist b. Lipid Specialist c. Endocrinologist 3. The member has clinical documentation of homozygous familial hypercholesterolemia, defined as one of the following (a. or b.): a. Genetic confirmation of two mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus. b. The member meets both of the following criteria (i. and ii.): i. The member meets one 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 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 documents that the member will be using evolocumab in combination with a maximally-tolerated statin unless all statins are contraindicated or not tolerated. 5. The prescriber documents that the member will not be using evolocumab in combination with lomitapide (Juxtapid), mipomersen (Kynamro), or another PCSK9 inhibitor.
B. Maintenance (≥ 6 months of therapy) When a benefit, reauthorization of evolocumab 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. Evolocumab is being prescribed by or in consultation with one of the following specialties (a. through c.): a. Cardiologist b. Lipid Specialist c. Endocrinologist 3. Prior to the start of therapy, the member had clinical documentation of homozygous familial hypercholesterolemia, defined as one of the following (a. or b.): a. Genetic confirmation of two mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus. b. The member meets both of the following criteria (i. and ii.): i. The member meets one 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 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 documents that the member will be using evolocumab in combination with a maximally-tolerated statin unless all statins are contraindicated or not tolerated. 5. The prescriber documents that the member will not be using evolocumab in combination with lomitapide, mipomersen or another PCSK9 inhibitor. 6. The member has experienced a reduction in LDL-C from baseline. 7. The member has been adherent to PCSK9 inhibitor therapy as evidenced by claims.
II. Heterozygous Familial Hypercholesterolemia A. Initiation (< 6 months of therapy) When a benefit, initial authorization of alirocumab or evolocumab 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. Alirocumab or evolocumab is being prescribed by or in consultation with one of the following specialties (a. through c.): a. Cardiologist b. Lipid Specialist c. Endocrinologist 3. The member has clinical documentation of heterozygous familial hypercholesterolemia, defined as one of the following (a. through c.): a. Genetic confirmation of one mutant allele at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus. b. The member has experienced one 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 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 of the following criteria (a., b. or c.): a. Documentation of an untreated LDL-C ≥ 190 mg/dL b. Documentation of an untreated LDL-C ≥ 160 mg/dL before age 20 years c. Documentation of a treated LDL-C ≥160 mg/dL prior to treatment with a PCSK9 inhibitor 5. The member meets one of the following criteria (a. or b.): a. The member meets all of the following criteria (i. through iii.) i. The member has been previously treated with one of the following as evidenced by pharmacy claims or when attested to by the prescriber if the member is new to the plan (1. or 2.): 1. The highest dose of a high intensity statin (atorvastatin 80 mg or rosuvastatin 40 mg) for at least 8 consecutive weeks. 2. 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. Either previous treatment (see II.A.5.i.) has been ineffective as defined by one of the following (1. through 3.): 1. Failure to achieve ≥ 50% reduction in LDL-C. 2. LDL-C ≥ 130 mg/dL. 3. LDL-C ≥ 70 mg/dL in patients with one 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 of the following (1 or 2): 1) event in men less than 45 years 2) event in women less than 55 years E) current smoking F) lipoprotein (a) ≥ 50 mg/dL iii. The prescriber attests that the member will be using alirocumab or evolocumab in combination with a maximally-tolerated, high intensity statin. b. The member is determined to be statin intolerant per one of the following criteria (i. or ii.): i. 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. ii. Documentation of one of the following (1. 2. or 3.) during any course of statin therapy: 1. Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN). 2. Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN). 3. Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis. 6. For alirocumab, the member has had a trial and inadequate response, contraindication or intolerance to evolocumab.
B. Maintenance (≥ 6 months of therapy) When a benefit, reauthorization of alirocumab or evolocumab 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. Alirocumab or evolocumab is being prescribed by or in consultation with one of the following specialties (a. through c.): a. Cardiologist b. Lipid Specialist c. Endocrinologist 3. The member has clinical documentation of heterozygous familial hypercholesterolemia, defined as one of the following (a. through c.): a. Genetic confirmation of one mutant allele at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus. b. The member has experienced one of the following physical signs of familial hypercholesterolemia (i. through iv.): i. tendon xanthoma ii. corneal arcus before age 45 years iii. tuberous xanthoma iv. xanthelasma c. The member met one of the following criteria prior to start of therapy (i. or ii.): i. WHO criteria/Dutch Lipid Clinical Network score > 8 points ii. Definite familial hypercholesterolemia based on the Simon Broome register 4. Prior to the start of therapy, the member met one of the following criteria (a., b. or c.): a. Documentation of an untreated LDL-C ≥ 190 mg/dL b. Documentation of an untreated LDL-C ≥ 160 mg/dL before age 20 years c. Documentation of a treated LDL-C ≥160 mg/dL prior to treatment with a PCSK9 inhibitor 5. Prior to the start of therapy, the member met one of the following criteria (a. or b.): a. The member meets all of the following criteria (i. through iii.) i. The member has been previously treated with one of the following as evidenced by pharmacy claims or when attested to by the prescriber if the member is new to the plan (1. or 2.): 1. The highest dose of a high intensity statin (atorvastatin 80 mg or rosuvastatin 40 mg) for at least 8 consecutive weeks. 2. 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. Either previous treatment (see II.A.5.i.) has been ineffective as defined by one of the following (1. through 3.): 1. Failure to achieve ≥ 50% reduction in LDL-C. 2. LDL-C ≥ 130 mg/dL. 3. LDL-C ≥ 70 mg/dL in patients with one 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 of the following (1 or 2): 1) event in men less than 45 years 2) event in women less than 55 years E) current smoking F) lipoprotein (a) ≥ 50 mg/dL iii. The prescriber attests that the member will continue to use alirocumab or evolocumab in combination with a maximally-tolerated, high intensity statin. b. The member is determined to be statin intolerant per one of the following criteria (i. or ii.): i. 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. ii. Documentation of one of the following (1. 2. or 3.) during any course of statin therapy: 1. Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN). 2. Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN). 3. Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis. 6. The member meets one 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, the member has a documented LDL-C ≤ 130 mg/dL. 7. The member has been adherent to PCSK9 inhibitor therapy as evidenced by claims.
III. Hypercholesterolemia, ASCVD A. Initiation (< 6 months of therapy) When a benefit, initial authorization of alirocumab or evolocumab 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. Alirocumab or evolocumab is being prescribed by or in consultation with one of the following specialties (a. through c.): a. Cardiologist b. Lipid Specialist c. Endocrinologist 3. The member has a documented diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) as defined by one 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 4. The member meets one of the following criteria (a. or b.): a. The member meets all of the following criteria (i. through iii.) i. The member has been previously treated with one of the following as evidenced by pharmacy claims or when attested to by the prescriber if the member is new to the plan (1. or 2.): 1. The highest dose of a high intensity statin (atorvastatin 80 mg or rosuvastatin 40 mg) for at least 8 consecutive weeks. 2. 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. Either regimen above (1 or 2) has been ineffective in achieving an LDL-C < 70 mg/dL. iii. The prescriber attests that the member will be using alirocumab or evolocumab in combination with a maximally-tolerated, high intensity statin. b. The member is determined to be statin intolerant per one of the following criteria (i. or ii.): i. 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. ii. Documentation of one of the following (1. 2. or 3.) during any course of statin therapy: 1. Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN). 2. Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN). 3. Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis. 5. The prescriber attests that the member is currently enrolled in a lipid or disease management clinic or undergoing lifestyle modifications to help manage their condition. 6. For alirocumab, the member has had a trial and inadequate response, contraindication or intolerance to evolocumab.
B. Maintenance (≥ 6 months of therapy) When a benefit, reauthorization of alirocumab or evolocumab 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. Alirocumab or evolocumab is being prescribed by or in consultation with one of the following specialties (a. through c.): a. Cardiologist b. Lipid Specialist c. Endocrinologist 3. The member has a documented diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) as defined by one 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 4. Prior to start of therapy, the member met one of the following criteria (a. or b.): a. The member meets all of the following criteria (i. through iii.) i. The member has been previously treated with one of the following as evidenced by pharmacy claims or when attested to by the prescriber if the member is new to the plan (1. or 2.): 1. The highest dose of a high intensity statin (atorvastatin 80 mg or rosuvastatin 40 mg) for at least 8 consecutive weeks. 2. 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. Either regimen above (1 or 2) has been ineffective in achieving an LDL-C < 70 mg/dL. iii. The prescriber attests that the member will continue to use alirocumab or evolocumab in combination with a maximally-tolerated, high intensity statin. b. The member is determined to be statin intolerant per one of the following criteria (i. or ii.): i. 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. ii. Documentation of one of the following (1. 2. or 3.) during any course of statin therapy: 1. Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN). 2. Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN). 3. Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis. 5. The member meets one 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. 6. The member has been adherent to PCSK9 inhibitor therapy as evidenced by claims. 7. The prescriber attests that the member is currently enrolled in a lipid or disease management clinic or undergoing lifestyle modifications to help manage their condition.
I. 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.
Quantity Level Limitation
For members who meet the above clinical criteria with a diagnosis of homozygous familial hypercholesterolemia (HoFH) only, Repatha Pushtronex (evolocumab) will be eligible for approval of 1 package/Pushtronex per 30 days or 3 packages/Pushtronex per 90 days (if benefit allows). |
| Limitations of Coverage |
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I. Coverage of alirocumab or evolocumab 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 |
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| Automatic Approval Criteria |
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None |
| Version: J-0434-007 |
| Effective Date Begin: 02/17/2018 |
| Effective End Begin: 07/13/2018 |
| Original Date: 07/09/2015 |
| Review Date: 01/31/2018 |
References:
- 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.
- Praluent [prescribing information]. Tarrytown, NJ: Sanofi-Aventis and Regeneron Pharmaceuticals, Inc.; September 2017.
- Repatha [prescribing information]. Thousand Oaks, CA: Amgen Inc.; December 2017.
- DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; c1974-2013. Accessed 12/28/2017.
- 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.
- 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.
- 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.
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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.
