Pharmacy Prior Authorization Criteria

PCSK9 Inhibitors - PA, ST, NF

Indications for Prior Authorization

Repatha (evolocumab)

For diagnosis of Prevention of Cardiovascular Events
Indicated in adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
For diagnosis of Primary Hyperlipidemia (Including Heterozygous Familial Hypercholesterolemia)
Indicated as an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.
For diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH)
Indicated as an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C
For diagnosis of Homozygous Familial Hypercholesterolemia
Indicated as an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C

Praluent (alirocumab)

For diagnosis of Prevention of Cardiovascular Events
Indicated to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
For diagnosis of Primary Hyperlipidemia (Including Heterozygous Familial Hypercholesterolemia)
Indicated as an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.
For diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH)
Indicated as an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.
For diagnosis of Homozygous Familial Hypercholesterolemia
Indicated as an adjunct to other LDL-C lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Criteria

Repatha

Prior Authorization, Step Therapy (Initial Authorization)

Length of Approval: 6 Months [A]
For diagnosis of Primary Hyperlipidemia [Including Heterozygous Familial Hypercholesterolemia (HeFH), Atherosclerotic Cardiovascular Disease (ASCVD), and Secondary Prevention of Cardiovascular Events in Patients with ASCVD]

One of the following diagnoses:

Both of the following:

Heterozygous familial hypercholesterolemia (HeFH)
Patient is 10 years of age or older

Atherosclerotic cardiovascular disease (ASCVD)

Primary hyperlipidemia

AND

One of the following:

Patient has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy
Patient is statin intolerant as evidenced by an inability to tolerate at least two statins, with at least one started at the lowest starting daily dose, due to intolerable symptoms or clinically significant biomarker changes of liver function or muscle function (e.g., creatine kinase)
Patient has an FDA labeled contraindication to all statins

AND

One of the following:

One of the following while on maximally tolerated lipid-lowering therapy (e.g., statins) within the last 120 days [5]:

Patient requires greater than or equal to 25% LDL-C reduction to achieve goal
Patient has LDL-C greater than or equal to 70 mg/dL with ASCVD
Patient has LDL-C greater than or equal to 100 mg/dL without ASCVD

Both of the following:

Patient has been receiving PCSK9 therapy as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe)

AND

LDL-C values drawn within the past 12 months while on maximally tolerated lipid lowering therapy is within normal limits

Praluent (F)

Prior Authorization (Initial Authorization)

One of the following diagnoses:

Both of the following:

Heterozygous familial hypercholesterolemia (HeFH)
Patient is 8 years of age or older

Atherosclerotic cardiovascular disease (ASCVD)

Primary hyperlipidemia

AND

One of the following:

Patient has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy
Patient is statin intolerant as evidenced by an inability to tolerate at least two statins, with at least one started at the lowest starting daily dose, due to intolerable symptoms or clinically significant biomarker changes of liver function or muscle function (e.g., creatine kinase)
Patient has an FDA labeled contraindication to all statins

AND

One of the following:

One of the following while on maximally tolerated lipid-lowering therapy (e.g., statins) within the last 120 days [5]:

Patient requires greater than or equal to 25% LDL-C reduction to achieve goal
Patient has LDL-C greater than or equal to 70 mg/dL with ASCVD
Patient has LDL-C greater than or equal to 100 mg/dL without ASCVD

Both of the following:

Patient has been receiving PCSK9 therapy as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe)

AND

LDL-C values drawn within the past 12 months while on maximally tolerated lipid lowering therapy is within normal limits

AND

For patients 10 years of age or older: Trial and failure, contraindication, or intolerance to Repatha

Repatha, Praluent (F)

Prior Authorization, Step Therapy (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Primary Hyperlipidemia [Including Heterozygous Familial Hypercholesterolemia (HeFH), Atherosclerotic Cardiovascular Disease (ASCVD), and Secondary Prevention of Cardiovascular Events in Patients with ASCVD]

Patient demonstrates positive clinical response to therapy as evidenced by a reduction in LDL-C levels from baseline

AND

One of the following:

Patient continues to receive other lipid-lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose
Patient has a documented inability to take other lipid-lowering therapy (e.g., statins, ezetimibe)

AND

Applies to Praluent only: For patients 10 years of age or older: Trial and failure, contraindication, or intolerance to Repatha

Praluent (NF)

Non Formulary (Initial Authorization)

One of the following diagnoses:

Both of the following:

Heterozygous familial hypercholesterolemia (HeFH)
Patient is 8 years of age or older

Atherosclerotic cardiovascular disease (ASCVD)

Primary hyperlipidemia

AND

One of the following:

Patient has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy
Patient is statin intolerant as evidenced by an inability to tolerate at least two statins, with at least one started at the lowest starting daily dose, due to intolerable symptoms or clinically significant biomarker changes of liver function or muscle function (e.g., creatine kinase)
Patient has an FDA labeled contraindication to all statins

AND

One of the following:

Submission of medical records (e.g., chart notes, laboratory values) documenting one of the following while on maximally tolerated lipid-lowering therapy (e.g., statins) within the last 120 days [5]:

Patient requires greater than or equal to 25% LDL-C reduction to achieve goal
Patient has LDL-C greater than or equal to 70 mg/dL with ASCVD
Patient has LDL-C greater than or equal to 100 mg/dL without ASCVD

Both of the following:

Patient has been receiving PCSK9 therapy as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe)

AND

Submission of medical records (e.g., laboratory values) documenting LDL-C values drawn within the past 12 months while on maximally tolerated lipid lowering therapy is within normal limits

AND

For patients 10 years of age or older: Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Repatha

Praluent (NF)

Non Formulary (Reauthorization)

Submission of medical records (e.g., chart notes, laboratory values) documenting a positive clinical response to therapy as evidenced by a reduction in LDL-C levels from baseline

AND

One of the following:

Patient continues to receive other lipid-lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose
Patient has a documented inability to take other lipid-lowering therapy (e.g., statins, ezetimibe)

AND

For patients 10 years of age or older: Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Repatha

Repatha

Prior Authorization, Step Therapy (Initial Authorization)

Length of Approval: 6 Months [A]
For diagnosis of Homozygous Familial Hypercholesterolemia

Diagnosis of homozygous familial hypercholesterolemia as confirmed by one of the following:

Genetic confirmation of 2 mutations in the LDL receptor, ApoB, PCSK9, or LDL receptor adaptor protein 1 (i.e., LDLRAP1 or ARH)

Both of the following:

Untreated LDL-C greater than 400 mg/dL

AND

One of the following:

Xanthoma before 10 years of age
Evidence of heterozygous familial hypercholesterolemia (HeFH) in both parents

AND

One of the following:

Patient is receiving other lipid-lowering therapy (e.g., statin, ezetimibe)
Patient has a documented inability to take other lipid-lowering therapy (e.g., statin, ezetimibe)

AND

Patient is 10 years of age or older

Praluent (F)

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [A]
For diagnosis of Homozygous Familial Hypercholesterolemia

Diagnosis of homozygous familial hypercholesterolemia as confirmed by one of the following:

Genetic confirmation of 2 mutations in the LDL receptor, ApoB, PCSK9, or LDL receptor adaptor protein 1 (i.e., LDLRAP1 or ARH)

Both of the following:

Untreated LDL-C greater than 400 mg/dL

AND

One of the following:

Xanthoma before 10 years of age
Evidence of heterozygous familial hypercholesterolemia (HeFH) in both parents

AND

One of the following:

Patient is receiving other lipid-lowering therapy (e.g., statin, ezetimibe)
Patient has a documented inability to take other lipid-lowering therapy (e.g., statin, ezetimibe)

AND

Trial and failure, contraindication, or intolerance to Repatha

Repatha, Praluent (F)

Prior Authorization, Step Therapy (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Homozygous Familial Hypercholesterolemia

Patient demonstrates positive clinical response to therapy as evidenced by a reduction in LDL-C levels from baseline

AND

One of the following:

Patient continues to receive other lipid-lowering therapy (e.g., statin, ezetimibe)
Patient has a documented inability to take other lipid-lowering therapy (e.g., statin, ezetimibe)

AND

Applies to Praluent only: Trial and failure, contraindication, or intolerance to Repatha

Praluent (NF)

Non Formulary (Initial Authorization)

Length of Approval: 6 Months [A]
For diagnosis of Homozygous Familial Hypercholesterolemia

Submission of medical records (e.g., chart notes, laboratory values) documenting diagnosis of homozygous familial hypercholesterolemia as confirmed by one of the following:

Genetic confirmation of 2 mutations in the LDL receptor, ApoB, PCSK9, or LDL receptor adaptor protein 1 (i.e., LDLRAP1 or ARH)

Both of the following:

Untreated LDL-C greater than 400 mg/dL

AND

One of the following:

Xanthoma before 10 years of age
Evidence of heterozygous familial hypercholesterolemia (HeFH) in both parents

AND

One of the following:

Patient is receiving other lipid-lowering therapy (e.g., statin, ezetimibe)
Patient has a documented inability to take other lipid-lowering therapy (e.g., statin, ezetimibe)

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Repatha

Praluent (NF)

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Homozygous Familial Hypercholesterolemia

Submission of medical records (e.g., chart notes, laboratory values) documenting a positive clinical response to therapy as evidenced by a reduction in LDL-C levels from baseline

AND

One of the following:

Patient continues to receive other lipid-lowering therapy (e.g., statin, ezetimibe)
Patient has a documented inability to take other lipid-lowering therapy (e.g., statin, ezetimibe)

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Repatha

Guideline ID
GL-161531
Formulary
EHB
Effective date
Dec 1, 2024
P&T approval date
May 20, 2015

P & T Revisions

2024-12-02, 2024-11-06, 2024-09-13, 2024-07-04, 2024-05-21, 2024-02-27, 2023-07-06, 2023-03-31, 2022-06-20, 2022-04-25, 2022-03-03, 2022-02-03, 2021-11-01, 2021-08-04, 2021-06-16, 2021-05-21, 2021-03-12, 2020-02-08, 2019-12-06, 2019-11-04

References

Praluent Prescribing Information. Regeneron Pharmaceuticals, Inc. Tarrytown, NY. March 2024.
Repatha Prescribing Information. Amgen Inc. Thousand Oaks, CA. October 2021.
Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2019; 73:e285-e350.
Alonso R, Cuevas A, Cafferata A. Diagnosis and Management of Statin Intolerance. J Atheroscler Thromb. 2019 Mar 1;26(3):207-215. doi: 10.5551/jat.RV17030. Epub 2019 Jan 19. PMID: 30662020; PMCID: PMC6402887.
Lloyd-Jones D, Morris P, et al. 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk. J Am Coll Cardiol. 2022 Oct, 80 (14) 1366–1418. https://doi.org/10.1016/j.jacc.2022.07.006
Harada-Shiba M, Arai H, Ishigaki Y, Ishibashi S, Okamura T, Ogura M, Dobashi K, Nohara A, Bujo H, Miyauchi K, Yamashita S, Yokote K; Working Group by Japan Atherosclerosis Society for Making Guidance of Familial Hypercholesterolemia. Guidelines for Diagnosis and Treatment of Familial Hypercholesterolemia 2017. J Atheroscler Thromb. 2018 Aug 1;25(8):751-770. doi: 10.5551/jat.CR003. Epub 2018 Jun 7. PMID: 29877295; PMCID: PMC6099072.
Cuchel M, Raal FJ, Hegele RA, et al. 2023 Update on European Atherosclerosis Society Consensus Statement on Homozygous Familial Hypercholesterolaemia: new treatments and clinical guidance. Eur Heart J. 2023;44(25):2277-2291. doi:10.1093/eurheartj/ehad197

End Notes

Per the 2018 ACC/AHA national treatment guidelines, adherence, response to therapy, and adverse effects should be monitored within 4 -12 weeks following LDL-C lowering medication initiation or dose adjustment, repeated every 3 to 12 months as needed. [3]

Revision History

2024-12-02: Updated Primary Hyperlipidemia and HoFH criteria; updated GL type for Repatha.
2024-11-06: Updated Primary Hyperlipidemia and HoFH criteria.
2024-09-13: Updated Primary Hyperlipidemia initial authorization criteria for Repatha, Praluent and Praluent NF.
2024-07-04: Updated LDL-C threshold for patients without ASCVD to align with LDL-C thresholds in 2022 ACC recommendations.
2024-05-21: Added in age criteria for HeFH indication for Praluent and background updates to align with updated prescribing information.
2024-02-27: Criteria streamlined
2023-07-06: Update to account for 2022 ACC recommendations of a lower LDL threshold of 55mg/dl for patients with ASCVD at very high risk.
2023-03-31: Annual Review - addition of broader diagnosis of Primary Hyperlipidemia where appropriate.
2022-06-20: Updates made to Repatha and Praluent HeFH and ASCVD criteria
2022-04-25: Updated NF reauth criteria.
2022-03-03: Annual Review - Addition of age criteria for Repatha used in pediatric patients aged 10 years and older with HeFH and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). Total statin intolerance no longer requires "documented in medical records"
2022-02-03: Update to add operational note for primary hyperlipidemia.
2021-11-01: Updated Repatha indications due to expanded age approval. No changes to clinical criteria.
2021-08-04: Removed prescriber requirement for all targets, Praluent has separate Formulary and NF guidelines, requires step through Repatha.
2021-06-16: Removed physician attestation from all initial and reauth criteria. Updated criteria due to Praluent HoFH indication.
2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
2021-03-12: Annual review; updated references
2020-02-08: Annual review; updated background and references
2019-12-06: Removed requirement for submission of medical records for statin/ezetimibe use.
2019-11-04: Updated criteria to add submission of medical records requirements.

PCSK9 Inhibitors - PA, ST, NF

Indications for Prior Authorization

Repatha (evolocumab)

Praluent (alirocumab)

Criteria

Repatha

Praluent (F)

Repatha, Praluent (F)

Praluent (NF)

Praluent (NF)

Repatha

Praluent (F)

Repatha, Praluent (F)

Praluent (NF)

Praluent (NF)

P & T Revisions

References

End Notes

Revision History

Provider Tools