WHA
 

PCSK9 inhibitors - PA, NF

Indications for Prior Authorization

Praluent (alirocumab)
  • For diagnosis of Prevention of Cardiovascular Events
    Indicated to reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events.

  • For diagnosis of Hypercholesterolemia
    Indicated as an adjunct to diet and exercise to reduce low density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia.

  • For diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH)
    Indicated as an adjunct to diet and and exercise to reduce low density lipoprotein cholesterol (LDL-C) in adults and pediatric patients aged 8 years and older with HeFH.

  • For diagnosis of Homozygous Familial Hypercholesterolemia
    Indicated as an adjunct to diet and exercise to reduce low density lipoprotein cholesterol (LDL-C) in adults with homozygous familial hypercholesterolemia (HoFH).

Lerochol (lerodalcibep-liga)
  • For diagnosis of Hypercholesterolemia
    Indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

Criteria

Praluent

Prior Authorization

Length of Approval: When approved; no reauthorization required
For diagnosis of Hypercholesterolemia [Including Heterozygous Familial Hypercholesterolemia (HeFH)], Atherosclerotic Cardiovascular Disease (ASCVD), Prevention of Cardiovascular (CV) Events in Patients at increased risk for a major adverse cardiovascular event

  • One of the following diagnoses:
    • Both of the following:
      • Heterozygous familial hypercholesterolemia (HeFH)
      • Patient is 8 years of age or older
      OR
    • Atherosclerotic cardiovascular disease (ASCVD) (e.g., history of acute coronary syndromes (ACS), myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral artery disease (PAD))
      • OR
    • Primary hyperlipidemia or hypercholesterolemia
      • OR
    • At increased risk for a major adverse cardiovascular (CV) event
    AND
  • One of the following [3]:
    • Patient has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy and has not reached LDL-C goal
    • 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) [3]
    • Patient has an FDA labeled contraindication to all statins
    AND
  • One of the following:
    • Patient has not achieved LDL-C goal while on maximally tolerated lipid-lowering therapy (e.g., statins, ezetimibe) within the last 120 days as demonstrated by one of the following [7]:
      • Patient has LDL-C greater than or equal to 55 mg/dL with ASCVD
      • Patient has LDL-C greater than or equal to 70 mg/dL without ASCVD but at high risk (e.g., with ASCVD risk factors [age greater than or equal to 65, current smoker, diabetes], subclinical atherosclerosis)
      • Patient has LDL-C greater than or equal to 100 mg/dL without ASCVD and not at high risk
      OR
    • Both of the following:
      • Patient has been receiving PCSK9 therapy as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe)
        • AND
      • Patient has reached LDL-C goal
    AND
  • For patients 10 years of age or older: Trial and failure, contraindication, or intolerance to Repatha
Lerochol

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Hypercholesterolemia [Including Heterozygous Familial Hypercholesterolemia (HeFH)], Atherosclerotic Cardiovascular Disease (ASCVD)

  • One of the following diagnoses:
    • Heterozygous familial hypercholesterolemia (HeFH)
    • Atherosclerotic cardiovascular disease (ASCVD) (e.g., history of acute cor¬onary syndromes (ACS), myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascular¬ization, stroke, transient ischemic attack (TIA), or periph¬eral artery disease (PAD))
    • Primary hyperlipidemia or hypercholesterolemia
    AND
  • One of the following [3]:
    • Patient has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy and has not reached LDL-C goal
    • 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) [3]
    • Patient has an FDA labeled contraindication to all statins
    AND
  • One of the following:
    • Patient has not achieved LDL-C goal while on maximally tolerated lipid-lowering therapy (e.g., statins) within the last 120 days as demonstrated by one of the following [7]:
      • Patient has LDL-C greater than or equal to 55 mg/dL with ASCVD
      • Patient has LDL-C greater than or equal to 70 mg/dL without ASCVD but at high risk (e.g., with ASCVD risk factors [age greater than or equal to 65, current smoker, diabetes], subclinical atherosclerosis)
      • Patient has LDL-C greater than or equal to 100 mg/dL without ASCVD and not at high risk
      OR
    • Both of the following:
      • Patient has been receiving Lerochol as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe)
        • AND
      • Patient has reached LDL-C goal
    AND
  • One of the following:
    • Trial of Repatha
      • OR
    • Contraindication or intolerance to PCSK9 inhibitor (e.g., Repatha, Praluent)
Lerochol

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Hypercholesterolemia [Including Heterozygous Familial Hypercholesterolemia (HeFH)], Atherosclerotic Cardiovascular Disease (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)
    • Patient has a documented inability to take other lipid-lowering therapy (e.g., statins, ezetimibe)
    AND
  • One of the following:
    • Trial of Repatha
      • OR
    • Contraindication or intolerance to PCSK9 inhibitor (e.g., Repatha, Praluent)
Praluent

Non Formulary (Initial Authorization)

Length of Approval: 6 Months [A]
For diagnosis of Hypercholesterolemia [Including Heterozygous Familial Hypercholesterolemia (HeFH)], Atherosclerotic Cardiovascular Disease (ASCVD), Prevention of Cardiovascular (CV) Events in Patients at increased risk for a major adverse cardiovascular event

  • One of the following diagnoses:
    • Both of the following:
      • Submission of medical records (e.g., chart notes) confirming diagnosis of Heterozygous familial hypercholesterolemia (HeFH)
      • Patient is 8 years of age or older
      OR
    • Submission of medical records (e.g., chart notes) confirming diagnosis of atherosclerotic cardiovascular disease (ASCVD) (e.g., history of acute coronary syndromes (ACS), myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or periph¬eral artery disease (PAD))
      • OR
    • Submission of medical records (e.g., chart notes) confirming diagnosis of primary hyperlipidemia or hypercholesterolemia
      • OR
    • At increased risk for a major adverse cardiovascular (CV) event
    AND
  • Submission of medical records (e.g., chart notes) and/or paid claims confirming one of the following:
    • Patient has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy and has not reached LDL-C goal
    • 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 patient has not achieved LDL-C goal while on maximally tolerated lipid-lowering therapy (e.g., statins, ezetimibe) within the last 120 days as demonstrated by one of the following [7]:
      • Patient has LDL-C greater than or equal to 55 mg/dL with ASCVD
      • Patient has LDL-C greater than or equal to 70 mg/dL without ASCVD but at high risk (e.g., with ASCVD risk factors [age greater than or equal to 65, current smoker, diabetes], subclinical atherosclerosis)
      • Patient has LDL-C greater than or equal to 100 mg/dL without ASCVD and not at high risk
      OR
    • Both of the following:
      • Submission of medical records (e.g., chart notes) and/or paid claims confirming 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 patient has reached LDL-C goal
    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

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Hypercholesterolemia [Including Heterozygous Familial Hypercholesterolemia (HeFH)], Atherosclerotic Cardiovascular Disease (ASCVD), Prevention of Cardiovascular (CV) Events in Patients at increased risk for a major adverse cardiovascular event

  • 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
  • Submission of medical records (e.g., chart notes) and/or paid claims confirming 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
Praluent (F)

Prior Authorization

Length of Approval: When approved; no reauthorization required
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)
      • OR
    • Both of the following [6]:
      • 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
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)
      • OR
    • 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-623226

  • Formulary
    premium

  • Effective date
    Jun 1, 2026

  • P&T approval date
    May 20, 2015

P & T Revisions

2026-05-22, 2026-05-18, 2026-05-18, 2026-04-16, 2025-12-19, 2025-12-05, 2025-11-24, 2025-11-06, 2025-05-01, 2025-04-30, 2025-03-27, 2025-03-07, 2025-02-06, 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

  1. Praluent Prescribing Information. Regeneron Pharmaceuticals, Inc. Tarrytown, NY. October 2025. Accessed February 2026
  2. 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. Accessed february 2026
  3. 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. Accessed February 2026
  4. 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. Accessed February 2026
  5. 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. Accessed February 2026
  6. 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. Accessed February 2026
  7. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia
  8. Lerochol Prescribing Information. LIB Therapeutics, Inc. Cincinnati, OH. December 2025.
  1. Per the 2026 ACC/AHA national treatment guidelines, clinicians should perform a lipid profile 4 to 12 week after initiation or dose adjustment and every 6 to 12 months thereafter to assess efficacy and adherence to lipid lowering therapies (LLTs). [7]
  • 2026-05-22: Addition of Lerochol as a target drug.
  • 2026-05-18: Addition of Lerochol as a target drug.
  • 2026-05-18: Addition of Lerochol as a target drug.
  • 2026-04-16: 2026 Annual Review. Indications updated in line with FDA label. Criteria update to align with updated treatment guidelines.
  • 2025-12-19: no criteria changes, added IL statute operational note
  • 2025-12-05: No criteria changes, added IL statute note
  • 2025-11-24: Updated criteria due to updates to labelled indications. Background updates.
  • 2025-11-06: Removing Repatha from guideline effective 12/1/25 and updated guideline name.
  • 2025-05-01: Approval length updated to "Approved- no reauthorization required"
  • 2025-04-30: Removing reauthorization requirement as part of extended reauthorization program.
  • 2025-03-27: Removing reauthorization requirement as part of extended reauthorization program.
  • 2025-03-07: 2025 Annual Review. No criteria changes. Background updates.
  • 2025-02-06: Background updates to align with update in Repatha prescribing information.
  • 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.