Pharmacy Prior Authorization Criteria

Leqvio (inclisiran) - PA, NF

Indications for Prior Authorization

Leqvio (inclisiran) injection, for subcutaneous use

• For diagnosis of Primary Hyperlipidemia
  Indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce low-density lipoprotein cholesterol (LDL-C).

Criteria

Leqvio

Prior Authorization (Initial Authorization)

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

• One of the following diagnoses:
• Heterozygous familial hypercholesterolemia (HeFH)
• Atherosclerotic cardiovascular disease (ASCVD)
• Primary hyperlipidemia
AND
• One of the following: [4]
• 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:
• Patient has been receiving at least 12 consecutive weeks of ezetimibe (Zetia) therapy as adjunct to maximally tolerated statin therapy
• Patient has a history of contraindication or intolerance to ezetimibe
AND
• One of the following:
• Both of the following:
• Patient has been receiving at least 12 consecutive weeks of Repatha therapy as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe)
AND
• Despite adherence to Repatha therapy, patient has been unable to achieve LDL-C goal as evidenced by one of the following within the last 120 days:
• LDL-C greater than or equal to 55 mg/dL with ASCVD [7]
• LDL-C greater than or equal to 70 mg/dL without ASCVD [7]
OR
• Patient is unable to maintain adherence to Repatha therapy due to one of the following:
• Manual dexterity problems (e.g., tremors, arthritis)
• Visual impairment (e.g., best-corrected visual acuity of 20/200 or worse) [6]
OR
• Patient has experienced a hypersensitivity reaction, defined as angioedema, vasculitis, urticaria, to Repatha therapy
AND
• Prescribed by or in consultation with one of the following:
• Cardiologist
• Endocrinologist
• Lipid specialist
AND
• Medication will not be used in combination with PCSK9 inhibitor therapy [2,3]

Leqvio

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Primary Hyperlipidemia [Including Heterozygous Familial Hypercholesterolemia (HeFH), Atherosclerotic Cardiovascular Disease (ASCVD)]

• Patient demonstrates positive clinical response to therapy as evidenced by LDL-C reduction 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
• One of the following:
• Both of the following:
• Patient has previously received at least 12 consecutive weeks of Repatha therapy as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe)
AND
• Despite adherence to Repatha therapy, patient was unable to achieve LDL-C goal as evidenced by one of the following within the last 120 days:
• LDL-C greater than or equal to 55 mg/dL with ASCVD [7]
• LDL-C greater than or equal to 70 mg/dL without ASCVD [7]
OR
• Patient continues to be unable to maintain adherence to Repatha therapy due to one of the following:
• Manual dexterity problems (e.g., tremors, arthritis)
• Visual impairment (e.g., best-corrected visual acuity of 20/200 or worse) [6]
OR
• Patient has experienced a hypersensitivity reaction, defined as angioedema, vasculitis, urticaria, to Repatha therapy
AND
• Medication will not be used in combination with PCSK9 inhibitor therapy [2,3]

Leqvio

Non Formulary (Initial Authorization)

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

• One of the following diagnoses:
• Heterozygous familial hypercholesterolemia (HeFH)
• 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:
• Patient has been receiving at least 12 consecutive weeks of ezetimibe (Zetia) therapy as adjunct to maximally tolerated statin therapy
• Patient has a history of contraindication or intolerance to ezetimibe
AND
• Submission of medical records (e.g., chart notes, laboratory values) documenting one of the following:
• Both of the following:
• Patient has been receiving at least 12 consecutive weeks of Repatha therapy as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe)
AND
• Despite adherence to Repatha therapy, patient has been unable to achieve LDL-C goal as evidenced by one of the following within the last 120 days:
• LDL-C greater than or equal to 55 mg/dL with ASCVD [7]
• LDL-C greater than or equal to 70 mg/dL without ASCVD [7]
OR
• Patient is unable to maintain adherence to Repatha therapy due to one of the following:
• Manual dexterity problems (e.g., tremors, arthritis)
• Visual impairment (e.g., best-corrected visual acuity of 20/200 or worse) [6]
OR
• Patient has experienced a hypersensitivity reaction, defined as angioedema, vasculitis, urticaria, to Repatha therapy
AND
• Prescribed by or in consultation with one of the following:
• Cardiologist
• Endocrinologist
• Lipid specialist
AND
• Medication will not be used in combination with PCSK9 inhibitor therapy [2,3]

Leqvio

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Primary Hyperlipidemia [Including Heterozygous Familial Hypercholesterolemia (HeFH), Atherosclerotic Cardiovascular Disease (ASCVD)]

• Submission of medical records (e.g., chart notes, laboratory values) documenting LDL-C reduction 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
• Submission of medical records (e.g., chart notes, laboratory values) documenting one of the following:
• Both of the following:
• Patient has previously received at least 12 consecutive weeks of Repatha therapy as adjunct to maximally tolerated lipid lowering therapy (e.g., statins, ezetimibe)
AND
• Despite adherence to Repatha therapy, patient was unable to achieve LDL-C goal as evidenced by one of the following:
• LDL-C greater than or equal to 55 mg/dL with ASCVD [7]
• LDL-C greater than or equal to 70 mg/dL without ASCVD [7]
OR
• Patient continues to be unable to maintain adherence to Repatha therapy due to one of the following:
• Manual dexterity problems (e.g., tremors, arthritis)
• Visual impairment (e.g., best-corrected visual acuity of 20/200 or worse) [6]
OR
• Patient has experienced a hypersensitivity reaction, defined as angioedema, vasculitis, urticaria, to Repatha therapy
AND
• Medication will not be used in combination with PCSK9 inhibitor therapy [2,3]

P & T Revisions

2024-07-04, 2024-02-27, 2023-09-01, 2023-07-06, 2023-03-02, 2022-05-31, 2022-03-11

References

1. Leqvio prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp. July 2023.
2. Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519.
3. Raal FJ, Kallend D, Ray KK, et al. Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia. N Engl J Med. 2020;382(16):1520-1530.
4. 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.
5. Scientific Steering Committee on behalf of the Simon Broome Register Group. Risk of fatal coronary heart disease in familial hypercholesterolaemia. BMJ. 1991;303:893-6.
6. Vision Impairment and Blindness | Examination-Based Studies | Information on Data Sources | Vision and Eye Health Surveillance System | Vision Health Initiative (VHI) | CDC. www.cdc.gov. Published February 27, 2019. Accessed April 5, 2022.
7. 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

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Revision History

• 2024-07-04: Updated LDL-C threshold for patients without ASCVD to align with LDL-C thresholds in 2022 ACC recommendations.
• 2024-02-27: criteria streamlined
• 2023-09-01: Updated criteria for updated indication of primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
• 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.
• 2023-03-02: Annual Review - no criteria changes
• 2022-05-31: Addition of NF criteria and updated adherence to PCSK9 criteria
• 2022-03-11: New UM Program

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