Pharmacy Prior Authorization Criteria

Omega-3-Acid Derivatives

Indications for Prior Authorization

Vascepa (icosapent ethyl)

• For diagnosis of Severe Hypertriglyceridemia
  Indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia.

  Limitations of Use: The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

• For diagnosis of Prevention of Cardiovascular Events
  Indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (greater than or equal to 150 mg/dL) and 1) established cardiovascular disease or 2) diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.

Generic icosapent ethyl

• For diagnosis of Severe Hypertriglyceridemia
  Indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia.

  Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

• For diagnosis of Prevention of Cardiovascular Events [off-label]
  Indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (greater than or equal to 150 mg/dL) and 1) established cardiovascular disease or 2) diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.

Lovaza (omega-3-acid ethyl esters)

• For diagnosis of Severe Hypertriglyceridemia
  Indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG).

  Limitations of Use: The effect of Lovaza on the risk for pancreatitis has not been determined. The effect of Lovaza on cardiovascular mortality and morbidity has not been determined.

Criteria

Brand Lovaza, Brand Vascepa, Generic icosapent ethyl

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Severe Hypertriglyceridemia

• Diagnosis of hypertriglyceridemia
AND
• Patient has a pre-treatment triglyceride level greater than or equal to 500 mg/dL
AND
• Applies to Brand Lovaza ONLY: Trial and failure, contraindication or intolerance to generic omega-3-acid ethyl esters

Brand Lovaza, Brand Vascepa, Generic icosapent ethyl

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Severe Hypertriglyceridemia

• Patient demonstrates positive clinical response to therapy
AND
• Applies to Brand Lovaza ONLY: Trial and failure, contraindication or intolerance to generic omega-3-acid ethyl esters

Brand Vascepa, Generic icosapent ethyl

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Prevention of Cardiovascular Events

• Both of the following:
• Diagnosis of hypertriglyceridemia
AND
• Patient has a pre-treatment triglyceride level of 150 mg/dL to 499 mg/dL [2,3]
AND
• One of the following:
• Patient has established cardiovascular disease (CVD) (e.g., coronary artery disease, cerebrovascular or carotid disease, peripheral artery disease, etc.) [2]
OR
• Both of the following:
• Diagnosis of diabetes mellitus [2]
AND
• Patient has two or more risk factors for developing cardiovascular disease (see background section for definitions) [2, 4]
AND
• Medication will be used as an adjunct to maximally tolerated statin therapy, unless there is a contraindication or intolerance to statin therapy [2]

Brand Vascepa, Generic icosapent ethyl

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Prevention of Cardiovascular Events

• Patient demonstrates positive clinical response to therapy.
AND
• Medication continues to be used as an adjunct to maximally tolerated statin therapy, unless there is a contraindication or intolerance to statin therapy [2]

P & T Revisions

2024-10-02, 2023-10-26, 2023-09-06, 2022-10-04, 2022-09-08, 2021-11-01, 2021-08-31, 2021-05-21, 2020-12-02, 2020-09-02, 2020-04-06, 2020-01-06, 2019-09-13

References

1. Lovaza prescribing information. GlaxoSmithKline. Research Triangle Park, NC. February 2021.
2. Vascepa prescribing information. Amarin Pharma Inc. Bedminster, NJ. April 2023.
3. Icosapent ethyl prescribing information. Teva Pharmaceuticals. Parsippany, NJ. August 2021.
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. Supplement to: Bhatt DL, Steg PG, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792

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End Notes

1. In patients treated with statins, it is recommended to measure creatine kinase levels in individuals with severe statin-associated muscle symptoms. [3]

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Revision History

• 2024-10-02: 2024 Annual Review. Added trial of generic omega-3-acid ethyl esters to reauthorization criteria for Lovaza. Background updates.
• 2023-10-26: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-09-06: Annual Review - No criteria changes
• 2022-10-04: Addition of new generic strength for Vascepa
• 2022-09-08: Annual Review - No criteria changes
• 2021-11-01: Removed generic omega-3-acid ethyl esters (generic Lovaza) as target. Added embedded step through generic omega-3-acid ethyl esters for Brand Lovaza.
• 2021-08-31: annual review: updated references
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2020-12-02: Updated to add new generic for Vascepa; updated prevention of cardiovascular events criteria
• 2020-09-02: Updated criteria per PA streamlining initiative
• 2020-04-06: Updated criteria formatting for severe hypertriglyceridemia per PA request (no change to clinical intent)
• 2020-01-06: Update to add generic omega-3-acid ethyl esters as a target
• 2019-09-13: New program for 1/1/2020 implementation.

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