Quantity Limitations
Quantity limitations apply to brand and associated generic products.
Commercial Utilization Management Policy
Version Date: September 2022
Restricted Product(s)
- Vascepa® (icosapent ethyl)
- Icosapent ethyl (generic Vascepa® )
FDA Approved Use
- As an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL)
- As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels (150 mg/dL or greater) and established cardiovascular disease (CVD) or diabetes mellitus and 2 or more additional risk factors for CVD
Criteria for Approval of Restricted Product(s)
- The patient is at least 18 years of age; AND
- The patient has a baseline triglyceride (TG) level of ≥ 500 mg/dL; OR
- The patient has a treated (e.g. with statins) triglyceride (TG) level of 135-499 mg/dL; AND
- The patient has established cardiovascular disease; OR
- The patient has diabetes mellitus and at least ONE of the following:
- Age ≥ 55 years for men or ≥ 65 years for women
- Cigarette smoker or stopped smoking within the past 3 months
- Hypertension (≥ 140 mm Hg systolic or ≥90 mm Hg diastolic) or on antihypertensive medication
- HDL-C ≤40 mg/dL for men or ≤ 50 mg/dL for women
- hsCRP > 3.00 mg/dL
- Renal dysfunction CrCl > 30 and < 60 mL/min
- Retinopathy defined as any of the following: non-proliferative retinopathy, pre-proliferative retinopathy, proliferative retinopathy, maculopathy, advanced diabetic eye disease, or a history of photocoagulation
- Micro- or macroalbuminuria; AND
- The patient is currently on statin therapy; AND
- The patient does not have any FDA labeled contraindications to the requested agent; AND
- If the requested medication is generic icosapent ethyl capsules;
- The patient has tried and failed, is intolerant to, or has an FDA labeled contraindication to Brand Vascepa® (medical record documentation required); AND
- For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
Duration of Approval: 365 days (1 year)
| Medication | Quantity per Day (unless specified) |
|---|---|
| Vascepa (icosapent ethyl) 0.5 gram | 8 capsules |
| Vascepa (icosapent ethyl) 1 gram | 4 capsules |
Quantity Limit Exception Criteria
- The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
- The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
- The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
- If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
Duration of Approval: 365 days (1 year)
References
All information referenced is from FDA package insert unless otherwise noted below.
Bhatt DL, Steg PG, Miller M, et al; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.[PubMed 30415628]10.1056/NEJMoa1812792
Policy Implementation/Update Information
Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.
September 2022: Criteria update: Added icosapent ethyl 0.5 gram (generic Vascepa) to the policy.
June 2022: Criteria change: Medical record documentation required for failure/intolerance/contraindication of generic Vascepa.
March 2022: Criteria change: Removed age requirements for those with established cardiovascular disease and diabetes.
May 2021: Criteria change: Removed LDL requirement.
Nov 2020: Criteria update: Added icosapent ethyl 1 gram (generic Vascepa) to the policy.
June 2020: Criteria change: Added “baseline” to requirement of triglyceride level of ≥ 500.
April 2020: Original utilization management criteria issued.
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