ModifiedCentenePolicy CP.PMN.187

Icosapent Ethyl (Vascepa) Coverage

Defines medical necessity and prior authorization criteria for icosapent ethyl (Vascepa) for Centene-affiliated health plans (HIM, Medicaid), including indications for hypertriglyceridemia and reduction of cardiovascular disease risk, and requirements for documentation and step therapy.

Policy Summary

PayerCentene

PolicyIcosapent Ethyl (Vascepa) Coverage

Policy CodePolicy CP.PMN.187

Change TypeMaterial clinical revisions

Effective Date

Next Review Date

Key ActionSubmit prior authorization with supporting chart notes and labs (fasting TG, LDL‑C) and document required prior therapy trials or contraindications.

SourceLink

POLICY UPDATE CHANGES

For reduction of CVD risk, statin adherence duration was reduced from 4 months to 8 weeks and statin trial/failure criteria were simplified to require insufficient therapeutic response to one high-intensity statin for 8 weeks or reversible muscle-related symptoms associated with both rosuvastatin and atorvastatin.

Step therapy bypass for Illinois Health Insurance Marketplace per IL HB 5395 was added.

Initial approval duration for this maintenance medication was extended from 6 months to 12 months.

12 monthsInitial authorization duration

≥500Severe HTG threshold

150-499CVD-risk TG range

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8 weeksStatin trial duration (CVD)

Coverage Criteria for Icosapent Ethyl (Vascepa)

Dosing, availability, and updated administrative/statin prerequisites

Covered when ALL of the following are met for indicated uses (content focuses on dosing, product availability, and updated administrative/statin prerequisites):

Dosing: Prescribed dose corresponds to 2 g PO twice daily (total 4 g/day max)2 g PO BID

See product availability for capsule strengths

Product formulation: Prescription corresponds to available capsule strengths (0.5 g or 1 g)0.5 g or 1 g capsules

Prior authorization constraints: Request does not exceed health-plan approved quantity limit and initial approval duration may be up to 12 months for maintenance therapyinitial approval 12 months

Step therapy bypass applies for IL HIM per IL HB 5395 where applicable

Statin trial for CVD risk indication: Statin adherence/trial shortened to 8 weeks; simplified trial/failure criteria: insufficient therapeutic response to one high-intensity statin for 8 weeks OR reversible muscle-related symptoms associated with both rosuvastatin and atorvastatin8 weeks of high-intensity statin trial

Applies specifically to reduction of CVD risk indication

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (HIM.PA.154 for Health Insurance Marketplace members or CP.PMN.53 for Medicaid members) or other evidence of coverage documents.

Statin therapy may be contraindicated in certain clinical situations; examples include decompensated liver disease (e.g., jaundice, ascites, variceal bleeding, encephalopathy), laboratory‑confirmed acute liver injury or rhabdomyolysis resulting from statin treatment, pregnancy/actively trying to become pregnant/nursing (note: the FDA requested removal of the pregnancy contraindication in July 2021), and immune‑mediated hypersensitivity to the HMG‑CoA reductase inhibitor class evidenced by allergic reactions to at least two different statins. Providers should document these contraindications when statin intolerance or contraindication is used to justify therapy decisions.

Requests for uses that are non‑FDA approved and lack adequate supporting documentation per the referenced off‑label use policies will be considered not authorized (not medically necessary) under this policy. Providers seeking coverage for off‑label indications must submit the required evidence per HIM.PA.154 (HIM) or CP.PMN.53 (Medicaid) to support safety and efficacy.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence. For Medicaid members, follow the applicable state Medicaid manual for any coverage provisions that supersede this policy.

Clinical Thresholds and Key Parameters

Fasting triglycerides for indications

Severe hypertriglyceridemia thresholdFasting triglycerides ≥ 500 mg/dL for hypertriglyceridemia without ASCVD (lab dated within 90 days)

CVD risk indication TG rangeFasting triglycerides 150-499 mg/dL (labs dated within 90 days)

Lab timing requirementRelevant fasting TG lab must be dated within 90 days for initial CVD-risk and hypertriglyceridemia indications

LDL-C for CVD risk indication

LDL-C range for CVD risk indicationLDL-C between 41-100 mg/dL (lab dated within 90 days)

Lab timing requirementLDL-C must be documented within 90 days of request

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation supporting the member meets all approval criteria, including diagnosis, pertinent chart notes, and labs (see criteria for required lab timing). Requests lacking required documentation or for non‑FDA approved indications may be denied per the policy and applicable off‑label use policies.

Prior authorization required with documentation of diagnosis, labs, prior therapies, and adherence per listed criteria.
Requests for non‑FDA approved indications may be denied unless supported by HIM.PA.154 (Health Insurance Marketplace) or CP.PMN.53 (Medicaid) or other evidence of coverage documentation.

Documentation Required

Documentation Requirements

Provider must submit relevant clinical documentation (office chart notes, medication history, and lab results). Labs supporting triglyceride and lipid values must be dated within 90 days of the request.chart notes should document prior therapy trials, dosing, duration, tolerability, and adherence.

Background

Icosapent ethyl (Vascepa) is an ethyl ester of eicosapentaenoic acid (EPA) indicated to reduce the risk of major cardiovascular events when added to maximally tolerated statin therapy in adults with elevated triglycerides and either established atherosclerotic cardiovascular disease or diabetes with additional risk factors, and it is also approved to reduce triglyceride levels in patients with severe hypertriglyceridemia. Typical dosing for the approved indications is 2 g orally twice daily (total 4 g/day), and the product is available as 0.5 g and 1 g capsules. Clinical benefit for cardiovascular risk reduction has been demonstrated when used in conjunction with maximally tolerated statin therapy; its effect on pancreatitis risk in severe hypertriglyceridemia is not established.

Definitions and Abbreviations

Atherosclerotic cardiovascular disease (ASCVD)

DefinitionAtherosclerotic cardiovascular disease (ASCVD): history of conditions such as acute coronary syndromes, clinically significant coronary heart disease, coronary or other arterial revascularization, myocardial infarction, peripheral arterial disease presumed atherosclerotic, stable or unstable angina, or stroke/TIA

AbbreviationASCVD stands for atherosclerotic cardiovascular disease

Use in criteriaASCVD diagnosis qualifies members for CVD risk reduction indication

Triglyceride (TG)

DefinitionTriglyceride (TG): abbreviated as TG in the policy (triglyceride)

RoleFasting TG values are used to determine eligibility for hypertriglyceridemia and CVD risk indications

Policy Revision History

2025-10-23policy_revisionLatest

Added step therapy bypass for Illinois Health Insurance Marketplace per IL HB 5395; implemented health-plan quantity limit requirement for all indications; extended initial approval duration for maintenance therapy from 6 months to 12 months; reduced required statin adherence for CVD risk indication from 4 months to 8 weeks and simplified statin trial/failure criteria.

2024-11-05annual_review

1Q 2025 annual review completed with no significant clinical policy changes; references reviewed and updated.

2023-11-07annual_review

Policy Summary

PayerCentene

PolicyIcosapent Ethyl (Vascepa) Coverage

Policy CodePolicy CP.PMN.187

Change TypeMaterial clinical revisions

Effective Date

Next Review Date

Key ActionSubmit prior authorization with supporting chart notes and labs (fasting TG, LDL‑C) and document required prior therapy trials or contraindications.

SourceLink

On This Page

Used with TG criterionLDL-C criterion is required in conjunction with fasting TG 150-499 mg/dL for CVD-risk indication

Maximum dose and dosing

Maximum total daily dose4 g per day (maximum)

Typical dosing regimen2 g orally twice daily (2 g PO BID)

Capsule/day limitUp to 4 capsules per day

Blood pressure threshold

Systolic/diastolic thresholdHypertension defined as blood pressure ≥ 140 mmHg systolic OR ≥ 90 mmHg diastolic

Inclusion as CVD risk factorHypertension qualifies as a cardiovascular disease risk factor in Appendix G

Medication noteAlso counts if member is on antihypertensive medication

HDL-C thresholds

HDL-C thresholdsHDL-C ≤ 40 mg/dL for men or ≤ 50 mg/dL for women

RoleListed as a CVD risk factor in Appendix G

Use in risk assessmentThresholds used to identify elevated cardiovascular risk when present

Renal dysfunction (creatinine clearance)

Creatinine clearance rangeRenal dysfunction defined as creatinine clearance (CrCL) > 30 and < 60 mL/min

Alternate phrasingListed as renal dysfunction or chronic kidney disease in Appendix G

RoleConsidered a CVD risk factor for eligibility assessment

Required documentation: office chart notes, lab results (fasting TG, LDL‑C as applicable), and medication history documenting trials and adherence.
Fasting TG for hypertriglyceridemia must be ≥ 500 mg/dL and dated within 90 days.
For CVD risk reduction, fasting TG 150–499 mg/dL and LDL‑C 41–100 mg/dL labs must be dated within 90 days.

Step Therapy

Step Therapy / Generic‑First Requirement

Step therapy requirements apply for hypertriglyceridemia without ASCVD: trial of a fibrate for at least 3 consecutive months in the last 6 months at maximally indicated doses, and trial of generic omega‑3 (lovaza or generic icosapent ethyl as applicable) at maximally indicated doses, unless contraindicated or intolerant. For hypertriglyceridemia, if requesting brand Vascepa the member must have used generic icosapent ethyl unless contraindicated or experienced clinically significant adverse effects. Quantity limits and dose limits must be followed.

Fibrate trial: ≥3 months within last 6 months at maximally indicated doses unless contraindicated.
Generic omega‑3 (e.g., Lovaza®) required prior to brand therapy unless contraindicated.
For brand Vascepa requests, member must use generic icosapent ethyl first unless contraindicated.

Step Therapy

Step Therapy Bypass (Illinois HIM)

For Illinois Health Insurance Marketplace (IL HIM) requests, step therapy bypass applies per IL HB 5395 — the step therapy requirements noted above do not apply for IL HIM members. Providers should indicate IL HIM status when requesting a bypass.

Step therapy bypass for IL HIM per IL HB 5395.
Provider should document payer/plan type to facilitate IL HIM step therapy bypass.

Billing Rule

Dose and Product

Dose and product information must be documented in the prescribing information submitted. The approved dosing regimen is 2 g PO twice daily (total 4 g/day). Product formulations available are capsules 0.5 g and 1 g; requests must not exceed 4 g/day or 4 capsules/day as applicable and must comply with the health‑plan approved quantity limit.

Dosing regimen: 2 g PO BID; maximum 4 g per day.
Product availability: capsules 0.5 g and 1 g.
Requests must not exceed health‑plan approved quantity limits and should include prescribing documentation supporting dosing (e.g., 2 g BID).

Note

Medicaid Coverage Conflict

Medicaid: when state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for coverage details and any differing requirements.

State Medicaid provisions override this policy where conflicts exist.
Providers should consult the state Medicaid manual for applicable coverage rules.

AbbreviationTG = triglyceride

Low-density lipoprotein cholesterol (LDL-C)

DefinitionLow-density lipoprotein cholesterol (LDL-C): abbreviated LDL-C in the policy

RoleLDL-C between 41-100 mg/dL is required for the CVD risk reduction indication

AbbreviationLDL-C = low-density lipoprotein cholesterol

Statin-associated muscle symptoms (SAMS)

DefinitionStatin-associated muscle symptoms (SAMS): clinical syndrome of muscle pain, aching, cramps, or weakness, often bilateral and involving large muscle groups; symptoms typically appear after statin initiation or dose increase and often resolve after cessation

Clinical featuresIncludes myalgia, cramps, and weakness; symptoms may appear early and usually resolve within weeks after stopping statin but can take months

Rechallenge relevanceReappearance of symptoms with statin rechallenge and disappearance with cessation supports diagnosis; SAMS considerations are part of statin intolerance evaluation for CVD-risk indication

Albuminuria definitions

Microalbuminuria criteriaMicroalbuminuria: a positive micral or strip test, an albumin/creatinine ratio ≥ 2.5 mg/mmol, or an albumin excretion rate ≥ 20 mg/min on at least two successive occasions

Macroalbuminuria criteriaMacroalbuminuria: dipstick evidence of gross proteinuria, albumin/creatinine ratio ≥ 25 mg/mmol, or albumin excretion ≥ 200 mg/min on at least two successive occasions

RoleMicro- or macroalbuminuria is listed as a cardiovascular disease risk factor in Appendix G

1Q 2024 annual review completed with no significant clinical policy changes; references reviewed and updated.