CurrentCentenePolicy CP PMN.187

Icosapent Ethyl (Vascepa)

Clinical policy defining medical necessity criteria, prior authorization requirements, dosing limits, continued therapy criteria, exclusions, and related administrative guidance for icosapent ethyl (Vascepa) for Centene lines of business (HIM, Medicaid).

Policy Summary

PayerCentene

PolicyIcosapent Ethyl (Vascepa)

Policy CodePolicy CP PMN.187

Change TypeClarification / administrative updates

Effective DateMar 1, 2019

Next Review Date

Key ActionProvider must submit chart notes, lab results or other clinical information supporting that member has met all approval criteria; fasting labs must be dated within 90 days for TG (and LDL-C where required).

SourceLink

POLICY UPDATE CHANGES

Multiple annual reviews noted 'no significant changes'; administrative template and reference updates listed.

Redirection to generic icosapent ethyl for brand Vascepa requests was added previously and later removed for the CVD risk reduction indication per revision history.

2Primary FDA indications covered (TG lowering; CVD risk reduction)

4 g/dayMaximum daily dose

90 daysRequired recency of lab results

6 months

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Initial approval duration (hypertriglyceridemia)

12 monthsApproval duration for continued therapy

Coverage Summary

Coverage stance: covered_with_criteria — the policy covers icosapent ethyl (Vascepa) when specified clinical criteria are met for either TG lowering (severe hypertriglyceridemia) or cardiovascular (CVD) risk reduction as an adjunct to statin therapy. Scope: clinical policy defining medical necessity criteria, prior authorization requirements, dosing limits, continued therapy criteria, exclusions, and administrative guidance for Centene lines of business.

Primary FDA indications covered (per policy): 1) adjunct to statin therapy to reduce risk of major CV events in adults with elevated TGs and either established CVD or diabetes plus ≥2 risk factors; and 2) as adjunct to diet to reduce TG levels in adults with severe hypertriglyceridemia.

Thresholds summary (policy-specified): • Fasting TG ≥ 500 mg/dL (hypertriglyceridemia approval; labs within 90 days). • Fasting TG 150–499 mg/dL (CVD risk reduction; labs within 90 days). • Age ≥ 18 years for hypertriglyceridemia; Age ≥ 45 years for CVD risk reduction. • Initial re-authorization response: ≥ 20% reduction in TG from baseline. • Dose limit: ≤ 4 g/day and ≤ 4 capsules/day.

Approval durations and monitoring: initial approval duration for hypertriglyceridemia is 6 months; continued therapy approvals (both indications) are typically for 12 months with required evidence of response (TG and/or LDL-C monitoring as specified) and fasting labs dated within 90 days for baseline and reauthorization.

Initial Approval Criteria — Hypertriglyceridemia (no ASCVD)

Initial Approval Criteria - Hypertriglyceridemia without ASCVD

Covered when ALL of the following are met:

ALL of the following

Diagnosis of hypertriglyceridemia.
Age >= 18 years.
Fasting triglycerides (TG) >= 500 mg/dL.>= 500 mg/dL
lab must be dated within 90 days
Failure of a >= 3 consecutive month trial of fibrate therapy in the last 6 months at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced.
Failure of omega-3-acid ethyl esters (generic Lovaza) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced.

Initial Approval Criteria — CVD Risk Reduction (ASCVD or Diabetes + risk factors)

Initial Approval Criteria - Reduction of Cardiovascular Disease Risk (ASCVD or Diabetes + risk factors)

Covered when ALL of the following are met:

ALL of the following

ASCVD evidence (any)
- Acute coronary syndromes.
- Clinically significant coronary heart disease diagnosed by invasive or noninvasive testing (e.g., coronary angiography, stress test treadmill, stress echocardiography, or nuclear imaging).
- Coronary or other arterial revascularization.
- Myocardial infarction.

Continued Therapy — Hypertriglyceridemia

Continued Therapy - Hypertriglyceridemia without ASCVD

Approved when member meets ongoing response and continuity criteria:

ALL of the following

Continuity of care
- Member is currently receiving medication via Centene benefit.
- Member has previously met initial approval criteria.
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums).
Evidence of response

Continued Therapy — CVD Risk Reduction

Continued Therapy - Reduction of Cardiovascular Disease Risk

Approved when member meets ongoing response and continuity criteria:

ALL of the following

Continuity of care
- Member is currently receiving medication via Centene benefit.
- Member has previously met initial approval criteria.
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums).
Response evidence:

Other Diagnoses / Indications

Other Diagnoses/Indications

When request is for indications not covered explicitly by this policy:

ANY of the following

On-formulary pathway: If drug is on formulary/PDL, follow the no coverage criteria policy for the relevant line of business (HIM.PA.33 for marketplace; CP.PMN.255 for Medicaid).
Non-formulary pathway: If drug is NOT on formulary/PDL, follow the non-formulary policy for the relevant line of business (HIM.PA.103 for marketplace; CP.PMN.16 for Medicaid).
Off-label pathway: If requested use (diagnosis, age, dosing) is not specifically listed and initial criteria do not apply, refer to the off-label use policy (HIM.PA.154 for marketplace; CP.PMN.53 for Medicaid).

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Coverage is subject to prior authorization. The request must include documentation that the required criteria are met (diagnosis, relevant labs, prior therapy trials, statin use or documented intolerance) as specified in the initial approval sections.

Documentation Required

Submit supporting documentation

Submit supporting documentation such as chart notes and lab results demonstrating that the member meets all approval criteria. Fasting labs for triglycerides (and LDL‑C where required) must be dated within 90 days.

Applicable Codes

NDC / Product availabilityNDC

No codes listed

Clinical Evidence & References

4 g/dayMaximum daily dose (<=)

90 daysRequired recency of fasting labs

>=500 mg/dLTG threshold for hypertriglyceridemia approval

150-499 mg/dLTG range for CVD risk reduction approval

Key evidence cited in the policy: the REDUCE-IT trial (Bhatt DL et al., N Engl J Med. 2019) is listed as the key trial supporting CVD risk reduction with icosapent ethyl. The policy also cites the Vascepa Prescribing Information (Amarin Pharma, Sept 2021) as the prescribing information reference.

Policy explicitly states it references FDA labeling and clinical guidelines — the prescribing information is cited and guideline sources (ACC/AHA, AHA, Endocrine Society, ADA, etc.) are included in the reference list to support clinical context and recommendations.

Background & Definitions

Background: Icosapent ethyl (Vascepa) is an ethyl ester of eicosapentaenoic acid (EPA) indicated to reduce triglyceride (TG) levels and, as an adjunct to maximally tolerated statin therapy, to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adults with elevated TGs and the specified risk criteria. The policy references FDA-approved indications and the Vascepa Prescribing Information and places use in the context of clinical guidelines and evidence (including REDUCE-IT). Dosing for both indications is 2 g PO twice daily (maximum 4 g/day); capsules are available as 0.5 g and 1 g formulations.

Definitions: • ASCVD — atherosclerotic cardiovascular disease. • SAMS — statin-associated muscle symptoms. • TG — triglycerides. • LDL-C — low-density lipoprotein cholesterol.

Revision History

11.02.20annual_review

1Q 2021 annual review: no significant changes; added redirection to generic icosapent ethyl for brand Vascepa requests; references reviewed and updated.

09.30.21annual_review

1Q 2022 annual review: no significant changes; revised requirement from medical justification to must use generic; references reviewed and updated.

10.05.22template_update

Template changes applied to other diagnoses/indications and continued therapy section; no significant clinical changes.

Policy Summary

PayerCentene

PolicyIcosapent Ethyl (Vascepa)

Policy CodePolicy CP PMN.187

Change TypeClarification / administrative updates

Effective DateMar 1, 2019

Next Review Date

SourceLink

On This Page

If request is for brand Vascepa, member must use generic icosapent ethyl, unless contraindicated or clinically significant adverse effects are experienced.

Dose limits

Dose does not exceed 4 g per day.<= 4 g/day
Dose does not exceed 4 capsules per day.<= 4 capsules/day

Stable or unstable angina.

Peripheral arterial disease presumed to be of atherosclerotic origin.

Stroke or transient ischemic attack (TIA).

Or diabetes with risk factors: Diabetes with >= 2 additional cardiovascular disease (CVD) risk factors (see Appendix G).

Laboratory and age requirements

Age >= 45 years.>= 45 years
Fasting TG between 150-499 mg/dL.150-499 mg/dL
labs must be dated within 90 days

Statin therapy and LDL criteria for members on statins

Vascepa is prescribed in conjunction with a statin at the maximally tolerated dose.
LDL-C between 41-100 mg/dL.41-100 mg/dL
labs must be dated within 90 days
Evidence of adherence to statin regimen
- If on high intensity statin: Member has been adherent for at least the last 4 months to maximally tolerated doses of a high intensity statin.
- If on moderate intensity statin: Member has been adherent for at least the last 4 months to a moderate intensity statin and either intolerance to two high intensity statins OR a statin risk factor.
- If on low intensity statin: Member has been adherent for at least the last 4 months to a low intensity statin and either intolerance to one high and one moderate intensity statin OR a statin risk factor and history of intolerance to two moderate intensity statins.

For members not on statin therapy

Statin contraindicated: Statin therapy is contraindicated per Appendix F; member has tried at least two statins, one hydrophilic (pravastatin, fluvastatin, or rosuvastatin); member has documented statin risk factors.
Statin intolerant (SAMS) criteria: Member is statin intolerant due to statin-associated muscle symptoms (SAMS) with intolerable SAMS persisting >= 2 weeks that resolved with discontinuation and recurred with re-challenge; and documentation of re-challenge with titration from lowest dose and/or intermittent dosing (e.g., 1-3 times weekly).

Dose limits

Dose does not exceed 4 g per day.<= 4 g/day
Dose does not exceed 4 capsules per day.<= 4 capsules/day

Initial re-authorization: >= 20% reduction in TG levels from baseline.>= 20% reduction

Subsequent re-authorizations: continued reduction or maintenance in reduction of TG levels from baseline.

Dose and brand

If request is for a dose increase, new dose does not exceed 4 g per day and 4 capsules per day.<= 4 g/day; <= 4 capsules/day
If request is for brand Vascepa, member must use generic icosapent ethyl, unless contraindicated or clinically significant adverse effects are experienced.

Member is responding positively to therapy as evidenced by no increase in TG and LDL-C levels from baseline.

no increase from baseline

Statin adherence: If statin tolerant; documentation of adherence to a statin at the maximally tolerated dose.

Dose limits: If request is for a dose increase, new dose does not exceed 4 g per day and 4 capsules per day.<= 4 g/day; <= 4 capsules/day

Billing Rule

Dose limit enforcement

Dose requests must not exceed 4 g per day or 4 capsules per day. Requests for dose increases are subject to these same limits.

Step Therapy

Therapy trials required

For the hypertriglyceridemia indication, documentation of a trial and failure of fibrate therapy (≥3 consecutive months within the last 6 months at up to maximally indicated doses) and trial and failure of omega‑3‑acid ethyl esters (Lovaza) at up to maximally indicated doses are required unless contraindicated or clinically significant adverse effects are documented.

Documentation Required

Statin adherence/intolerance documentation

For the CVD risk reduction indication, document that Vascepa is prescribed with a statin at the maximally tolerated dose and adherence for at least 4 months, or provide documentation of statin intolerance/contraindication per policy criteria, including evidence of SAMS with re‑challenge and titration/intermittent dosing as outlined.

12.15.22annual_review

1Q 2023 annual review: no significant changes; removed Commercial line of business; removed redirection to generic icosapent ethyl for brand Vascepa requests for CVD risk reduction indication; references reviewed and updated.

11.07.23annual_review

1Q 2024 annual review: no significant changes; references reviewed and updated.

02.25annual_reviewLatest

1Q 2025 annual review: no significant changes; references reviewed and updated; policy last review date recorded as 02.25.