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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsDelaware First Health Lovaza Prior Auth Update | O…
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    CurrentDelaware First HealthPolicy CP.PMN.52

    Omega-3-Acid Ethyl Esters (Lovaza) Coverage

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    Defines medical necessity and prior authorization criteria for coverage of omega-3-acid ethyl esters (Lovaza) for Medicaid members, primarily for treatment of severe hypertriglyceridemia in adults.

    Policy Summary
    PayerDelaware First Health
    PolicyOmega-3-Acid Ethyl Esters (Lovaza) Coverage
    Policy CodePolicy CP.PMN.52
    Change TypeClarified generic preferenceextended initial approval to 12 months
    Effective DateAug 1, 2012
    Next Review DateN/A
    Key ActionObtain prior authorization and submit documentation showing fasting triglycerides ≥500 mg/dL, age ≥18, and a ≥3-month fibrate trial (unless contraindicated); prefer generic before brand.
    SourceLink
    POLICY UPDATE CHANGES

    Policy clarified that it applies to generic omega-3-acid ethyl esters.

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

    ≥500Fasting triglyceride threshold
    ≥18Minimum age
    4 g/dayMax daily dose
    12 mo

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    Approval duration
    ≥3 moFibrate trial

    Coverage Criteria

    Initial Approval

    Initial Approval — Hypertriglyceridemia (must meet ALL):

    Initial Approval Criteria: Diagnosis of hypertriglyceridemia
    Initial Approval Criteria: Age ≥ 18 years
    Initial Approval Criteria: Fasting triglycerides ≥ 500 mg/dL (laboratory result dated within 90 days)>= 500 mg/dL (lab within 90 days)
    Initial Approval Criteria: Failure of a ≥ 3 consecutive month trial of fibrate therapy in the last 6 months at up to maximally indicated doses, unless contraindicated or intolerant≥ 3 months trial within last 6 months

    Therapeutic alternatives include fenofibrate (see appendix).

    Initial Approval Criteria: If request is for brand Lovaza, member must use generic omega-3-acid ethyl esters unless contraindicated or clinically significant adverse effects are experienced
    Initial Approval Criteria: Dose does not exceed 4 g (4 capsules) per day<= 4 g/day

    Approval duration: 12 months

    Continued Therapy

    Continued Therapy — Hypertriglyceridemia (must meet ALL):

    Continued Therapy Criteria: Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations

    Refer to state-specific addendums CC.PHARM.03A and CC.PHARM.03B for continuity of care details.

    Continued Therapy Criteria: Member is responding positively to therapy (clinical improvement documented in chart notes)

    Provider must submit documentation such as office notes or labs to demonstrate response.

    Continued Therapy Criteria: If request is for brand Lovaza, member must use generic omega-3-acid ethyl esters unless contraindicated or clinically significant adverse effects are experienced
    Continued Therapy Criteria:

    Other Indications / Off-label pathway

    Other Diagnoses/Indications:

    Other Indications Handling: If the drug has had a label change within the last 6 months that is not yet reflected in this policy, follow the applicable formulary/no-coverage/non-formulary policies: CP.PMN.255 (Medicaid no coverage criteria) or CP.PMN.16 (Medicaid non-formulary).
    Other Indications Handling: If the requested use is not listed under section III (Diagnoses/Indications not authorized) AND criterion 1 does not apply, refer to the off-label use policy CP.PMN.53 for the relevant line of business for justification and evidence requirements.

    Requests for non-FDA indications require adequate documentation of efficacy/safety per off-label policy.

    Non‑FDA approved indications that are not specifically addressed in this policy will not be routinely authorized. However, such uses may be considered when the provider supplies sufficient documentation of efficacy and safety in accordance with the off‑label use process referenced in policy CP.PMN.53 or applicable evidence of coverage documents. When pursuing coverage for an off‑label indication, submit supporting clinical information (office notes, relevant literature, and objective data) that demonstrates the requested use meets the criteria for medical necessity under the off‑label policy.

    Uses for indications not listed in this policy that lack supporting off‑label justification or evidence are not authorized. Requests missing required documentation that initial or continuation criteria are met (for example: diagnosis, member age ≥18, fasting triglycerides ≥500 mg/dL dated within 90 days, prior fibrate trial or contraindication to fibrates, preference for generic before brand when applicable, and adherence to the ≤4 g/day dose limit) are subject to denial.

    Coding & Key Clinical Thresholds

    inv-06: Fasting triglycerides
    Fasting triglyceride threshold>= 500 mg/dL
    Lab timing requirementFasting triglyceride result must be dated within 90 days
    Context of useRequired for initial approval of Lovaza for severe hypertriglyceridemia

    Provider Actions & Prior Authorization

    Prior Authorization

    Prior authorization required — approve only when initial criteria met

    Prior authorization is required for omega-3‑acid ethyl esters (Lovaza) for hypertriglyceridemia. Approvals are granted when all initial criteria are met, including a documented diagnosis of hypertriglyceridemia, member age ≥ 18 years, and a lab‑confirmed fasting triglyceride level ≥ 500 mg/dL dated within 90 days; dose must not exceed 4 g/day and brand requests require use of generic unless contraindicated. Approval duration: 12 months.

    • Diagnosis of hypertriglyceridemia required
    • Age ≥ 18 years
    • Fasting triglycerides ≥ 500 mg/dL (lab within 90 days)
    • Dose ≤ 4 g/day
    • Prefer generic omega-3‑acid ethyl esters before brand Lovaza unless contraindicated
    Step Therapy

    Fibrate trial required before approval (step‑therapy)

    A step‑therapy requirement mandates prior trial and failure of fibrate therapy: a consecutive ≥3‑month fibrate trial at up to maximally indicated doses within the last 6 months is required unless the member is contraindicated or intolerant.

    Background

    Omega‑3‑acid ethyl esters (Lovaza) are an ethyl ester combination of omega‑3 fatty acids used as an adjunct to diet to lower triglyceride levels. This policy addresses use for severe hypertriglyceridemia and specifies that non‑FDA indications not covered in the document require sufficient supporting documentation per the off‑label use policy (CP.PMN.53) before coverage will be considered.

    Definitions

    inv-12: Lovaza (omega-3-acid ethyl esters)
    CompositionCombination of ethyl esters of omega-3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
    FDA‑approved indicationIndicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>= 500 mg/dL) hypertriglyceridemia
    Common nameLovaza (omega-3-acid ethyl esters)

    Initial Therapy Criteria

    Initial Approval

    Initial Approval — Hypertriglyceridemia (must meet ALL):

    Initial Approval Criteria: 1. Diagnosis of hypertriglyceridemia; 2. Age >= 18 years; 3. Fasting triglycerides >= 500 mg/dL (laboratory result dated within 90 days); 4. 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; 5. If request is for brand Lovaza, member must use generic omega-3-acid ethyl esters unless contraindicated or clinically significant adverse effects are experienced; 6. Dose does not exceed 4 g (4 capsules) per day.see individual nodes

    Approval duration: 12 months

    Continuation Therapy Criteria

    Continued Therapy

    Continued Therapy — Hypertriglyceridemia (must meet ALL):

    Continued Therapy Criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria, OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If request is for brand Lovaza, member must use generic omega-3-acid ethyl esters unless contraindicated or clinically significant adverse effects are experienced; 4. If request is for a dose increase, new dose does not exceed 4 g (4 capsules) per day.see individual nodes

    Approval duration: 12 months; Renewal interval: 12 months

    Step Therapy Requirements

    StepRequirementDuration / TimingExceptions / Notes
    1
    Member must have trialed fibrate therapy (e.g., fenofibrate) prior to approval
    Failure of a ≥3 consecutive month trial within the last 6 months
    Unless contraindicated or clinically significant adverse effects/intolerance are documented; therapeutic alternatives listed (e.g., fenofibrate).

    Quantity Limits

    inv-16: Lovaza / omega-3-acid ethyl esters
    Maximum daily dose4 g/day
    Standard dosing regimens4 g once daily or 2 g twice daily
    Quantity limit phrasingDose must not exceed 4 g (4 capsules) per day for coverage
    Policy Summary
    PayerDelaware First Health
    PolicyOmega-3-Acid Ethyl Esters (Lovaza) Coverage
    Policy CodePolicy CP.PMN.52
    Change TypeClarified generic preferenceextended initial approval to 12 months
    Effective DateAug 1, 2012
    Next Review DateN/A
    Key ActionObtain prior authorization and submit documentation showing fasting triglycerides ≥500 mg/dL, age ≥18, and a ≥3-month fibrate trial (unless contraindicated); prefer generic before brand.
    SourceLink
    On This Page
    Coverage CriteriaCoding & Key Clinical ThresholdsProvider Actions & Prior AuthorizationBackgroundDefinitionsInitial Therapy CriteriaContinuation Therapy CriteriaStep Therapy RequirementsQuantity Limits
    If request is for a dose increase, the new dose does not exceed 4 g (4 capsules) per day
    <= 4 g/day

    Approval duration: 12 months

    • Trial duration: ≥ 3 consecutive months
    • Timeframe: within the last 6 months
    • Dosing: up to maximally indicated doses (see therapeutic alternatives, e.g., fenofibrate)
    • Exception: contraindication or clinically significant adverse effects
    Documentation Required

    Required supporting documentation

    Submit supporting clinical documentation with the prior authorization request to show all approval criteria are met, such as office/chart notes and laboratory results demonstrating diagnosis, age, fasting triglyceride value and prior fibrate therapy.

    • Office chart notes documenting diagnosis and clinical history
    • Laboratory results showing fasting triglycerides (date must be within 90 days)
    • Medication history documenting fibrate trial duration, dose, and response or intolerance
    Denial Risk

    Denial risk when documentation or criteria are missing

    Requests missing required documentation or elements of the criteria risk denial. Common deficiencies include absent/insufficient diagnosis, missing age confirmation, no fasting triglyceride lab within 90 days, or lack of documentation of the required fibrate trial (or justification for exemption); brand requests without evidence of generic intolerance may also be denied.

    • No documented diagnosis of hypertriglyceridemia
    • Age not confirmed as ≥ 18 years
    • Fasting triglyceride value < 500 mg/dL or lab dated > 90 days
    • No documentation of a ≥3‑month fibrate trial in the last 6 months or lack of documented contraindication/intolerance
    • Brand Lovaza requests without documentation that generic omega‑3‑acid ethyl esters are contraindicated or not tolerated