ModifiedAmbetter NevadaPolicy CP.PMN.187

Icosapent Ethyl (Vascepa)

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Prior authorization and medical-necessity criteria for icosapent ethyl in adults with hypertriglyceridemia or cardiovascular-risk reduction indications across commercial, health insurance marketplace, and Medicaid lines of business.

Policy Summary

PayerAmbetter Nevada

PolicyIcosapent Ethyl (Vascepa)

Policy CodePolicy CP.PMN.187

Change TypeModified

Effective DateMar 1, 2019

Last ReviewFeb 1, 2021

Next Review DateN/A

Key ActionFor brand Vascepa requests, document medical justification for inability to use generic icosapent ethyl when available.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for cardiovascular disease risk reduction.

Retired policy HIM.PA.29.

Added redirection to generic icosapent ethyl for brand Vascepa requests.

2FDA-approved indication categories

4 g/dayMaximum covered dose

6 monthsInitial approval duration

12 monthsContinuation approval duration

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ModifiedAmbetter NevadaPolicy CP.PMN.187

Icosapent Ethyl (Vascepa)

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Policy Summary

PayerAmbetter Nevada

PolicyIcosapent Ethyl (Vascepa)

Policy CodePolicy CP.PMN.187

Change TypeModified

Effective DateMar 1, 2019

Last ReviewFeb 1, 2021

Next Review DateN/A

Key ActionFor brand Vascepa requests, document medical justification for inability to use generic icosapent ethyl when available.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for cardiovascular disease risk reduction.

Retired policy HIM.PA.29.

Added redirection to generic icosapent ethyl for brand Vascepa requests.

2FDA-approved indication categories

4 g/dayMaximum covered dose

6 monthsInitial approval duration

12 monthsContinuation approval duration

90 daysLaboratory recency

Coverage Criteria

Initial Therapy: Hypertriglyceridemia Without ASCVD

Covered when ALL of the following are met. Approval duration: 6 months.

ALL of the following

Diagnosis of hypertriglyceridemia.
Member is age 18 years or older.>= 18 years
Fasting triglycerides (TG) are at least 500 mg/dL; laboratory results must be dated within 90 days.>= 500 mg/dL
Lab must be dated within 90 days.
Failure of a trial of fibrate therapy for at least 3 consecutive months within the last 6 months at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced.>= 3 consecutive months within the last 6 months
Failure of omega-3-acid ethyl esters (generic Lovaza) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced.
If the request is for brand Vascepa, medical justification supports inability to use generic icosapent ethyl, if available, such as contraindications to excipients.
Dose does not exceed 4 g (4 capsules) per day.<= 4 g (4 capsules) per day

Initial Therapy: Reduction of Cardiovascular Disease Risk

Covered when ALL of the following are met. Approval duration: 6 months.

ALL of the following

ONE of the following diagnoses
- ASCVD evidenced by a history of ONE of the following
  - Acute coronary syndromes.
  - Clinically significant coronary heart disease (CHD) diagnosed by invasive or noninvasive testing, such as coronary angiography, treadmill stress testing, stress echocardiography, or nuclear imaging.
  - Coronary or other arterial revascularization.
  - Myocardial infarction.

Other Diagnoses/Indications

Coverage follows the applicable off-label use policy for the relevant line of business.

If the diagnosis is not specifically listed under Section III (Diagnoses/Indications for which coverage is NOT authorized), refer to the applicable off-label use policy: CP.CPA.09 for commercial, HIM.PHAR.21 for health insurance marketplace, or CP.PMN.53 for Medicaid.

Continuation Therapy: Hypertriglyceridemia Without ASCVD

Covered when ALL of the following are met. Approval duration: 12 months.

ALL of the following

Member is currently receiving the medication through a Centene benefit or has previously met the initial approval criteria.
ONE of the following response criteria
- For initial re-authorization, TG levels have decreased by 20% from baseline.>= 20% reduction from baseline
- For subsequent re-authorizations, TG levels have continued to decrease or the reduction in TG levels from baseline has been maintained.
If the request is for brand Vascepa, medical justification supports inability to use generic icosapent ethyl, if available, such as contraindications to excipients.

Continuation Therapy: Reduction of Cardiovascular Disease Risk

Covered when ALL of the following are met. Approval duration: 6 months.

ALL of the following

Member is currently receiving the medication through a Centene benefit or has previously met the initial approval criteria.
Member is responding positively to therapy, as evidenced by no increase in TG and LDL-C levels from baseline.
If the member is statin tolerant, documentation supports adherence to a statin at the maximally tolerated dose.
If the request is for brand Vascepa, medical justification supports inability to use generic icosapent ethyl, if available, such as contraindications to excipients.
If the request is for a dose increase, the new dose does not exceed 4 g (4 capsules) per day.

Continuation Therapy: Other Diagnoses/Indications

Coverage follows the applicable pathway below.

ONE of the following

ALL of the following
- Member is currently receiving the medication through a Centene benefit.
- Documentation supports a positive response to therapy.
If the diagnosis is not specifically listed under Section III (Diagnoses/Indications for which coverage is NOT authorized), refer to the applicable off-label use policy: CP.CPA.09 for commercial, HIM.PHAR.21 for health insurance marketplace, or CP.PMN.53 for Medicaid.

Coverage is not authorized for non-FDA-approved indications that are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the applicable off-label use policy—CP.CPA.09 for commercial, HIM.PHAR.21 for health insurance marketplace, or CP.PMN.53 for Medicaid—or according to applicable evidence of coverage documents.

Coverage is excluded for members with known hypersensitivity, including anaphylactic reaction, to Vascepa or any of its components.

For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Refer to the state Medicaid manual for coverage provisions pertaining to this clinical policy.

Clinical Thresholds and Coding Details

Threshold

Severe hypertriglyceridemiaFasting triglycerides (TG) ≥ 500 mg/dL.

Threshold

Elevated triglyceridesFasting TG 150–499 mg/dL for cardiovascular-risk reduction; the FDA-approved indication begins at TG ≥ 150 mg/dL.

Laboratory requirement

Laboratory recencyQualifying laboratory results must be dated within 90 days.

Step-therapy requirement

Authorization and Provider Requirements

Prior Authorization

Initial Approval Criteria

Before approving initial therapy, the provider must document that the member meets all applicable criteria for the requested indication. Initial approval is available for hypertriglyceridemia without ASCVD or reduction of cardiovascular disease risk; approval duration is 6 months.

Hypertriglyceridemia without ASCVD: diagnosis of hypertriglyceridemia; age ≥ 18 years; fasting TG ≥ 500 mg/dL with laboratory results dated within 90 days; failure of a ≥ 3-consecutive-month fibrate trial during the last 6 months at up to maximally indicated doses, unless contraindicated or clinically significantly adverse; failure of omega-3-acid ethyl esters (generic Lovaza) at up to maximally indicated doses, unless contraindicated or clinically significantly adverse; any brand request must include justification for inability to use generic icosapent ethyl; dose must not exceed 4 g (4 capsules) daily.
Cardiovascular-risk reduction: age ≥ 45 years; ASCVD or diabetes with ≥ 2 CVD risk factors; fasting TG 150–499 mg/dL and LDL-C 41–100 mg/dL, with both laboratory results dated within 90 days; and the applicable statin therapy, adherence, intolerance, or contraindication requirements.
Cardiovascular-risk reduction diagnosis: ASCVD may be supported by acute coronary syndrome, clinically significant CHD, coronary or other arterial revascularization, myocardial infarction, atherosclerotic peripheral arterial disease, stable or unstable angina, or stroke/TIA; alternatively, diabetes with ≥ 2 CVD risk factors may qualify.
For cardiovascular-risk reduction, Vascepa must be prescribed with a maximally tolerated statin when the member is receiving statin therapy. Members not receiving statin therapy must meet the applicable contraindication or statin-intolerance pathway.

Clinical Background

Icosapent ethyl (Vascepa) is an ethyl ester of eicosapentaenoic acid (EPA). FDA-approved uses include reducing triglycerides in adults with severe hypertriglyceridemia and reducing cardiovascular disease risk when added to maximally tolerated statin therapy in qualifying adults with elevated triglycerides and either established cardiovascular disease or diabetes with at least two additional cardiovascular risk factors. The effect of treatment on pancreatitis risk in severe hypertriglyceridemia has not been determined.

Definitions and Abbreviations

Definition

Icosapent ethylAn ethyl ester of eicosapentaenoic acid (EPA).

Definition

ASCVDAtherosclerotic cardiovascular disease.

Definition

CVDCardiovascular disease.

Definition

EPAEicosapentaenoic acid.

Initial Therapy Criteria

Initial therapy: hypertriglyceridemia without ASCVD

Covered when ALL of the following are met:

Eligibility and treatment history

Diagnosis and laboratory criteria
- Diagnosis of hypertriglyceridemia.
- Age 18 years or older.Age ≥18 years
- Fasting triglycerides are at least 500 mg/dL, with the laboratory result dated within 90 days.TG ≥500 mg/dL; lab within 90 days
Required prior therapy

Continuation Criteria

Continuation therapy: hypertriglyceridemia without ASCVD

Continued coverage requires ALL of the following:

Continuation response

Eligibility for continuation
- The member is currently receiving the medication through the Centene benefit.
- The member previously met the initial approval criteria.
Positive response to therapy
- For initial reauthorization, triglyceride levels have decreased by at least 20% from baseline.TG reduction ≥20% from baseline

Step-Therapy Requirements

Step	Required therapy	Duration	Failure or qualification criteria
1	Fibrate therapy	At least 3 consecutive months during the last 6 months	Failure at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced.

Step	Required therapy	Duration	Failure or qualification criteria
2	Omega-3-acid ethyl esters (generic Lovaza)	Not specified	Failure at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced.

Step	Required therapy or pathway	Duration	Failure or qualification criteria
3	Maximally tolerated statin therapy	At least 4 months of adherence for statin-treated members	Use a maximally tolerated high-intensity statin; or a moderate-intensity statin with intolerance to two high-intensity statins or a statin risk factor; or a low-intensity statin with intolerance to one high- and one moderate-intensity statin, or a statin risk factor plus intolerance to two moderate-intensity statins.
3	Qualifying statin contraindication or intolerance pathway	As applicable	Members not receiving statins must have a contraindication under Appendix F, or statin intolerance documented after trying at least two statins, including one hydrophilic statin. The intolerance pathway requires applicable statin risk factors or SAMS with symptoms persisting at least 2 weeks, resolution after discontinuation, recurrence on rechallenge, and rechallenge using the lowest dose and/or intermittent dosing.

Quantity and Dose Limits

Quantity limit

Quantity limitIcosapent ethyl (Vascepa) is limited to 4 g or 4 capsules per day.

Dose limit

Maximum daily dose4 g per day; the dosing regimen is 2 g orally twice daily.

Policy Summary

PayerAmbetter Nevada

PolicyIcosapent Ethyl (Vascepa)

Policy CodePolicy CP.PMN.187

Change TypeModified

Effective DateMar 1, 2019

Last ReviewFeb 1, 2021

Next Review DateN/A

Key ActionFor brand Vascepa requests, document medical justification for inability to use generic icosapent ethyl when available.

SourceLink

On This Page

Peripheral arterial disease presumed to be of atherosclerotic origin.

Stable or unstable angina.

Stroke or transient ischemic attack (TIA).

Diabetes with at least 2 cardiovascular disease risk factors (see Appendix G).

Member is age 45 years or older.>= 45 years

Fasting TG are between 150 and 499 mg/dL; laboratory results must be dated within 90 days.150-499 mg/dL

Lab must be dated within 90 days.

LDL-C is between 41 and 100 mg/dL; laboratory results must be dated within 90 days.41-100 mg/dL

Lab must be dated within 90 days.

For members on statin therapy, ONE of the following regimens applies

ALL of the following
- Vascepa is prescribed in conjunction with a statin at the maximally tolerated dose.
- Member has been adherent for at least the last 4 months to a high-intensity statin at the maximally tolerated dose (see Appendix D).>= 4 months
ALL of the following
- Vascepa is prescribed in conjunction with a statin at the maximally tolerated dose.
- Member has been adherent for at least the last 4 months to a moderate-intensity statin at the maximally tolerated dose (see Appendix D).>= 4 months
- ONE of the following
  - Intolerance to two high-intensity statins.
  - A statin risk factor (see Appendix E).
ALL of the following
- Vascepa is prescribed in conjunction with a statin at the maximally tolerated dose.
- Member has been adherent for at least the last 4 months to a low-intensity statin at the maximally tolerated dose (see Appendix D).>= 4 months
- ONE of the following
  - Intolerance to one high-intensity and one moderate-intensity statin.
  - A statin risk factor (see Appendix E) and history of intolerance to two moderate-intensity statins.

For members not on statin therapy, ONE of the following applies

Statin therapy is contraindicated per Appendix F.
ALL of the following
- For statin-intolerant members, member has tried at least two statins, one of which must be hydrophilic (pravastatin, fluvastatin, or rosuvastatin).
- ONE of the following
  - Member has documented statin risk factors (see Appendix E).
  - ALL of the following
    Member is statin intolerant due to statin-associated muscle symptoms (SAMS).
    Documentation of intolerable SAMS persisting at least two weeks, which disappeared with discontinuing statin therapy and recurred with a statin re-challenge.>= 2 weeks
    Documentation of re-challenge with titration from the lowest possible dose and/or intermittent dosing frequency, such as 1 to 3 times weekly.

If the request is for brand Vascepa, medical justification supports inability to use generic icosapent ethyl, if available, such as contraindications to excipients.

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

If the request is for a dose increase, the new dose does not exceed 4 g (4 capsules) per day.<= 4 g (4 capsules) per day

<= 4 g (4 capsules) per day

Failure of a fibrate trial lasting at least 3 consecutive months during the last 6 months, at up to maximally indicated doses, unless contraindicated or clinically significantly adverse.

Age requirement

Minimum age18 years or older for hypertriglyceridemia without ASCVD.

Age requirement

Minimum age45 years or older for cardiovascular-risk reduction.

Laboratory requirement

LDL-C range and recencyLDL-C must be 41–100 mg/dL, with the laboratory result dated within 90 days.

Statin requirement

Statin adherenceAt least the last 4 months of adherence to a maximally tolerated statin regimen for members receiving statin therapy.

Continuation requirement

Initial reauthorization responseAt least a 20% reduction in TG levels from baseline.

Dose limit

Maximum daily dose4 g, equivalent to 4 capsules, per day.

CVD risk factor

HypertensionBlood pressure ≥ 140 mmHg systolic or ≥ 90 mmHg diastolic, or treatment with antihypertensive medication.

CVD risk factor

Renal dysfunctionCreatinine clearance greater than 30 and less than 60 mL/min, or chronic kidney disease.

CVD risk factor

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

Statin risk factor

ALT elevationUnexplained ALT elevation greater than 3 times the upper limit of normal.

CVD risk factor

Microalbuminuria ratioAlbumin/creatinine ratio ≥ 2.5 mg/mmol on at least two successive occasions.

CVD risk factor

Macroalbuminuria ratioAlbumin/creatinine ratio ≥ 25 mg/mmol on at least two successive occasions.

CVD risk factor

Microalbuminuria excretion rateTimed-collection albumin excretion rate ≥ 20 mg/min on at least two successive occasions.

CVD risk factor

Macroalbuminuria excretion rateTimed-collection albumin excretion rate ≥ 200 mg/min on at least two successive occasions.

Dose must not exceed 4 g (4 capsules) per day.

Prior Authorization

Continued-Therapy Authorization

For continued authorization, the provider must establish prior approval history or current receipt through a Centene benefit and document a positive response to therapy. Continued approval is generally granted for 12 months.

Hypertriglyceridemia without ASCVD: initial reauthorization requires a ≥ 20% reduction in TG from baseline; subsequent reauthorizations require continued reduction or maintenance of the reduction from baseline.
Cardiovascular-risk reduction: TG and LDL-C must not have increased from baseline. If the member is statin tolerant, document adherence to a statin at the maximally tolerated dose.
Other diagnoses/indications: continued therapy may be authorized when the member is receiving the medication through a Centene benefit and documentation supports a positive response; duration is the requested duration or 12 months, whichever is less, when applicable.
For a dose increase, the new dose must not exceed 4 g (4 capsules) daily. Brand requests must include medical justification for inability to use generic icosapent ethyl.

Step Therapy

Use Generic Icosapent Ethyl

Requests for brand Vascepa should be redirected to generic icosapent ethyl when generic product is available. Brand coverage requires medical justification that the member cannot use the generic product, such as a contraindication to an excipient.

Apply the generic-first requirement to both initial and continued-therapy requests.
Document the specific clinical reason generic icosapent ethyl cannot be used when requesting brand Vascepa.

Step Therapy

Required Fibrate and Omega-3 Trial

For hypertriglyceridemia without ASCVD, initial therapy requires documented failure of preferred alternatives unless contraindicated or not tolerated at clinically significant levels.

Trial a fibrate for at least 3 consecutive months within the preceding 6 months at up to maximally indicated doses. Preferred alternatives include fenofibrate (up to 145 mg/day) or gemfibrozil (up to 1,200 mg/day).
Trial omega-3-acid ethyl esters (generic Lovaza) at up to maximally indicated doses; the listed regimen is up to 4 g/day.
Document the dates, doses, adherence, treatment response, contraindication, or clinically significant adverse effects for each required alternative.

Step Therapy

Statin Adherence and Intolerance Pathway

For cardiovascular-risk reduction, document the member’s statin therapy status and adherence or the qualifying pathway for statin intolerance or contraindication.

If taking a statin, document adherence for at least the last 4 months to a maximally tolerated regimen. A high-intensity statin may qualify; a moderate-intensity statin requires intolerance to two high-intensity statins or a statin risk factor; a low-intensity statin requires intolerance to one high- and one moderate-intensity statin or a statin risk factor plus intolerance to two moderate-intensity statins.
If not taking a statin, document a contraindication under Appendix F, or trials of at least two statins including one hydrophilic statin (pravastatin, fluvastatin, or rosuvastatin).
For statin intolerance, document applicable statin risk factors or SAMS, including symptoms lasting at least 2 weeks that resolved after discontinuation and recurred on rechallenge, plus rechallenge using the lowest possible dose and/or intermittent dosing.

Documentation Required

Required Clinical Documentation

The provider must submit clinical documentation supporting that the member has met all approval criteria. Acceptable records may include office chart notes, laboratory results, medication history, and other relevant clinical information.

Document the diagnosis and requested indication.
Document age, relevant ASCVD or diabetes/CVD-risk history, and the clinical rationale for therapy.
Submit laboratory results with collection dates when required, including fasting TG and LDL-C values dated within 90 days.
Document contraindications, clinically significant adverse effects, statin intolerance, or inability to use generic therapy when relied upon.

Documentation Required

Initial-Therapy Supporting Records

Initial-therapy requests must include records sufficient to verify the applicable indication, laboratory thresholds, prior-treatment requirements, dose, and generic-product status.

Submit office or specialist notes showing the diagnosis, age, ASCVD history or diabetes with at least 2 CVD risk factors, and treatment rationale.
Submit fasting TG and LDL-C laboratory reports with dates; TG must be ≥ 500 mg/dL for hypertriglyceridemia without ASCVD, or TG 150–499 mg/dL and LDL-C 41–100 mg/dL for cardiovascular-risk reduction.
For hypertriglyceridemia without ASCVD, submit medication history showing the required fibrate and omega-3-acid ethyl ester trials, including doses, duration, adherence, failures, contraindications, or adverse effects.
For cardiovascular-risk reduction, submit statin fill or treatment history, adherence, maximally tolerated dose, intolerance or contraindication documentation, and any required rechallenge records.
If requesting brand Vascepa, submit medical justification for inability to use generic icosapent ethyl; verify the requested dose does not exceed 4 g daily.

Documentation Required

Continuation-Therapy Supporting Records

Continuation requests must include records demonstrating approval history or current benefit receipt, treatment response, current therapy, and any dose or product change being requested.

Document that the member is currently receiving the medication through a Centene benefit or previously met initial approval criteria.
For hypertriglyceridemia, submit baseline and current TG values demonstrating at least a 20% reduction for initial reauthorization and continued reduction or maintenance thereafter.
For cardiovascular-risk reduction, submit baseline and current TG and LDL-C values showing no increase, plus documentation of adherence to the maximally tolerated statin dose when the member is statin tolerant.
For other diagnoses/indications, submit documentation of positive response and the requested duration.
For dose increases, document the new dose and confirm it does not exceed 4 g (4 capsules) daily. For brand requests, document inability to use generic icosapent ethyl.

Denial Risk

Denial Conditions

Deny or do not authorize the request when required indication, laboratory, step-therapy, statin-pathway, generic-product, documentation, or dose criteria are not met.

The requested indication is not covered under the applicable criteria, or required clinical documentation is absent or insufficient.
Required TG or LDL-C thresholds are not met, or laboratory results are not dated within 90 days when required.
Required fibrate or omega-3-acid ethyl ester trials are not completed, or required contraindication/adverse-effect documentation is absent.
Required statin adherence, intolerance, contraindication, or rechallenge criteria are not met for cardiovascular-risk reduction.
Brand Vascepa is requested without medical justification for inability to use generic icosapent ethyl.
The requested dose, including an increase, exceeds 4 g (4 capsules) per day.

Denial Risk

Unaddressed Off-Label Indications

Non-FDA-approved indications not addressed by this policy are not authorized under these criteria unless supported under the applicable off-label use policy or evidence-of-coverage document.

Refer commercial requests to CP.CPA.09.
Refer health insurance marketplace requests to HIM.PHAR.21.
Refer Medicaid requests to CP.PMN.53.

Denial Risk

Hypersensitivity Contraindication

Do not authorize use in a member with known hypersensitivity, including anaphylactic reaction, to Vascepa or any of its components.

Screen for documented hypersensitivity before approval or continuation.
No boxed warnings are reported in the policy.

Billing Rule

Brand-to-Generic Redirection

Brand Vascepa requests may be redirected to generic icosapent ethyl under the plan’s generic-first approach. The provider should submit the request for generic therapy unless a clinically supported exception applies.

When generic icosapent ethyl is available, use the generic product in place of brand Vascepa.
A brand exception requires medical justification, such as a contraindication to an excipient in the generic product.

Definition

SAMSStatin-associated muscle symptoms.

Definition

LDL-CLow-density lipoprotein cholesterol.

Definition

TGTriglyceride.

Definition

High-intensity statin therapyA daily statin dose shown to lower LDL-C, on average, by approximately 50% or more.

Definition

Low-intensity statin therapyA daily statin dose shown to lower LDL-C, on average, by less than 30%.

Clinical definition

Statin-associated muscle symptoms (SAMS)Typically include bilateral muscle pain or aching, cramps, and weakness involving large muscle groups. Symptoms often begin after statin initiation or dose escalation and generally improve after discontinuation; recurrence with rechallenge and resolution after cessation provide the strongest evidence of statin association.

Definition and qualifying measures

MicroalbuminuriaMay be established by a positive Micral or other strip test, an albumin/creatinine ratio ≥ 2.5 mg/mmol, or a timed-collection albumin excretion rate ≥ 20 mg/min, with qualifying measures documented on at least two successive occasions.

Definition and qualifying measures

MacroalbuminuriaMay be established by dipstick evidence of gross proteinuria, an albumin/creatinine ratio ≥ 25 mg/mmol, or a timed-collection albumin excretion rate ≥ 200 mg/min, with qualifying measures documented on at least two successive occasions.

Failure of a consecutive 3-month trial of fibrate therapy during the last 6 months at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects were experienced.Fibrate trial ≥3 consecutive months in the last 6 months
Failure of omega-3-acid ethyl esters (generic Lovaza) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects were experienced.

Product and dose requirements

If brand Vascepa is requested, medical justification supports inability to use generic icosapent ethyl, if available, such as contraindications to excipients.
The dose does not exceed 4 g (4 capsules) per day.Dose ≤4 g/day

Initial therapy: reduction of cardiovascular disease risk

Covered when ALL of the following are met:

Diagnosis, laboratory, and treatment criteria

Qualifying diagnosis
- ASCVD history
  - A history of acute coronary syndrome.
  - Clinically significant coronary heart disease diagnosed by invasive or noninvasive testing, such as coronary angiography, treadmill stress testing, stress echocardiography, or nuclear imaging.
  - Coronary or other arterial revascularization.
  - Myocardial infarction.
  - Peripheral arterial disease presumed to be of atherosclerotic origin.
  - Stable or unstable angina.
  - Stroke or transient ischemic attack (TIA).
- Diabetes with at least two cardiovascular disease risk factors.Diabetes plus ≥2 CVD risk factors
Age 45 years or older.Age ≥45 years
Fasting triglycerides are 150–499 mg/dL, with the laboratory result dated within 90 days.Fasting TG 150–499 mg/dL; lab within 90 days
LDL-C is 41–100 mg/dL, with the laboratory result dated within 90 days.LDL-C 41–100 mg/dL; lab within 90 days
Statin pathway
- Member is receiving statin therapy
  - Vascepa is prescribed in conjunction with a statin at the maximally tolerated dose.
  - Applicable statin regimen
    Adherence for at least the last 4 months to a high-intensity statin.Statin adherence ≥4 months
    Adherence for at least the last 4 months to a moderate-intensity statin, with intolerance to two high-intensity statins or a statin risk factor.Statin adherence ≥4 months
    Adherence for at least the last 4 months to a low-intensity statin, with intolerance to one high- and one moderate-intensity statin, or a statin risk factor plus a history of intolerance to two moderate-intensity statins.
Brand and dose requirements
- If brand Vascepa is requested, medical justification supports inability to use generic icosapent ethyl, if available, such as contraindications to excipients.
- The dose does not exceed 4 g (4 capsules) per day.Dose ≤4 g/day

For subsequent reauthorizations, triglyceride levels continue to decrease or the reduction from baseline is maintained.

If brand Vascepa is requested, medical justification supports inability to use generic icosapent ethyl, if available, such as contraindications to excipients.

If a dose increase is requested, the new dose does not exceed 4 g (4 capsules) per day.Dose ≤4 g/day

Continuation therapy: cardiovascular-risk reduction

Continued coverage requires ALL of the following:

Continuation response

Eligibility for continuation
- The member is currently receiving the medication through the Centene benefit.
- The member previously met the initial approval criteria.
The member is responding positively to therapy, evidenced by no increase in triglyceride or LDL-C levels from baseline.No increase in TG or LDL-C from baseline
Statin management
- The member is statin tolerant and documentation shows adherence to a statin at the maximally tolerated dose.
- The statin-tolerance condition does not apply because the member is not statin tolerant.
If brand Vascepa is requested, medical justification supports inability to use generic icosapent ethyl, if available, such as contraindications to excipients.
If a dose increase is requested, the new dose does not exceed 4 g (4 capsules) per day.Dose ≤4 g/day

Statin adherence ≥4 months

Member is not receiving statin therapy

Statin therapy is contraindicated under Appendix F.
Statin-intolerance pathway
- The member has tried at least two statins, including at least one hydrophilic statin: pravastatin, fluvastatin, or rosuvastatin.
- ANY of the following
  - The member has documented statin risk factors.
  - SAMS pathway
    Intolerable statin-associated muscle symptoms persisted for at least two weeks, disappeared after discontinuation of statin therapy, and recurred with statin rechallenge.
    Rechallenge was performed by titrating from the lowest possible dose and/or using intermittent dosing, such as one to three times weekly.