CurrentHealth NetPolicy CP CPA.357

Icosapent Ethyl (Vascepa) Clinical Policy

Covers medical necessity and authorization criteria for icosapent ethyl (Vascepa) for treatment of hypertriglyceridemia and reduction of cardiovascular disease risk for Health Net (Centene-affiliated) commercial lines of business.

Policy Summary

PayerHealth Net

PolicyIcosapent Ethyl (Vascepa) Clinical Policy

Policy CodePolicy CP CPA.357

Change TypeNo material changes

Effective DateMar 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation including office notes and labs within 90 days showing fasting triglycerides and LDL-C as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 g/daymax daily dose

6 moinitial approval

12 mocontinuation approval

150-499TG range (CVD pathway)

41-100LDL-C range (CVD pathway)

2 g BID

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Coverage Criteria

inv-01: Initial Therapy - Hypertriglyceridemia without ASCVD

Covered when ALL of the following are met

Initial: Hypertriglyceridemia without ASCVD: 1. Diagnosis of hypertriglyceridemia; 2. Age >= 18 years; 3. Failure of a >=3 consecutive month trial of fibrate therapy in the last 6 months at maximally indicated doses, unless contraindicated or clinically significant adverse effects occurred; 4. Failure of omega-3-acid ethyl esters (generic Lovaza) at maximally indicated doses, unless contraindicated or clinically significant adverse effects occurred; 5. Requested dose does not exceed 4 g per day (4 capsules/day);

Approval duration: 6 months

inv-02: Initial Therapy - Reduction of Cardiovascular Disease Risk

Covered when ALL of the following are met

Initial: CVD risk reduction: 1. Either (a) diagnosis of ASCVD evidenced by history of acute coronary syndromes, coronary or other arterial revascularization, clinically significant CHD by testing, myocardial infarction, stable or unstable angina, peripheral arterial disease of atherosclerotic origin, or stroke/TIA; OR (b) diabetes mellitus with >=2 CVD risk factors; 2. Age >=45 years for the ASCVD pathway (per policy); 3. Labs dated within 90 days showing fasting TG 150-499 mg/dL and LDL-C 41-100 mg/dL; 4. Vascepa prescribed in conjunction with a maximally tolerated statin (adherent for at least the last 4 months to maximally tolerated dose) OR documentation of statin contraindication/intolerance per policy (including required trials/re-challenges); 5. Requested dose does not exceed 4 g per day (4 capsules/day);labs within 90 days

inv-03: Continuation Therapy - Hypertriglyceridemia without ASCVD

Continued therapy covered when ONE of the following is met and member is responding

Continued: Hypertriglyceridemia without ASCVD: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria; 2. Member is responding: initial re-authorization requires >=20% reduction in triglyceride (TG) levels from baseline; subsequent re-authorizations require continued reduction or maintenance of TG reduction from baseline; 3. Requested dose does not exceed 4 g per day (4 capsules/day);>=20% TG reduction for initial reauthorization

Approval duration: 12 months

inv-04: Continuation Therapy - Reduction of Cardiovascular Disease Risk

Continued therapy covered when ALL of the following are met

Continued: CVD risk reduction: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria; 2. Member is responding: evidenced by no increase in TG and LDL-C levels from baseline; 3. If statin tolerant, documentation of adherence to a statin at maximally tolerated dose; 4. Requested dose does not exceed 4 g per day (4 capsules/day);no increase in TG and LDL-C from baseline

Approval duration: 12 months

inv-05: Statin and Icosapent Ethyl Clinical Criteria

Clinical considerations and contraindications relevant to prescribing statins and icosapent ethyl

Statin contraindications or intolerance considerations: Statin contraindications include laboratory-confirmed acute liver injury or rhabdomyolysis due to statin treatment; decompensated liver disease (jaundice, ascites, variceal bleeding, encephalopathy); pregnancy, actively trying to become pregnant, or nursing (note: FDA requested removal of the contraindication in July 2021); and immune-mediated hypersensitivity to HMG-CoA reductase inhibitors evidenced by allergic reaction to at least two different statins.

FDA communication referenced regarding pregnancy

Risk factors increasing statin-associated risk: Risk factors include men and women >=50 years, hypertension (BP >=140/90 mmHg or on antihypertensive medication), current or recent smoker (within 3 months), low HDL-C (<40 mg/dL men, <50 mg/dL women), renal dysfunction/CKD, micro- or macroalbuminuria, obesity/overweight, family history of premature coronary disease, dyslipidemia, and other comorbidities that increase risk (impaired renal/hepatic function, concomitant drugs affecting statin metabolism, Asian ancestry, age >75, history of hemorrhagic stroke).

See Appendix H and policy sections

Icosapent ethyl dosing criteria reference:

Requests for non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with Health Net’s off‑label use policy (CP.CPA.09) or applicable evidence of coverage documents.

The policy lists decompensated liver disease (examples include development of jaundice, ascites, variceal bleeding, or encephalopathy) as a contraindication to statin therapy and therefore an important clinical consideration when evaluating statin co‑therapy with icosapent ethyl.

Uses of icosapent ethyl for non‑FDA approved indications that fall outside the explicit indications in this document are considered not authorized unless the request is supported by off‑label use documentation meeting the requirements of policy CP.CPA.09 or by an applicable evidence of coverage determination.

This policy was adapted from a previously approved policy (CP PMN.187). Review history indicates no significant changes across recent annual reviews; administrative edits included removal of prior redirections from generic icosapent ethyl to brand Vascepa and routine updates to references.

Coding and Dosing

Icosapent Ethyl dosing/formulation (no explicit CPT/HCPCS/NDC codes listed)mixed

not provided	Icosapent ethyl dosing: 2 g PO twice daily (2 g PO BID); maximum dose 4 g/day
not provided	Product availability: capsules 0.5 g and 1 g

Fasting triglycerides for CVD risk reduction pathway — lab range required

Fasting triglycerides (CVD risk reduction pathway)150-499 mg/dL (labs must be dated within 90 days)

Lab timing requirementFasting TG must be documented within 90 days of request

ContextRequired when requesting icosapent ethyl for reduction of cardiovascular disease risk pathway (ASCVD or diabetes with ≥2 risk factors)

LDL-C required range for CVD risk reduction pathway

LDL-C range (CVD risk reduction pathway)41-100 mg/dL (labs must be dated within 90 days)

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

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria for icosapent ethyl (Vascepa). Requests lacking required documentation may be denied.

Prior authorization required for Vascepa (icosapent ethyl)
Submit clinical documentation: office notes, labs, other supporting information

Step Therapy

Step Therapy Prerequisites

Step therapy prerequisites must be documented when applicable. For hypertriglyceridemia without ASCVD, provider must demonstrate prior trial and failure (or contraindication) of a fibrate (e.g., fenofibrate, gemfibrozil) and of omega-3-acid ethyl esters (e.g., Lovaza) at maximally indicated doses unless contraindicated or significant adverse effects occur.

Failure of a ≥3 month trial of fibrate therapy at up to maximally indicated doses (unless contraindicated)

Background

Icosapent ethyl (Vascepa) is an ethyl ester of eicosapentaenoic acid (EPA) used as an adjunct to statin therapy to reduce cardiovascular events in adults with elevated triglycerides and/or to reduce triglyceride levels in severe hypertriglyceridemia. Prescribing and authorization criteria in this policy distinguish use for hypertriglyceridemia without ASCVD and use for reduction of cardiovascular disease risk, with specific laboratory and treatment prerequisites defined for each pathway.

Definitions

atherosclerotic cardiovascular disease (ASCVD)

DefinitionAtherosclerotic cardiovascular disease (ASCVD)

Examples included in ASCVDAcute coronary syndromes; coronary or other arterial revascularization; clinically significant CHD by testing; myocardial infarction; stable/unstable angina; peripheral arterial disease of atherosclerotic origin; stroke or TIA

Policy useASCVD diagnosis is a primary eligibility pathway for CVD risk reduction with icosapent ethyl

SAMS — statin-associated muscle symptoms

Term expansionSAMS = statin-associated muscle symptoms

Acronym useUsed throughout policy to document statin intolerance and required re-challenge/descriptions

Policy Summary

PayerHealth Net

PolicyIcosapent Ethyl (Vascepa) Clinical Policy

Policy CodePolicy CP CPA.357

Change TypeNo material changes

Effective DateMar 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation including office notes and labs within 90 days showing fasting triglycerides and LDL-C as required.

SourceLink

On This Page

Icosapent ethyl dosing: 2 g PO twice daily (2 g PO BID) with a maximum dose of 4 g per day; product availability includes 0.5 g and 1 g capsules. Prescribing and prior authorization should align with these dosing parameters.

2 g PO BID, max 4 g/day

ContextRequired alongside fasting TG for initial approval in the CVD risk reduction pathway

Maximum dose — 4 g per day (4 capsules/day)

Maximum daily dose4 g per day

Maximum capsules per day4 capsules per day

Dosing contextApplies to both hypertriglyceridemia and CVD risk reduction pathways

LDL-C reduction threshold for low-intensity statin — < 30%

Low-intensity statin LDL-C reduction thresholdAverage LDL-C lowering < 30%

Examples of low-intensity statinsSimvastatin 10 mg; Pravastatin 10-20 mg; Fluvastatin 20-40 mg; Lovastatin 20 mg

Use in policyLow-intensity definition used when assessing statin regimens for CVD risk reduction pathway

Failure of omega-3-acid ethyl esters (generic Lovaza) at up to maximally indicated doses (unless contraindicated)

Documentation Required

Dosing and Product Availability

Icosapent ethyl dosing and formulation details should be included in the authorization. Typical dosing is 2 g PO twice daily (maximum 4 g/day). Product is available as 0.5 g and 1 g capsules.

Dose: 2 g PO BID (max 4 g/day)
Product availability: capsules 0.5 g and 1 g

Note

Policy Adaptation Notes — No Significant Changes

Policy adaptation and review history: no significant changes were made in recent adaptations and annual reviews; prior administrative redirections to generic icosapent ethyl for brand Vascepa requests were removed. References were reviewed and updated during policy adaptations.

Policy adapted from prior policy CP PMN.187; no significant changes
Removed redirections to generic icosapent ethyl for brand Vascepa
References reviewed and updated during annual reviews

Documentation Required

References and Guideline Citations

References and guideline citations to support clinical requests should be provided or may be requested by the plan. Relevant references include the Vascepa Prescribing Information and major guideline and trial publications (e.g., REDUCE-IT, ACC/AHA, AHA, ADA statements).

Vascepa Prescribing Information
Bhatt DL et al., REDUCE-IT (N Engl J Med 2019)
ACC/AHA, AHA, ADA and Endocrine Society guideline statements listed in references

Denial Risk

Non‑FDA Indication Denial Risk

Non‑FDA approved (off‑label) indications that are not addressed in this policy will be denied unless sufficient documentation per the plan's off‑label use policy (e.g., CP.CPA.09) or evidence of coverage documents is provided.

Off‑label use requires sufficient evidence per off‑label use policy CP.CPA.09

Related criteriaSAMS documentation may be required when statin intolerance is claimed in the CVD risk reduction pathway

TG — triglyceride

AbbreviationTG = triglyceride

ContextUsed in lab thresholds for both hypertriglyceridemia and CVD risk reduction pathways

UnitsPolicy lists TG values in mg/dL (e.g., 150-499 mg/dL)

Low Intensity Statin Therapy — dose shown to lower LDL-C by <30% (examples)

Definition (Low Intensity Statin)Daily dose shown to lower LDL-C, on average, by < 30%

Example agents/dosesSimvastatin 10 mg; Simvastatin 20-40 mg; Pravastatin 10-20 mg; Fluvastatin 20-40 mg; Lovastatin 20 mg

Policy relevanceUsed to classify the member's statin regimen when evaluating eligibility for icosapent ethyl in the CVD risk reduction pathway

SAMS (Statin-Associated Muscle Symptoms) — clinical syndrome description

Clinical syndrome descriptionSAMS includes myalgia, cramps, and weakness, usually bilateral involving large muscle groups; symptoms often appear early after starting or increasing statin dose and usually resolve after cessation

Diagnostic considerationsPersistence >2 months after stopping statin should prompt evaluation for other causes or underlying muscle disease

Rechallenge evidenceReappearance of symptoms with statin rechallenge and disappearance with cessation offers best evidence that symptoms are truly SAMS