CurrentPremera BluecrossPolicy N/A

Pharmacologic Treatment of High Cholesterol

Policy governing medical necessity and site‑of‑service review for injectable and oral lipid‑lowering therapies (including PCSK9 inhibitors, inclisiran, icosapent ethyl, and omega‑3 products) for Premera members; intended for providers authorizing or administering these drugs.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of High Cholesterol

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 2, 202618d

Next Review DateN/A

Key ActionObtain prior authorization with documentation of age, required prior therapy trials (including trial of generic omega‑3 ethyl esters or high‑intensity statin when indicated), triglyceride/LDL values, and prescribed dosing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Repatha, Praluent, Leqvio, Vascepa, Lovazadrugs explicitly addressed

18+minimum patient age

>=500TG threshold (severe)

>=150TG threshold (CV risk)

3 yrsapproval duration

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Medical Necessity Criteria

Repatha (evolocumab) medical necessity

Repatha (evolocumab) — Covered when ALL of the following are met

Repatha ASCVD: Individual aged ≥18 AND prescribed by or in consultation with a cardiologist, endocrinologist, or clinician focusing on cardiovascular risk management/lipid disorders AND has ASCVD (previous MI or history of acute coronary syndrome; stable or unstable angina; past history of stroke or TIA; peripheral arterial disease of atherosclerotic origin; or prior coronary/arterial revascularization) AND has tried one high‑intensity statin for ≥8 continuous weeks with LDL‑C ≥70 mg/dL OR has documented statin intoleranceLDL‑C ≥70 mg/dL

Dose limited to 140 mg q2w or 420 mg q4w

Repatha HeFH: Individual aged ≥10 AND prescribed by or in consultation with a relevant specialist AND meets HeFH criteria (untreated LDL‑C ≥190 mg/dL OR genetic confirmation OR Dutch Lipid Network score >5 OR Simon Broome criteria) AND has tried a high‑intensity statin for ≥8 continuous weeks with LDL‑C ≥70 mg/dL OR has documented statin intoleranceLDL‑C ≥190 mg/dL

Age ≥10 years

Repatha HoFH: Individual aged ≥10 AND prescribed by or in consultation with a relevant specialist AND meets HoFH criteria (untreated LDL‑C >400 mg/dL OR treated LDL‑C ≥300 mg/dL OR genetic confirmation of two mutant alleles) AND has tried a high‑intensity statin for ≥8 continuous weeks with LDL‑C ≥70 mg/dL OR has documented statin intoleranceLDL‑C >400 mg/dL or treated LDL‑C ≥300 mg/dL

Dose limited to 420 mg every 2 weeks

Repatha primary hyperlipidemia: Individual aged ≥18 AND prescribed by or in consultation with a relevant specialist AND meets risk criteria (CAC ≥100 Agatston units or ≥75th percentile OR 10‑year ASCVD risk ≥7.5% OR diabetes) AND has tried a high‑intensity statin for ≥8 continuous weeks with LDL‑C ≥100 mg/dL OR has documented statin intoleranceLDL‑C ≥100 mg/dL

Praluent (alirocumab) medical necessity

Praluent (alirocumab) — Covered when ALL of the following are met

Praluent ASCVD: Individual aged ≥18 AND has tried Repatha first with inadequate response or intolerance AND prescribed by or in consultation with a cardiologist, endocrinologist, or clinician focusing on cardiovascular risk management/lipid disorders AND has ASCVD (previous MI or history of acute coronary syndrome; stable or unstable angina; past history of stroke or TIA; PAD of atherosclerotic origin; or prior coronary/arterial revascularization) AND has tried one high‑intensity statin for ≥8 continuous weeks with LDL‑C ≥70 mg/dL OR has documented statin intoleranceLDL‑C ≥70 mg/dL

Dose limited to 150 mg q2w or 300 mg q4w

Praluent HeFH: Individual aged ≥8 AND has tried Repatha first with inadequate response or intolerance AND prescribed by or in consultation with a relevant specialist AND meets HeFH criteria (untreated LDL‑C ≥190 mg/dL OR genetic confirmation OR Dutch Lipid Network score >5 OR Simon Broome criteria) AND has tried a high‑intensity statin for ≥8 continuous weeks with LDL‑C ≥70 mg/dL OR has documented statin intoleranceLDL‑C ≥190 mg/dL

Leqvio (inclisiran) medical necessity

Leqvio (inclisiran) — Covered when ALL of the following are met

Leqvio ASCVD: Individual aged ≥18 AND has tried Repatha first with inadequate response or intolerance AND prescribed by or in consultation with a cardiologist, endocrinologist, or clinician focusing on cardiovascular risk management/lipid disorders AND has ASCVD (previous MI or history of acute coronary syndrome; stable or unstable angina; past history of stroke or TIA; PAD of atherosclerotic origin; or prior coronary/arterial revascularization) AND has tried one high‑intensity statin for ≥8 continuous weeks with LDL‑C ≥70 mg/dL OR has documented statin intoleranceLDL‑C ≥70 mg/dL

Dose limited to 284 mg at onset, 3 months, then every 6 months

Leqvio HeFH: Individual aged ≥18 AND has tried Repatha first with inadequate response or intolerance AND prescribed by or in consultation with a relevant specialist AND meets HeFH criteria (untreated LDL‑C ≥190 mg/dL OR genetic confirmation OR Dutch Lipid Network score >5 OR Simon Broome criteria) AND has tried a high‑intensity statin for ≥8 continuous weeks with LDL‑C ≥70 mg/dL OR has documented statin intoleranceLDL‑C ≥190 mg/dL

Icosapent ethyl (Vascepa) medical necessity

Icosapent ethyl (Vascepa, generic) — Covered when ALL of the following are met

Vascepa CV risk reduction: Individual aged ≥18 AND triglycerides ≥150 mg/dL AND on moderate‑ or high‑intensity statin therapy unless not tolerated/contraindicated AND has established cardiovascular disease OR diabetes plus 2 additional risk factors (family history of premature ASCVD, tobacco use, hypertension, renal dysfunction) AND has had a trial and treatment failure or intolerance to generic icosapent ethyl when requiredTG ≥150 mg/dL

Dose 4 g/day

Vascepa severe hypertriglyceridemia: Individual aged ≥18 AND has tried and failed one of the listed fibrates (fenofibrate, fenofibric acid, gemfibrozil) OR tried and failed prescription niacin ER AND has had a trial and treatment failure or intolerance to generic icosapent ethyl when applicableDose 4 g/day

Lovaza (omega‑3‑acid ethyl esters) medical necessity

Lovaza (omega‑3‑acid ethyl esters) — Covered when ALL of the following are met

Lovaza severe hypertriglyceridemia: Individual aged ≥18 AND meets criteria for treatment of severe hypertriglyceridemia (has tried and failed specified fibrate or prescription niacin per product criteria) AND has had a trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters when requiredage ≥18

Icosapent ethyl — CV risk reduction

Icosapent ethyl (Vascepa or generic) for CV risk reduction — Covered when ALL of the following are met

Age: The individual is aged 18 years or older>=18 years

Triglycerides: Triglyceride (TG) levels are greater than or equal to 150 mg/dL>=150 mg/dL

Statin therapy: Individual is on moderate‑intensity or high‑intensity statin therapy unless not tolerated or contraindicated

Risk criteria: Has established cardiovascular disease OR diabetes mellitus plus at least 2 additional cardiovascular risk factors (family history of premature ASCVD, tobacco use, hypertension, renal dysfunction)

Generic icosapent ethyl — step therapy and coverage

Generic icosapent ethyl for secondary prevention — Covered when ALL of the following are met

Age: The individual is aged 18 years or older>=18 years

Triglycerides: Triglyceride (TG) levels are greater than or equal to 150 mg/dL>=150 mg/dL

Statin therapy: Individual is on moderate‑intensity or high‑intensity statin therapy unless not tolerated or contraindicated

Risk criteria: Has established cardiovascular disease OR diabetes mellitus plus 2 additional CV risk factors

Omega‑3 ethyl esters (Lovaza) — severe hypertriglyceridemia

Omega‑3‑acid ethyl esters (Lovaza) and other omega‑3 products for severe hypertriglyceridemia — Covered when ALL of the following are met

Age: The individual is aged 18 years or older>=18 years

Triglycerides: Triglyceride (TG) levels are greater than or equal to 500 mg/dL>=500 mg/dL

Prior therapy: The individual has had a trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters

Dose: The daily dose is 4 grams per day (single 4‑gram dose or two 2‑gram doses)

Authorization durations and reauthorization criteria

Initial approval and reauthorization

Initial approval duration: Initial approval will be for 3 years3 years

Reauthorization evidence: Ongoing therapy approved for 3 years when chart notes document continued clinical benefit (i.e., at goal TG values specific to the individual)3 years

Chart documentation required

Initial and ongoing therapy criteria

Covered when ALL of the following are met

Age: The individual is aged 18 years or older.>=18 years

Cardiovascular history: Meets one of: prior MI/acute coronary syndrome; stable or unstable angina; past history of stroke or TIA; PAD of atherosclerotic origin; or prior coronary/arterial revascularization (e.g., CABG, PCI)

Triglyceride threshold: Triglyceride (TG) levels ≥500 mg/dL.>=500 mg/dL

Prior therapy: Trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters.

Initial medical necessity criteria

Covered when ALL of the following are met

Eligibility: The individual is aged 18 years or olderage >= 18 years

ASCVD history (one required): One of: previous MI/acute coronary syndrome; angina (stable or unstable); past history of stroke or TIA; PAD of atherosclerotic origin; prior coronary or other arterial revascularization (e.g., CABG, PCI)

Lipid threshold: Triglyceride (TG) levels ≥500 mg/dLTG >= 500 mg/dL

Prior therapy: Trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters

Re-authorization criteria

Re-authorization

Ongoing approval: Ongoing therapy will be approved for 3 years when chart notes document continued clinical benefit (i.e., at goal TG values specific to the individual).documented clinical benefit

Re-authorization interval up to 3 years

Initial coverage criteria

Covered when ALL of the following are met

Eligibility and baseline: Individual aged ≥18 AND triglyceride (TG) levels ≥500 mg/dLage >=18; TG >=500 mg/dL

Clinical history: Meets one of: prior MI/acute coronary syndrome; angina; past history of stroke/TIA; PAD of atherosclerotic origin; or prior coronary/arterial revascularization

Therapy trial requirement: Trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters

Step therapy requirement

Dose requirement: Prescribed daily dose is 4 grams per day (single 4‑g dose or two 2‑g doses)

Reauthorization criteria

Reauthorization

Ongoing benefit: Ongoing therapy will be approved for 3 years when chart notes document continued clinical benefit (i.e., at goal TG values specific to the individual)documentation of benefit

Reauthorization period is 3 years

Initial approval (medical necessity)

Covered when ALL of the following are met:

Initial therapy criteria: Patient aged ≥18 AND meets at least one ASCVD-related condition (previous MI/acute coronary syndrome, angina, history of stroke/TIA, PAD of atherosclerotic origin, or prior coronary/arterial revascularization) AND triglyceride (TG) ≥500 mg/dL AND trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters AND prescribed daily dose is 4 grams per day (single 4-g dose or two 2-g doses)TG >= 500 mg/dL; dose = 4 g/day

Initial approval will be for 3 years.

Re-authorization / ongoing therapy

Re-authorization when the following is met:

Re-authorization criteria: Chart notes document continued clinical benefit (i.e., at goal TG values specific to the individual).documented clinical benefit at individual goal TG values

Ongoing therapy will be approved for 3 years when documentation provided.

Statin trial requirement

Additional requirement for patients with ASCVD:

Statin requirement: Has tried one high‑intensity statin therapy (e.g., atorvastatin ≥40 mg daily or rosuvastatin equivalent) prior to or concurrent with therapy as applicable.trial of high-intensity statin

Initial therapy

Covered when ALL of the following are met

Initial coverage criteria: Patient aged ≥18 AND meets at least one ASCVD criterion (prior MI/acute coronary syndrome, angina, prior stroke/TIA, PAD, or prior arterial revascularization) AND fasting triglyceride level ≥500 mg/dL AND trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters AND prescribed daily dose is 4 grams per day (single 4-g dose or two 2-g doses)

Initial approval duration: 3 years.

Continuation therapy / Reauthorization

Re-authorization when ALL of the following are met

Reauthorization criteria: Chart notes document continued clinical benefit (e.g., at goal triglyceride values specific to the individual).

Re-authorization duration: 3 years.

Initial coverage criteria

Covered when ALL of the following are met:

Age: The individual is aged 18 years or older

Cardiovascular history or equivalent: Meets one of: prior MI/acute coronary syndrome; angina; past history of stroke/TIA; PAD of atherosclerotic origin; or prior coronary/arterial revascularization

Statin trial: Has tried one high‑intensity statin therapy (e.g., atorvastatin ≥40 mg daily or rosuvastatin equivalent)

Triglyceride level: Triglyceride (TG) levels ≥500 mg/dL>= 500 mg/dL

Re-authorization criteria

Re-authorization covered when ALL of the following are met:

Documentation of benefit: Chart notes document continued clinical benefit (i.e., at goal TG values specific to the individual)

Approval period: 3 years

Initial and ongoing therapy for adults with severe hypertriglyceridemia and qualifying ASCVD

Covered when ALL of the following are met:

Age: The individual is aged 18 years or older>=18 years

Qualifying cardiovascular condition: Meets one of: previous MI/acute coronary syndrome; angina; past history of stroke/TIA; PAD of atherosclerotic origin; or prior coronary/arterial revascularization

Lipid and prior therapy requirements: Has tried one high‑intensity statin (e.g., atorvastatin ≥40 mg daily or rosuvastatin) AND TG ≥500 mg/dL AND trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters AND daily dose is 4 g/dayTG >= 500 mg/dL; Dose = 4 g/day

Initial therapy – medical necessity

Covered when ALL of the following are met:

Adult: The individual is aged 18 years or older.age >= 18

Atherosclerotic disease or equivalent: Meets one of: previous MI/acute coronary syndrome; angina; past history of stroke/TIA; PAD of atherosclerotic origin; or prior coronary/arterial revascularization.

Prior lipid therapy: Has tried one high‑intensity statin therapy (e.g., atorvastatin ≥40 mg daily or rosuvastatin)trial of high‑intensity statin

Triglyceride threshold: Triglyceride (TG) levels ≥500 mg/dL.

Initial therapy medical necessity

Covered when ALL of the following are met

Adult age: The individual is aged 18 years or older>=18 years

Atherosclerotic disease history: Meets one of: previous MI/acute coronary syndrome; angina; past history of stroke/TIA; PAD of atherosclerotic origin; or prior coronary/arterial revascularization

Lipid thresholds and prior therapy: TG ≥500 mg/dL AND trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters AND has tried one high‑intensity statin (e.g., atorvastatin ≥40 mg daily or rosuvastatin equivalent)TG >= 500 mg/dL

Dose requirement:

Re-authorization

Reauthorization: Ongoing therapy will be approved for 3 years when chart notes document continued clinical benefit (i.e., at goal TG values specific to the individual)evidence of benefit

Initial and reauthorization durations are 3 years

Initial therapy

Covered when ALL of the following are met

Adult and triglyceride threshold: Individual aged ≥18 AND TG ≥500 mg/dLage >= 18; TG >= 500 mg/dL

ASCVD history (one required): Meets one of: previous MI/acute coronary syndrome; angina; past history of stroke/TIA; PAD of atherosclerotic origin; or prior coronary/arterial revascularization

Therapy prerequisites: Has tried one high‑intensity statin (e.g., atorvastatin ≥40 mg daily or rosuvastatin) AND trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters

Dose requirement: Requested therapy is at a daily dose of 4 grams per day (single 4‑g dose or two 2‑g doses)

Re-authorization

Reauthorization

Reauthorization documentation: Ongoing therapy will be approved for 3 years when chart notes document continued clinical benefit (i.e., at goal TG values specific to the individual)documentation of clinical benefit

Approval period for reauthorization is 3 years

Initial and ongoing therapy

Covered when ALL of the following are met

Eligibility and clinical criteria: Individual aged ≥18; has one of: prior MI/acute coronary syndrome, stable or unstable angina, past history of stroke/TIA, PAD of atherosclerotic origin, or prior coronary/arterial revascularization; TG ≥500 mg/dL; has tried one high‑intensity statin (e.g., atorvastatin ≥40 mg daily or rosuvastatin ≥20 mg) AND trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters; intended daily dose is 4 g/dayTG >= 500 mg/dL

Initial approval for 3 years; reauthorization requires chart documentation of continued clinical benefit

Initial therapy

Covered when ALL of the following are met

Eligibility: Individual aged ≥18 yearsage >= 18 years

Clinical indication: Meets one of: prior MI/acute coronary syndrome; angina; past history of stroke/TIA; PAD of atherosclerotic origin; or prior coronary/arterial revascularization

Prior therapy: Has tried one high‑intensity statin (e.g., atorvastatin ≥40 mg or rosuvastatin) AND trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters

Laboratory: Triglyceride (TG) levels ≥500 mg/dLTG >= 500 mg/dL

Re-authorization / Continuation

Re-authorization covered when

Ongoing benefit: Chart notes document continued clinical benefit (e.g., at goal TG values specific to the individual)

Re-authorization granted for 3 years when documented

Initial coverage criteria

Covered when ALL of the following are met

Main eligibility: Patient aged ≥18 AND TG ≥500 mg/dL AND trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters AND has tried one high‑intensity statin (e.g., atorvastatin ≥40 mg daily or rosuvastatin) AND prescribed daily dose is 4 grams per day (single 4‑g dose or two 2‑g doses)

Initial approval for 3 years; re-authorization requires chart notes documenting continued clinical benefit

Site‑of‑service (SOS) criteria in this policy are applied during medical‑benefit reviews of infusion or injection therapies. When the SOS criteria are not met, the policy states that the hospital‑based outpatient setting and other infusion sites are considered not medically necessary for administration of infusion/injection therapy. The SOS rules include distance and availability considerations (for example, no outpatient infusion center within 50 miles or no contracted home infusion agency) and clinical justifications (e.g., unstable cardiac or pulmonary disease, unstable vascular access, severe prior hypersensitivity, or grade 3–4 cytokine release syndrome) that must be documented to justify a non‑preferred site.

The policy excludes requests that lack documentation of required prior trials: therapy without a documented trial and treatment failure or intolerance to specified generic or alternative agents (as required per product‑specific criteria) will not meet coverage. Examples include required prior trials of generic icosapent ethyl, fibrates, niacin ER, or generic omega‑3‑acid ethyl esters when those step‑therapy pathways apply; absence of that documentation may lead to denial.

For indications tied to severe hypertriglyceridemia, coverage is contingent on a laboratory threshold of triglycerides ≥500 mg/dL and documentation of a prior trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters. The requested prescription dose must be the policy‑specified therapeutic dose of 4 g/day.

The policy requires that, before approval of a prescription omega‑3 product, there is evidence the member has had a trial and either treatment failure or intolerance to generic omega‑3‑acid ethyl esters. This step‑therapy requirement must be documented in the chart or prior‑therapy history for the request to meet medical necessity.

Coverage for therapy linked to severe hypertriglyceridemia is consistently conditioned on TG ≥500 mg/dL plus documentation of prior therapy attempts with generic omega‑3 products (and, when applicable, a high‑intensity statin trial). The prescription must be for the specified therapeutic dosing of 4 g/day.

Within the segments cited, no additional explicit exclusion lists are presented beyond the general step‑therapy and TG/dose thresholds; the policy instead indicates that failure to meet the stated criteria will render the request ineligible.

The policy supports use of prescription omega‑3 products only at the therapeutic dosing specified in the criteria. Use at doses other than 4 g/day or for patients with triglycerides <500 mg/dL is not supported by the medical‑necessity criteria in these sections.

This fragment does not provide an explicit exclusion list; it reiterates the eligibility requirements (age, TG threshold, prior trials, and dosing) that must be met for coverage.

No separate exclusion section appears in this excerpt; the policy relies on the requirement that all listed criteria be satisfied for coverage, implying requests that do not meet them are excluded.

This segment contains no distinct exclusions; instead it specifies required conditions (TG threshold, prior generic omega‑3 trial, dose) that must be met for medical necessity—absence of which results in non‑coverage.

No explicit exclusions are listed in this fragment. The content focuses on the combination of qualifying ASCVD history, prior statin and omega‑3 trials, laboratory threshold, and dosing required for coverage.

This excerpt does not state additional exclusions; it infers that failure to meet any of the stated criteria (age, ASCVD history, TG threshold, prior trials, correct dose) will preclude coverage of the requested therapy.

Across the documented criteria, the policy makes clear that if an individual does not meet all of the listed requirements (for example, age, triglyceride threshold, documented prior trial/failure or intolerance to generics, and correct dosing), the therapy is not eligible for coverage under these medical‑necessity criteria.

Requests for patients with triglycerides below 500 mg/dL or requests that lack documentation of a trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters (when step therapy applies) are not supported by the policy and may be denied. The policy also requires the prescribed daily dose to be 4 g/day for coverage when that dosing is specified.

Billing and Clinical Thresholds

Covered CPT/HCPCS/other codesmixed

No codes listed

Affected billing codes (placeholder)mixed

affected codes

No explicit CPT/HCPCS/ICD codes in this sectionmixed

No codes listed

No explicit codes in this excerptmixed

No codes listed

inv-64: LDL-C thresholds — key numeric thresholds referenced across indications

LDL-C thresholds (actionable)≥70 mg/dL; ≥100 mg/dL; ≥190 mg/dL; ≥300 mg/dL; >400 mg/dL (threshold applied per specific indication)

LDL-C ≥70 mg/dL useUsed for ASCVD indications after high‑intensity statin trial or statin intolerance

LDL-C ≥100 mg/dL useApplied for primary hyperlipidemia indications when CAC/ASCVD risk criteria met

LDL-C ≥190 mg/dL useThreshold for untreated HeFH population

LDL-C ≥300 mg/dL and >400 mg/dLUsed in HoFH criteria (treated LDL‑C ≥300 mg/dL or untreated >400 mg/dL)

Prior Authorization, Documentation and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for specified therapies in this policy. Requests must document the patient's age, relevant laboratory values, prior therapies and trials, prescriber specialty, and dosing. Failure to provide required documentation may result in denial.

Prior authorization required when medical necessity criteria apply
Document age, triglyceride/LDL-C values, prior therapy trials, and prescriber specialty
Dose documentation required (e.g., 4 g/day for omega‑3 products; PCSK9 products per labeled dosing)

Documentation Required

Approval Duration and Reauthorization

Initial approvals for eligible therapies are granted for 3 years. Reauthorization for continuation of therapy will be approved for 3 years when chart notes document continued clinical benefit (for example, goal triglyceride or LDL-C values appropriate to the individual).

Background and Context

Background: Familial hypercholesterolemia (FH) is an inherited disorder characterized by markedly elevated LDL‑C due to genetic defects that impair LDL clearance. Elevated LDL contributes to atherosclerotic plaque formation and cardiovascular disease; first‑line management includes lifestyle measures and statin therapy, with additional lipid‑lowering therapies considered for persistent elevation or statin intolerance. This policy provides medical‑necessity criteria and site‑of‑service guidance for lipid‑lowering agents relevant to FH and broader ASCVD risk management.

Key Definitions and Terms

inv-164: Familial hypercholesterolemia (FH) definition

DefinitionFamilial hypercholesterolemia (FH) is a genetic disorder caused by a defect in a specific gene leading to inability to remove LDL cholesterol and resulting in very high LDL levels.

Clinical consequenceUntreated high LDL leads to atherosclerotic plaque and cardiovascular disease

Management contextFirst‑line management includes diet/exercise and statins; additional agents considered when LDL remains elevated or statin intolerance exists

inv-165: Site of service (SOS) definition

DefinitionSite of service: location where drug is administered (physician office, infusion center, home infusion, hospital‑based outpatient).

Medical necessity noteHospital‑based outpatient setting is considered medically necessary for initial course or re‑initiation (first 90 days) per SOS criteria

Policy Revision History

2026-07-02policy_effectiveLatest

Policy effective date updated to July 2, 2026 with authorization durations and reauthorization criteria specifying initial approval for 3 years and reauthorization for 3 years when chart notes document continued clinical benefit.

2026-03-10policy_review

Policy last reviewed on March 10, 2026; documentation reiterates initial approval of 3 years and reauthorization criteria requiring chart notes demonstrating continued clinical benefit (goal TG values).

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of High Cholesterol

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 2, 202618d

Next Review DateN/A

SourceLink

On This Page

Praluent HoFH: Individual aged ≥18 AND has tried Repatha first with inadequate response or intolerance AND prescribed by or in consultation with a relevant specialist AND meets HoFH criteria (untreated LDL‑C ≥400 mg/dL OR treated LDL‑C ≥300 mg/dL OR genetic confirmation of two mutant alleles) AND has tried a high‑intensity statin for ≥8 continuous weeks with LDL‑C ≥70 mg/dL OR has documented statin intoleranceLDL‑C >400 mg/dL or treated LDL‑C ≥300 mg/dL

Dose limited to 150 mg q2w

Praluent primary hyperlipidemia: Individual aged ≥18 AND has tried Repatha first with inadequate response or intolerance AND prescribed by or in consultation with a relevant specialist AND meets risk criteria (CAC ≥100 Agatston units or ≥75th percentile OR 10‑year ASCVD risk ≥7.5% OR diabetes) AND has tried a high‑intensity statin for ≥8 continuous weeks with LDL‑C ≥100 mg/dL OR has documented statin intoleranceLDL‑C ≥100 mg/dL

Leqvio primary hyperlipidemia: Individual aged ≥18 AND has tried Repatha first with inadequate response or intolerance AND prescribed by or in consultation with a relevant specialist AND meets risk criteria (CAC ≥100 Agatston units or ≥75th percentile OR 10‑year ASCVD risk ≥7.5% OR diabetes) AND has tried a high‑intensity statin for ≥8 continuous weeks with LDL‑C ≥100 mg/dL OR has documented statin intoleranceLDL‑C ≥100 mg/dL

Prior therapy: Has had a trial and treatment failure or intolerance to generic icosapent ethyl when required

Dose: The daily dose is 4 grams per day4 g/day

Taken as four 0.5-g capsules twice daily or two 1-g capsules twice daily

Prior fibrate/niacin requirement: The individual has tried and failed one fibrate (fenofibrate, fenofibric acid, gemfibrozil) OR tried and failed prescription niacin ER

Prior icosapent trial: Has had a trial and treatment failure or intolerance to generic icosapent ethyl when required by product-specific pathway

Dose: The daily dose is 4 grams per day4 g/day

Taken as four 0.5-g capsules twice daily or two 1-g capsules twice daily

Dose: Daily dose is 4 grams per day (single 4‑gram dose or two 2‑gram doses).4 g/day

Dose requirement: Daily dose is 4 grams per day (single 4‑g dose or two 2‑g doses)4 g/day

Prior omega-3 trial: Trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters

Dose: Daily dose is 4 grams per day (single 4-g dose or two 2-g doses)4 g/day

Prior omega‑3 therapy: Trial and treatment failure or intolerance to generic omega‑3‑acid ethyl esters

Dose requirement: Daily dose is 4 grams per day (single 4‑g dose or two 2‑g doses)4 g/day

Daily dose is 4 grams per day (single 4‑g dose or two 2‑g doses)

Dose: Daily dose is 4 grams per day (single 4‑g dose or two 2‑g doses)4 g/day

inv-65: CAC / ASCVD risk — coronary calcium and 10-year ASCVD risk thresholds

Coronary artery calcium (CAC)CAC ≥100 Agatston units or ≥75th percentile for age/sex/ethnicity

10‑year ASCVD riskCalculated 10‑year ASCVD risk ≥7.5%

Use in risk stratificationCAC or 10‑year ASCVD risk used to qualify patients for primary hyperlipidemia therapy

inv-66: Triglyceride thresholds — >=150 mg/dL for CV risk reduction; >=500 mg/dL for severe hypertriglyceridemia

CV risk reduction triglyceride threshold (actionable)>=150 mg/dL (eligibility for icosapent ethyl to reduce CV events)

Severe hypertriglyceridemia threshold>=500 mg/dL (separate indication for omega‑3/ethyl esters)

Context of thresholds≥150 mg/dL applies for CV‑risk reduction when on statin with ASCVD or diabetes + risk factors; ≥500 mg/dL applies for treatment of severe hypertriglyceridemia

inv-67: Daily dose — 4 grams per day (typical prescription/administration details)

Standard prescription daily dose (actionable)4 grams per day

Dose forms describedTaken as four 0.5‑g capsules twice daily or two 1‑g capsules twice daily (product dependent)

Alternative dosing formatAlso described as single 4‑g dose or two 2‑g doses depending on product formulation

inv-68: Triglyceride level — >= 500 mg/dL (multiple references)

Severe hypertriglyceridemia threshold (actionable)>=500 mg/dL

Repeated specificationTG ≥500 mg/dL is the consistent laboratory cutoff for prescription omega‑3 therapy across indications

Use contextRequired for initial approval of omega‑3 therapies for severe hypertriglyceridemia and many ASCVD‑related indications

inv-69: Age — >= 18 years (minimum age referenced across indications)

Minimum eligible age (actionable)>=18 years

Adult requirement contextMost omega‑3 and CV risk/ASCVD indications require adults aged 18 years or older

Pediatric exceptions noted elsewhereSome non‑omega‑3 agents (e.g., Repatha, Praluent) have lower age thresholds in their specific indications, but the omega‑3 criteria specify ≥18 years

inv-70: Daily dose — 4 grams per day (restated)

Required daily dose (actionable)4 grams per day (single 4‑g dose or two 2‑g doses)

Administration examplesSingle 4‑gram dose equals 4 capsules; or two 2‑gram doses (2 capsules twice daily)

DocumentationDose (4 g/day) must be documented for prior authorization and reauthorization

inv-71: Triglyceride level threshold — >= 500 mg/dL

Triglyceride threshold (actionable)>=500 mg/dL

Applied across criteriaTG ≥500 mg/dL repeatedly required for severe hypertriglyceridemia and ASCVD‑related prescribing pathways

Triggers for denialRequests lacking TG ≥500 mg/dL risk denial per policy

inv-72: Daily dose — 4 grams per day (administration form)

Daily dose — administration form (actionable)4 grams per day taken as single 4‑g dose or two 2‑g doses

Capsule descriptionSingle 4‑g dose corresponds to 4 capsules in some formulations; two 2‑g doses given twice daily are an alternate regimen

Approval requirementPrescribed dose must equal 4 g/day for initial approval and reauthorization

inv-73: Triglyceride level — >= 500 mg/dL

Triglyceride level (actionable)>=500 mg/dL

Clinical contextsUsed for initial therapy, ASCVD‑related indications, and severe hypertriglyceridemia pathways

Consistent policy cutoffTG ≥500 mg/dL is the consistent requirement across multiple coverage sections

inv-74: Age — >= 18 years

Minimum age (actionable)>=18 years

Applies to omega‑3 and Vascepa indicationsAge ≥18 specified for CV risk reduction and severe hypertriglyceridemia uses

Reauthorization implicationsAge documentation is required for prior authorization and reauthorization

inv-75: Triglyceride (TG) — >= 500 mg/dL

Triglyceride (TG) threshold (actionable)>=500 mg/dL

Used with prior therapy requirementTG ≥500 mg/dL combined with trial/failure or intolerance to generic omega‑3 ethyl esters is required

Dose pairingTG threshold coupled with prescribed 4 g/day dosing for approval

inv-76: Daily dose — 4 g/day

Daily dose (actionable)4 g/day (single 4‑g dose or two 2‑g doses)

Formulation noteDescribed as 4 capsules (single 4‑g) or two 2‑g doses depending on product

Policy enforcementNon‑standard dosing (not 4 g/day) may be denied per policy

inv-77: Triglyceride threshold — >= 500 mg/dL

Triglyceride threshold (actionable)>=500 mg/dL

Context of useRequired for adults with qualifying ASCVD or equivalent conditions prior to approval

Documentation requirementTG value must be provided for prior authorization; missing TG ≥500 mg/dL may trigger denial

inv-78: Daily dose — 4 grams per day

Daily dose — prescription requirement (actionable)4 grams per day

Administration optionsSingle 4‑g dose or two 2‑g doses; taken with food per product labeling

Prior authorization notePrescribed daily dose must equal 4 g/day for approval and reauthorization

inv-79: Triglyceride (TG) — >= 500 mg/dL

Triglyceride (TG) requirement (actionable)>=500 mg/dL

Role in criteriaDefines eligibility for prescription omega‑3 therapies across initial and ongoing therapy sections

Denial riskRequests for therapy when TG <500 mg/dL may not meet medical necessity

inv-80: Daily dose — 4 grams per day

Daily dose — consistent requirement (actionable)4 grams per day

Common phrasingDescribed repeatedly as single 4‑g dose or two 2‑g doses depending on formulation

Policy consequenceDose other than 4 g/day is not supported by criteria and may be denied

inv-81: Triglyceride threshold — >= 500 mg/dL

Triglyceride threshold (actionable)>=500 mg/dL

Multiple corroborating sectionsThe ≥500 mg/dL cutoff appears across initial approval, continuation, and ASCVD‑related criteria

Clinical implicationMeets the definition of severe hypertriglyceridemia per policy for omega‑3 therapy consideration

inv-82: Daily dose — 4 grams per day

Daily dose — prescribing format (actionable)4 grams per day (single 4‑g dose or two 2‑g doses)

Capsule equivalenceSingle 4‑g dose corresponds to four capsules in some product formulations

Authorization noteDose must be documented for prior authorization and reauthorization

inv-83: Triglyceride level — >= 500 mg/dL

Triglyceride level (actionable)>=500 mg/dL

Eligibility repeatedUsed as the laboratory cutoff for eligibility across multiple sections of the policy

Step therapy tie‑inTG threshold is enforced alongside prior trial/failure to generic omega‑3s

inv-84: Prescription daily dose — 4 grams per day

Prescribed daily dose (actionable)4 grams per day (single 4‑g dose or two 2‑g doses)

Typical administrationTaken as four 0.5‑g capsules twice daily or two 1‑g capsules twice daily depending on product

Documentation requirementDose must be specified in authorization request; non‑4 g/day dosing may be denied

inv-85: Triglyceride (TG) — >= 500 mg/dL

Triglyceride (TG) threshold (actionable)>=500 mg/dL

Consistent policy cutoffAppears in initial coverage criteria across multiple sections as the required laboratory value

Reauthorization implicationChart notes must document TG values and benefit to continue therapy

inv-86: Triglyceride threshold — >= 500 mg/dL

Triglyceride threshold (actionable)>=500 mg/dL

Policy-wide applicationUsed for severe hypertriglyceridemia and ASCVD‑related initial therapy requirements

Denial riskLack of documented TG ≥500 mg/dL is a common trigger for denial

inv-87: Daily dose — 4 grams per day

Daily dose (actionable)4 grams per day

Administration examplesSingle 4‑g dose (4 capsules) or two 2‑g doses (2 capsules twice daily)

Authorization enforcementRequests prescribing doses other than 4 g/day may be denied

inv-88: Triglyceride level — >= 500 mg/dL

Triglyceride level (actionable)>=500 mg/dL

Repeated criterionTG ≥500 mg/dL is reiterated across initial therapy and ASCVD sections

Therapeutic implicationDefines severe hypertriglyceridemia for coverage of omega‑3 agents

inv-89: Triglyceride level — >= 500 mg/dL

Triglyceride level (actionable)>=500 mg/dL

Consistent appearanceThreshold appears in the main eligibility and initial approval criteria

Documentation neededProvider must supply TG lab value showing ≥500 mg/dL for approval

inv-90: Daily dose — 4 grams per day

Daily dose (actionable)4 grams per day

Dosage formsSingle 4‑g dose or two 2‑g doses; capsule counts vary by product

Policy enforcementDose documentation required for prior authorization and reauthorization

inv-91: Minimum age — >= 18 years

Minimum age for eligibility (actionable)>=18 years

Applies to omega‑3 and ASCVD indicationsAge ≥18 specified repeatedly across initial and ongoing therapy sections

DocumentationAge must be documented in authorization request

inv-92: Triglyceride threshold — >= 500 mg/dL

Triglyceride threshold (actionable)>=500 mg/dL

Role in coverage logicPrimary laboratory criterion for severe hypertriglyceridemia and many ASCVD‑related approvals

Required for initial approvalTG ≥500 mg/dL must be met for initial 3‑year approval in cited pathways

inv-93: Required daily dose — 4 grams per day

Required daily dose (actionable)4 grams per day (single 4‑g dose or two 2‑g doses)

Authorization notePrescribed dose must equal 4 g/day for initial approval and reauthorization

Dosage documentationDose should be documented in chart notes for prior authorization

Initial approval duration: 3 years

Re-authorization duration: 3 years when chart notes document continued clinical benefit

Chart documentation must include baseline and follow-up lab values demonstrating benefit

Prior Authorization

Required Prior PCSK9 Therapy

For PCSK9 agents where step therapy is required, the policy requires trial of the specified prior PCSK9 agent(s) before coverage of an alternative PCSK9 product. For example, Praluent (alirocumab) and Leqvio (inclisiran) include requirements that Repatha (evolocumab) be tried first with inadequate response or intolerance documented before approval of the alternate agent.

Praluent and Leqvio: trial and inadequate response or intolerance to Repatha required and must be documented
Preserve documentation of duration and reason for switching (inadequate response or intolerance)

Documentation Required

Prescriber Specialty Documentation

Prescriptions for these specialty therapies should be written by or in consultation with an appropriate specialist. The policy requires the prescriber to be a cardiologist, endocrinologist, or a clinician who focuses on cardiovascular risk management and/or lipid disorders; this must be documented in the chart or prior authorization submission.

Prescriber specialty requirement: cardiology, endocrinology, or clinician focusing on cardiovascular risk/lipid disorders
Document specialist consultation when applicable

Documentation Required

Statin Trial / Intolerance Documentation

Prior authorization determinations require explicit documentation of prior trials when applicable. For ASCVD indications where PCSK9 therapy is requested, the member must have tried a high-intensity statin for at least 8 continuous weeks unless statin intolerance is documented. Absence of a documented statin trial or statin intolerance where required may result in denial.

Document trial of one high-intensity statin (e.g., atorvastatin ≥40 mg or rosuvastatin ≥20 mg) for ≥8 continuous weeks when applicable
If statin intolerance is claimed, provide documentation (e.g., rhabdomyolysis, muscle symptoms resolving on discontinuation, or intolerance to both atorvastatin and rosuvastatin)

Denial Risk

Dose Documentation and Incorrect Dosing Risk

Ensure dosing on the prior authorization request matches policy-specified dosing. Requests with incorrect dosing (for example, omega‑3 products not prescribed at 4 g/day where 4 g/day is required) or lacking dose documentation may be denied.

Omega‑3 products: document daily dose = 4 g/day (single 4‑gram dose or two 2‑gram doses)
PCSK9 agents: document dosing per product labeling (e.g., Repatha limits)
Provide explicit dose and administration frequency in the request

Use in reviewsSOS criteria apply to medical benefit reviews to determine appropriateness of administration site

inv-166: Established cardiovascular disease (ASCVD) definition

DefinitionEstablished cardiovascular disease (ASCVD) includes prior myocardial infarction, acute coronary syndrome, stable or unstable angina, prior stroke or transient ischemic attack, peripheral arterial disease of atherosclerotic origin, or prior coronary/arterial revascularization.

ExamplesIncludes prior MI/ACS, angina, stroke/TIA, PAD, CABG/PCI/angioplasty/stent

Role in criteriaASCVD history is used to qualify patients for certain lipid‑lowering therapies and icosapent ethyl CV‑risk reduction indications

inv-167: very high triglycerides — TG >=500 mg/dL

Definition (actionable)Very high triglycerides: TG ≥500 mg/dL

Clinical implicationTG ≥500 mg/dL is the policy cutoff for medical necessity of prescription omega‑3 therapy

Appears across criteriaRepeatedly referenced in initial approval, ongoing therapy, and ASCVD‑related sections

inv-168: ASCVD history — examples enumerated

ASCVD history examplesIncludes prior myocardial infarction, acute coronary syndrome, angina (stable or unstable), past stroke or transient ischemic attack, peripheral arterial disease of atherosclerotic origin, prior coronary/arterial revascularization (e.g., CABG, PCI)

Use in eligibilityPresence of these histories qualifies individuals for omega‑3 therapy pathways when TG threshold met

Documentation neededChart notes documenting ASCVD history are required for prior authorization in applicable pathways

inv-169: ASCVD populations — qualifying conditions

ASCVD qualifying populationsIndividuals with prior MI/ACS, angina, prior stroke/TIA, PAD of atherosclerotic origin, or prior coronary/arterial revascularization

Role in therapy selectionThese populations are specifically listed to determine eligibility for omega‑3 therapies and other lipid‑lowering agents

Cross‑referenceOften paired with TG ≥500 mg/dL and prior therapy requirements in coverage criteria

inv-170: ASCVD qualifying conditions — list of events and diagnoses

List of ASCVD qualifying conditions (actionable)Previous MI or ACS; stable or unstable angina; history of stroke or TIA; PAD of atherosclerotic origin; prior coronary/arterial revascularization (e.g., CABG, PCI, angioplasty, stent)

PurposeUsed to establish clinical eligibility for several covered indications

DocumentationMedical records must reflect one or more of these events to meet ASCVD criteria

inv-171: Therapeutic dose — 4 g/day definition

Therapeutic dose definition (actionable)Therapeutic dose = 4 g/day (either single 4‑g dose or two 2‑g doses)

Capsule equivalenceSingle 4‑g dose often equals 4 capsules; two 2‑g doses given twice daily are alternative regimen

Policy enforcementDose must be 4 g/day for approval; deviations may result in denial

inv-172: ASCVD or equivalent — definition and examples

ASCVD or equivalent (actionable)ASCVD or equivalent includes prior MI/ACS, angina, prior stroke/TIA, PAD of atherosclerotic origin, or prior coronary/arterial revascularization

Use in eligibilityMeeting ASCVD or equivalent criteria is required for certain CV‑risk reduction and omega‑3 therapy pathways

DocumentationProvider should document the specific ASCVD event or procedure in the chart for prior authorization

inv-173: high-intensity statin — examples and threshold

High‑intensity statin — examples (actionable)Examples include atorvastatin ≥40 mg daily or rosuvastatin (dose commonly ≥20 mg daily)

Role in prior therapyTrial of one high‑intensity statin is required in many ASCVD‑related approval pathways

Documentation neededEvidence of a ≥8‑week high‑intensity statin trial or statin intolerance should be provided when required

inv-174: PAD of atherosclerotic origin — definition

PAD definitionPeripheral arterial disease (PAD) of atherosclerotic origin is included as a qualifying cardiovascular condition

Use in criteriaPAD is listed among events/diagnoses that satisfy ASCVD criteria for therapy eligibility

ExamplesPAD of atherosclerotic origin appears alongside MI, stroke, angina, and revascularization procedures in policy lists

inv-175: High-intensity statin therapy — example agents and requirement

High‑intensity statin therapy (actionable)Trial of one high‑intensity statin (e.g., atorvastatin ≥40 mg daily or rosuvastatin equivalent) is required when applicable

Role in ASCVD pathwaysRequired prior to or concurrent with omega‑3 therapy in ASCVD populations per policy

DocumentationChart documentation of statin trial or intolerance should be submitted for prior authorization

inv-176: high‑intensity statin — example description

High‑intensity statin (example)Atorvastatin ≥40 mg daily or rosuvastatin (dose not fully specified in extracted text)

Policy noteUsed as the example of required statin therapy prior to escalating lipid‑lowering treatment

Clinical implicationEvidence of such statin use is a common prior‑therapy requirement in the policy

inv-177: High-intensity statin — example agents (restated)

High‑intensity statin — examplesExamples include atorvastatin ≥40 mg daily or rosuvastatin (as referenced in policy)

Requirement contextServes as the required prior lipid therapy in ASCVD‑related and some omega‑3 pathways

Documentation requirementProvide evidence of trial or intolerance for prior authorization

inv-178: Covered omega-3 dosing — daily dose description

Covered omega‑3 dosing (actionable)Daily dose of 4 grams per day (single 4‑g dose or two 2‑g doses)

Administration examplesTaken as four 0.5‑g capsules twice daily or two 1‑g capsules twice daily depending on product

Policy enforcement4 g/day is required for approval; non‑standard doses are not supported by criteria

inv-179: ASCVD‑related history — enumerated examples

ASCVD‑related history examplesPrior MI/ACS, angina, prior stroke/TIA, PAD of atherosclerotic origin, prior coronary/arterial revascularization

Use in eligibilityPresence of these histories qualifies for omega‑3 therapy when TG and other criteria met

DocumentationProviders must document relevant ASCVD history for prior authorization

inv-180: Severe hypertriglyceridemia — TG >=500 mg/dL definition

Severe hypertriglyceridemia definition (actionable)Triglyceride levels ≥500 mg/dL

Coverage implicationDefines patients eligible for prescription omega‑3 ethyl esters and related therapies

Repeated policy useUsed consistently across initial approval and ongoing therapy sections

inv-181: High-intensity statin — examples

High‑intensity statin examplesAtorvastatin ≥40 mg daily or rosuvastatin (dose referenced in policy)

RoleRequired prior therapy or concurrent therapy in ASCVD‑related indications

DocumentationEvidence of statin trial or intolerance should be provided for authorization

inv-182: very high triglycerides — TG >=500 mg/dL (restated)

Very high triglycerides (restated, actionable)Triglyceride (TG) levels ≥500 mg/dL

Policy useKey laboratory cutoff for determining medical necessity of omega‑3 therapies

Appears in multiple sectionsReferenced throughout initial approval, reauthorization, and ASCVD criteria

inv-183: prescribed dose — 4 g/day (definition)

Prescribed dose definition (actionable)Prescribed dose = 4 grams per day (single 4‑g dose or two 2‑g doses)

Administration examplesSingle 4‑g dose often equals 4 capsules; two 2‑g doses (2 capsules twice daily) is alternate regimen

Authorization requirementDose must be 4 g/day for approval; non‑conforming doses may be denied

inv-184: High‑intensity statin — example (fallback)

High‑intensity statin (example) — documentationExample: atorvastatin ≥40 mg daily (rosuvastatin dose referenced) required as prior therapy when applicable

Use in prior‑therapy requirementsProviders must document trial of a high‑intensity statin or intolerance when required by criteria

Policy noteAbsence of documented high‑intensity statin trial may trigger denial for some indications