ModifiedHealth NetPolicy CP.CPA.269

Clinical Policy: Evolocumab (Repatha)

Defines clinical criteria, dosing, contraindications, and supporting guidance for coverage of evolocumab (Repatha) for members with primary hypercholesterolemia, HeFH, and HoFH; intended for providers requesting prior authorization or prescribing this therapy.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Evolocumab (Repatha)

Policy CodePolicy CP.CPA.269

Change TypeMultiple annual updates and operational clarifications

Effective DateOct 1, 2015

Next Review DateN/A

Key ActionSubmit prior authorization with indication, dosing regimen, and documentation of LDL-C response or familial hypercholesterolemia evidence.

SourceLink

POLICY UPDATE CHANGES

Revised FDA-approved indication wording per product labeling to include adults and pediatric patients aged 10 years and older for homozygous familial hypercholesterolemia (HoFH) and aligned cardiovascular disease wording with the product labeling.

For HoFH, lowered untreated LDL requirement to 400 mg/dL and revised familial evidence criteria to require familial hypercholesterolemia in at least one parent.

Per March SDC, reduced statin adherence duration from 4 months to 8 weeks and simplified statin trial/failure criteria; removed ezetimibe trial criteria and removed age restriction from Praluent redirection.

Added Leqvio to list of drugs where coadministration is not allowed and required that treatment plans do not include coadministration with Leqvio, Juxtapid, or Praluent for continuation.

Clarified that Praluent redirection for HoFH applies only to adults because Praluent is approved only for adults with HoFH.

140/420available single-dose strengths

≥50%LDL-C reduction (high-intensity statin)

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400 mg/dLlowered untreated LDL for HoFH

8 weeksrequired statin adherence

hypersensitivitydocumented contraindications

1Q 2026most recent annual review

Coverage Criteria for Evolocumab (Repatha)

Initial therapy coverage criteria

Covered when ALL of the following are met:

Indication: Member has primary hypercholesterolemia (including heterozygous familial hypercholesterolemia [HeFH]) or homozygous familial hypercholesterolemia (HoFH)

Risk or LDL threshold: Either member is at very high risk for ASCVD OR has persistently elevated LDL-C despite maximally tolerated statin therapy and ezetimibeLDL-C ≥ 100 mg/dL

Very high risk defined by major ASCVD events or major event plus high-risk conditions

Documentation of FH when applicable: For HeFH, diagnostic criteria documented via Dutch Lipid Clinic Network score or Simon Broome criteria (family history, physical findings such as tendinous xanthomata or arcus cornealis, LDL levels, or DNA evidence)

Definite FH = total Dutch score > 8; Simon Broome criteria also accepted

Dosing and titration

Dosing guidance and adjustments:

Standard dosing for primary hypercholesterolemia/HeFH: 140 mg subcutaneous every 2 weeks OR 420 mg subcutaneous once monthly

HoFH dosing and titration: 420 mg subcutaneous once monthly; dosage may be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks; patients on lipid apheresis may initiate 420 mg every 2 weeks to correspond with apheresis schedule

Documented Criteria Updates (partial)

Documented policy changes and criteria elements appearing in these chunks

HoFH indication updates: Revised FDA-approved indication wording to include adults and pediatric patients aged 10 years and older for HoFH; lowered untreated LDL requirement to 400 mg/dL; evidence of familial hypercholesterolemia revised to require familial hypercholesterolemia in at least one parentLDL >= 400 mg/dL untreated

1Q 2025 annual review

Statin trial/adherence requirements: Per March SDC, statin adherence duration reduced to 8 weeks for all indications; statin trial/failure criteria simplified (insufficient response to one high-intensity statin for 8 weeks or reversible muscle-related symptoms with rosuvastatin and atorvastatin); ezetimibe trial criteria removed8 weeks statin adherence

March SDC update

Coadministration exclusions: Treatment plans must not include coadministration with Leqvio, Juxtapid, or Praluent; Leqvio was added to the non-coadministration list

Contraindication: hypersensitivity to evolocumab or any of its components. Requests for therapy in members with a documented hypersensitivity reaction to evolocumab are excluded from coverage per the policy's contraindications (Appendix C).

Coadministration with other lipid-lowering biologics is not permitted. Treatment plans that include coadministration with Leqvio, Juxtapid, or Praluent are not allowed and such plans must not be part of the requested therapy for either initial or continuation approvals.

Operational denial trigger: therapy is not appropriate and may be denied when there is documentation of a known hypersensitivity to evolocumab or its components. Providers should document absence of hypersensitivity before approval is granted.

Coding and coverage caveat: inclusion or exclusion of codes in this policy is for informational purposes only and does not guarantee coverage. Coverage is determined by whether the member meets the clinical criteria in the policy and by correct claim coding; providers should reference up-to-date professional coding guidance when submitting claims.

Coding and Code References

References (no billing codes listed in this section)mixed

No codes listed

Referenced HCPCS CodesHCPCS

C9399	Unclassified drugs or biologicals
J3590	Unclassified biologics

Persistently elevated LDL-C — policy threshold

Persistently elevated LDL-C thresholdLDL-C ≥ 100 mg/dL despite maximally tolerated statin therapy and ezetimibe

Context in risk definitionsListed as a high‑risk condition contributing to 'very high risk' for future ASCVD events

Use in coverage logicOne pathway to meet initial therapy criteria is persistently elevated LDL‑C at or above this threshold despite therapy

Untreated LDL for HoFH — numeric threshold

Untreated LDL threshold for HoFH400 mg/dL (lowered per 1Q 2025 update)

Context of changePart of 1Q 2025 annual review revising HoFH indication language and thresholds

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for this therapy. Providers must submit a complete prior authorization request that includes the clinical indication, relevant diagnostic documentation (e.g., FH scoring or genetic testing when applicable), current and prior lipid-lowering therapies with doses and durations, and a treatment plan that does not include prohibited coadministration (see related callouts).

Required fields: diagnosis, LDL-C values (baseline and recent), prior/ongoing statin type, dose, intensity, duration and rationale for intolerance if applicable, prior use/failure of other PCSK9 or lipid agents when required, and planned regimen.

Billing Rule

Prior Authorization and Coding References — informational

Codes shown in policy materials (including HCPCS C9399 and J3590) are provided for informational purposes only. Inclusion or exclusion of specific codes in this policy does not guarantee coverage or proper reimbursement; claims may be denied if coding or clinical documentation does not support medical necessity. Providers should verify and use the most up-to-date professional coding guidance prior to claim submission.

Background on Evolocumab

Background: Evolocumab (Repatha) is a monoclonal antibody that inhibits PCSK9 and is indicated to lower low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH), and homozygous familial hypercholesterolemia (HoFH). The policy supports use for members at very high risk of atherosclerotic cardiovascular disease or those with persistently elevated LDL-C despite maximally tolerated statin therapy ± ezetimibe, and it defines dosing options (for example, 140 mg SC every 2 weeks or 420 mg SC once monthly for primary hypercholesterolemia/HeFH, with specific HoFH dosing and titration pathways).

Definitions and Clinical Thresholds

Very high risk for future ASCVD events — definition and components

Definition summaryVery high risk = history of multiple major ASCVD events OR one major ASCVD event plus multiple high‑risk conditions

Examples of major ASCVD eventsRecent acute coronary syndrome, prior myocardial infarction, ischemic stroke, symptomatic peripheral arterial disease

High‑risk conditions (examples)Age ≥ 65 years; HeFH; prior CABG or PCI outside the major events; diabetes; hypertension; CKD (eGFR 15–59); current tobacco smoking; persistently elevated LDL‑C ≥100 mg/dL despite therapy; history of congestive heart failure

Statin intensity categories — definitions and examples

High‑intensity statinAverage LDL‑C lowering ≥ 50% — examples: atorvastatin 40–80 mg; rosuvastatin 20–40 mg

Moderate‑intensity statin

Policy Summary

PayerHealth Net

PolicyClinical Policy: Evolocumab (Repatha)

Policy CodePolicy CP.CPA.269

Change TypeMultiple annual updates and operational clarifications

Effective DateOct 1, 2015

Next Review DateN/A

Key ActionSubmit prior authorization with indication, dosing regimen, and documentation of LDL-C response or familial hypercholesterolemia evidence.

SourceLink

On This Page

1Q 2024 annual review

Praluent redirection clarification: Praluent redirection for HoFH applies only to adults because Praluent is approved only for adults with HoFH

1Q 2026 clarification

Evidence requirement linkageUsed with revised familial evidence criteria for HoFH diagnosis in policy

HCPCS: C9399 = Unclassified drugs or biologicals; J3590 = Unclassified biologics.
Inclusion/exclusion of codes is not a coverage guarantee — confirm with current coding resources.

Denial Risk

Coadministration with Specific Agents Not Allowed

Per policy updates, coadministration with certain lipid-lowering agents is not allowed. Treatment plans that include concurrent use of Leqvio (inclisiran), Juxtapid (lomitapide), or Praluent (alirocumab) are not acceptable and can trigger denial of initial or continuation requests.

Do not coadminister with: Leqvio, Juxtapid, or Praluent.
Continuation requests must attest the treatment plan does not include coadministration with these agents.

Step Therapy

Step Therapy Expectations

Step therapy expectations: when clinically appropriate and tolerated, members should remain on maximally tolerated statin therapy and ezetimibe prior to initiation unless criteria allow bypass. Documentation must show the statin name, dose, intensity, duration (or reason for intolerance), and any concurrent ezetimibe use or rationale for omission.

Continue maximally tolerated statin and ezetimibe when possible.
Document statin type, dose, intensity, duration, and rationale for intolerance if claimed.

Note

Protocol Change — ezetimibe and statin criteria updated

Protocol change note: per the March SDC policy revision, ezetimibe trial requirements were removed and statin trial/failure criteria were simplified. For all indications the statin adherence duration was reduced and statin trial rules were adjusted (see full policy history for dates). Ensure authorization requests reflect these updated requirements.

Ezetimibe trial criteria removed per March SDC.
Statin adherence duration and trial/failure criteria simplified per March SDC (refer to policy history for exact changes and effective dates).

Documentation Required

FH Diagnostic Documentation — acceptable methods

Acceptable diagnostic documentation for familial hypercholesterolemia (HeFH) includes validated clinical scoring tools or genetic testing results. Examples of acceptable documentation are a completed Dutch Lipid Clinic Network score, Simon Broome criteria documentation, or documented pathogenic mutation in LDLR/apoB/PCSK9 genes.

Acceptable methods: Dutch Lipid Clinic Network scoring, Simon Broome criteria, or genetic test demonstrating a pathogenic mutation in LDLR, apoB, or PCSK9.

Documentation Required

Statin Therapy Documentation Requirements

Statin therapy documentation must specify the statin name, dose, and intensity classification (high/moderate/low), the dates of therapy, and the clinical rationale for continued use or for declaring intolerance. When statin intolerance is claimed, provide supporting clinical details (e.g., SAMS history, rechallenge outcomes) and any reversible muscle-related symptoms associated with atorvastatin or rosuvastatin when applicable.

Required details: statin name, dose, intensity, start/stop dates, and rationale for intolerance if applicable.
If SAMS is claimed, include symptom description, temporal relationship to statin, and results of any rechallenge.

Average LDL‑C lowering ~30–50% — examples: atorvastatin 10–20 mg; rosuvastatin 5–10 mg; simvastatin 20–40 mg; pravastatin 40–80 mg

Low‑intensity statinAverage LDL‑C lowering < 30% — examples: simvastatin 10 mg; pravastatin 10–20 mg; lovastatin 20 mg

Statin intolerance — definition and operational notes

Operational definition of statin intoleranceClinical statin-associated muscle symptoms (SAMS) such as myalgia, cramps, weakness that resolve with cessation and recur on rechallenge; intolerance may be documented when statin therapy cannot be tolerated despite attempts at rechallenge or use of alternative statins

Typical clinical featuresSymptoms usually bilateral, involve large muscle groups, appear early after starting or increasing dose, and usually resolve within weeks after stopping therapy; persistence >2 months after cessation prompts evaluation for other causes

Implications for documentationWhen claiming intolerance, provide type and dose of prior statin(s), rationale for discontinuation or modification, and evidence of rechallenge or alternative‑statin trials as applicable