ModifiedCentenePolicy HIM.PA.156

Evolocumab (Repatha) prior authorization and coverage criteria

Defines clinical and prior authorization criteria for coverage of evolocumab (Repatha) for members under Centene-affiliated health plans (HIM line of business), including indications, required attestations, dosing limits, and continuation criteria.

Policy Summary

PayerCentene

PolicyEvolocumab (Repatha) prior authorization and coverage criteria

Policy CodePolicy HIM.PA.156

Change TypeMultiple material revisions (dosing, statin adherence, coadministration, approval duration)

Effective DateJun 1, 2021

Next Review Date

Key ActionSubmit prior authorization with provider attestation of diagnosis, baseline and recent LDL-C values, documentation of statin use or intolerance, and specified dosing regimen.

SourceLink

POLICY UPDATE CHANGES

Updated HoFH continuation criteria to allow a maximum dose of 420 mg every 2 weeks if a clinically meaningful response is not achieved after 12 weeks of 420 mg monthly, consistent with FDA label.

Added bypass of ezetimibe trial when member requires >25% additional LDL lowering and lowered minimum LDL requirement to 55 mg/dL for members with ASCVD at very high risk.

Expanded pediatric age indications for HeFH and HoFH and added option for 420 mg every 2 weeks for patients on lipid apheresis.

Reduced statin adherence duration from 4 months to 8 weeks and simplified statin trial/failure criteria; removed ezetimibe trial criteria.

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

Extended initial approval duration from 3 months to 12 months for this maintenance medication for a chronic condition.

12 monthsstandard approval duration

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Age ≥10minimum pediatric age

8 weeksreduced statin adherence

≥55 mg/dLminimum LDL for very high-risk ASCVD

420 mgmaximum HoFH dose option

Coverage Criteria for Evolocumab (Repatha)

Initial Approval — Primary Hypercholesterolemia (including HeFH) and Cardiovascular Event Risk Reduction

Covered when ALL of the following are met:

Primary criteria: 1) Diagnosis of one of the following: (a) HeFH with provider attestation of baseline LDL-C and diagnostic confirmation per WHO/Dutch Lipid Network or Simon Broome criteria; (b) Primary hypercholesterolemia that is not HeFH with provider attestation of confirmatory genetic testing OR exclusion of secondary causes AND baseline LDL-C (prior to lipid-lowering therapy) ≥ 190 mg/dL; or (c) Increased risk for CV events with provider attestation of ASCVD (e.g., acute coronary syndromes, clinically significant CHD, coronary or other arterial revascularization, myocardial infarction, peripheral arterial disease of atherosclerotic origin, stable or unstable angina, stroke or TIA).see children

Approval duration: 12 months

Prescriber and age: 2) Prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist; 3) Age: ≥18 years for primary hypercholesterolemia (not HeFH) or ASCVD; ≥10 years for HeFH.

Statin therapy requirements (members ≥18): 4) For members ≥18 years on statin therapy: Repatha prescribed with a maximally tolerated statin AND member adherent for at least 8 weeks to a maximally tolerated statin regimen (high-intensity preferred) OR meets the policy's statin intolerance documentation requirements; 5) For members ≥18 not on statin therapy: documentation that statin therapy is contraindicated OR for statin-intolerant patients documentation of trials/rechallenge per policy (e.g., trial of ≥2 statins including a hydrophilic statin and evidence of SAMS with rechallenge).>= 8 weeks

Recent LDL-C: 6) Provider's attestation of a recent LDL-C (within last 60 days) meeting one of the following: (a) If member has ASCVD: ≥ 70 mg/dL OR ≥ 55 mg/dL if member is at very high risk; (b) If member has severe primary hypercholesterolemia (including HeFH): ≥ 100 mg/dL.

Coadministration and dosing limits: 7) Treatment plan does not include coadministration with Leqvio, Juxtapid, or Praluent; 8) Dose does not exceed 140 mg SC every 2 weeks or 420 mg SC per month.

Initial Approval — Homozygous Familial Hypercholesterolemia (HoFH)

Covered when ALL of the following are met:

HoFH diagnosis: 1) Diagnosis of homozygous familial hypercholesterolemia (HoFH); 2) Provider attestation that diagnosis is defined by one of: (a) genetic mutation consistent with HoFH (eg, LDLR, PCSK9, APOB, LDLRAP1); (b) treated LDL-C ≥ 300 mg/dL or non–HDL‑C ≥ 330 mg/dL; or (c) untreated LDL‑C ≥ 400 mg/dL with either tendinous/cutaneous xanthoma prior to age 10 years or evidence of familial hypercholesterolemia in at least one parent.

Prescriber and LDL/age requirements: 3) Prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist; 4) Member meets one of: (a) age ≥10 and <18 with LDL‑C ≥ 130 mg/dL within last 60 days despite statin therapy (unless contraindicated or intolerant); or (b) age ≥18 with recent LDL‑C ≥ 70 mg/dL OR ≥ 55 mg/dL if member has ASCVD and is very high risk.

Statin therapy requirements (members ≥18): 5) For members ≥18 on statin therapy: Repatha prescribed with a maximally tolerated statin AND adherence for ≥8 weeks to maximally tolerated statin regimen OR documented statin intolerance per policy; 6) For members ≥18 not on statin therapy: documentation that statin therapy is contraindicated OR evidence of statin intolerance with required trials/rechallenge.

Continued Therapy (all indications in Section I)

Covered when ALL of the following are met:

Continuation eligibility: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is enrolled in continuity-of-care per state rules;

Statin adherence for continued therapy: 2) If statin tolerant, provider attestation of adherence to a statin at the maximally tolerated dose;

Clinical response: 3) Member is responding positively as evidenced by provider attestation of lab results within the last 3 months showing LDL‑C reduction since initiation of Repatha therapy;LDL reduction within 3 months

Coadministration exclusion: 4) Treatment plan does not include coadministration with Leqvio, Juxtapid, or Praluent;

Dosing/Indication criteria (initial and continuation; HeFH and HoFH)

Covered when dosing and indication align with FDA label and policy criteria for HeFH, HoFH, or primary hypercholesterolemia with increased CV risk.

Label-consistent dosing: Member has an FDA-indicated diagnosis (primary hypercholesterolemia including HeFH, HoFH, or hypercholesterolemia with increased CV risk) AND the prescribed dosing matches label: 140 mg SC every 2 weeks or 420 mg SC once monthly as standard options; for HoFH, 420 mg SC once monthly with the option to increase to 420 mg every 2 weeks if a clinically meaningful response is not achieved after 12 weeks of 420 mg monthly; patients on lipid apheresis may initiate 420 mg every 2 weeks to align with apheresis schedule.

Reflects FDA label and policy updates; HoFH continuation option per FDA.

Prior therapy and risk stratification

Coverage requires consideration of background lipid-lowering therapy and risk status.

Background lipid-lowering therapy: Member is on a maximally tolerated statin if tolerated; ezetimibe trial is generally required but may be bypassed when the member requires >25% additional LDL‑C lowering or per very high-risk ASCVD criteria; documentation of statin trials, contraindications, or intolerance must be provided.>25% additional LDL lowering to bypass ezetimibe

Very high ASCVD risk: Member meets criteria for very high risk of future ASCVD events defined as either multiple major ASCVD events OR one major ASCVD event plus multiple high-risk conditions (eg, age ≥65, HeFH, diabetes, CKD, persistently elevated LDL‑C ≥100 mg/dL despite therapy, prior CABG or PCI, current tobacco use); this designation impacts LDL‑C thresholds (eg, minimum LDL‑C of ≥55 mg/dL for some very high-risk members).LDL-C >=55 mg/dL for some very high-risk members

HeFH diagnostic criteria

Diagnosis of heterozygous familial hypercholesterolemia must be supported by one of the recognized diagnostic frameworks.

Accepted diagnostic frameworks: Dutch Lipid Clinic Network scoring OR Simon Broome criteria: Dutch score uses family history, clinical history, physical exam (eg, tendinous xanthomata, arcus cornealis), cholesterol levels and DNA analysis with total >8 = definite FH; Simon Broome defines definite FH by cholesterol thresholds plus tendinous xanthomas or DNA evidence. Providers should document scores and supporting findings.Dutch score >8 = definite FH

See Appendix D for scoring details.

Updated coverage criteria

Policy criteria were updated across indications to reflect FDA labeling, ACC guidance, pediatric expansions, and administrative changes.

HoFH continuation dosing update: Allow maximum dose of 420 mg every 2 weeks if a clinically meaningful response is not achieved after 12 weeks of 420 mg monthly (also option for patients on lipid apheresis to initiate 420 mg q2w).420 mg q2w after 12 weeks

Per FDA label update and 07.13.21 RT4.

Statin adherence and trial changes: Reduced required statin adherence duration to 8 weeks and simplified statin trial/failure criteria (eg, insufficient response to one high-intensity statin for 8 weeks or reversible muscle-related symptoms with rosuvastatin and atorvastatin); ezetimibe trial removed in many scenarios per November SDC updates.8 weeks

Per November SDC; see policy history.

Coadministration exclusions and approvals:

Requests for uses that are not FDA‑approved and are not specifically addressed in this policy are excluded from coverage unless the request includes sufficient documentation of efficacy and safety consistent with applicable off‑label use policies (for example, HIM.PA.154) or the member’s evidence of coverage. Providers requesting coverage for off‑label indications should include the supporting clinical rationale and references to the off‑label policy or other evidence to allow medical review.

Evolocumab is contraindicated in patients with known hypersensitivity to the drug; hypersensitivity is listed as a policy contraindication and should be documented. Background statin therapy considerations follow the statin guidance in this policy: statin use may be contraindicated for conditions such as decompensated liver disease, laboratory‑confirmed acute liver injury or rhabdomyolysis related to statins, pregnancy or nursing (see statin section), or immune‑mediated hypersensitivity to the statin class. Documentation of any statin contraindication or intolerance is required when a member is not receiving statin therapy.

Coadministration of evolocumab with certain other lipid‑lowering biologics is not permitted. The treatment plan must not include coadministration with Leqvio, Juxtapid, or Praluent for either initial or continuation therapy; requests that indicate concurrent use with these agents will be denied.

Requests for off‑label uses that are not supported by FDA labeling and are not justified with sufficient documentation per referenced off‑label policies or the member’s evidence of coverage may be denied. Providers seeking coverage for non‑labeled indications must submit clinical evidence and rationale consistent with the off‑label use policy to permit medical necessity review.

A claim submitted with diagnosis or procedure codes alone, without the clinical documentation required by this policy (for example, diagnostic confirmation, baseline and recent LDL‑C values, statin trial or documented intolerance, and specialist attestation), may be considered not medically necessary. Unsupported coding or assertions that do not meet the policy’s clinical criteria may result in denial.

Inclusion or exclusion of codes in this policy is for informational purposes and does not guarantee coverage. Absence of adequate documentation or incorrect coding may lead to claim denial; providers should reference current professional coding guidance and submit the clinical records required to support medical necessity determinations.

Coding and Code References

No explicit CPT/HCPCS/ICD-10 codes listed in this sectionmixed

No codes listed

Referenced billing codesHCPCS

C9399	Unclassified drugs or biologicals
J3590	Unclassified biologics

Informational HCPCS/Unclassified codesHCPCS

C9399	Unclassified drugs or biologicals.
J3590	Unclassified biologics

LDL-C thresholds — multiple numeric cutoffs

Baseline LDL-C for HeFH (age <20)>= 160 mg/dL (baseline, prior to lipid-lowering therapy)

Baseline LDL-C for HeFH (age >=20)>= 190 mg/dL (baseline, prior to lipid-lowering therapy)

Recent LDL-C for members with ASCVD>= 70 mg/dL (or >= 55 mg/dL if member is at very high ASCVD risk)

Recent LDL-C for severe primary hypercholesterolemia (including HeFH)>= 100 mg/dL

Continuation response criterion (HoFH initial dosing response)Clinically meaningful response defined as >= 30% reduction in LDL from baseline within initial dosing period

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior authorization and dosing requirements

Prior authorization is required. Requests must specify the indication and dosing regimen (e.g., 140 mg SC every 2 weeks or 420 mg SC monthly for primary hypercholesterolemia/ASCVD; 420 mg monthly for HoFH with option to increase to 420 mg every 2 weeks per HoFH criteria). For HoFH, note apheresis-related dosing and maximum dose limits.

Specify indication and requested dosing regimen on the prior authorization request
420 mg every 2 weeks dosing for HoFH may be requested when member is on lipid apheresis or did not achieve clinically meaningful response

Documentation Required

Required attestation and clinical documentation

Providers must attest to diagnosis-specific documentation and supply recent and baseline laboratory values as part of the prior authorization. Required attestations include diagnosis confirmation method (HeFH scoring or genetic testing), baseline LDL-C (pre-treatment), and recent LDL-C within the past 60 days. Provider attestation may be used in lieu of attaching full documentation per policy history.

Background

Evolocumab (Repatha) is a monoclonal antibody that inhibits PCSK9 and is indicated to lower LDL‑C and reduce the risk of major adverse cardiovascular events as an adjunct to diet and other lipid‑lowering therapies. The policy aligns coverage with FDA‑labeled indications (including pediatric indications from age ≥10 for familial hypercholesterolemia), specifies numeric LDL‑C thresholds and diagnostic frameworks for HeFH and HoFH, and requires specialist involvement and documentation of prior lipid‑lowering therapy and response. Dosing follows the label (standard regimens of 140 mg subcutaneously every 2 weeks or 420 mg once monthly, with an option for HoFH continuation to increase to 420 mg every 2 weeks in specified circumstances).

Definitions and Diagnostic Frameworks

HeFH — definition and diagnostic confirmation

HeFH definitionHeterozygous familial hypercholesterolemia; diagnosis confirmed by WHO/Dutch Lipid Clinic Network criteria or Simon Broome criteria (see Appendix D)

Diagnostic confirmation methodsDutch Lipid Clinic Network scoring OR Simon Broome definite criteria (e.g., elevated cholesterol plus tendinous xanthomas or DNA evidence)

Reference to documentationProviders should document scores, family history, physical findings, cholesterol levels, and DNA analysis when available

Statin-associated muscle symptoms (SAMS)

SAMS definitionStatin-associated muscle symptoms (SAMS): muscle pain, aching, cramps, or weakness, typically bilateral and involving large muscle groups; symptoms often resolve after statin cessation and may reappear on rechallenge

Typical features

Policy Summary

PayerCentene

PolicyEvolocumab (Repatha) prior authorization and coverage criteria

Policy CodePolicy HIM.PA.156

Change TypeMultiple material revisions (dosing, statin adherence, coadministration, approval duration)

Effective DateJun 1, 2021

Next Review Date

Key ActionSubmit prior authorization with provider attestation of diagnosis, baseline and recent LDL-C values, documentation of statin use or intolerance, and specified dosing regimen.

SourceLink

On This Page

Coadministration and dosing: 7) Treatment plan does not include coadministration with Leqvio, Juxtapid, or Praluent; 8) Dose does not exceed 420 mg per month, with option for 420 mg every 2 weeks when member is currently receiving lipid apheresis or per label; Approval duration: 12 months.

Dose increase limits: 5) If request is for a dose increase, new dose must not exceed indication-specific limits: (a) Primary hypercholesterolemia (including HeFH) or ASCVD: 140 mg every 2 weeks or 420 mg per month; (b) HoFH: 420 mg per month, or 420 mg every 2 weeks if member is on lipid apheresis or did not achieve a clinically meaningful response (defined as < 30% LDL reduction) with initial dosing.

Added requirement that treatment plans must not include coadministration with Leqvio, Juxtapid, or Praluent for both initial and continuation therapy; initial approval duration extended to 12 months for maintenance therapy.

LDL-C thresholds — FH categories and policy minimums

Dutch Lipid Clinic Network LDL-C point categories>= 330 mg/dL = 8 points; 250-329 mg/dL = 5 points; 190-249 mg/dL = 3 points

Policy minimum LDL threshold for very high-risk ASCVD members>= 55 mg/dL (used as minimum recent LDL for some very high-risk ASCVD members)

Persistently elevated LDL-C as a high-risk conditionLDL-C >= 100 mg/dL despite maximally tolerated statin and ezetimibe (listed in Appendix I)

HeFH baseline parity for non-genetic diseaseRecent LDL requirements for non-genetically mediated disease aligned with genetically mediated disease per updates

HoFH maximum continuation dose

HoFH continuation maximum dose (monthly)420 mg once monthly (standard maximum per indication)

HoFH continuation maximum dose (every 2 weeks)420 mg every 2 weeks if clinically meaningful response not achieved after 12 weeks of 420 mg monthly or if patient is receiving lipid apheresis

Provider attestation for q2w dosingAttestation required that member is currently receiving lipid apheresis or did not achieve >= 30% LDL reduction with initial dosing

Statin adherence duration and trial/failure criteria

Required statin adherence duration>= 8 weeks of continuous adherence to a maximally tolerated high-intensity statin (or alternate criteria for moderate/low intensity regimens)

Statin intolerance documentation pathwayIf not on statin, provider must attest statin contraindication or documented intolerance with required trials/rechallenge per policy

Simplified trial/failure criteriaInsufficient therapeutic response defined as inadequate LDL lowering after one high-intensity statin trial for 8 weeks or reversible muscle-related symptoms with rosuvastatin and atorvastatin

Attest to baseline LDL-C prior to lipid-lowering therapy (HeFH thresholds defined)
Attest to recent LDL-C within last 60 days (thresholds differ by indication)
For HeFH, document diagnostic criteria (Dutch Lipid Clinic Network score >8 or Simon Broome definite FH) or provide genetic testing results

Denial Risk

Non‑approved indications

Requests for indications that are non‑FDA approved and not addressed in this policy may be denied. Off‑label use may be considered only if sufficient evidence of efficacy and safety is provided consistent with Centene off‑label use policies.

Non‑FDA approved indications not in this policy require supporting evidence per HIM.PA.154 or applicable evidence of coverage documents

Step Therapy

Statin step therapy / tolerance requirements

Statin step therapy applies for members ≥ 18 years: Repatha must be prescribed with a maximally tolerated statin and providers must attest to at least 8 weeks adherence to a maximally tolerated statin regimen when statin tolerant. Documentation of prior statin trials or intolerance (including trials of ≥2 statins with one hydrophilic agent for intolerant members) must be attested.

If statin tolerant: attest member is on maximally tolerated statin and adherent for ≥ 8 weeks
If not on statin: attest statin contraindication or meet statin intolerance criteria (trial of ≥2 statins, one hydrophilic)

Step Therapy

Statin and ezetimibe step therapy considerations

Ezetimibe trial is generally expected as part of step therapy; however, an ezetimibe trial may be bypassed when the member requires >25% additional LDL lowering as reflected in clinical guidance. Continuation requests expect ongoing maximally tolerated statin therapy when statin tolerant.

Ezetimibe trial may be bypassed if >25% additional LDL lowering is required
Continuation requests: attest ongoing use of maximally tolerated statin when statin tolerant

Step Therapy

Step therapy bypass (IL)

Illinois-specific step therapy bypass applies per IL HB 5395: the step therapy requirements described do not apply to Illinois HIM requests. Ensure state-specific addendums are followed.

IL HB 5395: step therapy requirements are bypassed for Illinois HIM requests

Billing Rule

Coding implications and provider coding guidance

Coding entries in this policy are informational only. Inclusion or exclusion of codes does not guarantee coverage. Providers should reference the most current professional coding guidance before submitting claims; incorrect coding or missing documentation may result in claim denial.

Codes referenced are informational only (e.g., C9399, J3590)
Verify up-to-date coding guidance prior to claim submission to avoid denials

Myalgia, cramps, weakness; early onset after starting/increasing statin dose; resolves within weeks to months after stopping therapy

Rechallenge evidenceReappearance of symptoms with rechallenge and disappearance with cessation provides strongest evidence for SAMS

Very high risk of future ASCVD events — definition and examples

Definition of very high ASCVD riskEither history of multiple major ASCVD events OR one major ASCVD event plus multiple high-risk conditions (see Appendix I)

Examples of major ASCVD eventsRecent acute coronary syndrome (within 12 months), prior myocardial infarction, ischemic stroke, symptomatic peripheral artery disease

Examples of high-risk conditionsAge >= 65, HeFH, diabetes, CKD (eGFR 15-59), current tobacco smoking, persistently elevated LDL-C >=100 mg/dL despite therapy, prior CABG or PCI

Dutch Lipid Clinic Network score — point-based algorithm

Dutch Lipid Clinic Network score purposePoint-based diagnostic algorithm for FH using family history, clinical history, physical exam, cholesterol levels, and DNA analysis

LDL-C point assignmentsLDL-C >= 330 mg/dL = 8 points; 250-329 = 5 points; 190-249 = 3 points; 155-189 = 1 point

Definite FH thresholdTotal score > 8 indicates definite familial hypercholesterolemia

HoFH continuation dosing per FDA update

FDA-updated HoFH q2w optionAllow up to 420 mg every 2 weeks for continuation if clinically meaningful response not achieved after 12 weeks of 420 mg monthly

Apheresis alignment420 mg every 2 weeks may be used to align dosing with lipid apheresis schedules per FDA label update

Documentation for q2w escalationProvider attestation required that member is on lipid apheresis or failed to achieve >= 30% LDL reduction with initial dosing

Statin adherence requirement and simplified trial/failure criteria

Reduced statin adherence duration>= 8 weeks required adherence to maximally tolerated statin before Repatha for members >=18 (per November SDC)

Simplified trial/failure criteriaRequire insufficient therapeutic response to one high-intensity statin for 8 weeks or reversible muscle-related symptoms with rosuvastatin and atorvastatin; ezetimibe trial removed in many cases

Statin intolerance pathwayIf statin intolerant, documentation of trials including rechallenge and use of hydrophilic statins as required per policy