ModifiedCignaPolicy N/A

Proprotein Convertase Subtilisin Kexin Type 9 Inhibitors - Repatha Prior Authorization Policy

Defines Cigna's prior authorization requirements, coverage criteria, and approval durations for Repatha (evolocumab) for FDA‑approved indications and other supported uses for members covered by Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyRepatha (evolocumab) prior authorization — PCSK9 inhibitor coverage criteria

Policy CodePolicy N/A

Change TypeMaterial revisions to continuation criteria, LDL-C thresholds, and HoFH diagnostic thresholds

Effective DateMay 28, 2025

Next Review DateMay 28, 2025

Key ActionSubmit prior authorization with documentation of age, diagnosis, LDL-C values, prior statin trials or statin intolerance, and for continuation include prescriber documentation of response to therapy.

SourceLink

POLICY UPDATE CHANGES

A continuation-of-therapy criteria set was newly developed stating that patients currently receiving Repatha who previously met initial therapy criteria under the Coverage Review Department need only meet the continuation criteria (prescriber documents response to therapy).

Primary hyperlipidemia LDL-C threshold after statin + ezetimibe was changed from ≥100 mg/dL to ≥70 mg/dL and diabetes was added as an alternative risk criterion to CAC score ≥300.

Homozygous familial hypercholesterolemia diagnostic and LDL-C thresholds were changed: phenotypic confirmation language replaced with genetic confirmation in some revisions and untreated LDL-C threshold changed from >500 mg/dL to >400 mg/dL; parental requirement changed to at least one parent meeting FH-consistent levels.

1 yeartypical approval duration

≥ 8 weeks

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statin trial duration

≥ 70 mg/dLLDL-C post-statin threshold

55,70,190,300,400key LDL-C thresholds

Not allowedconcurrent PCSK9/siRNA use

Coverage and Clinical Criteria for Repatha (evolocumab)

Established Cardiovascular Disease (Initial and Continuation)

Approve for 1 year if the patient meets ONE of the following (A or B):

A or B

Initial Therapy requirements: i. Patient is ≥ 18 years of age; ii. Patient has had ONE of the following diagnoses: prior myocardial infarction or acute coronary syndrome; angina (stable or unstable); stroke or transient ischemic attack; coronary artery disease; peripheral arterial disease; OR prior coronary or other arterial revascularization procedure; iii. Patient meets ONE of: (a) Patient has tried one high-intensity statin (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily) for ≥ 8 continuous weeks AND LDL-C after this treatment remains ≥ 55 mg/dL; OR (b) Patient is statin intolerant as defined by the Statin Intolerance Criteria.

Continuation: Prescriber documents that the patient has experienced a response to therapy (examples include decreased LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B).

If the patient has not previously received Coverage Review Department approval for this indication or is restarting therapy, Initial Therapy criteria must be met.

Heterozygous Familial Hypercholesterolemia (HeFH)

Approve for 1 year if the patient meets ONE of the following (A or B):

A or B

Initial Therapy requirements for HeFH: i. Patient is ≥ 10 years of age; ii. ONE of: (a) untreated LDL-C ≥ 190 mg/dL; OR (b) diagnosis confirmed by genetic testing (e.g., pathogenic variant in LDLR, APOB, PCSK9, or LDLRAP1); OR (c) prescriber confirms Dutch Lipid Network criteria score > 5 or Simon Broome criteria meeting 'definite' or 'possible/probable' FH; iii. ONE of: (a) Patient has tried one high-intensity statin (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily) for ≥ 8 continuous weeks AND LDL-C after this treatment remains ≥ 70 mg/dL; OR (b) Patient is statin intolerant as defined by the Statin Intolerance Criteria.

Continuation: Prescriber documents that the patient has experienced a response to therapy (examples include decreased LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B).

If the patient has not previously received Coverage Review Department approval for this indication or is restarting therapy, Initial Therapy criteria must be met.

Homozygous Familial Hypercholesterolemia (HoFH)

Approve for 1 year if the patient meets ONE of the following (A or B):

A or B

Initial Therapy requirements for HoFH: i. Patient is ≥ 10 years of age; ii. ONE of: (a) Diagnosis confirmed by genetic testing (e.g., pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1); OR (b) Untreated LDL-C > 400 mg/dL AND either (1) clinical manifestations of HoFH before age 10 (cutaneous/tendon xanthomas, arcus cornea, tuberous xanthomas, or xanthelasma) OR (2) at least one parent had untreated LDL-C or total cholesterol levels consistent with familial hypercholesterolemia; OR (c) Treated LDL-C ≥ 300 mg/dL AND either (1) clinical manifestations before age 10 OR (2) at least one parent with FH-consistent untreated LDL-C/total cholesterol; iii. ONE of: (a) Patient has tried one high-intensity statin (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily) for ≥ 8 continuous weeks AND LDL-C after this treatment remains ≥ 70 mg/dL; OR (b) Patient is statin intolerant as defined by the Statin Intolerance Criteria.

Continuation: Prescriber documents that the patient has experienced a response to therapy (examples include decreased LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B).

If the patient has not previously received Coverage Review Department approval for this indication or is restarting therapy, Initial Therapy criteria must be met.

Primary Hyperlipidemia

Approve for 1 year if the patient meets ONE of the following (A or B):

A or B

Initial Therapy - Primary Hyperlipidemia: i. Patient is ≥ 18 years of age; AND ii. Patient meets ONE of: (a) coronary artery calcium score ≥ 300 Agatston units; OR (b) patient has diabetes; AND iii. Patient meets ONE of: (a) Patient has tried one high-intensity statin AND a high-intensity statin plus ezetimibe for ≥ 8 continuous weeks AND LDL-C after this regimen remains ≥ 70 mg/dL; OR (b) Patient is statin intolerant as defined by the Statin Intolerance Criteria.

Continuation: Prescriber documents that the patient has experienced a response to therapy (examples include decreased LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B).

If the patient has not previously received Coverage Review Department approval for this indication or is restarting therapy, Initial Therapy criteria must be met.

Initial Therapy — ALL criteria set (age, prior statin/ezetimibe, LDL thresholds, diagnosis-specific requirements)

Approve for 1 year if the patient meets ALL of the following (Initial Therapy):

Initial Therapy - Primary Hyperlipidemia: i. Patient is ≥ 18 years of age; AND ii. Patient meets ONE of: (a) coronary artery calcium score ≥ 300 Agatston units; OR (b) patient has diabetes; AND iii. Patient meets ONE of: (a) Patient has tried one high-intensity statin AND a high-intensity statin plus ezetimibe for ≥ 8 continuous weeks AND LDL-C after this regimen remains ≥ 70 mg/dL; OR (b) Patient is statin intolerant as defined by the Statin Intolerance Criteria.

High-intensity statin defined as atorvastatin ≥ 40 mg or rosuvastatin ≥ 20 mg daily; statin trial duration ≥ 8 continuous weeks.

Continuation Therapy — Patient Currently Receiving Repatha. Prescriber documentation of response or prior approval pathway.

Patient Currently Receiving Repatha. Approve if according to the prescriber:

Continuation of therapy: Prescriber documents that the patient has experienced a response to therapy (examples include decreased LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B).

If the patient previously met initial therapy criteria under the Coverage Review Department, only continuation criteria are required. If not, initial therapy criteria must be met for continuation approval.

Statin Intolerance Criteria

Statin intolerance qualifies if one of the following is met:

Statin intolerance: (1) Statin-related rhabdomyolysis (defined as marked CK elevation [≥ 10x ULN] with evidence of end-organ damage such as acute renal injury with a ≥ 0.5 mg/dL increase in serum creatinine or doubling, or myoglobinuria); OR (2) ALL of the following: (a) patient experienced skeletal-related muscle symptoms (myopathy or myalgia); AND (b) symptoms occurred during separate trials of both atorvastatin and rosuvastatin (as single-entity or combination products); AND (c) symptoms resolved upon discontinuation of each respective statin therapy.

Coverage determinations for Repatha are governed by the specific terms of the member’s applicable benefit plan. The plan document, applicable laws/regulations, and relevant collateral materials must be considered when making coverage decisions. If a member’s benefit plan contains an exclusion that applies to a requested service, that plan document supersedes this policy. Claims for services submitted without the covered diagnosis or procedure codes required by the applicable coverage policy will be denied as not covered.

Concurrent administration of Repatha with other PCSK9-targeted therapies is specifically excluded. Concurrent use with Praluent (alirocumab) or Leqvio (inclisiran) is considered not medically necessary and will be denied.

Requests for services billed for conditions or diagnoses that are not covered under this Repatha coverage policy will be denied as not covered. Providers must submit claims using the most appropriate covered diagnosis and/or procedure codes as of the date of service to avoid denial.

Repatha is considered not medically necessary for any uses other than those specifically listed in this policy. In particular, concurrent therapy with other PCSK9-targeted agents is excluded: Repatha should not be used with Praluent (alirocumab) or Leqvio (inclisiran).

Key Numeric Thresholds, Ages, and Coding-Adjacent Values

LDL-C numeric thresholds referenced

LDL-C ≥ 55 mg/dLReferenced as the post-treatment LDL-C threshold for adults with established cardiovascular disease after a high-intensity statin trial

LDL-C ≥ 70 mg/dLPost-treatment LDL-C threshold used for HeFH, HoFH (after statin) and primary hyperlipidemia initial-therapy pathways (changed from ≥100 mg/dL for primary hyperlipidemia)

Untreated LDL-C ≥ 190 mg/dLExample threshold referenced as consistent with heterozygous familial hypercholesterolemia in family-history notes

Treated LDL-C ≥ 300 mg/dLTreated (after antihyperlipidemic therapy) LDL-C threshold used as one diagnostic pathway for HoFH

Untreated LDL-C > 400 mg/dLHistorical/updated untreated LDL-C threshold for HoFH diagnostic pathway (revised from >500 mg/dL)

Prior Authorization, Documentation, and Operational Steps for Prescribers

Prior Authorization

Prior Authorization Required

Prior Authorization Required — approvals typically for 1 year. Prior authorization is required for Repatha (evolocumab) prescription benefit coverage. Approvals are generally granted for 1 year. If a patient previously met initial therapy criteria under the Coverage Review Department and is currently receiving Repatha, only continuation criteria apply; if past criteria were not previously met or the patient is restarting therapy, initial therapy criteria must be met.

Approvals typically for 1 year
If prior initial approval was obtained under Coverage Review and patient is currently on Repatha → continuation criteria only
If no prior approval or restarting therapy → must meet Initial Therapy criteria

Documentation Required

Initial Therapy Documentation Requirements

Initial therapy requests must include documentation of age, specific diagnosis/indication, baseline and most recent LDL-C values, and details of prior lipid-lowering therapy trials (including statin and ezetimibe). Prescribers must attest to diagnostic confirmation when required (e.g., genetic testing or diagnostic criteria for HeFH/HoFH).

Clinical Background and Indication Summary

Repatha (evolocumab) is a monoclonal antibody that targets proprotein convertase subtilisin/kexin type 9 (PCSK9) to reduce circulating low‑density lipoprotein cholesterol (LDL‑C). It is indicated to lower LDL‑C in adults with established cardiovascular disease, in patients with familial hypercholesterolemia (heterozygous and homozygous), and for primary hyperlipidemia where criteria are met. Clinical guidance positions high‑intensity statin therapy as first-line treatment; PCSK9 inhibitors such as Repatha are intended for use when LDL‑C goals are not achieved on maximally tolerated statin therapy (and often ezetimibe) or when statin intolerance applies.

Definitions and Terminology

High-intensity statin definition

Atorvastatin dosingAtorvastatin 40–80 mg once daily is defined as high-intensity statin therapy (expected to achieve ≥50% LDL-C lowering)

Rosuvastatin dosingRosuvastatin 20–40 mg once daily is defined as high-intensity statin therapy (expected to achieve ≥50% LDL-C lowering)

LDL reduction expectationHigh-intensity statins aim for ≥50% LDL-C lowering per guideline context cited in the policy

Established cardiovascular disease (ASCVD) — examples

Prior myocardial infarction/acute coronary syndromeListed as qualifying examples of established cardiovascular disease for Repatha initial-therapy criteria

Stroke or transient ischemic attackIncluded among the qualifying ASCVD diagnoses for established cardiovascular disease indication

Policy Changes and Revision Timeline

2025-05-28policy_effective_dateLatest

Policy effective date and last review recorded as 2025-05-28; document status modified with material clinical changes including lowered LDL-C thresholds and HoFH diagnostic updates.

2023-04-26annual_revision

Annual revision added a continuation-of-therapy pathway: patients already receiving Repatha who previously met initial Coverage Review criteria need only meet continuation criteria documented by the prescriber.

unknown

Policy Summary

PayerCigna

PolicyRepatha (evolocumab) prior authorization — PCSK9 inhibitor coverage criteria

Policy CodePolicy N/A

Change TypeMaterial revisions to continuation criteria, LDL-C thresholds, and HoFH diagnostic thresholds

Effective DateMay 28, 2025

Next Review DateMay 28, 2025

SourceLink

On This Page

High-intensity statin trial duration

Minimum durationHigh-intensity statin therapy must be tried for ≥ 8 continuous weeks before meeting the step requirement

Example statins (trial context)Atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily used in defining the required high-intensity statin trial

Applies across indicationsThis ≥ 8-week requirement appears in established CVD, HeFH, HoFH, and primary hyperlipidemia initial-therapy criteria

Age requirement

Adult requirementPatient is ≥ 18 years of age for established cardiovascular disease and primary hyperlipidemia initial-therapy criteria

Pediatric threshold for FHPatients with HeFH and HoFH may be eligible starting at ≥ 10 years of age (per indication-specific criteria)

Age noted in FDA-approved indicationsRepatha indications list adults and pediatric patients ≥ 10 years for FH; safety not established <10 years

Coronary artery calcium (Agatston) score qualifying as high risk

CAC (Agatston) score thresholdCoronary artery calcium or calcification score ≥ 300 Agatston units qualifies a patient as high risk for primary hyperlipidemia initial-therapy pathway

Alternative risk criterion addedDiabetes was added as an alternative to CAC ≥300 for primary hyperlipidemia high-risk qualification (history notes)

Guideline contextCAC scoring referenced in guideline context as a marker of subclinical atherosclerosis for considering non-statin therapies

LDL-C after statin (or statin+ezetimibe) qualifying threshold

LDL-C after statin threshold (established CVD)LDL-C remains ≥ 55 mg/dL after a high-intensity statin trial for established cardiovascular disease initial therapy

LDL-C after statin threshold (FH / primary hyperlipidemia)LDL-C remains ≥ 70 mg/dL after required high-intensity statin (and ezetimibe where specified) for HeFH, HoFH, and primary hyperlipidemia initial therapy

Applies when statin intolerance absentThese post-treatment LDL-C thresholds apply when a patient has completed the specified high-intensity statin (± ezetimibe) trial rather than meeting statin-intolerance criteria

Untreated LDL-C for HoFH (historical revision)

Revised untreated LDL-C for HoFHUntreated LDL-C diagnostic threshold for HoFH was changed from >500 mg/dL to >400 mg/dL (history notes)

Context for untreated LDL-C'Untreated' refers to LDL-C measured prior to therapy with any antihyperlipidemic agent

Related parental/clinical criteriaAn untreated LDL-C >400 mg/dL may be paired with clinical manifestations before age 10 or parental FH-consistent levels to meet HoFH criteria

Minimum duration of high-intensity statin trial (reiteration)

Minimum trial length reiteratedHigh-intensity statin therapy must be administered for ≥ 8 continuous weeks before considering PCSK9 inhibitor therapy (stated repeatedly across indications)

Applies to atorvastatin and rosuvastatin trialsThe ≥8-week minimum explicitly refers to trials of atorvastatin ≥40 mg daily or rosuvastatin ≥20 mg daily

Also applies when ezetimibe is requiredFor primary hyperlipidemia initial therapy, the combined high-intensity statin plus ezetimibe regimen must be tried for ≥ 8 continuous weeks before applying the ≥70 mg/dL threshold

Document patient age and the indication/diagnosis
Provide baseline (untreated when specified) and on-treatment LDL-C values
Detail prior statin trials (dose, duration) and any ezetimibe trial when required
For familial hypercholesterolemia, provide genetic testing results or diagnostic criteria (Dutch Lipid Network, Simon Broome)

Step Therapy

Required Prior Statin (and Ezetimibe) Therapy

Required prior statin (and ezetimibe) therapy — prescribers must document trials of high-intensity statin therapy at specified doses and durations or document statin intolerance. Ezetimibe is generally expected as the next step when statin alone is insufficient.

High-intensity statin defined as atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily (single-entity or combination product)
Minimum trial duration: ≥ 8 continuous weeks for high-intensity statin prior to approval in many initial therapy pathways
When required by indication, trial of ezetimibe plus high-intensity statin for ≥ 8 continuous weeks may be required
Statin intolerance pathways require documentation of rhabdomyolysis OR trials of atorvastatin and rosuvastatin with resolution of muscle symptoms upon discontinuation

Note

Provider Expectations

Provider expectations — statin at maximally tolerated doses and often ezetimibe expected prior to PCSK9 inhibitor use. Clinical guideline recommendations support maximally tolerated statin therapy (preferably high-intensity when tolerated) and addition of ezetimibe before considering PCSK9 monoclonal antibodies unless statin intolerance or other criteria apply.

Maximally tolerated statin therapy is the cornerstone of LDL-C lowering
Ezetimibe is typically the next non-statin agent before PCSK9 inhibitors
ACC/AHA guidance: aim for LDL-C goals (e.g., <70 mg/dL or ≥50% reduction in high-risk patients) with maximally tolerated statin ± ezetimibe before PCSK9 use

Documentation Required

Continuation Therapy

Continuation therapy — prescriber must document response to therapy for ongoing approval. For patients currently receiving Repatha who previously met initial therapy criteria under the Coverage Review Department, continuation approval is granted if the prescriber attests the patient has experienced a response to therapy.

Prescriber attestation that the patient has experienced a response to therapy is required for continuation approvals
Examples of response include reductions in LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B
If the patient is currently receiving Repatha but never had prior approval under Coverage Review, review under Initial Therapy criteria

Prior Authorization

Continuation Therapy Prior Authorization

Continuation therapy prior authorization — operational pathway for patients already on Repatha. If the patient previously met initial therapy criteria under the Coverage Review Department and is currently receiving Repatha, submit continuation prior authorization with prescriber attestation of response and supporting labs when available. If prior initial criteria were not documented with Coverage Review, submit as an initial therapy request.

For continuation PA, include prescriber attestation of clinical response and recent lipid values when available
If prior initial approval by Coverage Review exists → continuation only is required
If no prior documented approval or patient is restarting → full Initial Therapy documentation required

Denial Risk

Claims and Coding — Denial Risk

Claims not accompanied by covered diagnosis/procedure codes will be denied. When billing, providers must submit the most appropriate covered diagnosis and/or procedure codes. Claims for services not accompanied by covered code(s) under the applicable coverage policy will be denied as not covered.

Use the most appropriate diagnosis/procedure codes as of the date of service
Claims lacking covered diagnosis/procedure codes tied to the policy will be denied

Denial Risk

Concurrent Therapy Exclusion

Concurrent therapy exclusion — concurrent use of Repatha with Praluent or Leqvio is not medically necessary and requests for combination therapy will be denied.

Concurrent prescribing or claims for Repatha plus Praluent (alirocumab) are not medically necessary
Concurrent prescribing or claims for Repatha plus Leqvio (inclisiran) are not medically necessary

Coronary artery disease / prior revascularizationCoronary artery disease and prior coronary or other arterial revascularization (e.g., CABG, PCI, stent) are listed qualifying conditions

Statin intolerance definition

Statin-related rhabdomyolysisOne qualifying statin-intolerance criterion is statin-related rhabdomyolysis defined by CK ≥10×ULN plus end-organ damage (e.g., acute renal injury or myoglobinuria)

Separate trials with symptom resolutionAlternatively, statin intolerance is met if the patient experienced skeletal-muscle symptoms during separate trials of atorvastatin and rosuvastatin and symptoms resolved upon discontinuation of each statin

Documentation requirementStatin intolerance must be documented per the specified criteria (history of symptoms, trials, and resolution) to substitute for the high-intensity statin trial requirement

Dutch Lipid Network criteria (brief reference)

PurposeThe Dutch Lipid Network criteria is a structured scoring system to classify likelihood of familial hypercholesterolemia using family history, clinical history, physical exam, LDL-C levels, and DNA analysis

Scoring thresholdsScores stratify FH likelihood: definite (>8), probable (6–8), possible (3–5), unlikely (<3) as presented in the policy references

Components include LDL-C rangesLDL-C strata contributing to score include values such as ≥330 mg/dL, 250–329 mg/dL, 190–249 mg/dL which are mapped to numeric point values in the criteria

HoFH_threshold_revision

Homozygous familial hypercholesterolemia diagnostic and numeric thresholds were revised historically (untreated LDL-C threshold lowered from >500 mg/dL to >400 mg/dL and parental requirement relaxed to at least one parent meeting FH-consistent levels).