CurrentCignaPolicy IP0250

Proprotein Convertase Subtilisin Kexin Type 9 Inhibitors - Praluent (alirocumab) Coverage Criteria

This policy governs prior authorization and medical necessity criteria for coverage of Praluent (alirocumab) for Cigna-administered health benefit plans, affecting prescribers and patients seeking insurance coverage for Praluent.

Policy Summary

PayerCigna

PolicyProprotein Convertase Subtilisin Kexin Type 9 Inhibitors - Praluent (alirocumab)

Policy CodePolicy IP0250

Change TypeNo material change / routine review

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets the specific indication criteria and prior statin trial or statin intolerance as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4FDA‑approved indication groups

1Typical approval duration (years)

≥8 wksRequired statin trial duration

MultipleLDL‑C thresholds noted

Coverage Criteria for Praluent (alirocumab)

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.

Employer Plan Additional Requirement

Approve for 1 year if BOTH A and B are met:

Employer plan criteria: A) Patient meets the above medical necessity criteria; AND B) ONE of: i) BOTH: (a) patient has tried Repatha (evolocumab) [may require prior authorization]; AND (b) patient experienced inadequate efficacy or significant intolerance per prescriber; OR ii) BOTH: (a) patient has heterozygous familial hypercholesterolemia; AND (b) (document truncated in source).

Coverage policies do not override specific customer benefit plan exclusions. The terms of a member's particular benefit plan document (for example, Group Service Agreement, Evidence of Coverage, Certificate of Coverage, or Summary Plan Description) may differ from the standard Coverage Policy and may contain specific exclusions. In the event of a conflict between this Coverage Policy and a customer's benefit plan document, the customer's benefit plan document supersedes the Coverage Policy and controls benefit determinations.

Services billed for diagnoses or conditions that are not covered under this Coverage Policy will be denied as not covered. Providers must submit claims with the most appropriate covered diagnosis and/or procedure codes in effect on the date of service; claims without covered code(s) under the applicable Coverage Policy are subject to denial.

Coding, Thresholds, and Definitions

Product referencedmixed

alirocumab

Praluent (alirocumab subcutaneous injection) — product name referenced in policy

LDL-C thresholds — examples

LDL-C ≥55 mg/dLUsed for Established Cardiovascular Disease initial-therapy criteria when LDL-C remains ≥55 mg/dL after ≥8 weeks of high-intensity statin

LDL-C ≥70 mg/dLUsed for HeFH, HoFH, and Primary Hyperlipidemia initial-therapy criteria when LDL-C remains ≥70 mg/dL after specified statin (and ezetimibe where required) trials

LDL-C ≥190 mg/dL (untreated)Diagnostic threshold used for HeFH initial-therapy eligibility (untreated LDL-C ≥190 mg/dL)

>400 mg/dL (untreated)Used as an HoFH diagnostic threshold (untreated LDL-C >400 mg/dL) often with additional clinical criteria

Treated LDL-C ≥300 mg/dLUsed as an HoFH criterion when treated LDL-C remains ≥300 mg/dL with additional clinical/parental criteria

Coronary artery calcium score ≥300 Agatston unitsAcceptable criterion for Primary Hyperlipidemia initial-therapy eligibility as an alternative to diabetes

Statin trial duration

Minimum duration≥ 8 continuous weeks on a high-intensity statin (required prior to measuring post-treatment LDL-C for initial-therapy criteria)

Applies to indicationsRequired for Established CV disease, HeFH, HoFH, and Primary Hyperlipidemia initial-therapy pathways when a high-intensity statin trial is specified

Combination regimensFor Primary Hyperlipidemia the patient must often have tried high-intensity statin plus ezetimibe for ≥8 continuous weeks before qualifying based on LDL-C ≥70 mg/dL

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required for Praluent. Approvals are generally provided for 1 year when the specific indication criteria are met. A patient who previously met initial therapy criteria and is currently receiving Praluent need only meet continuation criteria; patients restarting therapy or without prior approval must meet initial criteria.

Step Therapy

Required Prior Statin and Step with Repatha for Some Plans

Required prior statin and step with Repatha for some plans — For many indications patients must have trialed a maximally tolerated high‑intensity statin (e.g., atorvastatin ≥40 mg or rosuvastatin ≥20 mg) for ≥8 continuous weeks and still have LDL‑C above the policy thresholds. In some employer plans, a trial of Repatha (evolocumab) is required (and may itself require prior authorization); approval under employer plan criteria requires documented inadequate efficacy or significant intolerance to Repatha when specified.

Denial Risk

Coding Mismatch Denial Risk

Coding mismatch denial risk — Claims submitted for services not accompanied by covered diagnosis or procedure codes under this Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate and covered codes effective on the date of service.

Background

Praluent (alirocumab) is a proprotein convertase subtilisin kexin type 9 (PCSK9) monoclonal antibody indicated to lower LDL‑C and to reduce the risk of major cardiovascular events in adults with established cardiovascular disease. The agent is also indicated to lower LDL‑C in patients with primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), and homozygous familial hypercholesterolemia (HoFH), consistent with the FDA‑approved labeling and guidance summarized in this policy.

Definitions

High‑intensity statin

Atorvastatin dose rangeAtorvastatin 40–80 mg once daily (policy defines high-intensity as atorvastatin ≥40 mg)

Rosuvastatin dose rangeRosuvastatin 20–40 mg once daily (policy defines high-intensity as rosuvastatin ≥20 mg)

Policy definition (actionable)High-intensity statin is defined in the policy as atorvastatin ≥40 mg or rosuvastatin ≥20 mg — required when a high-intensity statin trial is specified

Statin intolerance

RhabdomyolysisStatin-related rhabdomyolysis is an accepted definition of statin intolerance in the policy

Separate trials requirementSkeletal muscle symptoms occurring with separate trials of atorvastatin and rosuvastatin that resolved upon discontinuation qualify as statin intolerance

Effect on criteriaMeeting the statin-intolerance definition allows bypassing the high-intensity statin LDL-C threshold requirement for initial-therapy eligibility