ModifiedCignaPolicy N/A

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

Prior authorization requirements and coverage criteria for Praluent (alirocumab) for Cigna-administered health benefit plans, including FDA‑approved indications (established cardiovascular disease, primary hyperlipidemia, HeFH, HoFH) and continuation therapy rules.

Policy Summary

PayerCigna

PolicyProprotein Convertase Subtilisin Kexin Type 9 Inhibitors - Praluent Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial revisions to continuation pathway and LDL-C thresholds

Effective Date

Next Review DateMay 28, 2025

Key ActionSubmit prior authorization showing trials of high-intensity statin (≥8 continuous weeks) or documented statin intolerance and required LDL‑C or diagnostic findings to support approval.

SourceLink

POLICY UPDATE CHANGES

Continuation-of-therapy criteria were newly developed allowing patients who previously met initial therapy criteria under the Coverage Review Department and are currently receiving Praluent to be approved based on evidence of response to therapy.

Established cardiovascular disease indication was renamed and the LDL-C threshold after one high-intensity statin was changed from ≥ 70 mg/dL to ≥ 55 mg/dL for initial therapy.

Heterozygous and homozygous familial hypercholesterolemia diagnostic confirmation language was changed between phenotypic confirmation and genetic testing in different revisions; recent entry states diagnosis has been confirmed by genetic testing.

1 yearTypical approval duration

≥ 8 wksRequired statin trial duration

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Coverage Criteria for Praluent (alirocumab)

inv-01: Initial Therapy / Indication-specific criteria

Covered when ONE of the FDA-approved indication groups below is met

Established Cardiovascular Disease

A) Initial Therapy: i. Patient is ≥ 18 years of age; AND ii. Patient has had ONE of the following conditions or diagnoses: prior myocardial infarction or acute coronary syndrome, angina (stable or unstable), past history of stroke or transient ischemic attack, coronary artery disease, peripheral arterial disease, or prior coronary/arterial revascularization; AND iii. Patient meets ONE of the following (a or b): a) Patient has tried one high-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) for ≥ 8 continuous weeks AND LDL-C after this treatment remains ≥ 55 mg/dL; OR b) Patient is statin intolerant as defined (rhabdomyolysis OR skeletal-related muscle symptoms with separate trials of atorvastatin and rosuvastatin with resolution upon discontinuation).
B) Patient Currently Receiving Praluent: Approve if according to the prescriber, the patient has experienced a response to therapy (examples: decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B). If the patient has not previously met initial criteria under the Coverage Review Department or is restarting therapy, initial criteria must be met.

Heterozygous Familial Hypercholesterolemia (HeFH)

A) Initial Therapy: i. Patient is ≥ 8 years of age; AND ii. Patient meets ONE of: untreated LDL-C ≥ 190 mg/dL (prior to antihyperlipidemic therapy), genetic confirmation of HeFH, OR prescriber confirms Dutch Lipid Network criteria score >5 (or Simon Broome thresholds); AND iii. Patient meets ONE of: a) tried one high-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) and post-treatment LDL-C remains ≥70 mg/dL after appropriate therapy/ezetimibe as applicable; OR b) statin intolerance as defined (rhabdomyolysis OR skeletal-related muscle symptoms with separate trials of atorvastatin and rosuvastatin with resolution upon discontinuation).
B) Patient Currently Receiving Praluent: Approve if according to the prescriber, the patient has experienced a response to therapy (examples: decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B). If the patient has not previously met initial criteria under the Coverage Review Department or is restarting therapy, initial criteria must be met.

Homozygous Familial Hypercholesterolemia (HoFH)

A) Initial Therapy: i. Patient is ≥ 18 years of age; AND ii. Patient has one of: genetic confirmation of HoFH, OR untreated LDL-C >400 mg/dL with supporting features, OR treated LDL-C ≥300 mg/dL with supporting features (supporting features include xanthomas, arcus cornealis, parental LDL-C levels); AND iii. Patient meets ONE of: a) tried one high-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) for ≥8 continuous weeks and post-treatment LDL-C remains ≥70 mg/dL; OR b) statin intolerance as defined (rhabdomyolysis OR skeletal-related muscle symptoms with separate trials of atorvastatin and rosuvastatin with resolution upon discontinuation).
B) Patient Currently Receiving Praluent: Approve if according to the prescriber, the patient has experienced a response to therapy (examples: decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B). If the patient has not previously met initial criteria under the Coverage Review Department or is restarting therapy, initial criteria must be met.

Primary Hyperlipidemia

A) Initial Therapy: i. Patient is ≥ 18 years of age; AND ii. Patient meets ONE of: coronary artery calcium score ≥300 Agatston units OR patient has diabetes; AND iii. Patient meets ONE of: a) Patient has tried one high-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) AND tried that 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 (rhabdomyolysis OR skeletal-related muscle symptoms with separate trials of atorvastatin and rosuvastatin with resolution upon discontinuation).
B) Patient Currently Receiving Praluent: Approve if according to the prescriber, the patient has experienced a response to therapy (examples: decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B). If the patient has not previously met initial criteria under the Coverage Review Department or is restarting therapy, initial criteria must be met.

inv-05: Statin Intolerance Criteria

Statin intolerance pathway (alternative to required statin trials):

Statin intolerance: Either (1) patient experienced statin-related rhabdomyolysis OR (2) patient experienced skeletal-related muscle symptoms while on separate trials of both atorvastatin and rosuvastatin with resolution upon discontinuation of each statin.

inv-02: Continuation therapy

Continuation therapy

Continuation Therapy: Approve if the patient is currently receiving Praluent and, according to the prescriber, has experienced a response to therapy (examples: decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B). If prior approval for that indication was not previously obtained through the Coverage Review Department, initial criteria must be met.

Approvals are typically for 1 year.

inv-04: Patient Currently Receiving Praluent (Continuation Therapy)

Continuation of therapy for patients currently receiving Praluent who have previously met initial therapy criteria under the Coverage Review Department:

Continuation of therapy: Prescriber documents that the patient has experienced a response to therapy; examples include decreases in LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels. If the patient has not previously met initial criteria under the Coverage Review Department or is restarting therapy, initial criteria must be met.

The Primary hyperlipidemia pathway is intended for patients without established cardiovascular disease, heterozygous familial hypercholesterolemia (HeFH), or homozygous familial hypercholesterolemia (HoFH). The policy explicitly states this indication is “not associated with established cardiovascular disease, heterozygous familial hypercholesterolemia (HeFH), or homozygous familial hypercholesterolemia (HoFH)” and should be used for patients with primary or combined hyperlipidemia/dyslipidemia rather than those with the listed conditions.

Concurrent administration of Praluent with other PCSK9-targeted agents is excluded. Specifically, the policy lists concurrent use with Repatha (evolocumab) or Leqvio (inclisiran) as not covered and notes that coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.

Praluent is considered not medically necessary for any uses not specified in the Recommended Authorization Criteria. The policy explicitly includes concurrent administration with other PCSK9-targeted agents (for example, Repatha/evolocumab or Leqvio/inclisiran) among the not‑medically‑necessary situations and states coverage is not recommended for circumstances outside the listed criteria.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Praluent. Approvals are typically granted for 1 year. A patient who previously met initial therapy criteria for the requested indication and is currently receiving Praluent need only meet continuation criteria (i.e., currently receiving therapy). If prior approval was not previously obtained or the patient is restarting Praluent, the initial therapy criteria must be met.

Requests for indications not listed in the Recommended Authorization Criteria will be denied as not covered.
Concurrent use with other PCSK9-targeted agents (e.g., Repatha/evolocumab or Leqvio/inclisiran) is not covered.

Documentation Required

Prior Authorization Requirement

Prior authorization requires documentation that the patient meets either the Initial Therapy criteria or, for patients currently receiving Praluent who previously met initial criteria, the Continuation criteria (response to therapy).

If the patient is restarting therapy or never had prior approval for the specific indication, evaluate under Initial Therapy criteria.

Coding and Billing Information

Drug referenceNDC | mixed

alirocumab

Praluent (alirocumab subcutaneous injection) - drug name referenced

Drug billing codesmixed

NDC/HCPCS not specified

Document references prescribing information but does not list specific billing codes in this section.

inv-12: Required statin trial duration

Required durationAt least 8 continuous weeks on one high-intensity statin (e.g., atorvastatin ≥40 mg or rosuvastatin ≥20 mg)

DocumentationMedical record must document the statin agent, dose, start and stop dates demonstrating ≥8 continuous weeks

ExceptionsStatin intolerance pathway may substitute for the required trial when intolerance criteria are met

inv-13: LDL-C after high-intensity statin + ezetimibe

Established CV disease initial therapyLDL-C ≥ 55 mg/dL after one high-intensity statin trial (revised threshold)

HeFH / HoFH and some primary hyperlipidemia paths

Definitions and Abbreviations

inv-26: High-intensity statin

High-intensity statin definitionAtorvastatin 40–80 mg daily or rosuvastatin 20–40 mg daily (achieves ≥50% LDL-C reduction)

Role in therapyHigh-intensity statins are the recommended first-line therapy and form the basis for required trials before PCSK9 inhibitors

Examples citedPolicy lists atorvastatin 40 mg to 80 mg QD and rosuvastatin 20 mg to 40 mg QD as high-intensity statins

inv-27: Statin intolerance / intolerance criteria

Statin intolerance definitionEither statin-related rhabdomyolysis or skeletal-muscle symptoms occurring with separate trials of both atorvastatin and rosuvastatin that resolve on discontinuation

Rhabdomyolysis criteriaMarkedly elevated creatine kinase (≥10× upper limit of normal) with end-organ damage (e.g., acute renal injury) describes statin-related rhabdomyolysis

Background

Praluent (alirocumab) is a PCSK9 monoclonal antibody approved to reduce LDL‑C and risk of cardiovascular events across multiple FDA‑approved populations. The policy describes the agent’s use for adults with established cardiovascular disease, patients with primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH, including pediatric patients ≥ 8 years where applicable), and homozygous familial hypercholesterolemia (HoFH). For patients currently receiving Praluent, continuation approvals require prescriber documentation of a therapeutic response (for example, reductions in LDL‑C, total cholesterol, non‑HDL‑C, or apolipoprotein B), and if prior approval for the indication was not previously obtained the patient must meet Initial Therapy criteria.