ModifiedCignaPOLICY: Hyperlipidemia - PCSK9 Inhibitors - Lerochol Prior Authorization Policy

Hyperlipidemia - PCSK9 Inhibitors - Lerochol Prior Authorization Policy

Prior authorization criteria and coverage guidance for Lerochol (lerodalcibep) for adults and select pediatric patients with hypercholesterolemia, including heterozygous familial hypercholesterolemia, for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyHyperlipidemia - PCSK9 Inhibitors - Lerochol Prior Authorization Policy

Policy CodePolicy POLICY: Hyperlipidemia - PCSK9 Inhibitors - Lerochol Prior Authorization Policy

Change TypeNew policy established (material change)

Effective Date

Next Review Date

Key ActionPrior authorization is required for Lerochol; approvals provided for 1 year and contingent on meeting initial or continuation criteria including age, diagnostic confirmation, prior trial of high‑intensity statin ± ezetimibe or documented statin intolerance, and LDL‑C thresholds.

SourceLink

POLICY UPDATE CHANGES

New policy established for Lerochol (lerodalcibep) with specified FDA‑approved indications and detailed prior authorization criteria.

2FDA indication groups

1 yrTypical approval duration

≥70 mg/dLLDL-C approval threshold

Excluded

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Concurrent use excluded

DLNCFH scoring referenced

Coverage criteria for Lerochol (lerodalcibep)

Initial and Continuation Therapy Criteria

Covered when ALL of the following are met for the specified indication group (Initial Therapy) or when meeting continuation rules:

HeFH - Initial Therapy

Age: Patient is >= 18 years of age>= 18 years
Diagnosis confirmation: Patient meets ONE of: untreated LDL-C >= 190 mg/dL prior to treatment; OR diagnosis confirmed by genetic testing (examples: pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1); OR meets diagnostic criteria thresholds (Dutch Lipid Network score >5 OR Simon Broome 'definite' or 'possible/probable')LDL-C >= 190 mg/dL OR genetic test OR diagnostic criteria
Examples of pathogenic variants listed in policy
Prior therapy or intolerance: Patient meets ONE of: (a) tried one high-intensity statin (atorvastatin >=40 mg or rosuvastatin >=20 mg) for >=8 continuous weeks AND LDL-C after treatment remains >=70 mg/dL; OR (b) statin intolerant defined by either statin-related rhabdomyolysis OR documented intolerance with separate trials of atorvastatin and rosuvastatin that produced skeletal muscle symptoms which resolved on discontinuation>=8 weeks; LDL-C >=70 mg/dL
Statin intolerance definitions detailed in policy

HeFH - Continuation: Approve if prescriber states the patient has experienced a response to therapy (e.g., decreasing LDL-C, total cholesterol, non‑HDL, or apolipoprotein B)

Continuation approvals require demonstration of response

Hypercholesterolemia - Initial Therapy

Age: Patient is >= 18 years of age>= 18 years
Risk requirement: Patient meets ONE of: coronary artery calcium score >= 300 Agatston units OR patient has diabetesCAC >=300 OR diabetes
Prior therapy or intolerance: Patient meets ONE of: (a) tried one high-intensity statin AND tried high-intensity statin + ezetimibe for >=8 continuous weeks AND LDL-C after regimen remains >=70 mg/dL; OR (b) statin intolerant as defined by rhabdomyolysis OR multi-trial documented muscle symptoms resolving on discontinuation>=8 weeks; LDL-C >=70 mg/dL

Hypercholesterolemia - Continuation: Approve if prescriber states the patient has experienced a response to therapy (examples listed)

Continuation branch

Dutch Lipid Network Criteria stratification

Alternate pathway using Dutch Lipid Network Criteria

DLNC score categories: DLNC total score categories: Definite FH (>8), Probable FH (6-8), Possible FH (3-5), Unlikely FH (<3). Components include family history, clinical history, physical exam (tendon xanthomas, arcus cornealis), LDL-C level bands, and DNA analysis (functional mutation in LDLR, APOB or PCSK9).

Requests to use Lerochol concurrently with other PCSK9-directed therapies or inclisiran are excluded from coverage. Specifically, concurrent administration of Lerochol with Praluent (alirocumab), Repatha (evolocumab), or Leqvio (inclisiran) is considered not medically necessary and will be denied.

The policy's "Conditions Not Covered" section lists uses that are considered not medically necessary; where the source provides no additional explicit items beyond concurrent-use exclusions, no further standalone exclusions are specified in this portion of the document.

Any use of Lerochol that is not an FDA‑approved indication supported by the policy’s criteria is considered not medically necessary. In particular, the policy identifies that combining Lerochol with other PCSK9 inhibitors or with inclisiran is specifically not medically necessary.

No additional not‑medically‑necessary statements or special coverage caveats are listed in the referenced sections beyond the concurrent‑use exclusion and the general statement that other uses not listed as approved or supported are not covered. The policy is new and effective with the stated review date and may be updated as new evidence becomes available.

Coding and laboratory thresholds

Affected codes (prescription benefit)mixed

affected codes

Placeholder — policy indicates prior authorization applies to prescription benefit coverage; explicit billing/code list not provided in this portion.

LDL-C thresholds

Untreated LDL-C (HeFH diagnostic branch)≥ 190 mg/dL (prior to treatment)

Post-treatment LDL-C threshold for many approval paths≥ 70 mg/dL (LDL-C remains ≥ 70 mg/dL after required statin ± ezetimibe regimen)

Age requirement tied to LDL-C thresholdsPatient must be ≥ 18 years of age for adult approval branches where LDL-C thresholds apply

Coronary artery calcium score

Coronary artery calcium (CAC) score cutoff≥ 300 Agatston units

Context for useCAC ≥ 300 may satisfy risk requirement in hypercholesterolemia initial therapy pathway (alternative to diabetes)

Provider actions, documentation, and prior authorization steps

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lerochol. Typical approvals are provided for 1 year. Approvals for continuation may rely on prior determinations; if prior criteria were not previously met, initial criteria must be documented and met.

PA approval duration: 1 year (typical).
Continuation vs initial: patients already approved may qualify under continuation; otherwise initial criteria apply.

Denial Risk

Documentation and Denial Risk

Requests must document required LDL-C/total cholesterol thresholds and evidence supporting a familial hypercholesterolemia (FH) diagnosis when applicable. Requests lacking this documentation or failing to meet LDL-C thresholds may be denied.

LDL-C/total cholesterol thresholds must be provided (see LDL-C thresholds by age and condition).

Background and drug information

Lerochol is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor indicated to reduce low‑density lipoprotein cholesterol (LDL‑C) as an adjunct to diet and exercise in patients with hypercholesterolemia, including heterozygous familial hypercholesterolemia. PCSK9 inhibitors lower LDL‑C by inhibiting PCSK9-mediated degradation of LDL receptors, thereby increasing clearance of LDL particles. The policy references diagnostic pathways for familial hypercholesterolemia, including clinical findings and genetic testing (for example, the Dutch Lipid Network Criteria), and requires prior authorization with documentation of diagnosis, prior lipid values, and prior therapy or documented statin intolerance as applicable.

Definitions and thresholds

PCSK9 inhibitor — definition

DefinitionA monoclonal antibody (or biologic) therapy that inhibits proprotein convertase subtilisin kexin type 9 (PCSK9) to lower LDL-C levels

Indication contextUsed as adjunct to diet and exercise for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH)

Comparable agentsIncludes other PCSK9 inhibitors (e.g., alirocumab, evolocumab) and contrasted with inclisiran (Leqvio) which is an siRNA agent

High‑intensity statin — definition (policy)

Atorvastatin thresholdAtorvastatin ≥ 40 mg daily (defines high‑intensity statin for policy step requirements)

Rosuvastatin thresholdRosuvastatin ≥ 20 mg daily (defines high‑intensity statin for policy step requirements)

Policy revision history

02/04/2026policy_addedLatest

New policy established for Lerochol (lerodalcibep) operationalizing prior authorization criteria, initial and continuation therapy rules, and specifying a 1-year approval duration.

Policy Summary

PayerCigna

PolicyHyperlipidemia - PCSK9 Inhibitors - Lerochol Prior Authorization Policy

Policy CodePolicy POLICY: Hyperlipidemia - PCSK9 Inhibitors - Lerochol Prior Authorization Policy

Change TypeNew policy established (material change)

Effective Date

Next Review Date

SourceLink

On This Page

Guideline noteProfessional guidance referenced supports CAC-based consideration for nonstatin therapy selection

Pediatric cholesterol thresholds (age-based)

Patient < 16 years - total cholesterol> 6.7 mmol/L (260 mg/dL)

Patient < 16 years - LDL-C> 4.0 mmol/L (155 mg/dL)

Patient > 16 years - total cholesterol> 7.5 mmol/L (290 mg/dL)

Patient > 16 years - LDL-C> 4.9 mmol/L (190 mg/dL)

Absence of required lipid values or FH evidence increases denial risk.

Documentation Required

Required Clinical Documentation

Provide clinical documentation to support the diagnosis and prior therapies: diagnosis, baseline and on-treatment lipid labs, documentation of statin (and ezetimibe when required) trials including doses and durations, and any genetic or family history findings relevant to FH.

Diagnosis and clinical indication.
Pre-treatment LDL-C and most recent LDL-C values.
Records showing trial of high-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) for ≥8 continuous weeks where required.
Documentation of concomitant ezetimibe trial when policy requires (statin + ezetimibe for ≥8 weeks).
Evidence of statin intolerance where claimed (e.g., rhabdomyolysis) including supporting clinical notes.
Genetic testing results or family/physical findings supporting FH when applicable.

Step Therapy

Step Therapy Requirements

Step therapy: patients must have trialed the required high-intensity statin therapy for the specified duration; where specified, trial of statin plus ezetimibe for ≥8 continuous weeks is also required before approval of Lerochol unless statin intolerance is documented.

High-intensity statin defined as atorvastatin ≥40 mg daily or rosuvastatin ≥20 mg daily (single-entity or combination products).
Required duration: ≥8 continuous weeks for high-intensity statin trials.
If policy arm requires, trial of high-intensity statin + ezetimibe for ≥8 continuous weeks must be documented.
Statin intolerance must be documented with clinical justification (e.g., rhabdomyolysis) to waive step therapy.

Documentation Required

Dutch Lipid Network Criteria Required When Applicable

Use the Dutch Lipid Network Criteria (DLNC) to stratify FH likelihood when applicable. Provide the DLNC score components or total score in the submission to support a diagnosis of definite, probable, or possible FH per the criteria.

Include DLNC component scores: family history, clinical history, physical exam findings (tendon xanthomas, arcus cornealis), LDL-C levels, and DNA analysis if available.
DLNC stratification: definite FH >8; probable 6–8; possible 3–5; unlikely <3.
If using DLNC, prescriber must confirm the DLNC total score and how it was calculated.

Denial Risk

Concurrent Use Exclusion

Concurrent use exclusion: requests for Lerochol in combination with other PCSK9-targeting therapies will be denied as not medically necessary.

Concurrent use with Praluent (alirocumab), Repatha (evolocumab), or Leqvio (inclisiran) is not permitted and will be denied.

Policy useTrial of a high‑intensity statin (atorvastatin ≥ 40 mg or rosuvastatin ≥ 20 mg) for ≥ 8 continuous weeks is required unless statin intolerance is documented

Raised cholesterol / LDL-C thresholds — quick reference

Summary of age-based cholesterol thresholds<16 years: total cholesterol >6.7 mmol/L (260 mg/dL) or LDL-C >4.0 mmol/L (155 mg/dL); >16 years: total cholesterol >7.5 mmol/L (290 mg/dL) or LDL-C >4.9 mmol/L (190 mg/dL)

Use with FH diagnostic pathwaysRaised cholesterol per these thresholds must be paired with tendon xanthomas, DNA evidence, or family history to meet FH criteria

Referenced scoring systemDutch Lipid Network Criteria components include LDL-C ranges and physical findings that align with these thresholds

DNA-based evidence for familial hypercholesterolemia

Acceptable DNA evidenceDetection of a pathogenic mutation in LDLR, familial defective APOB, or PCSK9 gene

Role in diagnostic pathwaysDNA-based evidence can satisfy the genetic confirmation pathway for HeFH or serve as the DNA analysis component in Dutch Lipid Network Criteria

Documentation expectationPrescriber must provide genetic test results showing the pathogenic variant consistent with familial hypercholesterolemia