Medical Mutual Ohio Nexletol Prior Auth Policy

Authorization Criteria for Nexletol / Nexlizet

Established Cardiovascular Disease (FDA-approved)

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

A_or_B: A) Initial Therapy: patient meets all of (i, ii, and iii) OR B) Patient currently receiving Nexletol with documented response to therapy

Examples of response include decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels.

Initial_Therapy_requirements: i. Patient is ≥ 18 years of age; ii. Patient has one of: previous myocardial infarction or acute coronary syndrome, angina (stable or unstable), prior stroke or transient ischemic attack, coronary artery disease, peripheral arterial disease, or prior coronary/arterial revascularization; iii. Patient meets one of: (a) tried a high-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) and that statin plus ezetimibe for ≥8 continuous weeks with LDL-C after this regimen ≥55 mg/dL OR (b) statin intolerance defined as either statin-related rhabdomyolysis OR skeletal-related muscle symptoms occurring on separate trials of both atorvastatin and rosuvastatin with resolution on discontinuation.LDL-C ≥55 mg/dL for pathway (a)

If restarting therapy or currently receiving Nexletol without prior coverage, review under Initial Therapy criteria if prior approval for this indication is not documented.

Heterozygous Familial Hypercholesterolemia (HeFH) (FDA-approved)

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

A_or_B: A) Initial Therapy: patient meets all of (i, ii, and iii) OR B) Patient currently receiving Nexletol with documented response to therapy

Examples of response include decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels.

Initial_Therapy_requirements_HeFH: i. Patient is ≥ 18 years of age; ii. Patient has one of: untreated LDL-C ≥190 mg/dL prior to lipid-lowering therapy, phenotypic confirmation of HeFH (pathogenic variant in LDLR, APOB, PCSK9, or LDLRAP1), OR meets diagnostic criteria (Dutch Lipid Network score >5 or Simon Broome criteria meeting 'definite' or 'possible/probable'); iii. Patient meets one of: (a) tried a high-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) and that statin plus ezetimibe for ≥8 continuous weeks with LDL-C after this regimen ≥70 mg/dL OR (b) statin intolerance defined as either statin-related rhabdomyolysis OR skeletal-related muscle symptoms occurring on separate trials of both atorvastatin and rosuvastatin with resolution on discontinuation.LDL-C ≥70 mg/dL for pathway (a)

Prescriber confirmation of Dutch Lipid Network score or Simon Broome classification may be requested.

Primary Hyperlipidemia (FDA-approved)

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

A_or_B: A) Initial Therapy: patient meets all of (i, ii, and iii) OR B) Patient currently receiving Nexletol with documented response to therapy

Examples of response include decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels.

Initial_Therapy_requirements_Primary: i. Patient is ≥ 18 years of age; ii. Patient has ONE of: coronary artery calcium score ≥300 Agatston units OR diabetes; iii. Patient meets one of: (a) tried a high-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) and that statin plus ezetimibe for ≥8 continuous weeks with LDL-C after this regimen ≥70 mg/dL OR (b) statin intolerance defined as either statin-related rhabdomyolysis OR skeletal-related muscle symptoms occurring on separate trials of both atorvastatin and rosuvastatin with resolution on discontinuation.LDL-C ≥70 mg/dL for pathway (a)

Primary hyperlipidemia in this policy is distinct from established CVD or HeFH.

Simon Broome — Definite FH

Definite Familial Hypercholesterolemia by Simon Broome criteria is present when the following combined conditions are met:

Simon Broome definite FH: Raised cholesterol meeting age-specific numeric thresholds AND (tendon xanthomas in the patient or a first- or second-degree relative OR DNA-based evidence of an LDL-receptor, familial defective APOB, or PCSK9 mutation)Age-specific cutoffs: <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)

Absence of documented lipid values meeting these thresholds may affect classification and coverage decisions.

Dutch Lipid Network — Scoring and classification

Dutch Lipid Network uses a points-based combination of family history, clinical history, physical exam, LDL-C level, and DNA analysis to classify FH:

Dutch_Lipid_components: Family history (points for first-degree relatives with premature coronary/vascular disease or high LDL-C, tendon xanthomata), clinical history (premature CAD or cerebral/peripheral vascular disease), physical exam (tendon xanthomas, arcus cornealis <45 years), LDL-C strata (points assigned by LDL-C level), and DNA analysis (functional mutation in LDLR, APOB, or PCSK9)Points assigned per documented finding as listed in source

Specific point values include tendon xanthomas = 6; DNA mutation = 8; LDL-C strata: ≥8.5 mmol/L (330 mg/dL) = 8 points; 6.5–8.4 mmol/L (250–329 mg/dL) = 5 points; 5.0–6.4 mmol/L (190–249 mg/dL) = 3 points; 4.0–4.9 mmol/L (155–189 mg/dL) = 1 point.

Dutch_Lipid_classification: Total score determines categoryDefinite >8; Probable 6-8; Possible 3-5; Unlikely <3

Sum component points to assign the appropriate category for authorization decisions.

Coverage is not recommended for uses that are not specifically listed in the Recommended Authorization Criteria. The policy states that such coverage decisions will be updated as new published data become available.

No explicit additional exclusions are stated in the provided excerpt.

Requests for uses not listed in this policy will be reviewed on a case-by-case basis; however, the policy indicates that coverage is not recommended for circumstances not included in the Recommended Authorization Criteria.

None specified in this excerpt.

Diagnostic Thresholds, Age Limits, and Scoring

Diagnostic numeric thresholdsmixed

LDL-C >= 8.5 mmol/L (330 mg/dL)	Dutch Lipid Network LDL-C stratum (8 points)
LDL-C 6.5 to 8.4 mmol/L (250 to 329 mg/dL)	Dutch Lipid Network LDL-C stratum (5 points)
LDL-C 5.0 to 6.4 mmol/L (190 to 249 mg/dL)	Dutch Lipid Network LDL-C stratum (3 points)
LDL-C 4.0 to 4.9 mmol/L (155 to 189 mg/dL)	Dutch Lipid Network LDL-C stratum (1 point)
Total cholesterol >6.7 mmol/L (260 mg/dL) or LDL-C >4.0 mmol/L (155 mg/dL) if <16 years	Simon Broome threshold for raised cholesterol in patients <16 years
Total cholesterol >7.5 mmol/L (290 mg/dL) or LDL-C >4.9 mmol/L (190 mg/dL) if >16 years	Simon Broome threshold for raised cholesterol in patients >16 years

LDL‑C thresholds after maximized therapy

Established CVDLDL-C ≥55 mg/dL after trial of a high‑intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) plus ezetimibe for ≥8 continuous weeks

HeFH (Heterozygous Familial Hypercholesterolemia)LDL-C ≥70 mg/dL after trial of a high‑intensity statin plus ezetimibe for ≥8 continuous weeks

Primary hyperlipidemiaLDL-C ≥70 mg/dL after trial of a high‑intensity statin plus ezetimibe for ≥8 continuous weeks

Coronary artery calcium score

Coronary artery calcium scoreCoronary artery calcium (Agatston) score ≥300 units

Primary hyperlipidemia pathwayA coronary artery calcium score ≥300 Agatston units meets the criterion for primary hyperlipidemia evaluation

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for pharmacy benefit coverage of Nexletol and Nexlizet. Approvals follow the policy's clinical criteria; initial approvals are for the duration noted in the policy and continuation approvals typically require documented response to therapy.

Documentation Required

Dutch Lipid Network Score May Be Used

Prior authorization decisions may rely on the Dutch Lipid Network total score. Provide documentation of the calculated score or the component data used to calculate it (family history, clinical history, physical exam findings, LDL-C level, and DNA analysis when available). Scores map to diagnostic categories: Definite (>8), Probable (6–8), Possible (3–5), and Unlikely (<3).

Provide component data if total score not explicitly recorded: family history (premature CAD or LDL-C percentile), clinical history (premature CAD or vascular disease), physical exam (tendon xanthomas, arcus cornealis), LDL-C numeric value, DNA testing results.

Drug and Condition Background

Bempedoic acid (Nexletol) is an adenosine triphosphate–citrate lyase inhibitor indicated to reduce low-density lipoprotein cholesterol (LDL-C) and to reduce the risk of myocardial infarction and coronary revascularization in specified adult populations. It is indicated as an adjunct to diet and may be used in combination with other LDL‑C–lowering therapies or alone when concomitant therapy is not possible; safety and effectiveness have not been established in pediatric patients.

Key Definitions and Diagnostic Criteria

Nexletol (bempedoic acid) — definition and indication summary

Drug classBempedoic acid (Nexletol) is an ATP‑citrate lyase inhibitor

Indicated populationsAdults to reduce LDL‑C: those with established CVD, at high risk for CVD, or with primary hyperlipidemia/HeFH as adjunct to diet and other LDL‑C lowering therapies

Use as adjunct or monotherapyIndicated in combination with other LDL‑C lowering therapies or alone when concomitant therapy is not possible

Regulatory/coverage actionPrior authorization is recommended for pharmacy benefit coverage of Nexletol/Nexlizet per policy criteria

Heterozygous Familial Hypercholesterolemia (HeFH) — definition

Untreated LDL‑C thresholdHeFH may be defined by an untreated LDL‑C ≥190 mg/dL

OpenPayer

Nexletol (bempedoic acid) — Pharmacy Benefit Prior Authorization

Authorization Criteria for Nexletol / Nexlizet

Diagnostic Thresholds, Age Limits, and Scoring

Prior Authorization, Documentation, and Denial Risks

Drug and Condition Background

Key Definitions and Diagnostic Criteria