Blue Cross Blue Shield Iowa Nexletol/Nexlizet Prior Auth | OpenPayer

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Blue Cross Blue Shield Iowa Nexletol/Nexlizet Prior Auth | OpenPayer

Coverage Criteria for Nexletol and Nexlizet

Initial approval — ASCVD or high-risk prevention (Nexletol or Nexlizet)

Covered when ALL of the following are met:

Initial ASCVD/high-risk criteria: 1. Member is 18 years of age or older; 2. Member has a history of either (a) clinical ASCVD (see Appendix A) OR (b) is high-risk for ASCVD defined by at least one of: PCE score ≥20%; an intermediate 10-year PCE score (7.5%–<20%) plus one or more ASCVD risk enhancers; an alternative risk score (e.g., MESA, QRISK3, PREVENT) estimating 10-year risk ≥20%; or diabetes with higher cardiovascular risk; 3. Member is engaging in healthy lifestyle changes; 4. Despite adherence to lifestyle changes and at least three months of maximally tolerated high-intensity statin therapy, member has one of: (a) LDL-C ≥70 mg/dL; (b) LDL-C ≥55 mg/dL with history of multiple clinical ASCVD events or one major ASCVD event plus multiple high-risk conditions (Appendix C); or (c) apolipoprotein B ≥80 mg/dL; 5. Plan to add Nexletol to statin and ezetimibe therapy or Nexlizet to statin therapy.age >=18; LDL-C >=70 mg/dL (or >=55 mg/dL for very-high-risk)

Approval duration: 12 months.

Alternate initial approval — when statin is contraindicated or not tolerated

Covered when ALL of the following are met:

ASCVD/high-risk with statin contraindication: 1. Member is 18 years of age or older; 2. Member has clinical ASCVD or is high-risk for ASCVD as defined in the policy (PCE ≥20%, intermediate PCE 7.5%–<20% with risk enhancers, alternative risk score ≥20%, or diabetes with higher risk); 3. Member is engaging in healthy lifestyle changes; 4. Member has one of: current LDL-C ≥70 mg/dL; LDL-C ≥55 mg/dL for very-high-risk history; or apolipoprotein B ≥80 mg/dL; 5. Member has a documented contraindication to statin therapy (e.g., active liver disease, pregnancy, breastfeeding) or a medically justifiable reason precluding statin use (e.g., prior rhabdomyolysis, CK ≥10x ULN, or statin intolerance per National Lipid Association definitions).LDL-C >=70 mg/dL; apoB >=80 mg/dL

Allows use when statins are contraindicated or intolerable; approval duration: 12 months.

Initial approval — Heterozygous Familial Hypercholesterolemia (HeFH)

Covered when ALL of the following are met:

HeFH with prior therapies: 1. Member is 18 years of age or older; 2. Definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) confirmed by ONE of: pathogenic variant in LDLR, APOB, PCSK9, or LDLRAP1 OR definite FH per Simon-Broome, Dutch Lipid Network, or MEDPED criteria; 3. Member is engaging in healthy lifestyle changes; 4. Despite adherence to lifestyle changes and at least three months of BOTH maximally tolerated high-intensity statin therapy and PCSK9-targeted therapy, member has been unable to achieve LDL-C <70 mg/dL (or <55 mg/dL for very-high-risk ASCVD history); 5. Plan to add Nexletol to statin and ezetimibe therapy or Nexlizet to statin therapy.LDL-C target not met after statin + PCSK9 therapy

Approval duration: 12 months.

Alternate HeFH criteria — statin contraindication

Covered when ALL of the following are met:

HeFH with statin contraindication: 1. Member is 18 years of age or older; 2. Definite HeFH as defined by genetic testing or diagnostic criteria (Simon-Broome, Dutch Lipid Network, or MEDPED); 3. Member is engaging in healthy lifestyle changes; 4. Despite adherence and at least a three-month trial of PCSK9-targeted therapy, member has been unable to achieve LDL-C <70 mg/dL (or <55 mg/dL for very-high-risk ASCVD history); 5. Member has a documented contraindication to statin use or medically justifiable reason precluding statin therapy (e.g., active liver disease, pregnancy, breastfeeding, prior rhabdomyolysis, CK ≥10x ULN, or statin intolerance per NLA).Prior PCSK9 trial; statin contraindication/intolerance

Approval duration: 12 months.

Initial approval — Primary hyperlipidemia

Covered when ALL of the following are met:

Primary hyperlipidemia criteria: 1. Member is 18 years of age or older; 2. Diagnosis of primary hyperlipidemia with both: (a) untreated LDL-C ≥160 mg/dL; and (b) no secondary cause of hyperlipidemia; 3. Member is engaging in healthy lifestyle changes; 4. Despite adherence to lifestyle changes and at least three months of maximally tolerated statin therapy, member has been unable to achieve LDL-C <70 mg/dL; 5. Plan to add Nexletol to statin and ezetimibe therapy or Nexlizet to statin therapy.untreated LDL-C >=160 mg/dL; current LDL-C >=70 mg/dL for alternate path

An alternative approval pathway allows documented statin contraindication/intolerance with current LDL-C ≥70 mg/dL; approval duration: 12 months.

Continuation of therapy

Covered when ALL of the following are met:

Continuation criteria: 1. Member has experienced a reduction in LDL-C or has maintained a reduction in LDL-C; 2. Member continues concomitant maximally tolerated LDL-C–lowering therapy (unless contraindicated or not tolerated); 3. Member continues to demonstrate adherence with Nexletol or Nexlizet, any concomitant LDL-C–lowering therapies (if applicable), and lifestyle modifications.

Approval will be for 12 months.

Indications reflected in clinical evidence

Clinical indications supported by document and trials (interpretive — present in source):

Supported indications: Patients with established ASCVD, heterozygous familial hypercholesterolemia (HeFH), or documented statin intolerance who require additional LDL-C lowering despite maximally tolerated statin therapy; includes use in combination with ezetimibe as studied. Clinical trial populations had baseline LDL-C levels ranging from ~120–157 mg/dL (CLEAR Wisdom, CLEAR Serenity) and ~139 mg/dL (CLEAR Outcomes); CLEAR Outcomes enrolled ≈14,000 statin-intolerant patients and demonstrated a reduction in MACE-4 (11.7% with bempedoic acid vs 13.3% placebo; HR 0.87).trial baseline LDL-C ~120–157 mg/dL; population size ~14,000 in CLEAR Outcomes

Efficacy evidence includes LDL-C reductions (e.g., placebo-corrected −21.4% in CLEAR Serenity; −17% in CLEAR Wisdom) and cardiovascular outcomes from CLEAR Outcomes.

Members who do not meet the policy's listed criteria are considered not medically necessary for Nexletol or Nexlizet. Approval for therapy is granted for 12 months when criteria are met. Members receiving samples or enrolled in the manufacturer's patient assistance programs must meet the initial approval criteria to continue receiving therapy, ensuring equitable coverage regardless of how the medication was obtained.

Avoid concomitant use of Nexletol with simvastatin >20 mg or pravastatin >40 mg because combined use increases the risk of statin-related myopathy. This interaction is highlighted in the safety data and should be considered when selecting background statin therapy or when documenting contraindications/intolerance to specific statins.

Use of Nexletol or Nexlizet is not medically necessary for members who do not meet the specific clinical criteria outlined in this policy (for example, age, diagnosis, required prior therapies, laboratory thresholds, or documented statin contraindication/intolerance). Prior authorization denials may result when submitted documentation does not demonstrate fulfillment of those criteria.

This section of the document does not contain additional explicit 'not medically necessary' statements beyond the policy-wide determination; billing and coding guidance is limited to the instruction to use appropriate CPT/HCPCS/revenue and ICD-CM codes when reporting services.

Billing and Coding

Procedures and billing codesmixed

No codes listed

LDL-C — Common thresholds used in criteria

Untreated LDL-C thresholdUntreated LDL-C ≥160 mg/dL (used for primary hyperlipidemia criteria)

Current/treated LDL-C thresholdLDL-C ≥70 mg/dL (common threshold for ASCVD/high‑risk and treatment consideration)

Very-high-risk LDL-C thresholdLDL-C ≥55 mg/dL (applies with history of multiple ASCVD events or one major event plus multiple high‑risk conditions)

LDL-C thresholds — persistently elevated and trial baselines

Persistently elevated LDL-C despite therapyPersistently elevated LDL‑C ≥100 mg/dL despite maximally tolerated statin therapy and ezetimibe (listed as a very‑high‑risk criterion)

Trial baseline LDL‑C examples

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required when coverage criteria must be met. Requests will be reviewed against the policy's medical necessity criteria (age ≥18, qualifying diagnosis or high ASCVD risk, documented lifestyle modifications, and required statin therapy trials or statin-intolerance documentation as applicable). Approval durations are generally for 12 months when criteria are met.

Prior authorization required before initiating Nexletol (bempedoic acid) or Nexlizet (bempedoic acid + ezetimibe).
Approval is typically for 12 months when criteria are satisfied.

Documentation Required

Prior Authorization Requirements & Required Clinical Documentation

Provide documentation to support the prior authorization request per the policy requirements. For statin-intolerance requests, document trials and re-challenges consistent with the National Lipid Association definition (Appendix D). For HeFH, provide genetic testing or validated diagnostic scoring documentation as specified.

Background and Clinical Context

Bempedoic acid (Nexletol) and the fixed-dose combination bempedoic acid/ezetimibe (Nexlizet) are FDA-indicated as adjuncts to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, and to reduce cardiovascular risk in selected patients who are unable to take recommended statin therapy. Nexletol acts by inhibiting ATP-citrate lyase in the liver, decreasing cholesterol synthesis and upregulating LDL receptors; Nexlizet combines bempedoic acid with ezetimibe to enhance LDL-C lowering.

Definitions and Clinical Terms

FDA‑Approved Indications

FDA indication — LDL‑C reductionIndicated as adjuncts to diet and exercise to reduce LDL‑C in adults with hypercholesterolemia (including HeFH)

FDA indication — with other therapiesCan be used in combination with other LDL‑C lowering therapies, or alone when concomitant therapy is not possible

FDA indication — event risk reductionIndicated to reduce risk of major cardiovascular events in adults at increased risk who are unable to take recommended statin therapy

Clinical ASCVD — definition

Clinical ASCVD componentsIncludes acute coronary syndromes, myocardial infarction, stable or unstable angina, coronary or other arterial revascularization (e.g., PCI, CABG), stroke of atherosclerotic origin, transient ischemic attack (TIA), and non‑cardiac peripheral arterial disease (PAD)