Adenosine Triphosphate-Citrate Lyase Inhibitors

Prior Authorization Required

New-to-market drugs in this class listed as non-preferred on the Apple Health Preferred Drug List (AHPDL) require prior authorization. Non-preferred brand products with an A-rated generic, biosimilar, or interchangeable biosimilar must also meet Non-Clinical Policy No. 0001 (NC-001), unless the clinical reviewer approves an exception based on medical necessity.

• Review the current AHPDL at https://www.hca.wa.gov/assets/billers-and-providers/applehealth-preferred-drug-list.xlsx.
• FDA-approved new indications are evaluated case by case under the FDA labeling.

Initial Authorization and Duration

Bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet) may be authorized when the applicable documented clinical criteria are met. Approval is issued for 12 months when all required criteria are satisfied.

• For cardiovascular risk reduction, the patient must be at least 18 years old, have established CVD or qualifying high CVD risk, and meet the required statin-related criteria.
• For primary hyperlipidemia or heterozygous familial hypercholesterolemia (HeFH), the patient must be at least 18 years old, have the qualifying diagnosis, be taking a maximally tolerated statin unless contraindicated or not tolerated, and have LDL-C ≥70 mg/dL.
• Dosage and quantity limits: Nexletol 180 mg once daily, limited to one 180 mg tablet per day; Nexlizet 180 mg bempedoic acid/10 mg ezetimibe once daily, limited to one tablet per day.

Preferred-Agent and Statin Sequence

For the cardiovascular-risk indication, document the required sequence of therapy: a qualifying trial of high-intensity statin therapy unless contraindicated, followed by the requested agent when LDL-C remains elevated; or documentation meeting the policy definition of statin intolerance.

• High-intensity statin options are atorvastatin ≥40 mg daily or rosuvastatin ≥20 mg daily.
• The minimum high-intensity statin trial is 12 weeks, and LDL-C must remain ≥70 mg/dL unless the patient meets the statin-intolerance pathway.
• For primary hyperlipidemia or HeFH, the patient must be taking a maximally tolerated statin unless contraindicated or not tolerated.

Preferred-Agent History

For a non-preferred agent, document the patient’s relevant history with preferred agents before requesting authorization.

• Document inadequate response, intolerance due to a severe adverse reaction, or a contraindication to the required preferred agents.

Initial Clinical Documentation

Submit clinical documentation supporting the requested indication and every applicable authorization criterion.

• Patient is 18 years of age or older.
• For cardiovascular risk reduction: document established CVD—coronary artery disease, symptomatic peripheral artery disease, or cerebrovascular atherosclerotic disease—or qualifying high CVD risk, including Reynolds Risk score >30%, SCORE Risk score >7.5% over 10 years, coronary artery calcium score >400 Agatston units, diabetes with age >65 years for women or >60 years for men, or Framingham risk score ≥20%.
• For cardiovascular risk reduction: document either a high-intensity statin trial with LDL-C remaining ≥70 mg/dL or statin intolerance defined by rhabdomyolysis with end-organ damage or myoglobinuria, or skeletal muscle symptoms during separate atorvastatin and rosuvastatin trials that resolved after discontinuation.
• For primary hyperlipidemia or HeFH: document the diagnosis, current maximally tolerated statin use unless contraindicated or not tolerated, and LDL-C ≥70 mg/dL.

Reauthorization Response Documentation

For reauthorization, submit documentation demonstrating that the patient remains stable or has experienced a positive clinical response to therapy.

• Examples include a decrease in LDL-C or achievement of the patient’s LDL-C goal.
• When all reauthorization criteria are met, authorization is issued for 12 months.

Preferred-Agent Trial Requirement

Non-preferred agents require documented inadequate response or intolerance to the required number of preferred agents before authorization.

• Document an inadequate response or documented intolerance due to a severe adverse reaction or contraindication to at least two preferred agents.
• If only one preferred agent exists in the class, document an inadequate response to that one preferred agent.

Clinical Criteria Not Met

The request may be denied when applicable clinical, step-therapy, documentation, or authorization requirements are not met.

• Denial risk applies when the patient does not meet the age, diagnosis, CVD-risk, statin-sequence, statin-intolerance, LDL-C, or other applicable criteria.
• Denial risk applies when required documentation of preferred-agent trials, contraindication, severe adverse reaction, inadequate response, disease stability, or positive clinical response is missing.
• Requests exceeding the approved dose or quantity limits may not be authorized: Nexletol 180 mg once daily, one tablet per day; Nexlizet 180 mg/10 mg once daily, one tablet per day.
• A clinical reviewer may determine medical necessity and approve on a case-by-case basis when criteria are not fully met; the reviewer may use reauthorization criteria for a patient established on therapy who is new to Apple Health.