Nexletol — Blue Cross Blue Shield of Alabama

Primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH])

Initial criteria

ONE of the following: • Diagnosis of primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) OR • For reducing the risk of myocardial infarction and coronary revascularization and ONE of: – High risk for a cardiovascular disease (CVD) event OR – Established CVD with: ▪ Acute coronary syndrome ▪ History of myocardial infarction ▪ Stable or unstable angina ▪ Coronary or other arterial revascularization ▪ Stroke ▪ Transient ischemic attack ▪ Peripheral arterial disease, including aortic aneurysm presumed to be of atherosclerotic origin
AND ONE of the following: • Tried and had inadequate response to at least one statin OR • Statin intolerant defined as experiencing ONE of: – Statin-related rhabdomyolysis – Statin-related skeletal muscle symptoms (e.g., myopathy, myalgia) – Statin-related elevated hepatic transaminase – Hypersensitivity to at least one statin – FDA labeled contraindication to all statins
OR • Another FDA labeled or compendia-supported indication exists for the requested agent and route of administration (AHFS or DrugDex 1 or 2a level of evidence)
AND ONE of the following: • Patient age is within FDA labeling for the requested indication OR • There is support for using the agent for patient’s age
AND • Patient does not have any FDA labeled contraindications to the requested agent

• Patient has been previously approved for the requested agent through the plan’s Prior Authorization process • Patient has had clinical benefit with the requested agent • Patient does not have any FDA labeled contraindications to the requested agent • Compendia allowed: AHFS or DrugDex 1 or 2a level of evidence

12 months