Nexletol — Blue Cross Blue Shield of Illinois

Initial criteria

• 1. ONE of the following: (A) BOTH of the following: (1) The patient has a diagnosis of ONE of the following: (A) Primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) OR (B) Reducing the risk of myocardial infarction and coronary revascularization AND ONE of the following: (1) High risk for cardiovascular disease event OR (2) Established cardiovascular disease (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 of atherosclerotic origin) AND (2) ONE of the following: (A) The patient has tried and had an inadequate response to at least ONE statin OR (B) The patient has intolerance defined as experiencing ONE of the following: statin-related rhabdomyolysis OR statin-related skeletal muscle symptoms OR statin-related elevated hepatic transaminase OR (C) The patient has hypersensitivity to at least ONE statin OR (D) The patient has an FDA labeled contraindication to ALL statins OR (B) The patient has another FDA labeled indication for the requested agent and route of administration OR (C) The patient has another indication supported in compendia for the requested agent and route of administration
• 2. If the patient has an FDA labeled indication, then ONE of the following: (A) Patient’s age is within FDA labeling OR (B) Support for use at patient’s age for requested indication
• 3. The patient does NOT have any FDA labeled contraindications to the requested agent
• Alternative coverage: NM Fully Insured or NM HIM member – patient does NOT have contraindications AND requested indication is rare disease AND (another FDA labeled indication or compendia-supported indication)
• Alternative coverage: Ohio Fully Insured or HIM Shop member – member resides in Ohio AND plan is Fully Insured or HIM Shop AND no contraindications AND (another FDA labeled indication OR compendia-supported indication OR prescriber submitted 2 peer-reviewed journal articles supporting proposed use)

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• 2. The patient has had clinical benefit with the requested agent
• 3. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months (36 months for BCBSOK)