bempedoic acid-ezetimibe — Blue Cross Blue Shield of Montana

Initial criteria

• Target agent will be approved when ALL of the following are met:
• 1. ONE of the following:
• A. BOTH of the following:
• 1. The patient has a diagnosis of ONE of the following: Primary hyperlipidemia (including heterozygous familial hypercholesterolemia) OR Reducing the risk of myocardial infarction and coronary revascularization AND ONE of the following: High risk for a cardiovascular disease (CVD) event OR Established CVD AND has ONE of the following: Acute coronary syndrome OR History of myocardial infarction OR Stable or unstable angina OR Coronary or other arterial revascularization OR Stroke OR Transient ischemic attack OR Peripheral arterial disease, including aortic aneurysm, presumed to be of atherosclerotic origin
• 2. ONE of the following: The patient has tried and had an inadequate response to at least ONE statin OR The patient has an intolerance defined as experiencing ONE of the following: Statin-related rhabdomyolysis OR Statin-related skeletal muscle symptoms (e.g., myopathy, myalgia) OR Statin-related elevated hepatic transaminase OR The patient has a hypersensitivity to at least ONE statin OR The patient has an FDA labeled contraindication to ALL statins
• B. The patient has another FDA labeled indication for the requested agent and route of administration OR
• C. The patient has another indication that is 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: The patient’s age is within FDA labeling for the requested indication for the requested agent OR There is support for using the requested agent for the patient’s age for the requested indication
• 3. The patient does NOT have any FDA labeled contraindications to the requested agent
• Additional approval pathways:
• • For BCBS NM Fully Insured or NM HIM member: patient does not have FDA labeled contraindications AND indication is a rare disease AND patient has another FDA labeled or compendia-supported indication
• • For Ohio Fully Insured or HIM Shop (SG) member: member resides in Ohio AND plan is Fully Insured or HIM Shop AND patient does not have FDA labeled contraindications AND one of the following: patient has another FDA labeled indication OR compendia-supported indication OR prescriber provides TWO supportive peer-reviewed articles

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

Approval duration

36 months (BCBSOK); 12 months (all other plans)