Reformatted initial diagnostic confirmation criteria for clarity. Removed required submission of baseline LDL-C level within 60 days of treatment initiation. For patients 7 to 9 years of age: Adjusted statin therapy trial requirement to include allowance for highest age-appropriate or maximally tolerated dose of statin therapy and removed high-intensity statin verbiage; Within statin intolerance requirements, updated statin-related skeletal muscle symptoms criteria to require occurrence with the trial of at least two statin therapies with resolution upon discontinuation. For patients 10 years of age and older: Adjusted statin therapy trial requirement to remove specific product and dosing criteria and allow any high-intensity or maximally tolerated statin therapy; Added requirement that the patient is currently treated with and adherent to ezetimibe to align with updated clinical guideline recommendations. Refined the requirements for statin intolerance. Adjusted LDL-C goals to align with updated clinical guideline recommendations and added required medical record documentation of failure to achieve target LDL-C despite treatment with other LDL-C lowering therapies. Within continuation criteria, removed requirement that the patient is adherent to or intolerant to statin therapy. Updated formatting throughout policy for clarity with no change to intent. Policy notification given 6/1/2026 for effective date 8/1/2026.

For HeFH: Reformatted initial diagnostic confirmation criteria for clarity and removed option of treated LDL-C ≥100 mg/dL after treatment with antihyperlipidemic agents. For hypercholesterolemia: Reformatted criteria for ASCVD, primary hyperlipidemia, and ASCVD risk sections to instead confirm the patient has a diagnosis of hypercholesterolemia and either ASCVD, ASCVD risk, severe hypercholesterolemia, or subclinical atherosclerosis; Adjusted ASCVD risk from 20% to 10% and CAC score (subclinical atherosclerosis) from 300 to 100 to align with updated clinical guideline recommendations. For HoFH: Reformatted initial diagnostic confirmation criteria for clarity. Adjusted statin therapy trial requirement to add allowance for maximally tolerated dose of statin therapy and to remove specific product and dosing criteria, allowing for any high-intensity or maximally tolerated statin therapy. Refined the requirements for statin intolerance. Added newly approved Lerochol as an option within PCSK9 inhibitor trial requirement. Adjusted and reformatted LDL-C goals (12 to 17 years: ≥100 mg/dL for HoFH; 18 years and older: ≥100 mg/dL for HoFH, ≥70 mg/dL for HeFH, ≥55 mg/dL if ASCVD or at high risk for ASCVD) to align with updated clinical guideline recommendations and added required medical record documentation of failure to achieve target LDL-C despite treatment with other LDL-C lowering therapies. For continuation criteria, added required medical record documentation to demonstrate clinical benefit with the requested agent. Updated formatting throughout policy for clarity. Policy notification given 6/1/2026 for effective date 8/1/2026.