Nexletol — Highmark

Initial criteria

• age ≥ 18 years
• diagnosis of HeFH confirmed by one of the following: molecular genetic testing showing pathogenic or likely pathogenic LDL receptor, ApoB, or PCSK9 variants OR Simon Broome Register criteria of definite or possible familial hypercholesterolemia OR Dutch Lipid Clinic Network diagnostic criteria probability of definite or probable familial hypercholesterolemia OR MEDPED tool probability of definite familial hypercholesterolemia
• therapeutic failure or insufficient response to a maximally tolerated statin OR statin intolerance defined by one of the following: while receiving at least two separate trials of different statins, experienced statin-related rhabdomyolysis or skeletal-related muscle symptoms that resolved on discontinuation OR during any course of statin therapy had CK increase to 10× ULN, LFTs increase to 3× ULN, or hospitalization due to severe statin-related adverse event
• current LDL-C ≥ 70 mg/dL OR current non-HDL-C ≥ 100 mg/dL OR meets very high-risk criteria (history of multiple major ASCVD events or one major ASCVD event and multiple high-risk conditions) with LDL-C ≥ 55 mg/dL or non-HDL-C ≥ 85 mg/dL OR <50% reduction in baseline LDL-C despite use with maximally tolerated statin therapy
• prescriber attests one of the following: will be using Nexletol or Nexlizet in combination with other LDL-C lowering therapies OR will be using Nexletol or Nexlizet when concomitant LDL-C lowering therapy not possible
• therapeutic failure, contraindication, or intolerance to ezetimibe

Reauthorization criteria

• member has experienced at least a 10% reduction in LDL-C from baseline
• prescriber attests that member will continue combination use with other LDL-C lowering therapies OR will continue monotherapy if concomitant therapy not possible

Approval duration

initial 6 months, reauthorization 12 months