Nexlizet — Highmark
Primary Hyperlipidemia, Not Associated with ASCVD or HeFH
Initial criteria
- age ≥ 18 years
- diagnosis of primary hyperlipidemia not associated with ASCVD or HeFH (ICD-10: E78.5)
- 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 <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