PCSK9 inhibitors — Blue Cross Blue Shield of Oklahoma

Initial criteria

• Patient’s LDL-C level remains ≥ 70 mg/dL after statin therapy OR patient has not achieved a 50% reduction in LDL-C from statin therapy OR, if ASCVD at very high risk, LDL-C remains ≥ 55 mg/dL after statin therapy
• OR patient is statin intolerant defined as experiencing ONE of: statin-related rhabdomyolysis; statin-related skeletal muscle symptoms (e.g., myopathy, myalgia); statin-related elevated hepatic transaminase
• OR patient has hypersensitivity or FDA labeled contraindication to atorvastatin and rosuvastatin
• Patient has another FDA labeled indication OR a compendia-supported indication for the requested agent and route
• If the patient has an FDA labeled indication, ONE of the following: patient’s age is within FDA labeling for that indication OR there is support for using the requested agent for patient’s age for that indication
• ONE of the following: requested agent is preferred OR requested agent is non-preferred AND ONE of the following: patient currently stable on the non-preferred agent; inadequate response to preferred agent; intolerance or hypersensitivity to preferred agent; FDA labeled contraindication to all preferred agents; preferred agent discontinued due to lack of efficacy/adverse event; preferred agent expected to be ineffective based on clinical characteristics or would cause adherence barrier/adverse reaction; preferred agent not in best interest based on medical necessity; patient tried another agent in same pharmacologic class with lack of efficacy or adverse event [chart notes required]
• Patient will NOT use the requested agent in combination with another PCSK9 inhibitor
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Special provisions: For BCBS MT Fully Insured or MT HIM members: patient age < 18 years, no FDA contraindications, indication supported by ≥2 peer-reviewed journal articles showing general safety and efficacy and age support (infancy/childhood/adolescence categories)
• For BCBS NM Fully Insured or NM HIM members: patient has rare disease, no FDA contraindications, and indication is FDA labeled or compendia supported
• For members residing in Ohio with Fully Insured or HIM Shop (SG) plans: no FDA contraindications, and indication is FDA labeled, compendia supported, or supported by ≥2 major peer-reviewed articles as generally safe and effective

Reauthorization criteria

• Patient previously approved for PCSK9 inhibitor through plan’s prior authorization process
• Patient has demonstrated clinical benefit with PCSK9 inhibitor
• If diagnosis HoFH, patient continues use of other lipid-lowering therapy (e.g., statin, ezetimibe, lipoprotein apheresis, lomitapide, evinacumab)
• If diagnosis ASCVD, HeFH, or hyperlipidemia, ONE of: patient adherent to high-intensity statin therapy (atorvastatin 40–80 mg or rosuvastatin 20–40 mg daily); OR statin intolerant (as above); OR hypersensitivity/contraindication to atorvastatin/rosuvastatin; OR therapy goal reached using single-agent PCSK9 inhibitor
• ONE of the following: requested agent is preferred; OR if non-preferred, documentation of current stability, inadequate response, intolerance, contraindication, discontinuation due to lack of efficacy/adverse event, expected ineffectiveness, not in best interest, or trial of another agent in same class causing lack of efficacy/adverse event [chart notes required]
• Patient will NOT use two PCSK9 inhibitors concurrently
• Patient does NOT have any FDA labeled contraindications to requested agent

Approval duration

12 months