PCSK9 inhibitors — Blue Cross Blue Shield of Illinois

Initial criteria

• 1. Patient meets ONE of the following lipid conditions after maximally tolerated statin therapy: LDL-C ≥ 70 mg/dL; OR less than 50% reduction in LDL-C; OR for ASCVD at very high risk, LDL-C ≥ 55 mg/dL
• 2. OR Patient is statin intolerant defined as ONE of: statin-related rhabdomyolysis; OR statin-related skeletal muscle symptoms (myopathy, myalgia); OR statin-related elevated hepatic transaminase
• 3. OR Patient has hypersensitivity to atorvastatin and rosuvastatin
• 4. OR Patient has FDA labeled contraindication to atorvastatin and rosuvastatin
• 5. Patient has another FDA labeled indication OR compendia-supported indication for the requested agent and route of administration
• 6. Patient’s age is within or supported for the FDA labeling of the requested indication
• 7. ONE of the following: (A) Requested agent is preferred OR (B) Requested agent is non-preferred AND ONE of: currently stable on requested agent [chart notes required]; OR tried and inadequate response to preferred agent; OR intolerance/hypersensitivity to preferred agent; OR FDA labeled contraindication to ALL preferred agents; OR preferred agent discontinued due to lack of efficacy/effectiveness/adverse event; OR preferred agent expected to be ineffective/cause adherence barrier/adverse reaction/harm [chart notes required]; OR preferred agent not in best interest of patient based on medical necessity [chart notes required]; OR tried another drug in same class discontinued due to inefficacy or adverse event [chart notes required]
• 8. Patient will NOT use another PCSK9 inhibitor concurrently
• 9. Patient has NO FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. Patient previously approved for a PCSK9 inhibitor through plan prior authorization
• 2. Patient has had clinical benefit with PCSK9 inhibitor
• 3. If diagnosis is HoFH, continues other lipid-lowering therapy (e.g., statin, ezetimibe, lipoprotein apheresis, lomitapide, evinacumab)
• 4. If diagnosis is ASCVD, HeFH, or hyperlipidemia, ONE of: adherent to high-intensity statin therapy (atorvastatin 40–80 mg, rosuvastatin 20–40 mg daily); OR statin intolerance as defined in initial criteria; OR hypersensitivity to atorvastatin and rosuvastatin; OR contraindication to atorvastatin/rosuvastatin; OR no additional therapy required as goal met with PCSK9 inhibitor alone
• 5. ONE of the following: (A) Requested agent is preferred OR (B) Requested agent is non-preferred AND ONE of: currently stable on requested agent [chart notes required]; OR tried and inadequate response to preferred agent; OR intolerance/hypersensitivity to preferred agent; OR FDA labeled contraindication to ALL preferred agents; OR preferred agent discontinued for inefficacy/adverse event [chart notes required]; OR preferred agent expected to be ineffective/cause adherence barrier/adverse reaction/harm [chart notes required]; OR preferred agent not in best interest based on medical necessity [chart notes required]; OR tried another drug in same class discontinued due to inefficacy/adverse event [chart notes required]
• 6. Not using requested agent in combination with another PCSK9 agent
• 7. No FDA labeled contraindications to the requested agent

Approval duration

12 months