PCSK9 inhibitors — Blue Cross Blue Shield of Alabama

Initial criteria

• The patient has been adherent to high-intensity statin therapy (atorvastatin 40-80mg or rosuvastatin 20-40mg daily) for at least 8 consecutive weeks AND ONE of the following: • LDL-C ≥ 70 mg/dL after this statin therapy OR • Has not achieved a 50% reduction in LDL-C from this statin therapy OR • If ASCVD at very high risk, LDL-C ≥ 55 mg/dL after this statin therapy OR • Statin intolerance defined as experiencing ONE of the following: - Statin-related rhabdomyolysis OR - Statin-related skeletal muscle symptoms (myopathy, myalgia) OR - Statin-related elevated hepatic transaminase OR - Hypersensitivity to atorvastatin and rosuvastatin OR - FDA labeled contraindication to atorvastatin and rosuvastatin OR • Has another FDA labeled indication for the requested agent and route of administration OR • Has another indication supported in compendia for the requested agent and route of administration
• If the patient has an FDA labeled indication, then ONE of the following: • The patient’s age is within FDA labeling for the requested indication for the requested agent OR • There is support for use of the requested agent for the patient’s age for the requested indication
• ONE of the following: • The requested agent is a preferred agent OR • The requested agent is a non-preferred agent AND the patient has ONE of the following: - Tried and had an inadequate response to the preferred agent OR - An intolerance or hypersensitivity to the preferred agent OR - An FDA labeled contraindication to ALL preferred agents
• The patient will NOT use the requested agent in combination with another PCSK9 agent
• The patient does NOT have any FDA labeled contraindications to the requested agent
• Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence

Reauthorization criteria

• The patient has been previously approved for therapy for PCSK9 inhibitors through the plan’s Prior Authorization process
• The patient has had clinical benefit with a PCSK9 inhibitor
• If diagnosis is HoFH, will continue to use other lipid-lowering therapy (e.g., statin, ezetimibe, lipoprotein apheresis, lomitapide, evinacumab)
• If diagnosis is ASCVD, HeFH, or hyperlipidemia, then ONE of the following: • The patient has been adherent to high-intensity statin therapy (atorvastatin 40-80mg, rosuvastatin 20-40mg daily) OR • Statin intolerance defined as experiencing ONE of the following: - Statin-related rhabdomyolysis OR - Statin-related skeletal muscle symptoms (myopathy, myalgia) OR - Statin-related elevated hepatic transaminase OR - Hypersensitivity to atorvastatin and rosuvastatin OR - FDA labeled contraindication to atorvastatin and rosuvastatin OR • Does not require additional therapy as goal achieved with single agent PCSK9 inhibitor
• ONE of the following: • The requested agent is a preferred agent OR • The requested agent is a non-preferred agent AND the patient has ONE of the following: - Tried and had an inadequate response to the preferred agent OR - An intolerance or hypersensitivity to the preferred agent OR - An FDA labeled contraindication to ALL preferred agents
• The patient will NOT be using the requested agent in combination with another PCSK9 agent
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months