PCSK9 inhibitors — Blue Cross Blue Shield of Montana

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 after statin therapy OR if patient has ASCVD at very high risk, LDL-C remains ≥ 55 mg/dL after statin therapy OR patient is statin intolerant defined as experiencing statin-related rhabdomyolysis OR statin-related skeletal muscle symptoms OR statin-related elevated hepatic transaminase OR patient has hypersensitivity to atorvastatin and rosuvastatin OR patient has an FDA labeled contraindication to atorvastatin and rosuvastatin
• Patient has another FDA labeled indication for the requested agent and route of administration OR an indication supported in compendia for the requested agent and route of administration
• If the patient has an FDA labeled indication, patient’s age is within FDA labeling for that indication OR there is support for use in the patient’s age for the requested indication
• Requested agent is a preferred agent OR, if non-preferred, one of: patient stable on requested agent (chart notes required) OR patient has tried and had 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 or adverse event OR preferred agent expected to be ineffective or harmful or cause adherence/comorbidity barrier (chart notes required) OR preferred agent not in best interest based on medical necessity OR patient has tried another drug in same class/mechanism discontinued due to failure or adverse event (chart notes required)
• Patient will NOT use requested agent in combination with another PCSK9 agent
• Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient previously approved for therapy through plan’s prior authorization process AND has had clinical benefit with a PCSK9 inhibitor
• If diagnosis HoFH: will continue other lipid-lowering therapies (statin, ezetimibe, lipoprotein apheresis, lomitapide, evinacumab)
• If ASCVD, HeFH, or hyperlipidemia: patient adherent to high-intensity statin therapy (atorvastatin 40-80 mg, rosuvastatin 20-40 mg daily) OR statin intolerant (rhabdomyolysis, myalgia/myopathy, elevated hepatic transaminase) OR hypersensitivity to atorvastatin/rosuvastatin OR contraindication to atorvastatin/rosuvastatin OR goal of therapy met using single agent PCSK9 inhibitor
• Requested agent is preferred OR, if non-preferred, one of: stable on requested agent (chart notes required) OR tried and failed preferred OR intolerance/hypersensitivity/contraindication to preferred OR discontinued due to lack of efficacy/adverse event OR preferred expected ineffective/harmful OR not in best interest OR tried similar drug discontinued due to failure (chart notes required)
• Patient will NOT use the requested agent with another PCSK9 agent
• Patient does NOT have any FDA labeled contraindications

Approval duration

12 months