PCSK9 inhibitors — Blue Cross Blue Shield of Kansas

Initial criteria

• History of untreated LDL-C greater than 400 mg/dL AND ONE of the following: (1) Cutaneous or tendon xanthomas before 10 years of age OR (2) Untreated elevated LDL-C levels consistent with heterozygous FH in both parents (or in digenic form, one parent may have normal LDL-C levels and the other may have LDL-C levels consistent with HoFH)
• The patient has tried a high-intensity statin (e.g., atorvastatin 40-80 mg, rosuvastatin 20-40 mg daily) for 8 weeks and had an inadequate response OR has intolerance or hypersensitivity to ALL high-intensity statins OR has an FDA labeled contraindication to ALL high-intensity statins
• The patient will use other lipid-lowering therapy such as statin, ezetimibe, lipoprotein apheresis, lomitapide, or evinacumab
• OR: The patient has a diagnosis of HeFH with ONE of the following: (1) Genetic confirmation of one mutant allele at the LDLR, Apo-B, PCSK9, or 1/LDLRAP1 gene OR (2) Pre-treatment LDL-C >190 mg/dL OR (3) Clinical manifestations of HeFH (e.g., xanthomas, corneal arcus) OR (4) Definite/possible FH per Simon Broome criteria OR (5) Dutch Lipid Clinic Network score >5 OR (6) Treated LDL-C ≥100 mg/dL after statin with/without ezetimibe
• OR: The patient has clinical ASCVD AND ONE of: acute coronary syndrome, myocardial infarction, angina, revascularization, stroke, TIA, or peripheral arterial disease presumed atherosclerotic
• OR: The patient has primary hyperlipidemia AND ONE of: CAC score ≥300 Agatston units OR pre-treatment LDL-C ≥190 mg/dL
• OR: The patient has 20–29% 10-year ASCVD risk AND LDL-C ≥130 mg/dL on maximally tolerated statins
• OR: The patient has 30–39% 10-year ASCVD risk AND LDL-C ≥100 mg/dL on maximally tolerated statin therapy
• OR: The patient has ≥40% 10-year ASCVD risk AND LDL-C ≥70 mg/dL on maximally tolerated statin therapy
• AND ONE of the following: (A) Adherent to high-intensity statin ≥8 weeks AND LDL-C ≥70 mg/dL after therapy, OR <50% LDL-C reduction, OR if ASCVD very high risk then LDL-C ≥55 mg/dL; OR (B) Statin intolerant (rhabdomyolysis, muscle symptoms, or elevated transaminases); OR (C) Hypersensitivity to atorvastatin and rosuvastatin; OR (D) FDA labeled contraindication to atorvastatin and rosuvastatin
• OR: The patient has another FDA-labeled or compendia-supported indication for the requested agent and route of administration
• If FDA-indicated, the patient’s age is within or supported by labeling for the indication
• The requested agent is a preferred agent OR if non-preferred, the patient has (1) inadequate response, (2) intolerance or hypersensitivity, or (3) 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

Reauthorization criteria

• Previously approved for therapy for PCSK9 inhibitors through plan’s PA process
• The patient has had clinical benefit with a PCSK9 inhibitor
• If HoFH, continues to use other lipid-lowering therapy (statin, ezetimibe, lipoprotein apheresis, lomitapide, evinacumab)
• If ASCVD, HeFH, or hyperlipidemia, the patient is adherent to high-intensity statin (atorvastatin 40-80 mg, rosuvastatin 20-40 mg) OR is statin intolerant (rhabdomyolysis, muscle symptoms, or elevated transaminases) OR has hypersensitivity or FDA labeled contraindication to atorvastatin and rosuvastatin OR patient no longer requires additional therapy as treatment goals met with one PCSK9 inhibitor
• Requested agent is a preferred agent OR if non-preferred, patient has (1) inadequate response to preferred agent, (2) intolerance or hypersensitivity to preferred agent, or (3) FDA labeled contraindication to ALL preferred agents
• Patient will NOT use requested agent in combination with another PCSK9 agent
• Patient has no FDA labeled contraindications to requested agent

Approval duration

12 months