PCSK9 inhibitors — Blue Cross Blue Shield of Texas

Initial criteria

• 1. ONE of the following regarding statin therapy: A. The patient’s LDL-C level remains ≥70 mg/dL after statin therapy OR B. The patient has not achieved a 50% reduction in LDL-C from statin therapy OR C. If the patient has ASCVD at very high risk, then LDL-C remains ≥55 mg/dL after statin therapy OR D. The patient is statin intolerant (rhabdomyolysis, skeletal muscle symptoms, elevated hepatic transaminase) OR E. The patient has a hypersensitivity or FDA labeled contraindication to atorvastatin and rosuvastatin.
• 2. The patient has another FDA labeled indication or an indication supported in compendia for the requested agent and route of administration.
• 3. If the patient has an FDA labeled indication, ONE of the following: A. Age within FDA labeling for the indication OR B. Supported use for patient’s age.
• 4. ONE of the following: A. The requested agent is preferred OR B. If non-preferred, ONE of the following: 1. Patient currently treated and stable, OR 2. Tried and failed preferred agent OR intolerance/hypersensitivity/contraindication to all preferred agents, OR 3. Preferred agent discontinued for lack of efficacy/adverse event, OR 4. Preferred agent expected to be ineffective, cause adherence barrier, worsen comorbid condition, or harm, OR 5. Preferred agent not in best interest by medical necessity, OR 6. Tried another drug in same class that failed or caused adverse event [chart notes required].
• 5. The patient will NOT be using the requested agent with another PCSK9 inhibitor.
• 6. No FDA labeled contraindications to the requested agent.
• 7. Compendia evidence allowed: AHFS, DrugDex 1, 2a, 2b.
• 8. Special cases for BCBS MT, NM, and OH members may allow approval based on peer-reviewed article support or compendia if labeled contraindications are absent and indication is rare or supported by literature as generally safe and effective, with age support where applicable.

Reauthorization criteria

• 1. The patient previously approved for PCSK9 inhibitor therapy through plan’s PA process.
• 2. The patient has demonstrated clinical benefit with a PCSK9 inhibitor.
• 3. If HoFH diagnosis: continues other lipid-lowering therapy (statin, ezetimibe, apheresis, lomitapide, evinacumab).
• 4. If ASCVD, HeFH, or hyperlipidemia: ONE of the following: A. Adherent to high-intensity statin (atorvastatin 40-80 mg, rosuvastatin 20-40 mg) OR B. Statin intolerant (rhabdomyolysis, skeletal muscle symptoms, elevated hepatic transaminase) OR C. Hypersensitivity or FDA labeled contraindication to atorvastatin/rosuvastatin OR D. No additional therapy required as treatment goal achieved with PCSK9 inhibitor.
• 5. ONE of the following related to agent preference: A. Requested agent is preferred OR B. If non-preferred, ONE of the following: 1. Patient stable on requested agent, OR 2. Tried and failed preferred agent OR intolerance/hypersensitivity/contraindication to all preferred agents, OR 3. Preferred agent discontinued due to lack of efficacy/adverse event, OR 4. Preferred agent expected to be ineffective, cause adherence barrier, worsen comorbid condition, or harm, OR 5. Preferred agent not in best interest by medical necessity, OR 6. Tried another drug in same class that failed or caused adverse event [chart notes required].
• 6. The patient will NOT use the requested agent with another PCSK9 inhibitor.
• 7. The patient has no FDA labeled contraindications to the requested agent.

Approval duration

12 months