PCSK9 inhibitors — Blue Cross Blue Shield of New Mexico

Initial criteria

• 1. The patient’s LDL-C level remains ≥70 mg/dL after statin therapy OR
• 2. The patient has not achieved a 50% reduction in LDL-C from statin therapy OR
• 3. If the patient has ASCVD at very high risk, the LDL-C remains ≥55 mg/dL after statin therapy OR
• B. The patient is statin intolerant defined as experiencing ONE of: statin-related rhabdomyolysis OR muscle symptoms (myopathy, myalgia) OR elevated hepatic transaminase OR
• C. The patient has hypersensitivity to atorvastatin and rosuvastatin OR
• D. The patient has an FDA labeled contraindication to atorvastatin and rosuvastatin OR
• C. The patient has an FDA labeled indication OR D. an indication supported in compendia for the requested agent and route AND
• 2. If FDA labeled indication, ONE of: A. patient age within FDA labeling OR B. supported age in compendia AND
• 3. ONE of: A. requested agent is a preferred agent OR B. non-preferred agent AND ONE of:
• 1. Patient currently stable on requested agent [chart notes required] OR
• 2. Patient has inadequate response, intolerance, hypersensitivity, or contraindication to preferred agent(s) [chart notes required] OR
• 3. Preferred agent discontinued due to inefficacy or adverse event [chart notes required] OR
• 4. Preferred agent expected to be ineffective, cause adherence barrier, worsen comorbid condition, impair function, or harm [chart notes required] OR
• 5. Preferred agent not in best interest of patient based on medical necessity [chart notes required] OR
• 6. Tried another drug in same class that failed [chart notes required] AND
• 4. Patient will NOT use requested agent in combination with another PCSK9 agent AND
• 5. Patient does NOT have any FDA labeled contraindications to requested agent
• Special population criteria:
• • BCBS MT Fully Insured or HIM member: patient age <18 years, no contraindications, indication supported in two peer-reviewed major journals, and age bracket supported by two studies [journal articles required]
• • BCBS NM Fully Insured or HIM member: indication is rare disease, no contraindications, and indication either FDA labeled, compendia supported, or supported by two peer-reviewed journal articles (JAMA, NEJM, Lancet, etc.)

Reauthorization criteria

• 1. Patient previously approved for therapy through PA process AND
• 2. Patient has had clinical benefit with a PCSK9 inhibitor AND
• 3. If HoFH: continues other lipid-lowering therapy (statin, ezetimibe, apheresis, lomitapide, evinacumab) AND
• 4. If ASCVD, HeFH, or hyperlipidemia: ONE of the following:
• A. Adherent to high-intensity statin (atorvastatin 40–80 mg OR rosuvastatin 20–40 mg daily) OR
• B. Statin intolerant (rhabdomyolysis, muscle symptoms, elevated hepatic transaminase) OR
• C. Hypersensitivity or contraindication to atorvastatin and rosuvastatin OR
• D. No longer requires additional therapy having met LDL goal with single PCSK9 inhibitor AND
• 5. ONE of (preferred status logic same as initial approval; documentation of stability or inadequate response, intolerance, etc.) AND
• 6. Will NOT use in combination with another PCSK9 agent AND
• 7. No FDA labeled contraindications to requested agent

Approval duration

12 months