Insurance Coverage Requirements for Repatha (Evolocumab)
Most insurance plans require patients to have established cardiovascular disease or familial hypercholesterolemia with LDL-C levels remaining elevated despite maximally tolerated statin therapy plus ezetimibe before covering Repatha.
Patient Eligibility Criteria
Insurance coverage for Repatha typically requires patients to meet one of the following clinical scenarios:
For Patients with Atherosclerotic Cardiovascular Disease (ASCVD):
- Documentation of established ASCVD (prior heart attack, stroke, or other cardiovascular event)
- LDL-C levels ≥70 mg/dL despite:
- Maximally tolerated high-intensity statin therapy
- Addition of ezetimibe to statin therapy 1
- Failure to achieve ≥50% reduction in LDL-C from baseline with current therapy 1
For Patients with Familial Hypercholesterolemia:
- Documented heterozygous familial hypercholesterolemia (HeFH) with:
- LDL-C ≥100 mg/dL despite maximally tolerated statin plus ezetimibe 1
- Documented homozygous familial hypercholesterolemia (HoFH) 2, 3
- These patients may qualify regardless of prior therapy due to severity
For Statin-Intolerant Patients:
- Documented statin intolerance to at least 2 different statins (including one at lowest approved dose) 1
- High cardiovascular risk profile
- Elevated LDL-C levels despite alternative lipid-lowering therapies
Documentation Requirements
Most insurers require the following documentation:
- Current and baseline LDL-C levels (lab results within past 3-6 months)
- Documentation of maximally tolerated statin therapy:
- Specific statin and dose
- Duration of treatment
- Reason for not using higher doses if not on maximum dose
- For statin intolerance:
- Documentation of specific adverse effects
- Failed trials of at least 2 different statins
- Strategies attempted to address intolerance (dose adjustments, alternate-day dosing)
- Medical records confirming ASCVD diagnosis or genetic/clinical criteria for FH
- Documentation of ezetimibe trial and response
Prior Authorization Process
Most insurers implement a step-therapy approach:
- First-line therapy: High-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg daily) 1
- Second-line therapy: Addition of ezetimibe to maximally tolerated statin 1
- Third-line therapy: PCSK9 inhibitor (Repatha) if LDL-C remains elevated despite steps 1 and 2
Renewal Requirements
For continued coverage, patients typically need to demonstrate:
- Adherence to therapy (prescription refill records)
- LDL-C response to therapy (typically ≥30-50% reduction from pre-Repatha levels)
- Annual reassessment of lipid levels and cardiovascular risk
Common Coverage Pitfalls
- Inadequate statin trials: Failure to document trials of maximum tolerated doses
- Missing documentation of ezetimibe trial before PCSK9 inhibitor request
- Incomplete medical records demonstrating ASCVD or FH diagnosis
- Insufficient LDL-C levels: Some plans require specific threshold values
- Premature discontinuation of statins without adequate documentation of intolerance
Special Considerations
- Pediatric patients (≥10 years) with HeFH or HoFH may have different coverage criteria 2, 4
- Patients on LDL apheresis may have specialized coverage pathways 2
- Medicare Part D and commercial insurance requirements often differ
- Some plans may require specialist (cardiologist or lipidologist) prescription or consultation
The high cost of Repatha (evolocumab) remains a significant barrier despite its proven efficacy in reducing cardiovascular events by 15-20% in high-risk patients 2, 5. This explains why insurers implement these stringent coverage criteria to ensure appropriate utilization in patients most likely to benefit.