Prior Authorization Requirements for Repatha (Evolocumab)
Prior authorization for Repatha (evolocumab) typically requires documentation of specific clinical criteria including diagnosis of atherosclerotic cardiovascular disease (ASCVD), familial hypercholesterolemia, or elevated LDL-C levels despite maximally tolerated statin therapy.
FDA-Approved Indications for Repatha
- Repatha is FDA-approved for:
- Reducing the risk of major adverse cardiovascular events (CV death, MI, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults with established cardiovascular disease 1
- Lowering LDL-C in adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) as an adjunct to diet, alone or in combination with other LDL-C-lowering therapies 1
- Lowering LDL-C in pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) 1
- Lowering LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH) 1
Common Prior Authorization Criteria
For Patients with Established ASCVD:
- Documentation of established atherosclerotic cardiovascular disease 2
- Evidence of being on maximally tolerated statin therapy 2
- Current LDL-C levels above target despite optimal therapy 2
- Documentation of inadequate response to high-intensity statin therapy (or moderate-intensity if high-intensity not tolerated) 2
For Patients with Familial Hypercholesterolemia:
- Confirmation of heterozygous or homozygous familial hypercholesterolemia diagnosis (genetic testing or clinical criteria) 2, 3
- For HeFH: Documentation of LDL-C levels remaining elevated despite maximally tolerated statin therapy 2, 3
- For HoFH: Documentation of LDL-C levels and current lipid-lowering therapies 2, 1
- For pediatric patients (aged 10 years and older): Documentation of HeFH or HoFH diagnosis and inadequate response to conventional therapy 1
For Primary Hyperlipidemia:
- Documentation of primary hyperlipidemia diagnosis 2
- Evidence of maximally tolerated statin therapy 2
- Documentation of LDL-C levels remaining significantly elevated despite optimal therapy 2
- Evidence of statin intolerance if applicable 2
Documentation Requirements
- Current and baseline lipid panel results (especially LDL-C levels) 2, 3
- Complete medication history including:
- Medical history documenting ASCVD events or familial hypercholesterolemia diagnosis 2, 1
- Treatment goals and target LDL-C levels 2, 3
Renewal Criteria
- Documentation of response to therapy (reduction in LDL-C levels) 2
- Continued adherence to statin therapy (if not contraindicated) 2
- Documentation of clinical benefit or LDL-C reduction of at least 40-50% from baseline 2, 3
- Absence of unacceptable adverse effects 2
Common Challenges and Pitfalls
- Incomplete documentation of maximally tolerated statin therapy or statin intolerance 2
- Failure to document adequate trial of high-intensity statins before seeking PCSK9 inhibitor therapy 2
- Missing baseline and current LDL-C levels 2, 3
- Inadequate documentation of ASCVD or familial hypercholesterolemia diagnosis 2, 1
- Not addressing potential cost barriers (Repatha is expensive and requires prior authorization due to cost considerations) 2, 4
Practical Tips for Successful Prior Authorization
- Provide comprehensive documentation of statin intolerance, including specific symptoms, CK levels if applicable, and failed statin rechallenge attempts 2
- Include all relevant clinical information supporting high cardiovascular risk 2, 3
- Document that the patient has been adherent to maximally tolerated statin therapy 2
- Include relevant cardiovascular imaging or test results that support the diagnosis 2, 3
- Consider patient assistance programs if cost is a barrier 2, 4
Remember that prior authorization requirements may vary by insurance plan, but these represent the most common criteria based on FDA-approved indications and clinical guidelines 2, 4.