Is Repatha (Evolocumab) SureClick medically indicated for a patient with mixed hyperlipidemia?

Medical Necessity Determination for Repatha (Evolocumab)

Repatha is medically indicated for this patient with mixed hyperlipidemia and established atherosclerotic cardiovascular disease (ASCVD), provided she meets specific criteria regarding maximally tolerated statin therapy and LDL-cholesterol levels that remain above goal.

Rationale for Approval

Patient's Clinical Profile Supports PCSK9 Inhibitor Use

This patient has established ASCVD based on her documented history of:

• Multifocal cerebral infarcts with severe intracranial stenosis 1
• Atherosclerotic disease confirmed on angiography 1
• History of stroke requiring hospitalization 1

Evolocumab is FDA-approved specifically to reduce the risk of MI, stroke, and coronary revascularization in adults with established ASCVD 1. The 2022 ACC Expert Consensus Decision Pathway confirms that evolocumab reduces cardiovascular events when added to statin therapy in patients with prior ASCVD 1, 2.

Critical Missing Information Required for Authorization

The following documentation is REQUIRED but NOT provided in the submitted materials:

1. Current LDL-cholesterol level - The fax does not include recent lipid panel results 3
2. Baseline LDL-cholesterol level before statin initiation 3
3. Documentation of maximally tolerated statin therapy - While the patient is on a statin (dose not clearly specified), there is no documentation of:
   • Duration of current statin therapy (minimum 4 weeks required) 3
   • Evidence that the patient is on high-intensity statin therapy 1
   • Documentation of statin dose optimization attempts 3
4. Evidence that LDL-C remains above goal despite statin therapy 1

Specific Criteria That Must Be Met

According to the 2022 ACC guidelines and the 2024 ESC guidelines, all of the following must be documented 1:

For patients with established ASCVD:

• Patient must be on maximally tolerated statin therapy (preferably high-intensity: atorvastatin ≥40 mg or rosuvastatin ≥20 mg daily) 1
• Minimum of 4 weeks on stable statin dose 3
• Current LDL-C must remain ≥70 mg/dL despite statin therapy for patients with additional high-risk conditions 1
• For very high-risk patients (which this patient qualifies as, given recurrent stroke), LDL-C goal is <55 mg/dL with ≥50% reduction from baseline 1

Ezetimibe should be added first before considering PCSK9 inhibitors:

• The 2024 ESC guidelines recommend that if LDL-C goal is not achieved with maximum tolerated statin, combination with ezetimibe is recommended (Class I, Level B) 1
• Only after maximally tolerated statin PLUS ezetimibe should PCSK9 inhibitor be added (Class I, Level A) 1
• There is no documentation that ezetimibe has been tried and failed in this patient 1

Dosing Appropriateness

The requested dose of "2 units every 28 days" requires clarification:

• Standard evolocumab dosing is either 140 mg every 2 weeks OR 420 mg once monthly 1, 4
• Both regimens provide comparable LDL-C reduction (64% and 58% respectively) 1, 4
• The term "2 units" is ambiguous and needs specification 1

Determination: PENDING - Additional Information Required

Required Documentation for Approval:

1. Complete lipid panel showing:

   • Baseline LDL-C before statin initiation 3
   • Current LDL-C on maximally tolerated statin therapy 3
   • Demonstration that LDL-C remains ≥70 mg/dL or has not achieved ≥50% reduction from baseline 1

2. Statin therapy documentation:

   • Current statin name and dose 3
   • Evidence of high-intensity statin therapy or documentation of intolerance to higher doses 1
   • Duration of current stable statin regimen (minimum 4 weeks) 3

3. Ezetimibe trial documentation:

   • Evidence that ezetimibe has been added to statin therapy 1
   • Duration of ezetimibe therapy (minimum 4 weeks) 1
   • LDL-C levels on statin plus ezetimibe combination 1
   • If ezetimibe not tried, rationale for contraindication or intolerance 1

4. Clarification of requested dose:

   • Specify either 140 mg every 2 weeks OR 420 mg monthly 1, 4

Clinical Considerations

This patient is at very high cardiovascular risk given her:

• Young age with established ASCVD 2
• Severe intracranial atherosclerotic disease 2
• History of multifocal strokes 2

If all criteria are met, evolocumab would provide significant benefit:

• 59-64% additional LDL-C reduction when added to statin therapy 2, 4
• 20% reduction in CV death, MI, or stroke demonstrated in FOURIER trial 2
• 27% reduction in lipoprotein(a), which may be particularly relevant given her atherosclerotic burden 2

Common Pitfalls to Avoid

• Do not approve without documented statin optimization - Patients must be on maximally tolerated statin therapy first 1
• Do not skip ezetimibe - Guidelines mandate ezetimibe trial before PCSK9 inhibitors unless contraindicated 1
• Ensure adequate treatment duration - Minimum 4 weeks on stable lipid-lowering therapy before adding evolocumab 3
• Document specific LDL-C values - Vague statements about "mixed hyperlipidemia" are insufficient for authorization 3