How can I initiate a prior authorization for evolocumab (Repatha) for a patient who finds the medication too expensive?

How to Initiate Prior Authorization for Repatha (Evolocumab)

Contact your patient's insurance company directly via phone or their online portal to initiate the prior authorization (PA) process, ensuring you have documented evidence that the patient meets guideline-based criteria: LDL-C ≥70 mg/dL despite maximally tolerated statin therapy (with or without ezetimibe), and either established cardiovascular disease or very high cardiovascular risk. 1

Step-by-Step PA Initiation Process

1. Gather Required Clinical Documentation

Before contacting the insurance company, compile:

• Current LDL-C level (must be ≥70 mg/dL on current therapy) 1
• Statin therapy history: Document the maximally tolerated statin dose and duration (typically ≥3 months)
• Ezetimibe trial: Most insurers require documented trial of ezetimibe added to statin, with LDL-C remaining ≥100 mg/dL 1
• Cardiovascular risk status:
  • Established ASCVD (prior MI, stroke, ACS, revascularization) 2
  • OR very high risk features (familial hypercholesterolemia, diabetes with target organ damage)
• Statin intolerance documentation (if applicable): Must document trials of at least 2-3 different statins with specific adverse effects

2. Initiate the PA Request

Method varies by insurer 3, 4:

• Online portal (fastest - average approval 0.17 days): Most major insurers now offer electronic PA submission
• Phone: Call the pharmacy benefits number on the patient's insurance card
• Fax: Traditional method but significantly slower (average 1.31 days to approval) 5

Critical point: The PA approval rate for PCSK9 inhibitors like Repatha is approximately 97.5% when appropriate documentation is provided 5, so thoroughness in documentation is more important than the submission method.

3. Include Guideline-Based Justification

For secondary prevention (established ASCVD):

• State that patient has established cardiovascular disease
• Document LDL-C ≥70 mg/dL on maximally tolerated statin + ezetimibe
• Reference that guidelines give this a Class I, Level A recommendation 1

For primary prevention (no prior MI/stroke):

• Document very high cardiovascular risk features
• Note LDL-C ≥100 mg/dL on maximally tolerated statin + ezetimibe 1
• This has Class IIb, Level C evidence but recent data supports benefit 6

4. Specify Dosing in PA Request

From FDA labeling 2:

• Standard dosing: 140 mg every 2 weeks OR 420 mg monthly
• For established ASCVD or primary hyperlipidemia: Either regimen is appropriate
• Document that LDL-C reduction can be measured as early as 4 weeks

5. Address Cost Concerns Proactively

If PA is approved but patient still cannot afford:

• Manufacturer assistance program: Amgen offers copay support and patient assistance programs - call 1-844-REPATHA (1-844-737-2842) 2
• Alternative if PA denied: Consider bempedoic acid as a more affordable option that doesn't require injection 7
• Document financial hardship in medical record for potential appeals

Common PA Pitfalls to Avoid

1. Insufficient statin optimization: Insurers will deny if you haven't documented maximally tolerated statin dose
2. Missing ezetimibe trial: Most plans require documented ezetimibe failure before approving PCSK9 inhibitors 1
3. Inadequate LDL-C documentation: Must show recent labs (typically within 3 months)
4. Wrong submission method: Faxing adds 1+ days to approval time vs. online submission 5
5. Incomplete cardiovascular risk documentation: Be specific about ASCVD events or risk factors

Expected Timeline

• Average approval time: 0.82 days (range 0-14 days) 5
• Online submission: ~0.17 days
• Fax submission: ~1.31 days 5
• If denied: Appeal immediately with additional documentation; consider peer-to-peer review with medical director

Documentation for Discharge Planning

If initiating during hospitalization (e.g., post-ACS), use a standardized discharge letter 7 that includes:

• Specific LDL-C target (<55 mg/dL for post-ACS)
• Timeline for adding Repatha if targets not met (typically 4-6 weeks after statin + ezetimibe)
• Clear instructions that PA should be initiated if LDL-C remains elevated

The PA process is labor-intensive but has a 97.5% approval rate when documentation is complete 5, so focus your effort on thorough upfront documentation rather than repeated submissions.