By Counterforce Health Team in Evkeeza (evinacumab-dgnb) —

How to Get Evkeeza (Evinacumab-dgnb) Covered by Aetna CVS Health in California: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Evkeeza Covered by Aetna CVS Health in California

Eligibility: Evkeeza requires prior authorization for homozygous familial hypercholesterolemia (HoFH) patients aged 5+ who've failed standard lipid-lowering therapies. Fastest approval path: Submit complete prior authorization through Aetna's Availity portal with genetic testing, LDL-C levels, and documented PCSK9 inhibitor failures. First step today: Contact your prescriber to gather HoFH confirmation and treatment history, then submit PA request via Aetna's provider portal. California residents have strong appeal rights through DMHC Independent Medical Review if initially denied.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Required Forms and Documentation
  4. Submission Portals and Contact Information
  5. Common Denial Reasons and Solutions
  6. Appeals Process for California Residents
  7. Specialty Pharmacy Enrollment
  8. Cost Assistance Programs
  9. When to Escalate to State Regulators
  10. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required Must be approved before treatment Aetna's 2024 precertification list Aetna Precert List
HoFH Diagnosis Genetic testing or clinical criteria Lab results, genetic counselor report Aetna Clinical Policy
Age Requirement 5 years and older Patient medical records FDA Label
Background Therapy Maximum tolerated statin + ezetimibe Prescription history Aetna PA Form
PCSK9 Inhibitor Trial Must try/fail Repatha or Praluent Treatment records Aetna PA Form
Prescriber Specialty Lipidologist, cardiologist, or endocrinologist Provider credentials Aetna Clinical Policy

Step-by-Step: Fastest Path to Approval

1. Verify HoFH Diagnosis (Patient/Prescriber)

What you need: Genetic testing showing mutations in LDLR, APOB, PCSK9, or LDLRAP1 genes, OR clinical diagnosis with untreated total cholesterol >500mg/dL. Timeline: Immediate if already available Submit to: Include with PA request

2. Document Treatment Failures (Prescriber)

What you need: Records showing inadequate response to maximum tolerated statin, ezetimibe, and PCSK9 inhibitor (unless contraindicated). Timeline: 1-2 days to compile records Submit to: Attach to PA form

3. Complete Prior Authorization Form (Prescriber)

What you need: Aetna's Evkeeza PA form with all clinical documentation. Timeline: 30 minutes to complete Submit to: Availity portal (preferred) or fax 1-888-267-3277

4. Submit Through Electronic Portal (Prescriber)

What you need: Availity account or Surescripts access. Timeline: Same day submission Expected response: 7-14 days for standard review

5. Enroll in Specialty Pharmacy (Patient/Prescriber)

What you need: Completed myRARE Start Form and insurance verification. Timeline: 2-3 days after PA approval Contact: Regeneron myRARE at 1-844-387-4936

6. Appeal if Denied (Patient/Prescriber)

What you need: Denial letter and additional clinical evidence. Timeline: File within 180 days of denial Submit to: Internal appeal first, then California DMHC if needed

7. Coordinate Treatment Administration (All parties)

What you need: Infusion site coordination and monitoring plan. Timeline: 1-2 weeks after drug delivery Monitor: Monthly LDL-C levels and safety parameters

Required Forms and Documentation

Primary Forms

Supporting Documentation

  • Genetic testing results confirming HoFH mutations
  • Laboratory reports showing LDL-C levels (treated and untreated)
  • Medical records documenting prior lipid-lowering therapy trials
  • Specialist consultation notes from lipidologist, cardiologist, or endocrinologist
  • Insurance card and member ID information
Clinician Corner: Your medical necessity letter should include: (1) specific HoFH mutation or clinical criteria met, (2) current LDL-C levels despite maximum therapy, (3) documented failures/intolerance to PCSK9 inhibitors with specific agents and timeframes, (4) treatment goals and monitoring plan, and (5) references to FDA labeling and clinical guidelines supporting Evkeeza use in HoFH.

Submission Portals and Contact Information

Electronic Submission (Preferred)

  • Availity Portal: Primary method for Aetna PA requests. Faster processing and real-time status updates. Access through Aetna provider portal
  • Surescripts Portal: Alternative electronic submission option for prescribers

Fax Submission

  • Specialty Medications: 1-888-267-3277
  • Medicare Advantage Plans: 1-844-268-7263
  • Cover sheet tip: Include "URGENT - Evkeeza PA Request" and patient member ID prominently

Phone Support

  • Provider Services: Number on back of patient's Aetna ID card
  • Member Services: 1-866-235-5660 (Medicare Part D members)
  • CVS Specialty Pharmacy: 1-800-237-2767

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
"Diagnosis not confirmed" Submit genetic testing or clinical HoFH criteria Lab results showing specific mutations
"Background therapy inadequate" Document maximum tolerated doses Prescription records with dosing and duration
"PCSK9 inhibitor not tried" Provide trial/failure documentation Treatment records showing specific agents, doses, outcomes
"Not medically necessary" Submit specialist attestation Lipidologist letter with clinical rationale
"Experimental/investigational" Reference FDA approval FDA label and indication

Appeals Process for California Residents

Internal Appeal (Required First Step)

Timeline: File within 180 days of denial notice Method: Submit through Aetna member portal or mail to address on denial letter Response time: 30-45 days for standard appeals, 72 hours for expedited

California DMHC Independent Medical Review (IMR)

When to use: After internal appeal denial or immediately for experimental/investigational denials Timeline: File within 180 days of plan's final denial Success rate: Over 50% for specialty drugs with proper documentation Cost: Free to patients Decision time: 30 days standard, 3-7 days expedited

How to apply:

  1. Complete IMR application at healthhelp.ca.gov
  2. Call DMHC Help Center: 888-466-2219 (multilingual support available)
  3. Submit all medical records and denial letters
  4. Independent medical expert reviews case at health plan's expense
Note: IMR decisions are binding on health plans. If approved, Aetna must authorize treatment within 5 working days.

When patients and clinicians need help navigating complex insurance approvals for specialty medications like Evkeeza, Counterforce Health provides targeted support by analyzing denial letters and crafting evidence-backed appeals that align with each payer's specific requirements. The platform helps turn insurance denials into successful approvals by identifying the exact denial basis and providing the clinical documentation that payers expect to see.

Specialty Pharmacy Enrollment

CVS Specialty Pharmacy Process

  1. Initiate enrollment after PA approval through CVS Specialty at 1-800-237-2767
  2. Complete benefits verification including copay assistance eligibility
  3. Schedule delivery to infusion site or patient's preferred location
  4. Coordinate with Regeneron myRARE for patient support services

Required Information

  • Approved prior authorization number
  • Complete prescription with dosing (15mg/kg IV every 4 weeks)
  • Infusion site address and contact information
  • Patient insurance and demographic details
  • Prescriber DEA and NPI numbers

Cost Assistance Programs

Manufacturer Support

  • myRARE Patient Support: 1-844-387-4936 for enrollment assistance and copay support
  • Eligibility: Commercial insurance patients may qualify for copay assistance
  • Coverage: Potential reduction of out-of-pocket costs for eligible patients

Foundation Programs

  • Patient Advocate Foundation: Co-pay relief program for qualifying patients
  • HealthWell Foundation: Financial assistance for rare disease treatments
  • National Organization for Rare Disorders (NORD): Patient assistance programs
Tip: Apply for manufacturer copay assistance before first infusion to ensure maximum savings eligibility.

When to Escalate to State Regulators

Contact DMHC if:

  • Aetna delays internal appeal beyond 30-45 days
  • Plan refuses to implement approved IMR decision
  • Procedural violations in appeal process
  • Urgent medical situation requires immediate intervention

DMHC Help Center: 888-466-2219 Online complaint: File at healthhelp.ca.gov

Documentation to Include:

  • All denial letters and appeal responses
  • Complete medical records supporting treatment need
  • Timeline of delays or procedural issues
  • Evidence of harm from treatment delays

For complex cases involving multiple denials or procedural issues, Counterforce Health can help patients and providers build comprehensive appeals that address each specific denial reason with targeted clinical evidence and payer-specific documentation requirements.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take for Evkeeza in California? Standard PA decisions take 7-14 days when submitted electronically with complete documentation. Expedited reviews for urgent cases are completed within 72 hours.

What if Evkeeza is not on Aetna's formulary? Request a formulary exception along with your PA request. Provide clinical evidence showing medical necessity and lack of suitable formulary alternatives.

Can I get an expedited appeal if my LDL-C levels are dangerously high? Yes. Request expedited review if delays could seriously jeopardize your health. Include physician attestation of urgency with your appeal.

Does step therapy apply if I've already failed PCSK9 inhibitors with another insurer? Previous treatment failures with other insurers should be documented and submitted. Aetna typically accepts this evidence to satisfy step therapy requirements.

What happens if my internal appeal is denied? California residents can request Independent Medical Review (IMR) through DMHC within 180 days. IMR decisions are binding on health plans.

How much does Evkeeza cost without insurance coverage? The manufacturer's stated average wholesale acquisition cost is approximately $450,000 per year, based on weight-based dosing of 15mg/kg every 4 weeks.

Can my primary care doctor prescribe Evkeeza? Aetna typically requires prescription by or consultation with a specialist (lipidologist, cardiologist, or endocrinologist) for approval.

What if I move to another state while on Evkeeza therapy? Contact Aetna member services immediately to ensure continued coverage and identify in-network providers in your new location.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions vary by individual plan and medical circumstances. Always consult with your healthcare provider about appropriate treatment options and contact your insurance company directly for plan-specific requirements. For assistance with insurance appeals and coverage issues in California, contact the DMHC Help Center at 888-466-2219.

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