How to Get Evkeeza (Evinacumab-dgnb) Covered by Aetna in Texas: Complete Prior Authorization Guide with Appeals Process
Answer Box: Getting Evkeeza Covered by Aetna in Texas
Evkeeza (evinacumab-dgnb) requires prior authorization from Aetna for homozygous familial hypercholesterolemia (HoFH) in patients ≥5 years. Submit Aetna's precertification form with HoFH documentation (genetic testing or clinical criteria), prior therapy failures (statin + ezetimibe + PCSK9 inhibitor), and current LDL-C levels. Fax to 1-888-267-3277 or submit via provider portal. Texas law allows 4 years to appeal denials with external review available through Texas Department of Insurance.
First step today: Download Aetna's Evkeeza precertification form and gather genetic testing results or clinical HoFH documentation.
Table of Contents
- Coverage Basics
- Prior Authorization Process
- Step Therapy and Clinical Requirements
- Submission Methods and Timelines
- Cost Sharing and Specialty Pharmacy
- Appeals Process in Texas
- Common Denial Reasons and Solutions
- Renewal Requirements
- FAQ
- Sources and Further Reading
Coverage Basics
Is Evkeeza Covered by Aetna?
Yes, Aetna considers Evkeeza (evinacumab-dgnb) medically necessary for eligible patients with homozygous familial hypercholesterolemia (HoFH) aged 5 years and older. The drug is covered under the medical benefit as a specialty injectable, administered via IV infusion every 4 weeks at 15 mg/kg.
Which Aetna Plans Cover Evkeeza?
- Commercial plans (including Texas Health Aetna)
- Medicare Advantage plans
- Medicaid managed care plans
- All require prior authorization regardless of plan type
Coverage Requirements at a Glance
| Requirement | Details | Source |
|---|---|---|
| Prior Authorization | Required for all plans | Aetna Precert List |
| Age Limit | ≥5 years | Clinical Policy |
| Diagnosis | HoFH (ICD-10 E78.01) | Precert Form |
| Formulary Status | Specialty Tier 5/6 | Drug Guide |
| Site of Care | Outpatient hospital or approved infusion center | Site of Care Policy |
Prior Authorization Process
Step-by-Step: Fastest Path to Approval
- Verify Patient Eligibility (Clinic staff)
- Confirm active Aetna coverage via provider portal
- Check if plan is self-funded ERISA (different appeals process)
- Download Required Forms (Prescriber)
- Aetna Evkeeza Precertification Request Form
- Complete all sections including patient demographics and clinical justification
- Gather Clinical Documentation (Clinic staff)
- HoFH genetic testing report OR clinical criteria documentation
- LDL-C levels (baseline and current on therapy)
- Prior therapy records with dates and outcomes
- Current weight for dosing calculation
- Submit Complete Request (Prescriber)
- Preferred: Fax to 1-888-267-3277
- Alternative: Phone 1-866-752-7021 (urgent cases)
- Online: Aetna provider portal
- Submit ≥2 weeks before planned start date
- Track Status (Clinic staff)
- Note reference number from submission
- Follow up in 7-14 days if no response
- Check portal for status updates
- Respond to Requests (Prescriber)
- Answer any clinical questions within 24-48 hours
- Provide additional documentation if requested
- Obtain Approval (All)
- Approval typically valid for 6-12 months
- Coordinate with CVS Specialty for drug shipment and infusion scheduling
Step Therapy and Clinical Requirements
Required Prior Therapies
Aetna requires documentation of trials and failures (or contraindications/intolerance) of:
- At least two statins at maximally tolerated doses for ≥3 months each
- Statin + ezetimibe combination for ≥8 weeks
- PCSK9 inhibitor (alirocumab or evolocumab) for ≥3 months, if age-appropriate
HoFH Documentation Requirements
Option 1: Genetic Confirmation (Preferred)
- Genetic testing showing pathogenic variants in LDLR, APOB, PCSK9, or other HoFH-related genes
- Include full genetic report as PDF attachment
Option 2: Clinical Criteria
- Untreated LDL-C >500 mg/dL OR treated LDL-C ≥300 mg/dL
- PLUS cutaneous/tendon xanthomas before age 10
- AND/OR both parents with markedly elevated LDL-C
Laboratory Requirements
- Baseline (pre-treatment) lipid panel with date
- Current LDL-C on maximally tolerated therapy (within 1-3 months)
- Target LDL-C goal documented by specialist
Clinician Corner: Medical Necessity Letter Checklist
Include these elements in your supporting letter:Clear HoFH diagnosis with supporting evidenceDetailed prior therapy history with specific drugs, doses, durations, and outcomesCurrent LDL-C levels and cardiovascular riskClinical rationale citing FDA label for Evkeeza in HoFHConfirmation patient will continue maximally tolerated background therapy
Submission Methods and Timelines
How to Submit
- Fax (Preferred): 1-888-267-3277
- Phone (Urgent): 1-866-752-7021
- Provider Portal: Aetna provider portal
- Mail: Aetna PA, 1300 E. Campbell Rd., Richardson, TX 75081
Decision Timelines
- Standard Review: 24-72 hours after complete submission
- Expedited Review: 24 hours (if delay would jeopardize health)
- Submit Early: At least 2 weeks before planned treatment start
Cost Sharing and Specialty Pharmacy
Patient Costs
Cost sharing varies by specific Aetna plan. Common structures:
- Deductible: May apply before copay/coinsurance
- Specialty Tier: Typically 25-40% coinsurance or $100-500+ copay
- Out-of-pocket maximum: Annual limit protects against catastrophic costs
To find your exact costs: Log into your Aetna member portal or call the number on your insurance card.
Specialty Pharmacy Requirements
Evkeeza is dispensed through CVS Caremark specialty pharmacy as a specialty medical injectable. After PA approval:
- CVS Specialty coordinates shipment to infusion site
- Prior authorization transfers automatically within CVS Health system
- Patient receives care coordination support
Appeals Process in Texas
Texas provides strong patient protections for insurance appeals, with extended timelines compared to other states.
Internal Appeals (First Level)
- Filing Deadline: 4 years from denial notice (Texas law supersedes Aetna's 180-day standard)
- Decision Timeline: 45 business days standard; 72 hours expedited
- How to File: Aetna provider portal, mail to appeals department, or fax with supporting documentation
External Review (Texas Department of Insurance)
If internal appeal is denied, Texas offers independent external review:
- Filing Deadline: 4 months from final internal denial
- Decision Timeline: 20 days standard; 72 hours expedited
- Cost: Up to $650 (waivable for financial hardship)
- Process: File through Texas Department of Insurance
- Decision: Binding on Aetna if overturned
When to Request Expedited Review
Request expedited appeals when:
- Delay would jeopardize life or health
- Delay would significantly reduce ability to regain maximum function
- Standard timeline would cause irreversible adverse health consequences
From Our Advocates
We've seen HoFH denials overturned when families included comprehensive genetic testing reports and detailed documentation of failed prior therapies. The key is demonstrating that standard treatments have been inadequate despite good adherence. External review in Texas has been particularly effective for rare disease cases when internal appeals focus too narrowly on formulary status rather than medical necessity.
Common Denial Reasons and Solutions
| Denial Reason | How to Overturn |
|---|---|
| "HoFH diagnosis not confirmed" | Submit genetic testing report or detailed clinical criteria documentation with LDL-C values and family history |
| "Insufficient prior therapy" | Provide complete medication history with specific drugs, doses, durations, and documented failures/intolerance |
| "Age criteria not met" | Confirm patient is ≥5 years; cite updated FDA label for ages ≥1 year if applicable |
| "Experimental/investigational" | Reference FDA approval and Aetna clinical policy deeming it medically necessary |
| "Site of care issues" | Coordinate with approved infusion center or request exception per site of care policy |
Renewal Requirements
Evkeeza authorizations typically require renewal every 6-12 months. Submit renewal requests 90 days before expiration with:
- Updated LDL-C levels showing response to therapy
- Documentation of continued adherence to Evkeeza and background therapy
- Clinical notes confirming ongoing HoFH diagnosis and treatment plan
- Any new safety or efficacy data
FAQ
How long does Aetna prior authorization take in Texas? Standard decisions within 24-72 hours of complete submission. Expedited reviews (for urgent cases) within 24 hours.
What if Evkeeza is non-formulary on my plan? Submit a formulary exception request with medical necessity documentation. Aetna covers Evkeeza for HoFH even when non-formulary if criteria are met.
Can I request peer-to-peer review? Yes, prescribers can request physician-to-physician discussion during the PA review process. Contact the number on the denial letter or call 1-866-752-7021.
Does step therapy apply if I failed therapies outside Texas? Yes, prior therapy documentation from any location counts toward step therapy requirements. Include complete records with dates and outcomes.
What if my plan is self-funded ERISA? Self-funded employer plans follow federal (not Texas) appeals rules. Check with HR for specific appeals process and timelines.
How do I file a complaint with Texas regulators? Contact Texas Department of Insurance at 1-800-252-3439 for assistance with appeals or to file complaints about improper denials.
Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with each payer's specific requirements, pulling the right clinical evidence and procedural details to maximize approval rates for complex specialty medications like Evkeeza.
For patients navigating the Aetna prior authorization process, having comprehensive documentation and understanding Texas-specific appeal rights can make the difference between coverage and costly out-of-pocket expenses. When standard PA requests face obstacles, Counterforce Health's systematic approach to appeals has helped families access critical HoFH treatments by addressing the specific clinical and administrative requirements that payers expect.
Sources and Further Reading
- Aetna Evkeeza Precertification Form (PDF)
- Aetna Clinical Policy Bulletin 0989 - Evkeeza
- Aetna 2025 Precertification List (PDF)
- Texas Department of Insurance - External Review Process
- FDA Evkeeza Approval Letter
- Aetna Site of Care Policy
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage determinations. For additional help with Texas insurance appeals, contact the Texas Department of Insurance at 1-800-252-3439 or the Office of Public Insurance Counsel at 1-877-611-6742.
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