By Counterforce Health Team in Emgality (galcanezumab-gnlm) —

How to Get Emgality (galcanezumab-gnlm) Covered by Aetna CVS Health in Texas: Complete Appeals Guide

Answer Box: Getting Emgality Covered by Aetna CVS Health in Texas

Aetna CVS Health requires prior authorization for Emgality (galcanezumab-gnlm) with mandatory step therapy—you must first fail at least two generic migraine preventives like topiramate and propranolol. Your doctor submits the PA request through CVS Caremark with a migraine diary showing 4+ headache days monthly and documentation of failed preventives. If denied, you have 180 days to appeal internally, then access Texas's independent external review process at no cost. Start today: Ask your doctor to begin documenting current migraine frequency and gather records of any previously tried preventive medications.

Table of Contents

  1. Aetna CVS Health Coverage Policy Overview
  2. FDA Indications and Medical Necessity
  3. Step Therapy Requirements and Exceptions
  4. Required Documentation Checklist
  5. Prior Authorization Submission Process
  6. Appeals Process in Texas
  7. Common Denial Reasons and Solutions
  8. Costs and Patient Support Options
  9. When to Escalate to State Regulators
  10. Frequently Asked Questions

Aetna CVS Health Coverage Policy Overview

Aetna CVS Health covers Emgality for both FDA-approved indications but requires prior authorization across all plan types—commercial HMO/PPO, Medicare Advantage, and Medicaid managed care plans. The medication is classified as a high-tier specialty drug dispensed exclusively through CVS Specialty Pharmacy.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all plans Aetna CGRP Policy
Formulary Tier High-tier specialty (Tier 4-5) Plan-specific formulary
Step Therapy 2+ generic preventive failures required CGRP policy document
Quantity Limits 120mg monthly maintenance dose CVS Caremark system
Site of Care CVS Specialty Pharmacy only Specialty network
Diagnosis Codes G43.x (migraine), G44.0 (cluster headache) ICD-10 requirements

FDA Indications and Medical Necessity

Emgality received FDA approval for two distinct indications, both of which Aetna CVS Health covers when medical necessity criteria are met:

Migraine Prevention (September 2018)

  • 240mg loading dose (two 120mg injections), then 120mg monthly
  • Indicated for adults with episodic or chronic migraine
  • Clinical trials demonstrated significant reduction in monthly migraine days

Episodic Cluster Headache (June 2019)

  • 300mg monthly during cluster periods
  • First and only CGRP antibody approved for this indication
  • Shown to reduce weekly cluster attacks by an average of 8.7 versus 5.2 for placebo
Note: Off-label uses are generally not covered without exceptional clinical circumstances and extensive documentation.

Step Therapy Requirements and Exceptions

Aetna CVS Health mandates documented failure, intolerance, or contraindication to at least two generic migraine preventives before approving Emgality. This step therapy requirement applies to all plan types.

Required Prior Medications

Typical first-line preventives that must be tried:

  • Topiramate (generic for Topamax) - 50-100mg daily for 3+ months
  • Propranolol or other beta-blockers - therapeutic doses for 3+ months
  • Amitriptyline or other tricyclic antidepressants
  • Valproic acid (if no contraindications)

Medical Exceptions to Step Therapy

Step therapy can be bypassed with documented contraindications:

  • Cardiovascular history exempting beta-blockers
  • Psychiatric conditions precluding tricyclic antidepressants
  • Pregnancy planning avoiding teratogenic medications like valproic acid
  • Previous severe adverse reactions to required medications

Documentation must specify the contraindication and cite clinical guidelines or FDA labeling supporting the exception.

Required Documentation Checklist

Your healthcare provider must submit comprehensive clinical documentation through CVS Caremark's prior authorization system:

Essential Clinical Documents

  • Migraine diary showing ≥4 migraine days per month over 3 consecutive months (current within 6 months)
  • ICD-10 diagnosis code (G43.x for migraine, G44.0 for cluster headache)
  • Complete medication history with specific details for each failed preventive:
    • Drug name, dose, duration of trial
    • Reason for discontinuation (ineffective vs. intolerance)
    • Dates of treatment
  • Neurological examination findings
  • Current medication list including allergies
  • Treatment goals and expected outcomes

Step Therapy Documentation Template

For each previously tried medication, include:

"Patient trialed [medication name] [dose] daily for [duration] from [start date] to [end date]. Treatment was discontinued due to [specific reason: lack of efficacy/adverse effects/contraindication]. Baseline migraine frequency was [X] days/month; during treatment, frequency was [Y] days/month."

Prior Authorization Submission Process

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient/Clinic Staff)
    • Log into Aetna member portal to confirm current formulary status
    • Check CVS Caremark formulary for any recent changes
  2. Gather Documentation (Healthcare Provider)
    • Complete migraine diary for 3+ months
    • Collect records of failed preventive medications
    • Prepare medical necessity letter
  3. Submit PA Request (Healthcare Provider Only)
    • Online: Availity.com (preferred method)
    • Fax: 1-888-267-3277 (specialty PA)
    • Phone: 1-855-582-2025 (precertification)
  4. Await Decision (30-45 days standard, 24-72 hours expedited)
  5. If Approved: Enroll with CVS Specialty Pharmacy for dispensing
  6. If Denied: Review denial letter and prepare appeal within 180 days

Expedited Review Process

Request expedited review if treatment delay could cause serious harm:

  • Call: 1-866-235-5660 (24/7 prescription drug expedited appeals)
  • Required: Physician attestation that delay jeopardizes health
  • Timeline: 24-72 hour decision

Appeals Process in Texas

Texas provides robust patient protections for insurance denials, including access to independent external review at no cost to patients.

Internal Appeal Timeline

  • Deadline to file: 180 calendar days from denial date
  • Standard decision: 30 days for pre-service requests
  • Expedited decision: 72 hours for urgent situations
  • Required: Submit via Aetna member portal or written request

Independent External Review (Texas)

If your internal appeal is denied, Texas law provides binding independent review:

  • Eligibility: Denials based on medical necessity, appropriateness, or experimental/investigational determination
  • Cost: Free to patients (paid by Aetna)
  • Timeline: Request within 4 months of final internal denial
  • Decision timeframe: 20 days standard, 5 days urgent
  • Contact: Texas Department of Insurance at 1-800-252-3439
From our advocates: "We've seen Texas patients successfully overturn Emgality denials at the external review level by focusing on the specific clinical evidence—migraine diary data, documented preventive failures, and citing the FDA label's efficacy data. The key is showing you've met Aetna's own published criteria, not just general medical necessity."

Required Appeal Documentation

  • Copy of original denial letter
  • Updated clinical records since initial submission
  • Peer-reviewed literature supporting Emgality's efficacy
  • Physician letter addressing specific denial reasons
  • Patient impact statement (optional but helpful)

Common Denial Reasons and Solutions

Denial Reason Solution Strategy
Insufficient step therapy Submit detailed records of 2+ failed preventives with doses, durations, and failure reasons
Inadequate migraine documentation Provide 3-month migraine diary showing ≥4 headache days monthly
Non-formulary status Request formulary exception with medical necessity letter
Quantity limits exceeded Confirm dosing aligns with FDA labeling (120mg monthly maintenance)
Lack of specialist involvement Obtain neurology or headache specialist consultation

Medical Necessity Letter Template

Your provider's letter should address:

  1. Patient identification and confirmed diagnosis
  2. Current clinical status with migraine frequency/severity
  3. Prior treatment failures with specific details
  4. Clinical rationale for Emgality based on FDA indication
  5. Expected outcomes and monitoring plan
  6. Guideline support from American Headache Society or similar

Costs and Patient Support Options

List Price and Insurance Coverage

  • Monthly cost: ~$741.69 for 120mg pen
  • Annual cost: ~$8,900 with loading dose
  • Insurance coverage: Varies by plan tier and copay structure

Patient Assistance Programs

  • Lilly Cares Foundation: Income-based free medication program
  • Emgality Savings Program: Commercial insurance copay assistance
  • CVS Specialty: Patient financial counseling services

Contact Emgality.com for current eligibility requirements and application processes.

When to Escalate to State Regulators

Contact Texas regulators if you experience:

  • Unreasonable delays in appeal processing
  • Failure to provide required appeal forms
  • Violations of Texas insurance law

Texas Resources

Counterforce Health helps patients navigate complex prior authorization and appeal processes by analyzing denial letters and crafting evidence-based appeals that address insurers' specific coverage criteria. Our platform specializes in turning insurance denials into targeted rebuttals using payer-specific workflows and clinical documentation requirements.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in Texas? Standard PA decisions take 30-45 days. Expedited reviews for urgent medical situations are completed within 24-72 hours.

What if Emgality is non-formulary on my plan? Your doctor can request a formulary exception by demonstrating medical necessity and submitting clinical documentation supporting Emgality over formulary alternatives.

Can I request an expedited appeal in Texas? Yes, if treatment delay could seriously jeopardize your health. Call 1-866-235-5660 for expedited prescription drug appeals.

Does step therapy apply if I failed preventives outside Texas? Yes, documented treatment failures from any location count toward step therapy requirements if properly documented with dates, doses, and outcomes.

What happens if CVS Specialty Pharmacy delays my medication? Contact Aetna member services and request an expedited appeal if the delay affects your treatment. CVS Specialty may provide emergency supplies in certain situations.

How much does external review cost in Texas? External review through Texas's Independent Review Organization is free to patients—the insurer pays all costs.

Can I appeal if I'm on a self-funded employer plan? Self-funded ERISA plans follow federal appeal rules, not Texas state processes. Contact your employer's benefits administrator for specific procedures.

What if my migraine diary is incomplete? Work with your provider to reconstruct migraine frequency using medical records, prescription refill dates, and any available documentation. A neurologist can help validate the clinical picture.

Sources & Further Reading

For complex appeals requiring detailed clinical documentation and payer-specific strategy, Counterforce Health provides specialized support in translating medical necessity into successful insurance approvals.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently—always verify current requirements with Aetna CVS Health and consult your healthcare provider for medical decisions. For official Texas insurance regulations and appeal procedures, contact the Texas Department of Insurance.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.