By Counterforce Health Team in Trikafta (elexacaftor/tezacaftor/ivacaftor) —

Getting Trikafta Approved by Aetna CVS Health in California: Complete Prior Authorization and Appeals Guide 2024

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

Trikafta requires prior authorization from Aetna CVS Health. Submit documentation including CFTR genotype test results, cystic fibrosis diagnosis (ICD-10: E84.0-E84.9), and clinical notes. If denied, file an internal appeal within 180 days, then request California's Independent Medical Review (IMR) through DMHC—which overturns 68% of specialty drug denials. Start with your provider submitting the PA request via Aetna's portal or by calling 1-888-632-3862.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. ICD-10 Coding and Documentation Requirements
  4. Product Coding: NDC Numbers and Billing
  5. Common Denial Reasons and How to Fix Them
  6. Appeals Process in California
  7. Costs and Patient Assistance
  8. FAQ

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Mandatory for all Trikafta prescriptions Aetna 2024 PA List
CFTR Genotype Must document ≥1 F508del or other FDA-approved mutation FDA labeling, genetic test results
ICD-10 Code E84.0 (pulmonary), E84.1 (intestinal), or other E84.x Provider documentation
Age Requirement ≥2 years per FDA labeling Prescriber verification
Baseline Labs Liver function tests required Clinical records
Specialty Pharmacy CVS Caremark Specialty typically required Aetna member portal

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation

Who: Patient and provider
What: CFTR genotype test, diagnosis confirmation, prior therapy history
Timeline: Before PA submission

2. Submit Prior Authorization Request

Who: Prescribing provider
How: Aetna provider portal or call 1-888-632-3862
Timeline: Submit 2+ weeks before intended start

3. Include Complete Clinical Documentation

  • Cystic fibrosis diagnosis with appropriate ICD-10 code
  • CFTR genotype confirming eligible mutation
  • Baseline liver function tests
  • Treatment goals and clinical rationale

4. Follow Up Within 5 Business Days

Who: Provider office
Action: Confirm PA receipt and check status

5. If Approved: Fill at Specialty Pharmacy

Where: CVS Caremark Specialty (typically required)
Timeline: 2-5 business days for delivery

6. If Denied: File Internal Appeal

Timeline: Within 180 days of denial
Documents: Denial letter, medical records, physician statement

7. If Internal Appeal Denied: Request IMR

Who: Patient or provider
Where: California DMHC
Timeline: Within 6 months of final denial
Success Rate: 68% for specialty drugs

ICD-10 Coding and Documentation Requirements

Primary Cystic Fibrosis Codes

  • E84.0 - Cystic fibrosis with pulmonary manifestations (most common)
  • E84.1 - Cystic fibrosis with intestinal manifestations
  • E84.11 - Meconium ileus in cystic fibrosis
  • E84.19 - Cystic fibrosis with other intestinal manifestations
  • E84.8 - Cystic fibrosis with other manifestations
  • E84.9 - Cystic fibrosis, unspecified (avoid when possible)

Documentation Best Practices

Medical Necessity Elements:

  • Confirmed cystic fibrosis diagnosis
  • CFTR genotype showing F508del or other responsive mutation
  • Current symptoms and disease progression
  • Previous therapies tried (if applicable)
  • Expected treatment outcomes
  • Monitoring plan
Clinician Corner: Avoid using E84.9 (unspecified) as it can trigger claim reviews. Document specific manifestations to support E84.0 (pulmonary) or E84.1 (intestinal). Include genetic testing results showing the specific CFTR mutations to strengthen medical necessity.

Product Coding: NDC Numbers and Billing

Trikafta NDC Numbers (2024)

  • Tablets (28-count): 66794-015-28
  • Granules (56 packets): 66794-016-56
  • Alternative packaging: Check current DailyMed listing for updates

Billing Guidelines

Pharmacy Benefit (Standard):

  • Use 11-digit NDC for claims
  • Bill through CVS Caremark Specialty
  • Prior authorization required
  • Patient pays specialty copay

Medical Benefit (Rare):

  • Use J8499 + NDC if attempting medical billing
  • Expect denials—Trikafta is oral, not typically medical benefit
  • Reserve for exceptional circumstances only

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing CFTR genotype Submit genetic test results Lab report showing F508del or other eligible mutation
Lack of baseline labs Provide liver function tests Recent ALT, AST, bilirubin results
Age restriction Verify patient ≥2 years Date of birth documentation
Non-formulary status Request formulary exception Medical necessity letter, clinical guidelines
Quantity limits Justify dosing FDA labeling, weight-based calculations
Step therapy Document prior failures Previous CF therapy records, intolerance notes

Appeals Process in California

Internal Appeal (Required First Step)

Timeline: File within 180 days of denial
Process: Submit to Aetna member services
Decision: 30 days standard, 72 hours expedited
Required: Denial letter, medical records, physician statement

California Independent Medical Review (IMR)

When: After internal appeal denial
Timeline: File within 6 months of final denial
Cost: Free to patient
Success Rate: 68% overturn rate for specialty drugs
Decision Time: 45 days standard, 7 days expedited

How to File IMR:

  1. Visit healthhelp.ca.gov or call 888-466-2219
  2. Complete IMR application online or by phone
  3. Submit all supporting documentation
  4. DMHC assigns independent physician reviewer
  5. Binding decision issued
Note: California's IMR process is particularly favorable for specialty drugs like Trikafta when proper documentation is provided. The 68% success rate reflects strong patient protections under state law.

Counterforce Health's platform can significantly streamline this appeals process by automatically identifying the specific denial basis—whether it's PA criteria, step therapy, non-formulary status, or "not medically necessary"—and drafting targeted, evidence-backed rebuttals aligned to Aetna's own policies. The system pulls the right citations from FDA labeling, peer-reviewed studies, and specialty guidelines, then weaves them into appeals with required clinical facts like diagnosis codes, prior trials, and treatment goals.

Costs and Patient Assistance

Estimated Costs

  • List Price: $26,000/month ($312,000/year)
  • With Insurance: Varies by plan (specialty tier copay)
  • Patient Assistance: Available through Vertex

Financial Support Options

Vertex Patient Services:

  • Copay assistance program
  • Financial hardship applications
  • Insurance navigation support
  • Phone: 1-877-752-5933

Foundation Grants:

  • Cystic Fibrosis Foundation Compass Program
  • HealthWell Foundation (when open)
  • Patient Access Network Foundation

When to Escalate

Contact California regulators if:

  • Aetna doesn't respond within required timeframes
  • Internal appeal process is delayed beyond 30 days
  • IMR application is rejected without cause

California DMHC Help Center: 888-466-2219
File Complaint Online: healthhelp.ca.gov

FAQ

Q: How long does Aetna prior authorization take for Trikafta in California?
A: Standard PA decisions are typically made within 5-10 business days. Expedited requests for urgent cases must be decided within 72 hours per California law.

Q: What if Trikafta isn't on my Aetna formulary?
A: Request a formulary exception. Aetna must respond within 72 hours for standard requests, 24 hours for urgent requests. If no response, the request is automatically approved under California law.

Q: Can I appeal if I don't have the required CFTR genotype test?
A: Yes, but you'll need to obtain genetic testing first. Most appeals succeed when proper mutation documentation is provided showing F508del or other FDA-approved variants.

Q: Does step therapy apply if I've used other CF medications before?
A: Document any prior CF therapies, including outcomes and reasons for discontinuation. This strengthens your case for step therapy override.

Q: What's the difference between internal appeal and IMR?
A: Internal appeal is with Aetna directly (required first). IMR is California's external review with independent physicians—this has a 68% success rate for specialty drugs.

Q: Can I get expedited review for Trikafta?
A: Yes, if there's risk of serious harm from delay. Expedited internal appeals get 72-hour decisions; expedited IMR gets 7-day decisions.

From our advocates: We've seen cases where patients initially faced denials for missing genetic testing documentation, but once the CFTR genotype was properly submitted showing F508del mutations along with baseline liver function tests, the prior authorization was approved within days. The key is ensuring all required clinical elements are included upfront rather than submitting piecemeal documentation.

For patients navigating complex denials, Counterforce Health specializes in turning insurance denials into targeted appeals by identifying the specific denial basis and crafting evidence-backed rebuttals aligned to each payer's own policies—helping patients, clinicians, and specialty pharmacies get prescription drugs approved more efficiently.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical or legal advice. Coverage policies and requirements can change. Always verify current requirements with Aetna and consult your healthcare provider for medical decisions. For assistance with appeals and coverage issues, contact the California Department of Managed Health Care at 888-466-2219.

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