How to Get Trikafta (elexacaftor/tezacaftor/ivacaftor) Covered by Humana in California: Complete Prior Authorization and Appeals Guide
Quick Answer: Getting Trikafta Covered by Humana in California
Trikafta requires prior authorization from Humana in California. To get approved: (1) Submit Humana's "Request for Medicare Prescription Drug Coverage Determination" form with CFTR genetic testing results confirming F508del or other responsive mutation, (2) Include CF diagnosis documentation and baseline liver function tests, (3) Fax to 877-486-2621 or submit via Humana provider portal. Standard decisions take up to 72 hours. If denied, file internal appeal within 65 days, then request California Independent Medical Review (68% overturn rate for specialty drugs). Start today: Have your CF specialist gather genetic test results and complete clinical documentation.
Table of Contents
- What This Guide Covers
- Before You Start: Verify Your Coverage
- Gather Required Documentation
- Submit Your Prior Authorization Request
- Follow-Up and Timeline Expectations
- If You Need Additional Information
- If Your Request is Denied
- California Independent Medical Review Process
- Renewal and Re-Authorization
- Quick Reference Checklist
- Frequently Asked Questions
What This Guide Covers
This guide helps California patients with cystic fibrosis (CF) and their healthcare providers navigate Humana's prior authorization process for Trikafta (elexacaftor/tezacaftor/ivacaftor). Whether you have Humana Medicare Advantage, Medicare Part D, or another Humana plan, we'll walk you through each step to maximize your chances of approval.
Trikafta is a breakthrough CFTR modulator triple therapy that costs approximately $26,000 per month. Prior authorization is mandatory for all Humana plans, but with proper documentation, most medically appropriate requests get approved within 72 hours.
From our advocates: We've seen the strongest approvals when CF specialists submit complete genetic testing results upfront, rather than waiting for Humana to request them later. One small documentation gap can add weeks to the process, so thoroughness at the start saves time overall.
Before You Start: Verify Your Coverage
Check Your Plan Type and Formulary Status
Step 1: Confirm your specific Humana plan type:
- Medicare Advantage (Part C)
- Medicare Part D (Prescription Drug Plan)
- Commercial/Employer plan
Step 2: Verify Trikafta's formulary status using Humana's drug search tool. Most Humana plans cover Trikafta under the pharmacy benefit (not medical benefit), typically on a high specialty tier.
Step 3: Confirm your CF specialist is in-network. Out-of-network providers may face additional authorization hurdles.
Specialty Pharmacy Requirement
Trikafta must be dispensed through Humana's specialty pharmacy network. CenterWell Specialty Pharmacy is Humana's preferred specialty provider and offers clinical support, financial assistance coordination, and direct-to-patient shipping.
Gather Required Documentation
Essential Clinical Documentation
| Requirement | What You Need | Where to Get It |
|---|---|---|
| CF Diagnosis | ICD-10 codes (E84.0, E84.1, E84.8, E84.9) | CF specialist's records |
| CFTR Genotype | F508del or other responsive mutation | CLIA-certified lab report |
| Baseline Labs | Liver function tests (ALT, AST, bilirubin) | Recent lab results |
| Prior Therapies | Documentation of previous CF treatments | Medical records |
| Medical Necessity | Specialist attestation letter | CF specialist |
Key Documentation Details
CFTR Genetic Testing: Must demonstrate at least one F508del mutation or another FDA-approved responsive CFTR mutation. The test must be from a CLIA-certified laboratory, and you'll need the official genetic test report.
Liver Function Monitoring: Trikafta requires baseline liver function tests and ongoing monitoring due to potential hepatotoxicity. Include ALT, AST, alkaline phosphatase, and bilirubin levels.
Prior Treatment History: Document any previous CFTR modulators (Kalydeco, Symdeko) and their outcomes, including reasons for discontinuation if applicable.
Submit Your Prior Authorization Request
Submission Methods (Fastest to Slowest)
- Humana Provider Portal (recommended) - Real-time status tracking
- Fax: 877-486-2621 - Include cover sheet with member ID
- Phone: 866-488-5995 (Medicare pharmacy prior authorization line)
Required Forms
Download the "Request for Medicare Prescription Drug Coverage Determination" form from Humana's prior authorization page. Your prescriber must complete this form entirely.
Clean Request Packet Checklist
✓ Completed PA form with all fields filled
✓ CFTR genetic test report (CLIA-certified lab)
✓ CF diagnosis documentation with ICD-10 codes
✓ Baseline liver function tests
✓ Prior therapy records (if applicable)
✓ Medical necessity letter from CF specialist
✓ Patient demographics and Humana member ID
Follow-Up and Timeline Expectations
Standard Timelines
- Standard Prior Authorization: Up to 72 hours (3 business days)
- Expedited Requests: 24 hours (for urgent medical situations)
- Appeals: 65 days from denial date to file internal appeal
When to Follow Up
Day 3: If no decision received, call Humana at 866-488-5995 to check status and obtain reference number.
Sample Follow-Up Script: "Hi, I'm calling to check on a prior authorization request for Trikafta submitted on [date] for member [ID]. Can you provide the status and reference number? If additional information is needed, what specifically is required and what's the fastest way to submit it?"
What Speeds vs. Slows Decisions
Speeds approval:
- Complete CFTR genotype documentation
- Baseline lab results included
- Clear medical necessity rationale
- All forms properly completed
Slows approval:
- Missing genetic test results
- Incomplete prior therapy documentation
- Unclear or missing ICD-10 codes
- Drug interaction concerns not addressed
If You Need Additional Information
Humana may request additional clinical information before making a determination. Common requests include:
- More detailed genetic testing: If mutation type needs clarification
- Additional lab work: If baseline values are concerning
- Drug interaction assessment: If patient takes CYP3A4 inhibitors/inducers
- Specialist consultation notes: For complex cases
Respond to these requests within 14 days to avoid automatic denial. Submit additional information using the same method as your original request.
If Your Request is Denied
Common Denial Reasons and Solutions
| Denial Reason | How to Fix |
|---|---|
| No CFTR genotype documented | Submit official genetic test report from CLIA-certified lab |
| Insufficient medical necessity | Provide detailed specialist letter with clinical rationale |
| Drug interactions | Include interaction assessment and management plan |
| Missing baseline labs | Submit liver function tests (ALT, AST, bilirubin) |
Internal Appeal Process
Timeline: File within 65 days of denial notice
Required Documents:
- Original denial letter
- Additional clinical documentation addressing denial reason
- Updated medical necessity letter
- Any new lab results or specialist notes
Submission: Use same methods as original PA request, clearly marked as "APPEAL"
Peer-to-Peer Review
Request a peer-to-peer review where your CF specialist speaks directly with Humana's medical director. This can be highly effective for complex cases.
Script for requesting P2P: "I'd like to request a peer-to-peer review for the denied Trikafta prior authorization. My CF specialist is available [days/times] and can discuss the medical necessity directly with your medical director."
California Independent Medical Review Process
If Humana's internal appeal is denied, California residents have powerful external review rights through the Department of Managed Health Care (DMHC).
IMR Success Rate
California's Independent Medical Review overturns 68% of specialty drug denials, giving you strong odds if your case has proper medical documentation.
How to Request IMR
- File internal appeal first - Required before IMR
- Wait for final denial - Or 30 days with no response
- Submit IMR application within 6 months of final denial
- No cost to patient - California pays for the review
Contact Information:
- DMHC Help Center: 888-466-2219
- Online application: healthhelp.ca.gov
IMR Timeline
- Standard Review: 45 days maximum
- Expedited Review: 7 days (or 72 hours for urgent cases)
- Decision is binding - Humana must comply if overturned
Renewal and Re-Authorization
Trikafta typically requires annual re-authorization. Calendar reminder: Submit renewal request 30-45 days before current authorization expires.
Renewal Documentation
- Updated clinical response assessment
- Current liver function tests
- Continued medical necessity letter
- Any changes in health status or medications
Note: You won't need to repeat CFTR genetic testing for renewals - the mutation doesn't change.
Quick Reference Checklist
Before Starting
□ Verify Humana plan type and formulary status
□ Confirm CF specialist is in-network
□ Identify preferred specialty pharmacy (CenterWell recommended)
Documentation to Gather
□ CFTR genetic test report (CLIA-certified lab)
□ CF diagnosis with ICD-10 codes
□ Baseline liver function tests
□ Prior therapy history
□ Medical necessity letter from specialist
Submission
□ Download current PA form from Humana website
□ Submit via provider portal or fax to 877-486-2621
□ Follow up after 3 days if no response
□ Document all reference numbers
If Denied
□ File internal appeal within 65 days
□ Request peer-to-peer review
□ Consider California IMR if internal appeal fails
Need help with complex appeals? Counterforce Health specializes in turning insurance denials into successful approvals by creating evidence-backed appeals that align with payer policies. Their platform helps patients, clinicians, and specialty pharmacies navigate prior authorization requirements and appeals processes for specialty medications like Trikafta.
Frequently Asked Questions
Q: How long does Humana prior authorization take for Trikafta in California? A: Standard requests are decided within 72 hours (3 business days). Expedited requests for urgent situations are decided within 24 hours.
Q: What if Trikafta is non-formulary on my Humana plan? A: You can request a formulary exception by demonstrating medical necessity and that preferred alternatives are inappropriate for your specific CFTR mutation.
Q: Can I request an expedited appeal in California? A: Yes, if your health situation is urgent. Expedited internal appeals are decided within 72 hours, and expedited IMR reviews are decided within 7 days.
Q: Does step therapy apply if I've tried other CFTR modulators outside California? A: Documentation of prior therapies from any state typically satisfies step therapy requirements, as long as you have proper medical records.
Q: What counts as medical necessity for Trikafta? A: Confirmed CF diagnosis with eligible CFTR mutation (F508del or other responsive genotype), appropriate age (≥2 years), and clinical need as determined by a CF specialist.
Q: How much will Trikafta cost with Humana coverage? A: Costs vary by plan tier and coverage phase. Contact CenterWell Specialty Pharmacy for benefit verification and potential financial assistance programs.
Q: What if my CF specialist is out-of-network? A: You may still get coverage, but consider requesting a network exception or getting a referral from an in-network provider to strengthen your case.
Q: Can I appeal if Humana requires quantity limits? A: Yes, your specialist can request an override if standard quantity limits don't meet your clinical needs based on weight, age, or other factors.
Sources & Further Reading
- Humana Prior Authorization Forms and Requirements
- California DMHC Independent Medical Review
- Trikafta FDA Prescribing Information
- Humana Specialty Pharmacy Network
Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical advice. Coverage decisions depend on individual circumstances, plan specifics, and medical necessity as determined by qualified healthcare providers. Always consult with your healthcare team and insurance plan for guidance specific to your situation. For assistance with California insurance complaints or appeals, contact the Department of Managed Health Care at 888-466-2219.
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