By Counterforce Health Team in Kalydeco (ivacaftor) —

Getting Kalydeco (Ivacaftor) Covered by Cigna in Michigan: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Kalydeco (Ivacaftor) Covered by Cigna in Michigan

Eligibility: Patients with cystic fibrosis and documented FDA-approved CFTR mutations responsive to ivacaftor can get Kalydeco covered by Cigna with proper documentation.

Fastest Path: 1) Gather CFTR genotype test results and CF diagnosis documentation, 2) Have your CF specialist submit prior authorization through Cigna's specialty pharmacy network, 3) If denied, file internal appeal within 180 days, then Michigan DIFS external review within 127 days.

First Step Today: Contact your CF care team to confirm you have documented responsive CFTR mutations (G551D, R117H, S549N, etc.) and request they initiate Cigna's prior authorization process.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Kalydeco prescriptions Cigna specialty pharmacy network Cigna PA Policy
CFTR Genotype Must have FDA-approved responsive mutation Genetic testing lab report FDA Label
Age Requirement 2 years or older Patient medical record Cigna PA Policy
Specialist Prescriber Pulmonologist or CF specialist Prescriber credentials Cigna PA Policy
CF Diagnosis Clinical evidence of cystic fibrosis Sweat test, genetic testing, clinical notes Cigna PA Policy
Internal Appeals 180 days from denial Cigna member portal or written request Cigna Coverage Decisions
External Review 127 days from final denial Michigan DIFS portal Michigan DIFS

Step-by-Step: Fastest Path to Approval

1. Confirm Your CFTR Mutation Status

Who does it: Patient with CF care team
Document needed: Genetic test report showing responsive mutation
Timeline: Same day if results available
Key point: Kalydeco only works for specific mutations like G551D, R117H, S549N, and others listed in the FDA label.

2. Gather Clinical Documentation

Who does it: CF specialist or pulmonologist
Documents needed:

  • CF diagnosis confirmation (sweat test results, clinical presentation)
  • ICD-10 code (typically E84.0 for pulmonary CF)
  • Prior therapy history if applicable Timeline: 1-2 business days

3. Submit Prior Authorization

Who does it: Prescribing physician
How to submit: Through Cigna's specialty pharmacy network (typically Express Scripts/Accredo)
Timeline: Cigna responds within 72 hours for standard requests, 24 hours for expedited
Source: Cigna PA requirements

4. Monitor Approval Status

Who does it: Patient and care team
How: Check Cigna member portal or call member services
Timeline: Decision within 3 business days

5. If Denied: File Internal Appeal

Who does it: Patient or authorized representative
How to submit: Cigna member portal, fax, or mail
Timeline: Must file within 180 days of denial
Required: Copy of denial letter, physician letter of medical necessity

6. If Still Denied: Michigan External Review

Who does it: Patient
How to submit: Michigan DIFS portal or call 877-999-6442
Timeline: File within 127 days of final internal denial
Decision: Within 60 days (72 hours if expedited)

Coding That Supports Your Request

ICD-10 Codes for Cystic Fibrosis

The right diagnostic coding helps establish medical necessity:

  • E84.0: Cystic fibrosis with pulmonary manifestations (most common)
  • E84.1: Cystic fibrosis with intestinal manifestations
  • E84.8: Cystic fibrosis with other manifestations
  • E84.9: Cystic fibrosis, unspecified
Tip: Your physician should use the most specific code based on your primary symptoms. Pulmonary involvement (E84.0) is most common and well-supported for Kalydeco coverage.

NDC Codes and Billing

Kalydeco is billed as a pharmacy benefit using NDC codes, not medical benefit J-codes:

  • Tablets: NDC 51167-200-01 (60-count bottle)
  • Granules: NDC 51167-785-01 (56 packets)

The medication goes through specialty pharmacy networks, not medical billing. Annual list price is approximately $369,255 for a full year of treatment.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing genotype documentation Submit complete CFTR mutation analysis Lab report showing responsive mutation
Age requirement not met Verify patient is 2+ years old Birth certificate or medical record
Not prescribed by specialist Get prescription from CF specialist Pulmonologist or CF center prescription
Insufficient CF diagnosis evidence Provide comprehensive diagnostic workup Sweat test, genetic testing, clinical presentation
Step therapy requirement Document contraindications to alternatives Physician letter explaining why other CFTR modulators inappropriate

Appeals Process in Michigan

Michigan offers robust patient protections through the Patient's Right to Independent Review Act. Here's how to navigate the system:

Internal Appeals with Cigna

  • Timeline: 180 days from denial date
  • Process: Submit through member portal or written request
  • Required documents: Denial letter, physician support letter, clinical records
  • Decision: Within 30 days for standard, 72 hours for expedited

Michigan External Review

If Cigna's internal appeal is denied, Michigan law provides an independent review:

  • Timeline: 127 days from final internal denial
  • Process: File with Michigan DIFS
  • Cost: Free to patients
  • Decision: Binding on Cigna if approved
  • Expedited option: 72 hours for urgent cases with physician attestation
Note: Michigan's 127-day window is longer than the federal standard, giving patients extra time to gather documentation.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, identifies the specific denial basis, and drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements. For complex cases like Kalydeco appeals, having expert support can significantly improve approval odds.

Cost Assistance Options

Even with insurance coverage, Kalydeco can be expensive. Consider these options:

Manufacturer Support

  • Vertex CarePath: Patient assistance program for eligible patients
  • Copay assistance: May reduce out-of-pocket costs for commercially insured patients
  • Contact: Visit Vertex Pharmaceuticals patient support page

Foundation Assistance

  • Cystic Fibrosis Foundation: Compass program for CF-related expenses
  • Patient Advocate Foundation: Copay relief for specialty medications
  • Healthwell Foundation: Disease-specific assistance programs

State Programs

Michigan residents may qualify for additional support through Healthy Michigan (Medicaid expansion) or other state assistance programs.

FAQ

How long does Cigna prior authorization take for Kalydeco in Michigan?
Standard requests: 72 hours. Expedited requests (if health risk demonstrated): 24 hours. Source: Cigna PA policy

What if Kalydeco isn't on Cigna's formulary?
Request a formulary exception with clinical rationale. Your physician must demonstrate medical necessity and why formulary alternatives are inappropriate.

Can I get an expedited appeal in Michigan?
Yes. Both Cigna internal appeals and Michigan DIFS external reviews offer expedited options when delay would pose serious health risks.

Do I need to try other CFTR modulators first?
Depends on your specific mutations and Cigna plan. Some plans require step therapy with Trikafta first, while others approve Kalydeco directly for responsive mutations.

What happens if Michigan DIFS approves my external review?
The decision is binding. Cigna must provide coverage as directed by the independent medical review.

How much does Kalydeco cost without insurance?
Approximately $369,255 annually at list price. Actual costs vary based on pharmacy and available discounts.

From Our Advocates

We've seen many Kalydeco denials overturned when families provide comprehensive CFTR genotype documentation upfront. One key tip: make sure your genetic test report explicitly lists the specific mutation name (like "G551D" or "R117H") rather than just general "CFTR mutation detected." Cigna's system looks for exact mutation matches against their approved list, and vague reporting often triggers automatic denials that could have been avoided.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations change frequently. Always verify current requirements with your insurer and consult with your healthcare team for medical decisions. For personalized appeals assistance, Counterforce Health provides specialized support for prescription drug coverage challenges.

Last updated: Based on 2024 policies and Michigan regulations. Verify current requirements before submitting requests.

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