By Counterforce Health Team in Kalydeco (ivacaftor) —

Lowering Out-of-Pocket for Kalydeco (ivacaftor) with Aetna (CVS Health) in Michigan: Copay Cards, Appeals & Financial Assistance

Answer Box: Getting Kalydeco Covered in Michigan

Aetna (CVS Health) covers Kalydeco (ivacaftor) as a specialty drug requiring prior authorization and CFTR genotype confirmation. Michigan patients can access up to $20,000 annual copay assistance through Vertex GPS (commercial insurance only), plus foundation grants. First step today: Have your CF specialist submit PA via Aetna's Availity portal with CFTR mutation testing and enroll simultaneously with CVS Specialty. If denied, Michigan offers external review through DIFS within 127 days.

Table of Contents

  1. What Drives Kalydeco Costs with Aetna
  2. Benefit Investigation: Know Your Coverage
  3. Manufacturer & Foundation Assistance
  4. Formulary Exceptions & Step Therapy Overrides
  5. Specialty Pharmacy vs. Mail Order
  6. Appeals Process in Michigan
  7. Annual Renewal Planning
  8. Conversation Scripts
  9. FAQ

What Drives Kalydeco Costs with Aetna

Understanding Aetna's benefit design helps you navigate the system more effectively. Kalydeco's annual list price of approximately $369,255 means even small percentage coinsurance creates significant out-of-pocket costs.

Key Cost Factors

Specialty Tier Placement: Aetna classifies Kalydeco under its specialty pharmacy program, typically requiring percentage coinsurance rather than flat copays.

Prior Authorization Requirements: Aetna's Kalydeco policy requires confirmed CF diagnosis, CFTR genotype showing responsive mutations, age ≥4 months, and specialist prescriber.

Network Restrictions: Coverage typically requires use of CVS Specialty or other in-network specialty pharmacies, with higher costs for out-of-network dispensing.

Benefit Investigation: Know Your Coverage

Before starting treatment, gather specific information about your plan's coverage structure.

Essential Questions for Aetna

Call the member services number on your ID card and ask:

  1. "Is Kalydeco on my plan's formulary and what tier?"
  2. "What's my specialty drug coinsurance percentage?"
  3. "Do I have an annual out-of-pocket maximum?"
  4. "Which specialty pharmacies are in-network for Kalydeco?"
  5. "Are there step therapy requirements?"

Information to Record

  • Plan name and group number
  • Specialty tier coinsurance (e.g., 20%, 30%)
  • Annual out-of-pocket maximum
  • Prior authorization requirements
  • Preferred specialty pharmacy list
  • Any copay accumulator policies
Tip: Request written confirmation of benefit details via your member portal, as phone representatives sometimes provide incomplete information.

Manufacturer & Foundation Assistance

Multiple programs can significantly reduce your out-of-pocket costs for Kalydeco.

Vertex GPS Co-pay Assistance

Vertex's GPS program provides up to $20,000 annual copay reduction for commercially insured patients with no income limits.

Eligibility Requirements:

  • Commercial (private) insurance
  • US residency (including Michigan)
  • Not enrolled in government insurance (Medicare, Medicaid)

How to Enroll:

  • Complete form with your doctor and fax to 1-888-952-5933
  • Enroll online at vertexgpsportal.com
  • Call Patient Support at 1-877-752-5933 (press 2)

Foundation Grants

Several foundations offer copay assistance when funds are available:

  • CF Foundation Compass: Call 800-FIGHT-CF for personalized assistance navigation
  • PAN Foundation: Disease-specific CF grants
  • HealthWell Foundation: Specialty drug copay assistance
  • Good Days: Patient assistance programs
From our advocates: "We've seen Michigan families reduce their Kalydeco costs from $800+ monthly to under $50 by combining Vertex GPS with foundation grants. The key is applying early in the calendar year when foundation funds are most available."

Michigan-Specific Programs

Children's Special Health Care Services (CSHCS): Michigan's program for children with chronic conditions like CF. The CF Foundation has advocated for adequate CSHCS funding. Contact your county health department to apply.

University of Michigan CF Program: The state's largest CF center caring for ~520 patients has dedicated financial counselors to help with insurance navigation and assistance programs.

Formulary Exceptions & Step Therapy Overrides

When Aetna restricts Kalydeco coverage, you can request exceptions based on medical necessity.

When to Request Exceptions

  • Kalydeco is non-formulary on your plan
  • Step therapy requires trying other CFTR modulators first
  • Quantity limits don't match prescribed dosing
  • Age restrictions conflict with FDA labeling

Required Documentation

Aetna's exception process requires prescriber supporting statements including:

  1. CFTR Genotype Report: FDA-cleared test showing ivacaftor-responsive mutations
  2. Clinical Justification: Why formulary alternatives would be less effective or cause adverse effects
  3. Treatment History: Prior CFTR modulator trials and outcomes
  4. Specialist Confirmation: Letter from pulmonologist/CF specialist

Timeline & Process

  • Standard requests: Decision within 72 hours
  • Expedited requests: Decision within 24 hours if delay could seriously harm health
  • Automatic approval: If Aetna doesn't respond within stated timeframes

How to Submit:

Specialty Pharmacy vs. Mail Order

Aetna typically requires Kalydeco dispensing through in-network specialty pharmacies rather than retail locations.

CVS Specialty Advantages

  • Lower contracted pricing: Aetna's preferred specialty pharmacy rates
  • Coordinated prior authorization: CVS Specialty handles PA verification
  • Clinical support: Pharmacist counseling and adherence monitoring
  • Home delivery: Convenient shipping with temperature control

Cost Comparison Tips

  1. Verify network status: Use Aetna's pharmacy locator to confirm in-network specialty pharmacies
  2. Compare copays: Some plans offer preferred vs. standard specialty pharmacy tiers
  3. Check accumulator policies: Confirm whether manufacturer copay assistance counts toward your out-of-pocket maximum
Note: Using out-of-network specialty pharmacies often results in no coverage or significantly higher costs, even if the pharmacy can dispense Kalydeco.

Appeals Process in Michigan

Michigan provides strong patient protections for insurance denials through the Patient's Right to Independent Review Act.

Internal Appeals (First Level)

Timeline: Varies by plan type (typically 30-60 days to file) Process: Submit through Aetna member portal or written request Required: Medical records, prescriber letter, denial notice

External Review (Final Level)

Michigan's Department of Insurance and Financial Services (DIFS) offers independent medical review:

  • Timeline: 127 days after final internal denial to request
  • Process: Online form or paper submission to DIFS
  • Decision: Within 60 days (72 hours for expedited)
  • Binding: DIFS decision is final and enforceable

Contact DIFS: 877-999-6442 or online external review request

Expedited Appeals

For urgent medical situations, Michigan offers 72-hour expedited external review requiring:

  • Supporting letter from physician stating delay would harm patient
  • Documentation of medical urgency
  • Completed expedited review request form

Annual Renewal Planning

Kalydeco coverage can change at plan renewal, requiring proactive management.

What Changes Annually

  • Formulary placement: Drugs can move tiers or become non-formulary
  • Prior authorization criteria: Requirements may become more restrictive
  • Specialty pharmacy networks: Preferred pharmacies can change
  • Copay assistance programs: Foundation funding and manufacturer programs reset

Renewal Checklist

October-November:

  • Review next year's formulary and benefit documents
  • Confirm Kalydeco remains covered at current tier
  • Check for new prior authorization requirements

December:

  • Renew manufacturer copay assistance programs
  • Apply for foundation grants (funds often available early in calendar year)
  • Coordinate with CF clinic for any needed documentation updates

January:

  • Verify specialty pharmacy network status
  • Confirm prior authorization remains active
  • Monitor first prescription fill for any coverage issues

Conversation Scripts

Calling Aetna Member Services

"Hi, I'm calling about coverage for Kalydeco, spelled K-A-L-Y-D-E-C-O, for my [child's/my] cystic fibrosis. My member ID is [number]. I need to understand:

  1. Is this drug on my formulary and what tier?
  2. What's my copay or coinsurance for specialty drugs?
  3. Do I need prior authorization?
  4. Which specialty pharmacies are in-network?
  5. Are there step therapy requirements?

Can you please email me this information or tell me where to find it in my member portal?"

Provider Peer-to-Peer Request

"I'm requesting a peer-to-peer review for Kalydeco prior authorization denial for my patient with cystic fibrosis. The patient has [specific CFTR mutations] that are FDA-approved indications for ivacaftor. [Alternative therapies are not indicated/have failed/caused adverse effects]. I can provide genetic testing, treatment history, and current clinical status. When can we schedule the clinical discussion?"

At Counterforce Health, we help patients and clinicians turn insurance denials into successful appeals by providing evidence-backed rebuttals tailored to each payer's specific requirements. Our platform identifies denial reasons and drafts targeted responses using FDA labeling, peer-reviewed studies, and specialty guidelines.

FAQ

How long does Aetna prior authorization take for Kalydeco in Michigan? Standard PA decisions typically take 72 hours for complete submissions via Availity. Expedited requests are decided within 24 hours when medical urgency is documented.

What if Kalydeco isn't on my Aetna formulary? Request a formulary exception with supporting documentation from your CF specialist. Include CFTR genotype testing and clinical justification for why alternatives aren't appropriate.

Can I use manufacturer copay assistance with Aetna? Yes, if you have commercial insurance. Vertex GPS provides up to $20,000 annual copay reduction. Government insurance (Medicare, Medicaid) patients are ineligible.

Does Michigan have special protections for CF drug denials? Yes, Michigan's Patient's Right to Independent Review Act provides external review through DIFS with binding decisions. You have 127 days after final internal denial to request external review.

What counts as medical necessity for Kalydeco? Confirmed CF diagnosis, CFTR genotype showing responsive mutations, appropriate age (≥4 months), and clinical justification from a CF specialist or pulmonologist.

How do I find CF financial assistance in Michigan? Start with CF Foundation Compass (800-FIGHT-CF) for personalized navigation. Also contact University of Michigan CF Program financial counselors and apply for CSHCS if eligible.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage and assistance programs change frequently. Always verify current requirements with your specific plan, healthcare providers, and program administrators. For personalized guidance with insurance appeals and coverage issues, consider consulting with Counterforce Health or similar patient advocacy services.

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