By Counterforce Health Team in Kalydeco (ivacaftor) —

How to Get Kalydeco (ivacaftor) Covered by Aetna (CVS Health) in Ohio: Complete Prior Authorization and Appeals Guide

Quick Answer: To get Kalydeco (ivacaftor) covered by Aetna (CVS Health) in Ohio, you need prior authorization with CFTR genetic testing proving an FDA-responsive mutation, CF specialist prescription, and clinical documentation. If denied, use Ohio's external review process within 180 days. Start by gathering your genetic test results and calling Aetna at the number on your insurance card to request the PA form.

Table of Contents

  1. Ohio State Rules & How They Protect You
  2. Aetna (CVS Health) Prior Authorization Requirements
  3. Turnaround Standards & Timelines
  4. Step Therapy Protections in Ohio
  5. Continuity of Care Rights
  6. Appeals Process: Internal to External Review
  7. Practical Scripts & Documentation
  8. Common Denial Reasons & Solutions
  9. Costs & Patient Assistance
  10. FAQ

Ohio State Rules & How They Protect You

Ohio law provides specific protections for patients seeking coverage of specialty medications like Kalydeco (ivacaftor). Understanding these rights gives you leverage when working with Aetna (CVS Health).

Key Ohio Protections:

  • External Review Rights: After exhausting internal appeals, you have 180 days to request external review through the Ohio Department of Insurance
  • Step Therapy Override: Ohio Revised Code 3901.832 requires plans to grant exemptions when you've failed required drugs or when they're contraindicated
  • Prior Authorization Continuity: Ohio requires plans to honor existing approvals during transitions and has specific rules about continuity of care

Who's Covered: These protections apply to fully insured plans in Ohio. If you have an employer plan, ask HR whether it's "fully insured" (Ohio law applies) or "self-funded" (federal ERISA rules apply, but similar protections often exist).

Aetna (CVS Health) Prior Authorization Requirements

Aetna requires prior authorization for Kalydeco through CVS Caremark's specialty pharmacy division. Here's what you need:

Coverage Requirements Table

Requirement What It Means Documentation Needed Source
CFTR Mutation FDA-responsive mutation (G551D, R117H, etc.) Lab report showing specific variant Aetna Policy 1884-A
Age ≥4 months old Date of birth verification FDA Label
Diagnosis Confirmed cystic fibrosis ICD-10 code, specialist notes Aetna PA Criteria
Prescriber CF specialist or pulmonologist Provider credentials, DEA number Aetna Policy
Baseline Labs Liver function tests AST/ALT within 3 months FDA Label Safety

Essential Documents Checklist

✓ CFTR genetic testing report (must show FDA-responsive mutation)
✓ CF specialist consultation note (within 90 days)
✓ Current pulmonary function tests (FEV1/FVC if age-appropriate)
✓ Baseline liver function tests (AST, ALT, bilirubin)
✓ Prior CFTR modulator history (if applicable)
✓ Insurance card and member ID

Turnaround Standards & Timelines

Aetna (CVS Health) Decision Timelines:

  • Standard PA: Complete submissions typically decided within 24 hours via Availity portal
  • Incomplete submissions: 10-14 calendar days
  • Urgent requests: 48-72 hours when medically justified

Ohio External Review Timelines:

Tip: Mark requests as urgent if your CF specialist confirms that delay would seriously jeopardize your health or lung function.

Step Therapy Protections in Ohio

If Aetna requires you to try other CFTR modulators first, Ohio law mandates they grant an exception if:

  1. Prior failure/intolerance: You've tried the required drug and it didn't work or caused adverse effects
  2. Contraindication: The step drug is unsafe for you based on your medical history
  3. Stability: You're already stable on Kalydeco from a previous plan

Timeline: Plans must decide step therapy exemptions within 48 hours (urgent) or 10 calendar days (standard).

Step Therapy Override Documentation

Include in your request:

  • Prior medication history with dates, doses, outcomes
  • Adverse event documentation (hospitalizations, side effects)
  • Current stability evidence (recent PFTs, specialist notes)
  • Contraindication rationale (comorbidities, drug interactions)

Continuity of Care Rights

Ohio provides strong continuity protections, especially for Medicaid members:

For Aetna Better Health of Ohio (Medicaid/MyCare):

  • 365 days of continued coverage for ongoing specialist care
  • Ongoing treatment protection: Chemotherapy, transplant, and complex care must continue until completion
  • Transition periods: 90-365 days depending on service type

For Commercial Plans:

  • Honor existing prior authorizations until expiration
  • Transition supplies for formulary changes (typically 30-90 days)
  • Medical exception process for ongoing therapy

Appeals Process: Internal to External Review

Step 1: Internal Appeal with Aetna

Timeline: File within 60 days of denial

How to Submit:

  • Availity Provider Portal (fastest)
  • Fax or mail with completed appeal form
  • Include: denial letter, medical records, physician statement

Decision Time: 45-60 business days standard, 36-72 hours expedited

Step 2: Ohio External Review

If Aetna upholds the denial, you can request an Independent Review Organization (IRO) through Ohio.

Eligibility: Medical necessity denials involving clinical judgment

How to File:

  1. Submit written request to Aetna within 180 days of final internal denial
  2. Aetna forwards to Ohio Department of Insurance
  3. ODI assigns random IRO with CF expertise

Timeline: 30 days standard, 72 hours expedited

What to Include:

  • All denial letters and appeal decisions
  • Complete medical records
  • Physician letter of medical necessity
  • Published guidelines supporting Kalydeco use
  • Evidence of failed alternatives
Note: IRO decisions are binding on Aetna. If they overturn the denial, Aetna must immediately provide coverage.

Practical Scripts & Documentation

Phone Script for Calling Aetna

"I'm calling about prior authorization for Kalydeco (ivacaftor) for my cystic fibrosis. I'm an Ohio member and need to understand your PA requirements. I have CFTR genetic testing showing [specific mutation] which is FDA-approved for Kalydeco. Can you email me the PA form and tell me what clinical documentation you need?"

Medical Necessity Letter Essentials

Your CF specialist should include:

  • Diagnosis: Cystic fibrosis with specific ICD-10 code
  • Genotype: Exact CFTR mutation from lab report
  • Clinical status: Current symptoms, PFTs, exacerbations
  • Prior treatments: Other CFTR modulators tried, outcomes, reasons for discontinuation
  • Medical necessity: Why Kalydeco is specifically indicated
  • Monitoring plan: How response will be assessed

At Counterforce Health, we help patients and clinicians turn insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals using the right medical evidence and payer-specific requirements.

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
"No genetic testing" Submit complete CFTR report Lab report with specific mutations listed
"Not FDA-approved mutation" Verify mutation is on current label FDA label excerpt, genetic counselor letter
"Step therapy required" Request Ohio exemption ORC 3901.832 citation, prior failure documentation
"Not medically necessary" Provide clinical justification Specialist letter, PFTs, treatment history
"Experimental/investigational" Cite FDA approval FDA label, medical literature

Costs & Patient Assistance

Kalydeco Pricing: Approximately $369,255 annually (list price from Vertex Pharmaceuticals)

Financial Assistance Options:

  • Vertex Patient Services: Copay assistance and patient support
  • CF Foundation Compass: Care coordination and insurance navigation
  • State pharmaceutical assistance: Check Ohio Department of Health programs

If Uninsured in Ohio: Contact Ohio Department of Insurance Consumer Hotline at 800-686-1526 for marketplace enrollment assistance.

FAQ

How long does Aetna (CVS Health) PA take in Ohio? Complete submissions with genetic testing typically receive decisions within 24 hours via electronic portal. Incomplete requests take 10-14 days.

What if Kalydeco (ivacaftor) is non-formulary? Request a formulary exception with medical necessity documentation. Ohio law requires reasonable exception processes for medically necessary drugs.

Can I request expedited review? Yes, if your CF specialist certifies that delay would seriously jeopardize your health. Both PA and appeals can be expedited.

Does step therapy apply if I failed drugs outside Ohio? Yes, document prior failures from any plan. Ohio's step therapy law recognizes previous trials regardless of where they occurred.

What if my employer plan is self-funded? Federal ERISA rules apply instead of Ohio law, but many self-funded plans voluntarily follow similar appeal processes. Check your plan documents.

How do I get help with appeals in Ohio? Call the Ohio Department of Insurance Consumer Services at 800-686-1526 for free assistance with external review requests.

From our advocates: We've seen Ohio patients successfully overturn Kalydeco denials by submitting complete genetic testing upfront and clearly documenting why the specific CFTR mutation requires this therapy. The key is thorough preparation before the initial PA submission.

For complex appeals involving rare disease medications like Kalydeco, Counterforce Health provides specialized support in drafting evidence-based appeals that address payer-specific denial reasons and procedural requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and verify current insurance requirements with your plan. Coverage policies and state regulations may change.

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