By Counterforce Health Team in Kalydeco (ivacaftor) —

How to Get Kalydeco (ivacaftor) Covered by UnitedHealthcare in Washington: Complete Prior Authorization Guide with Appeals

Answer Box: Getting Kalydeco Covered by UnitedHealthcare in Washington

UnitedHealthcare requires prior authorization for Kalydeco (ivacaftor) based on confirmed cystic fibrosis diagnosis and FDA-approved CFTR mutations (like G551D, R117H) without step therapy requirements. Submit via the UnitedHealthcare Provider Portal with genetic test results, CF specialist documentation, and baseline liver function tests. Initial approval takes 5-14 business days; denials can be appealed through Washington's external review process within 180 days.

First step today: Verify your CFTR mutation is on the FDA-approved list and gather genetic testing documentation.

Table of Contents

  1. Before You Start: Plan Verification
  2. Coverage Requirements at a Glance
  3. What You Need to Gather
  4. Step-by-Step Submission Process
  5. Follow-Up and Tracking
  6. Typical Timelines in Washington
  7. Common Denial Reasons & Solutions
  8. Appeals Process for Washington Residents
  9. Renewal and Reauthorization
  10. Cost Assistance Options
  11. When to Contact Washington State Regulators
  12. Frequently Asked Questions

Before You Start: Plan Verification

Before submitting your Kalydeco prior authorization, confirm these essential details:

Verify Your Plan Type

  • Commercial/Employer plans: Follow standard UnitedHealthcare PA process
  • Medicare Advantage: Same OptumRx requirements apply
  • Medicaid (Apple Health): May have different state-specific requirements
  • Self-funded employer plans: Federal ERISA rules may apply instead of Washington state protections

Check Your Pharmacy Benefit

  • Kalydeco is typically covered under your specialty pharmacy benefit through OptumRx
  • Verify in-network specialty pharmacy access
  • Confirm your plan covers oral CFTR modulators (not just infused therapies)
Note: Washington state insurance protections apply to fully-insured plans but not self-funded employer plans. Contact your HR department if unsure about your plan type.

Coverage Requirements at a Glance

Requirement Details Documentation Needed
Diagnosis Confirmed cystic fibrosis ICD-10 E84.0 or E84.9
Age 1 month and older Patient age verification
CFTR Mutation FDA-approved ivacaftor-responsive mutation Genetic test results
Prescriber CF specialist or pulmonologist preferred Provider credentials
Lab Monitoring Baseline liver function tests ALT/AST <3x upper limit
Step Therapy Not required by UnitedHealthcare None
Prior Authorization Required for all CFTR modulators Complete PA form

Source: UnitedHealthcare Kalydeco Policy

What You Need to Gather

Essential Documents

Patient Information

  • Insurance card with member ID
  • Photo ID and date of birth
  • Current contact information

Medical Documentation

  • CF diagnosis confirmation from specialist
  • CFTR genetic testing report showing specific mutation
  • Recent pulmonary function tests (FEV1/FVC)
  • Baseline liver function tests (ALT, AST, bilirubin)
  • Current medication list

Clinical Notes

  • CF specialist evaluation and treatment plan
  • Documentation of CF symptoms and complications
  • Medical necessity letter explaining why Kalydeco is appropriate

CFTR Mutations Covered

Kalydeco is FDA-approved for patients with these mutation types:

  • Gating mutations: G551D, G1244E, G1349D, G178R, S549N, S549R
  • Residual function mutations: R117H, R117C, R117G, R117L
  • Other responsive mutations: See the complete FDA mutation list
Important: Kalydeco is not effective in patients homozygous for F508del mutation.

Step-by-Step Submission Process

Step 1: Access the Prior Authorization Form

Step 2: Complete Required Sections

Patient Demographics

  • Full name, date of birth, member ID
  • Prescriber information and NPI number

Clinical Information

  • CF diagnosis with ICD-10 code
  • Specific CFTR mutation from genetic testing
  • Current symptoms and disease severity
  • Baseline laboratory values

Step 3: Submit Documentation

Primary Method: UnitedHealthcare Provider Portal

  • Upload completed PA form
  • Attach genetic test results
  • Include clinical notes and lab reports

Alternative Methods

  • Fax: Use number provided in provider portal
  • Phone: 866-889-8054 for PA status
  • Electronic PA: CoverMyMeds platform selecting OptumRx

Step 4: Confirm Submission

  • Record confirmation number
  • Note submission date and method
  • Set follow-up reminder for 72 hours

Follow-Up and Tracking

Monitor Status Daily

  • Check UnitedHealthcare Provider Portal for updates
  • Call 866-889-8054 for verbal status updates
  • Document all interactions with reference numbers

Sample Call Script "I'm calling to check the status of a prior authorization for Kalydeco for patient [Name], member ID [Number], submitted on [Date]. The confirmation number is [Number]. Can you provide the current status and expected decision timeline?"

Red Flags Requiring Immediate Follow-Up

  • No acknowledgment after 48 hours
  • Request for additional information not clearly specified
  • Denial without detailed explanation

Typical Timelines in Washington

Review Type UnitedHealthcare Timeline Washington State Requirement
Standard PA 5-14 business days 30 days maximum (pre-service)
Expedited PA 24-72 hours 72 hours for urgent cases
Appeal Decision 30 days 30 days (pre-service), 60 days (post-service)
External Review 20 days in Washington 20 days (expedited: 72 hours)

Sources: UnitedHealthcare PA Guidelines and Washington State RCW 48.43.535

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing CFTR genotype Submit genetic test results FDA-cleared CFTR mutation panel results
Mutation not responsive Verify mutation is on FDA list Highlight specific mutation in FDA labeling
Lack of specialist confirmation Get CF center evaluation Letter from CF specialist or pulmonologist
Insufficient clinical documentation Provide comprehensive medical records Recent PFTs, symptom documentation, treatment history
Age restrictions Confirm patient meets age requirements Birth certificate or medical record confirmation

Appeals Process for Washington Residents

Internal Appeals (Required First Step)

Level 1 Internal Appeal

  • Submit within 180 days of denial
  • Include new clinical information
  • Use UnitedHealthcare Provider Portal or written request
  • Decision timeline: 30 days (expedited: 72 hours)

Required Information for Appeals

  • Original denial letter
  • Additional clinical documentation
  • Medical necessity letter with specific rationale
  • Relevant clinical guidelines or studies

External Review Process

Washington residents have strong appeal rights through the state's Independent Review Organization (IRO) process.

When You Can Request External Review

  • After completing internal appeals
  • Within 180 days of final internal denial
  • For any denial based on medical necessity

How to Request External Review

  1. Submit written request to UnitedHealthcare
  2. Include all relevant medical records
  3. UnitedHealthcare assigns certified IRO
  4. IRO reviews case independently

External Review Timeline

  • Standard review: 20 days maximum in Washington
  • Expedited review: 72 hours for urgent cases
  • Decision is binding on UnitedHealthcare
From our advocates: "We've seen Washington's external review process overturn approximately 50% of specialty drug denials when patients provide comprehensive clinical documentation. The key is demonstrating clear medical necessity and ensuring the genetic testing clearly shows an FDA-approved mutation."

Contact Washington State for Help

Renewal and Reauthorization

Kalydeco requires reauthorization every 12 months. Start the renewal process 30-45 days before expiration.

Required Documentation for Renewal

  • Continued CF diagnosis
  • Evidence of clinical benefit:
    • Stable or improved lung function (FEV1)
    • Reduced pulmonary exacerbations
    • Improved nutritional status
    • Better quality of life measures
  • Current liver function tests
  • Prescriber assessment of ongoing medical necessity

Tips for Successful Renewal

  • Keep detailed records of clinical improvements
  • Document any hospitalizations or exacerbations prevented
  • Include patient-reported outcome measures
  • Ensure all monitoring labs are current

Cost Assistance Options

Vertex Patient Services

  • Copay assistance program for eligible patients
  • Coverage investigation and prior authorization support
  • Contact: 1-877-752-5933
  • Patient assistance information

Cystic Fibrosis Foundation

  • Compass program for insurance navigation
  • Emergency financial assistance
  • Contact: 1-844-COMPASS (1-844-266-7277)

Washington State Programs

  • Apple Health (Medicaid) coverage
  • Premium assistance programs
  • Contact Washington Healthplanfinder: 1-855-923-4633

When navigating complex prior authorization requirements, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to craft point-by-point rebuttals aligned with payer-specific requirements.

When to Contact Washington State Regulators

Contact the Washington State Office of the Insurance Commissioner if:

  • UnitedHealthcare fails to respond within required timeframes
  • You believe the denial violates state insurance laws
  • The appeals process seems unfair or biased
  • You need help understanding your rights

Washington OIC Contact Information

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take for Kalydeco in Washington? A: Standard review takes 5-14 business days. Washington state law requires decisions within 30 days for pre-service requests. Expedited review is available for urgent cases within 72 hours.

Q: Does UnitedHealthcare require step therapy for Kalydeco? A: No, UnitedHealthcare does not require trying other CFTR modulators before approving Kalydeco for patients with responsive mutations.

Q: What if my CFTR mutation isn't on the FDA list? A: Kalydeco is only approved for FDA-listed responsive mutations. If you have a different mutation, discuss alternative CFTR modulators like Trikafta with your CF specialist.

Q: Can I get expedited review if my condition is urgent? A: Yes, if your health could be in serious jeopardy without immediate treatment, request expedited review. Decisions must be made within 72 hours.

Q: What happens if external review overturns the denial? A: The decision is binding on UnitedHealthcare, and they must provide coverage for Kalydeco as determined by the independent reviewer.

Q: Does Washington state law protect me if I have an employer plan? A: Only if your employer plan is fully-insured in Washington. Self-funded employer plans follow federal ERISA rules instead of state protections.

Q: How often do I need to renew my Kalydeco authorization? A: UnitedHealthcare requires reauthorization every 12 months with documentation of continued clinical benefit.

Q: What should I do if UnitedHealthcare requests a peer-to-peer review? A: Have your CF specialist schedule the call promptly. Prepare clinical documentation showing medical necessity and mutation-specific rationale for Kalydeco.

Disclaimer

This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance plan. Coverage policies may change, and individual circumstances vary. Always verify current requirements with UnitedHealthcare and consult with your CF care team for medical decisions.

For complex prior authorization challenges, Counterforce Health provides specialized support in turning insurance denials into successful appeals through evidence-based advocacy and payer-specific expertise.

Sources & Further Reading

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