By Counterforce Health Team in Kalydeco (ivacaftor) —

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

Answer Box: Get Kalydeco Covered by Aetna CVS Health in New York

Aetna CVS Health requires prior authorization for Kalydeco (ivacaftor) based on confirmed CFTR mutation testing and specialist oversight. To get approved in New York:

  1. Confirm eligibility: Document responsive CFTR mutation (G551D, R117H, or other FDA-approved variants) with genetic testing
  2. Submit PA: Complete Aetna's prior authorization form via Availity portal with CF specialist prescription and clinical documentation
  3. If denied: File internal appeal within 180 days, then New York external appeal through DFS within 4 months

First step today: Contact your CF specialist to order FDA-cleared CFTR mutation testing if not already completed, and gather recent pulmonary function tests.

Table of Contents

Policy Overview: How Aetna CVS Health Covers Kalydeco

Aetna CVS Health classifies Kalydeco (ivacaftor) as a specialty medication requiring prior authorization across all plan types—HMO, PPO, and Medicaid managed care. The drug typically falls on a higher formulary tier with significant cost-sharing, making prior authorization approval essential for affordability.

Coverage applies to:

  • Commercial Aetna plans with CVS Caremark pharmacy benefits
  • Aetna Medicaid managed care plans in New York
  • Medicare Advantage plans with Part D coverage (separate Medicare appeals process applies)

Kalydeco's annual list price approaches $370,000, making it one of the most expensive oral medications. Without proper authorization, patients face prohibitive out-of-pocket costs that can exceed $28,000 monthly.

Medical Necessity Requirements

Core Eligibility Criteria

Aetna CVS Health requires documentation of all the following for Kalydeco coverage:

Requirement Specification Documentation Needed
Diagnosis Confirmed cystic fibrosis ICD-10 codes, specialist notes
Genetics FDA-approved responsive CFTR mutation FDA-cleared genetic test results
Age 4 months or older Date of birth verification
Prescriber CF specialist or pulmonologist Provider credentials, consultation notes
Exclusions Cannot use with other ivacaftor-containing drugs Medication reconciliation

FDA-Approved Responsive Mutations

The FDA has approved Kalydeco for patients with at least one of 33 CFTR mutations shown to be responsive to ivacaftor therapy. Key mutations include:

Gating mutations: G551D, S549N, G178R, G551S, G970R, G1244E, S1251N, S1255P, G1349D Other responsive mutations: R117H, A455E, D579G, 711+3A→G, S945L, S977F, F1052V, K1060T, A1067T, G1069R, R1070W, F1074L, D1152H, 2789+5G→A, 3272-26A→G, 3849+10kbC→T

Note: Patients homozygous for F508del should not receive Kalydeco monotherapy, as this genotype requires combination CFTR modulators like Trikafta.

Step Therapy and Exceptions

Aetna CVS Health may require step therapy, meaning patients must try alternative CFTR modulators before Kalydeco approval. However, step therapy requirements depend on the specific CFTR genotype and FDA labeling.

Typical Step Therapy Protocol

  1. First-line: Trikafta (if FDA-approved for patient's mutations and age)
  2. Second-line: Symdeko or Orkambi (genotype-dependent)
  3. Exception pathway: Kalydeco if alternatives are contraindicated, ineffective, or not FDA-approved for the patient's specific mutations

Medical Exception Documentation

To bypass step therapy, providers must submit:

  • Clinical rationale explaining why alternatives aren't appropriate
  • Prior trial documentation if other CFTR modulators were previously attempted
  • Contraindication evidence (drug interactions, intolerance, adverse effects)
  • Genotype-specific justification citing FDA labeling

Quantity Limits and Renewal Requirements

Standard Dispensing Limits

CVS Specialty Pharmacy dispenses Kalydeco with the following restrictions:

  • Quantity limit: 30-day supply maximum per fill (60 tablets of 150mg)
  • Dosing frequency: Every 12 hours (twice daily) with food
  • Refill timing: After 75% of previous supply is used
  • Renewal authorization: Required every 12 months with clinical documentation

Renewal Documentation Requirements

Annual renewals require:

  • Recent CF specialist visit notes (within 90 days)
  • Updated pulmonary function tests showing clinical benefit or stability
  • Confirmation of continued appropriate CFTR genotype
  • Assessment of treatment response and tolerability
  • Documentation of ongoing medical necessity

Required Documentation and Diagnostics

Essential Clinical Documentation

Document Type Requirement Timing
Genetic testing FDA-cleared CFTR mutation analysis Before initial prescription
Pulmonary function FEV1, FVC baseline measurements Within 6 months
CF specialist evaluation Comprehensive assessment and treatment plan Within 90 days
Medical history Prior CFTR modulator trials, outcomes Current and complete
Laboratory results Liver function tests (baseline) Within 3 months

Genetic Testing Requirements

Aetna requires genetic confirmation through:

  • FDA-cleared CF mutation test (preferred method)
  • Bi-directional DNA sequencing for confirmation if needed
  • Laboratory report clearly identifying responsive mutations
  • CLIA-certified laboratory results only

CVS Specialty Pharmacy Requirements

Kalydeco must be dispensed through CVS Specialty Pharmacy or an approved network specialty pharmacy. Patients cannot fill prescriptions at retail pharmacies.

Enrollment Process

  1. Provider submission: Complete prior authorization through Availity portal
  2. CVS Specialty enrollment: Separate enrollment form required
  3. Patient intake call: CVS Specialty contacts patient for insurance verification
  4. Delivery coordination: Medication shipped to patient's preferred address
  5. Ongoing support: Clinical pharmacist monitoring and adherence support

Required Forms and Portals

  • Aetna PA form: Submit via Availity provider portal
  • CVS Specialty enrollment: Complete intake process
  • Patient assistance: Vertex Pharmaceuticals patient support program enrollment

Evidence to Support Medical Necessity

Clinical Guidelines and Literature

Strong medical necessity letters reference:

FDA labeling: Kalydeco prescribing information documenting approved mutations and efficacy data CF Foundation guidelines: Treatment recommendations for CFTR modulator therapy Peer-reviewed studies: Clinical trial data demonstrating improved lung function and quality of life Specialty society guidance: Pulmonology and CF specialist organization treatment algorithms

Sample Medical Necessity Statement

"This 16-year-old patient with cystic fibrosis and confirmed G551D mutation meets FDA-approved criteria for Kalydeco therapy. Genetic testing performed at [CLIA-certified lab] confirms responsive CFTR genotype. Current FEV1 of 68% predicted demonstrates moderate lung disease that would benefit from CFTR potentiator therapy per CF Foundation guidelines. Patient has not previously received ivacaftor therapy. Treatment goals include improving lung function, reducing pulmonary exacerbations, and enhancing quality of life consistent with FDA-approved indications."

Appeals Process in New York

New York provides robust appeal rights for Aetna denials through both internal company appeals and external state review.

Internal Appeals with Aetna

Timeline: File within 180 days of denial Process: Submit via member portal or written request Decision timeframe: 30 days standard, 72 hours expedited Required documentation: Complete clinical records, genetic testing, specialist letters

New York External Appeals

If internal appeals fail, New York's Department of Financial Services offers independent external review:

Eligibility: Final adverse determination from Aetna internal appeal Filing deadline: Within 4 months of internal denial Cost: $25 fee (waived for Medicaid or financial hardship) Timeline: 30 days standard, 72 hours expedited for urgent cases Process: Submit DFS external appeal application with supporting evidence Decision: Binding on both insurer and patient

Tip: New York's external appeal success rate for specialty drugs is higher when comprehensive medical literature and treatment guidelines are included with the appeal.

Consumer Assistance Resources

New York Department of Financial Services: File appeals online at dfs.ny.gov Community Health Advocates: Free assistance at 888-614-5400 Counterforce Health: Helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and drafting point-by-point rebuttals aligned to plan policies.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing genetic testing Submit FDA-cleared CFTR mutation results Laboratory report with responsive mutations
Non-formulary status File formulary exception request Medical necessity letter, alternatives tried
Step therapy requirement Document contraindications to alternatives Clinical rationale, prior trial failures
Age restrictions Verify FDA labeling for patient's age Birth certificate, prescriber confirmation
Lack of specialist oversight Obtain CF specialist consultation Pulmonologist evaluation and treatment plan

Cost Assistance Programs

Manufacturer Support

Vertex Patient Services: Comprehensive support program offering:

  • Insurance navigation assistance
  • Copay assistance for eligible commercial patients
  • Free drug program for qualifying uninsured patients
  • Prior authorization support and appeals assistance

Foundation and State Programs

CF Foundation Compass Program: Financial assistance and care coordination New York State pharmaceutical assistance: Income-based programs for eligible residents Patient advocacy organizations: Additional grant funding and support resources

At Counterforce Health, we help patients navigate complex insurance requirements by analyzing denial letters, identifying specific coverage criteria, and drafting evidence-backed appeals that address payer policies point-by-point. Our platform streamlines the appeals process for both patients and providers dealing with specialty medication denials.

FAQ

How long does Aetna CVS Health prior authorization take for Kalydeco in New York? Standard decisions are typically rendered within 8.5 hours if complete documentation is submitted via Availity portal. Incomplete submissions may take up to 30 days.

What if Kalydeco is not on my Aetna formulary? File a formulary exception request with medical necessity documentation. Non-formulary medications can be covered when medically necessary and alternatives are inappropriate.

Can I request expedited review for urgent cases? Yes. If delay poses serious health risks, request expedited review through both Aetna (72 hours) and New York external appeals (72 hours for urgent cases).

Does step therapy apply if I previously failed CFTR modulators outside New York? Prior therapy documentation from any location is relevant. Submit complete records of previous trials, outcomes, and reasons for discontinuation.

What happens if I'm denied after New York external appeal? External appeal decisions are binding. However, you may file complaints with New York DFS if procedural errors occurred or seek legal counsel for coverage disputes.

Are there age restrictions for Kalydeco coverage? Aetna follows FDA labeling: Kalydeco is approved for patients 4 months and older with responsive CFTR mutations. Age verification is required during prior authorization.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always verify current requirements with your insurance provider and consult healthcare professionals for medical decisions. For personalized assistance with insurance appeals and prior authorization, Counterforce Health provides specialized support for complex specialty medication coverage challenges.

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