By Counterforce Health Team in Koselugo (selumetinib) —

How to Get Koselugo (Selumetinib) Covered by Cigna in New York: Complete Guide with Forms, Appeals, and Timelines

Answer Box: Getting Koselugo (Selumetinib) Covered by Cigna in New York

Cigna requires prior authorization for Koselugo (selumetinib) in pediatric patients ≥2 years with NF1-related plexiform neurofibromas. Initial approval lasts 12 months with documented baseline LVEF and ophthalmologic evaluation. First step: Have your oncologist submit PA through Cigna's provider portal or CoverMyMeds with complete documentation. If denied, New York residents can appeal through Cigna's internal process (180 days) then external review via NY Department of Financial Services (4 months). Start today: Gather insurance card, MRI results, and baseline cardiac/eye exams.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timeline and Urgency
  4. Clinical Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals
  7. Renewal Requirements
  8. Specialty Pharmacy
  9. Troubleshooting
  10. Frequently Asked Questions

Coverage Basics

Is Koselugo (Selumetinib) Covered?

Cigna covers Koselugo for FDA-approved indications in pediatric patients aged 2 and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas. The drug requires prior authorization across all Cigna plans, including commercial and Medicare Advantage.

Which Plans Include Coverage?

All Cigna plans that include prescription drug benefits cover Koselugo when medically necessary. The medication is typically classified as a specialty drug and dispensed through Cigna's preferred specialty pharmacy network, primarily Accredo.

Coverage at a Glance:

Requirement Details Documentation Needed
Prior Authorization Required for all ages Complete PA form via provider portal
Age Eligibility ≥2 years (or ≥19 if started before 19) Birth certificate, treatment history
Diagnosis NF1 with symptomatic, inoperable PN MRI/CT imaging, genetic testing
Baseline Testing LVEF assessment, eye exam Echocardiogram, ophthalmologic evaluation
Prescriber Oncologist or specialist Medical necessity letter

Source: Cigna Koselugo Coverage Policy

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient/Family): Call Cigna member services using the number on your insurance card to confirm specialty drug benefits and PA requirements.
  2. Gather Documentation (Clinic): Collect baseline LVEF (echocardiogram), ophthalmologic evaluation, MRI showing inoperable plexiform neurofibromas, and genetic confirmation of NF1.
  3. Submit Prior Authorization (Prescriber): Use Cigna's provider portal, CoverMyMeds, or fax complete PA packet including medical necessity letter.
  4. Track Status (Clinic): Follow up at days 3, 7, and 14. Standard decisions come within 72 hours; urgent cases within 24 hours.
  5. Route to Specialty Pharmacy (Upon Approval): Prescription automatically transfers to Accredo or approved specialty pharmacy.
  6. Coordinate Delivery (Patient): Accredo contacts you for enrollment, insurance verification, and delivery scheduling.
  7. Begin Monitoring (Ongoing): Schedule required LVEF monitoring every 3 months in year one, then every 6 months.
Clinician Corner: Your medical necessity letter should address: confirmed NF1 diagnosis with genetic testing or clinical criteria, imaging evidence of symptomatic plexiform neurofibromas deemed inoperable, baseline cardiac and ophthalmologic clearance, treatment goals, and monitoring plan. Include references to FDA labeling and relevant clinical guidelines.

Timeline and Urgency

Standard Processing Times

  • Prior Authorization Decision: 72 hours for standard requests
  • Expedited/Urgent: 24 hours with physician attestation of harm
  • Internal Appeal: 30 days for medical necessity determinations
  • External Review (NY): 30 days standard, 72 hours expedited

When to Request Expedited Review

Request urgent processing if:

  • Tumor growth is documented on recent imaging
  • Patient experiences worsening symptoms (pain, functional impairment)
  • Delay would compromise treatment effectiveness

Clinical Criteria

Required Documentation for Approval

Diagnosis Requirements:

  • Confirmed neurofibromatosis type 1 (ICD-10: Q85.01)
  • Symptomatic plexiform neurofibromas
  • Tumors deemed inoperable by appropriate specialist

Safety Prerequisites:

  • Baseline LVEF assessment showing normal cardiac function
  • Comprehensive ophthalmologic evaluation including fundoscopy and OCT
  • Age verification (≥2 years old)

Ongoing Monitoring:

  • LVEF monitoring every 3 months (year 1), then every 6 months
  • Regular ophthalmologic assessments
  • Growth and development tracking in pediatric patients

Source: Koselugo Safety Information

Costs and Financial Assistance

Understanding Your Out-of-Pocket Costs

Koselugo is typically classified as a Tier 5 specialty medication with higher copays or coinsurance. Retail pricing can exceed $250,000 annually, making financial assistance crucial for most families.

Available Support Programs

Manufacturer Assistance:

  • Alexion OneSource provides case management and financial support
  • Copay assistance available for eligible commercially insured patients

Foundation Support:

  • Patient Advocate Foundation
  • National Organization for Rare Disorders (NORD)
  • Neurofibromatosis Network
Tip: Contact Accredo at 877-826-7657 during enrollment to discuss all available copay assistance programs and verify your out-of-pocket maximum.

Denials and Appeals

Common Denial Reasons & Solutions

Denial Reason How to Overturn
"Not medically necessary" Submit updated medical necessity letter with FDA approval documentation, peer-reviewed studies, and quality of life impact assessments
Missing baseline testing Provide echocardiogram results, ophthalmologic evaluation, and any required laboratory values
Age restrictions Submit birth certificate and treatment history; for patients ≥19, document initiation before age 19
Non-formulary status Request formulary exception emphasizing FDA pediatric approval and lack of alternatives

Appeals Process in New York

Internal Appeals (Cigna):

  • File within 180 days of denial notice
  • Use Cigna Appeal Request Form
  • Include denial letter, medical records, and new supporting evidence
  • Decision within 30 days

External Review (New York State):

  • Available after final internal denial
  • File with NY Department of Financial Services within 4 months
  • Independent medical review with binding decision
  • Expedited review available for urgent cases (72 hours)
From our advocates: We've seen families successfully overturn Koselugo denials by emphasizing the drug's unique FDA approval for pediatric NF1 and providing detailed imaging showing tumor burden. The key is demonstrating both medical necessity and the lack of alternative treatments for this rare condition.

New York residents benefit from robust appeal rights and should utilize both internal and external review processes when facing denials. Counterforce Health helps patients and clinicians build stronger appeals by analyzing denial reasons and crafting targeted, evidence-backed responses.

Renewal Requirements

Reauthorization Timeline

Initial Koselugo approvals last up to 12 months. Renewal requires:

  • Clinical Response Documentation: MRI showing tumor stabilization or improvement
  • Symptom Assessment: Functional improvement or pain reduction
  • Safety Monitoring: Current LVEF and ophthalmologic evaluations
  • Continued Eligibility: Ongoing NF1 diagnosis and treatment appropriateness

Preparing for Renewal

Start the reauthorization process 30-45 days before expiration. Gather updated imaging, specialist assessments, and safety monitoring results. Document any clinical improvements or quality of life benefits.

Specialty Pharmacy

Why Koselugo Requires Specialty Pharmacy

Koselugo's limited distribution network ensures proper handling, patient education, and safety monitoring. The medication requires temperature-controlled shipping and specialized pharmacist support.

Working with Accredo

Enrollment Process:

  • Accredo contacts patients after PA approval
  • Complete enrollment forms and insurance verification
  • Schedule delivery (typically monthly shipments)
  • Access 24/7 pharmacist support

What to Expect:

  • Temperature-controlled packaging
  • Delivery tracking and confirmation
  • Refill reminders and coordination
  • Clinical support for side effect management

Note: Some patients may be routed to Onco360 due to manufacturer requirements. Confirm your designated specialty pharmacy during PA approval.

Troubleshooting

Common Issues and Solutions

Portal Access Problems:

  • Contact Cigna provider services for technical support
  • Verify login credentials and user permissions
  • Try alternative submission methods (fax, phone)

Missing Documentation:

  • Use checklist to ensure all required documents are included
  • Follow up with ordering providers for missing test results
  • Confirm document formatting meets submission requirements

Communication Delays:

  • Maintain detailed records of all submissions and communications
  • Request confirmation numbers for all submissions
  • Set calendar reminders for follow-up calls

Frequently Asked Questions

Q: How long does Cigna prior authorization take for Koselugo in New York? A: Standard PA decisions come within 72 hours. Urgent cases with physician attestation of potential harm are decided within 24 hours.

Q: What if Koselugo is non-formulary on my Cigna plan? A: Request a formulary exception emphasizing FDA approval for pediatric NF1 and lack of alternative treatments. Include medical necessity documentation and specialist support.

Q: Can I request an expedited appeal in New York? A: Yes. Both Cigna internal appeals and New York external reviews offer expedited processing for urgent medical situations with appropriate physician documentation.

Q: Does step therapy apply to Koselugo? A: Generally no, as Koselugo is the first FDA-approved treatment specifically for NF1-related plexiform neurofibromas in children. However, plans may require documentation of symptom severity.

Q: What happens if I move from New York to another state? A: Contact Cigna to understand how the move affects your coverage. Appeal rights and timelines may differ by state, but your approved therapy should continue.

Q: How often do I need new prior authorizations? A: Initial approvals last up to 12 months. Renewals require evidence of clinical benefit and continued medical necessity.

Q: What if my child ages out of pediatric coverage? A: Discuss transition plans with your oncologist. Patients who started Koselugo before age 19 may continue coverage. Adult patients may be candidates for mirdametinib (Gomekli), recently approved for adult NF1.

When to Contact New York Regulators

If Cigna fails to meet response timelines or you believe your appeal was improperly handled, contact the New York Department of Financial Services at 1-800-342-3736. File complaints for:

  • Missed appeal deadlines
  • Improper denial reasons
  • Lack of expedited processing when medically necessary

For additional support with insurance denials and appeals, Community Health Advocates provides free assistance to New York residents at 888-614-5400.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may vary by plan and change over time. Always verify current requirements with your insurance provider and consult healthcare professionals for medical decisions. Counterforce Health specializes in turning insurance denials into successful appeals through evidence-based advocacy and can provide personalized support for complex prior authorization cases.

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