By Counterforce Health Team in Koselugo (selumetinib) —

Do You Qualify for Koselugo Coverage by UnitedHealthcare in North Carolina? Decision Tree & Next Steps

Answer Box: Quick Qualification Check

Getting Koselugo (selumetinib) covered by UnitedHealthcare in North Carolina: You'll likely qualify if your child (age 2-18) has confirmed NF1 with symptomatic, inoperable plexiform neurofibromas documented by MRI. First step: Gather baseline LVEF testing, ophthalmologic exam results, and surgical consultation notes confirming inoperability. Submit prior authorization through UnitedHealthcare's provider portal with complete documentation. If denied, North Carolina's Smart NC external review program offers free appeals with 61% success rates.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Document Checklist
  4. If "Possibly Eligible": Tests to Request
  5. If "Not Yet": Alternative Options
  6. If Denied: Appeal Path Chooser
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & Fixes
  9. North Carolina External Review Process
  10. Frequently Asked Questions
  11. Sources & Further Reading

How to Use This Decision Tree

This guide walks you through UnitedHealthcare's specific requirements for Koselugo (selumetinib) coverage in North Carolina. Start with the eligibility triage below to determine your approval likelihood, then follow the corresponding section for next steps.

Important: Koselugo is FDA-approved only for pediatric patients (age 2+) with NF1-related plexiform neurofibromas. Adults now have mirdametinib (Gomekli) as an alternative MEK inhibitor option.

Eligibility Triage: Do You Qualify?

✅ Likely Eligible if ALL apply:

  • Age: 2-18 years old
  • Diagnosis: Confirmed NF1 (genetic testing or NIH clinical criteria met)
  • Plexiform neurofibromas: Present, symptomatic (pain, disfigurement, motor dysfunction, airway/visual compromise), and surgically inoperable
  • Imaging: Recent MRI or PET-CT documenting measurable PN
  • Prescriber: Pediatric oncologist, neurologist, or geneticist involved
  • Baseline testing: LVEF assessment and ophthalmologic exam completed

⚠️ Possibly Eligible if SOME apply:

  • Age 2-18 but missing recent imaging
  • NF1 diagnosis suspected but not genetically confirmed
  • PN present but surgical consultation not yet obtained
  • Baseline cardiac/eye exams pending

❌ Not Yet Eligible if:

  • Age under 2 or over 18 (unless treatment started before age 19)
  • No confirmed PN or PN deemed operable
  • Missing NF1 diagnosis confirmation
  • No qualified specialist involved

If "Likely Eligible": Document Checklist

Required Documentation for Prior Authorization

Clinical Records:

  • Medical records confirming NF1 diagnosis (genetic testing results or NIH criteria documentation)
  • Current MRI or CT imaging with radiologist interpretation showing plexiform neurofibromas
  • Surgical consultation notes documenting inoperability due to location, vascularity, or risk
  • Clinical notes detailing specific symptoms (pain scores, functional limitations, quality of life impact)

Baseline Safety Assessments:

  • Baseline LVEF via echocardiogram or MUGA scan (required for cardiac monitoring)
  • Comprehensive ophthalmologic examination results
  • Patient's current weight and height for BSA calculation (must be ≥0.55 m²)

Prescriber Information:

  • Letter from pediatric oncologist, neurologist, or geneticist confirming medical necessity
  • Attestation that Koselugo will be used as monotherapy at 25 mg/m² twice daily

Submission Process

  1. Contact UnitedHealthcare at 800-711-4555 to obtain current prior authorization forms
  2. Submit via OptumRx electronic prior authorization system for fastest processing
  3. Standard review timeline: 15 days for routine requests
  4. Expedited review: Available for urgent cases (72 hours)
Tip: Use UnitedHealthcare's provider portal for real-time status updates and faster document uploads.

If "Possibly Eligible": Tests to Request

Missing Genetic Confirmation

  • Request NF1 genetic testing (full gene sequencing with deletion/duplication analysis)
  • Timeline: Results typically available in 2-4 weeks
  • Insurance note: Document medical necessity for genetic testing to support treatment access

Incomplete Imaging

  • Order MRI with and without contrast focusing on plexiform neurofibroma locations
  • Include: Volumetric measurements for baseline comparison
  • Specialist referral: Ensure imaging is interpreted by neuroradiology if available

Surgical Assessment Pending

  • Obtain surgical consultation with pediatric surgeon or neurosurgeon familiar with NF1
  • Documentation needed: Specific reasons why complete resection is not feasible
  • Timeline: Schedule within 30 days to avoid delays

Baseline Testing

  • Cardiac evaluation: Echocardiogram with LVEF measurement
  • Ophthalmologic exam: Complete evaluation including visual acuity, visual fields, and retinal assessment
  • Laboratory work: Consider baseline liver function and blood counts per clinical judgment

If "Not Yet": Alternative Options

For Patients Under Age 2

  • Monitor and document symptom progression
  • Prepare for future approval by establishing care with NF1 specialist
  • Consider clinical trials through ClinicalTrials.gov

For Adults (18+)

  • Discuss mirdametinib (Gomekli) with oncologist—FDA-approved for adults with NF1-PN as of 2025
  • Review grandfathering policies if Koselugo treatment began before age 19

Exception Request Strategy

  • Document exceptional circumstances requiring Koselugo over alternatives
  • Gather supporting literature for off-label use (if applicable)
  • Prepare peer-to-peer review with medical director

If Denied: Appeal Path Chooser

Level 1: Internal Appeal (UnitedHealthcare)

  • Timeline: File within 180 days of denial notice
  • Process: Submit additional clinical documentation addressing specific denial reasons
  • Expected response: 30 days for standard review, 72 hours for urgent
  • Success strategy: Focus on addressing each denial criterion with new evidence

Level 2: Peer-to-Peer Review

  • Request: Have prescribing physician speak directly with UnitedHealthcare medical director
  • Timing: Often available during or after Level 1 appeal
  • Preparation: Physician should review denial letter and prepare clinical rationale

Level 3: North Carolina External Review

  • Eligibility: Must exhaust internal appeals first (unless urgent)
  • Timeline: 120 days from final internal denial to request external review
  • Contact: Smart NC at 1-855-408-1212
  • Success rate: Approximately 61% of accepted cases result in overturned denials

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before dispensing UnitedHealthcare provider portal UHC PA Notification
Age Limit 2-18 years old FDA labeling FDA Access Data
Diagnosis Confirmed NF1 with symptomatic, inoperable PN Medical records UHC PA criteria
Baseline Testing LVEF and ophthalmologic exam Clinical documentation FDA safety requirements
Prescriber Pediatric specialist required Medical license verification UHC PA criteria
Authorization Period 12 months initially PA approval letter UHC policy

Common Denial Reasons & Fixes

Denial Reason How to Overturn
"Experimental/investigational" Submit FDA approval letter and pediatric indication documentation
"Not medically necessary" Provide detailed symptom documentation, functional impact assessment, and quality of life measures
"Age inappropriate" Confirm patient age 2-18; if borderline, document treatment initiation date
"Missing baseline testing" Submit LVEF and ophthalmologic exam results
"Inadequate trial documentation" Clarify that no prior therapy required for first-line NF1-PN treatment
"Non-formulary" Request formulary exception with clinical justification

North Carolina External Review Process

North Carolina residents have strong appeal rights through the state's Smart NC program, which provides free external review services for insurance denials.

Key Benefits

  • No cost to patients or families
  • Independent medical review by specialists in relevant field
  • Binding decision on insurance companies
  • Fast turnaround for urgent cases (24-72 hours)

How to Request

  1. Call Smart NC: 1-855-408-1212
  2. Complete external review form (available online or by phone)
  3. Submit within 120 days of final internal denial
  4. Include all documentation: denial letters, medical records, clinical justification

Timeline

  • Standard review: 45 days maximum
  • Expedited review: 72 hours for urgent cases
  • Ultra-expedited: 24-72 hours for urgent drug denials
From our advocates: We've seen families successfully overturn Koselugo denials through North Carolina's external review process by focusing on clear documentation of symptom impact and surgical inoperability. The key is presenting a complete clinical picture that demonstrates medical necessity beyond just having an NF1 diagnosis.

For comprehensive support with insurance appeals and prior authorization documentation, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and creating point-by-point rebuttals aligned with payer policies.

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take for Koselugo? A: Standard reviews take up to 15 days. Expedited reviews for urgent cases are completed within 72 hours. Use the electronic PA system for fastest processing.

Q: What if Koselugo is non-formulary on my plan? A: Request a formulary exception by demonstrating medical necessity and lack of suitable alternatives. Include clinical documentation supporting why Koselugo is specifically required.

Q: Can I get an expedited appeal in North Carolina? A: Yes. Both UnitedHealthcare internal appeals and North Carolina external reviews offer expedited processing for urgent medical situations that could seriously jeopardize health.

Q: Does step therapy apply to Koselugo? A: Typically no, as Koselugo is often considered first-line therapy for pediatric NF1-PN. However, verify your specific plan's requirements with UnitedHealthcare.

Q: What happens if my child turns 19 during treatment? A: Many insurers allow continuation if treatment began before age 19. Document the start date and request continuation approval before the birthday.

Q: How much does Koselugo cost without insurance? A: Retail costs approximately $2,651 for 28×10mg capsules and $6,617 for 28×25mg capsules. AstraZeneca offers patient assistance programs that may help reduce costs.

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 and insurance company for specific coverage decisions. Coverage policies may vary by plan type and may change over time. For personalized assistance with insurance appeals and documentation, consider consulting with healthcare advocates like Counterforce Health who specialize in turning denials into successful approvals.

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