By Counterforce Health Team in Koselugo (selumetinib) —

How to Get Koselugo (Selumetinib) Covered by Blue Cross Blue Shield in Florida: Complete Guide to Prior Authorization, Appeals, and Approval Success

Quick Answer: Getting Koselugo Covered by Florida Blue Cross Blue Shield

Koselugo (selumetinib) is covered by Florida Blue Cross Blue Shield for pediatric patients (≥2 years) with NF1 and symptomatic, inoperable plexiform neurofibromas. Coverage requires prior authorization with specific documentation: confirmed NF1 diagnosis, baseline cardiac (LVEF) and eye exams, and imaging showing inoperable tumors.

Fastest path to approval: 1) Schedule baseline LVEF and ophthalmologic evaluations immediately, 2) Have your provider submit PA through CoverMyMeds with complete clinical documentation, 3) If denied, file internal appeal within 180 days with detailed medical necessity letter.

Table of Contents

Coverage Basics

Is Koselugo Covered by Florida Blue?

Yes. Koselugo is listed as a covered specialty medication in Florida Blue's 2025 ValueScript Rx Medication Guide, but requires prior authorization (PA), limited distribution through specialty pharmacy, and quantity limits.

Which Florida Blue Plans Cover Koselugo?

Coverage applies across Florida Blue commercial plans, but specific cost-sharing varies by plan type:

  • Individual and Family Plans: Check your specific formulary tier
  • Employer Group Plans: Coverage details in your Summary of Benefits
  • Medicare Advantage: May have different PA criteria
Note: Patients with government insurance (Medicare, Medicaid, Tricare) are not eligible for manufacturer copay assistance programs due to federal regulations.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Schedule Required Baseline Tests (Patient/Family)
    • Echocardiogram for LVEF assessment
    • Comprehensive ophthalmologic exam
    • Timeline: Complete within 2 weeks before PA submission
  2. Gather Clinical Documentation (Provider)
    • NF1 diagnosis confirmation (genetic testing, clinical criteria)
    • Recent MRI showing plexiform neurofibromas
    • Documentation of symptoms and functional impact
    • Timeline: 1-2 business days to compile
  3. Submit PA Electronically (Provider)
    • Platform: CoverMyMeds or Availity
    • Include all required documentation
    • Timeline: Same-day submission possible
  4. Track PA Status (Provider/Patient)
    • Electronic submissions: Response within 72 hours to 10 days
    • Check status through provider portal
    • Timeline: Most decisions within 5 business days
  5. If Approved: Coordinate with specialty pharmacy
  6. If Denied: Begin appeal process immediately
  7. Ongoing: Schedule renewal PA before current authorization expires

Medical Necessity Criteria

Coverage Requirements Table

Requirement Details Documentation Needed Source
Age ≥2 years, <18 years at initial authorization Birth certificate or medical record FDA Label
Diagnosis Confirmed NF1 Genetic testing or clinical criteria documentation Florida Blue Policy
Tumor Status Symptomatic, inoperable plexiform neurofibromas Recent MRI with radiologist interpretation FDA Label
Cardiac Function Baseline LVEF assessment Echocardiogram report Koselugo HCP Site
Eye Exam Baseline ophthalmologic evaluation Complete eye exam report Koselugo HCP Site
Prescriber Oncology or neurology specialist Provider credentials verification Florida Blue Policy

Clinician Corner: Medical Necessity Letter Checklist

When writing the medical necessity letter, include:

  • Patient demographics and confirmed NF1 diagnosis with genetic or clinical evidence
  • Detailed description of plexiform neurofibromas including location, size, and symptoms
  • Functional impact on daily activities, pain levels, or organ function
  • Inoperability assessment with surgical consultation notes if available
  • Baseline safety evaluations completed (cardiac and ophthalmologic)
  • FDA approval citation for pediatric NF1 with symptomatic, inoperable plexiform neurofibromas
  • Treatment goals and monitoring plan

Timing and Deadlines

PA Processing Timeline

  • Electronic submission: 72 hours to 10 calendar days
  • Fax submission: Up to 15 business days
  • Expedited review: 72 hours for urgent cases
  • Peer-to-peer review: Available if initial PA denied

Appeal Deadlines

  • Internal appeal: 180 days from denial notice
  • External review: 4 months after final internal denial
  • Expedited appeals: 72 hours for urgent medical needs

Costs and Financial Assistance

Understanding Your Costs

Koselugo is typically placed on the highest specialty tier, which may involve:

  • Coinsurance: 20-40% of drug cost
  • Copay: $100-500+ per month depending on plan
  • Deductible: Must be met before coverage begins

Manufacturer Support Programs

Alexion OneSource Program offers:

  • Copay assistance: Up to $0 copay for eligible commercial insurance patients
  • Insurance navigation: Help with PA and appeals process
  • Patient support: Coordination with specialty pharmacy
Important: Government insurance beneficiaries (Medicare, Medicaid) are not eligible for copay assistance but may qualify for other support programs.

Contact OneSource: alexiononesource.com or call the number provided on the Koselugo website.

Common Denial Reasons

Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Lack of NF1 diagnosis Submit genetic testing or detailed clinical criteria Genetic report or comprehensive neurology note
Missing baseline evaluations Complete LVEF and eye exams Echocardiogram and ophthalmology reports
Insufficient symptom documentation Provide detailed functional impact assessment Pain scales, functional assessments, quality of life measures
Age requirements Confirm patient is ≥2 years and <18 at initial request Birth certificate and current medical records
Non-specialty prescriber Transfer prescription to oncologist or neurologist Specialist consultation note and prescription

Appeals Process

Florida Blue Internal Appeal

  1. File within 180 days of denial notice
  2. Submit through Florida Blue member portal or provider portal
  3. Include additional documentation not in original PA
  4. Request peer-to-peer review if available
  5. Expect response within 30-60 days

External Review Process

If internal appeal fails:

  1. Contact Florida Department of Financial Services
    • Phone: 1-877-MY-FL-CFO (1-877-693-5236)
    • Online: Submit insurance complaint through DFS website
  2. Submit within 4 months of final internal denial
  3. No cost to consumer for external review
  4. Independent medical review by qualified specialist
  5. Binding decision if reviewer approves coverage
Tip: External reviews often succeed when the drug is FDA-approved for the specific indication and no alternatives exist—both true for Koselugo in pediatric NF1.

Specialty Pharmacy Requirements

Why Specialty Pharmacy is Required

Florida Blue requires Koselugo to be dispensed through an in-network specialty pharmacy due to:

  • High cost and specialized handling requirements
  • Patient monitoring and support services
  • Insurance coordination and prior authorization management

Common Specialty Pharmacies

  • Onco360 (frequently used for oncology medications)
  • Accredo Specialty Pharmacy
  • CVS Specialty
  • Walgreens Specialty Pharmacy

Your provider will coordinate the transfer to an approved specialty pharmacy once PA is approved.

Frequently Asked Questions

Q: How long does Florida Blue PA take for Koselugo? A: Electronic submissions typically receive responses within 72 hours to 10 calendar days. Faxed forms may take up to 15 business days.

Q: What if Koselugo isn't on my formulary? A: File a formulary exception request with medical necessity documentation. The drug's FDA approval for pediatric NF1 strengthens your case.

Q: Can I request an expedited appeal? A: Yes, if the medication is urgently needed for your health condition. Expedited reviews must be completed within 72 hours.

Q: Does step therapy apply to Koselugo? A: No, Koselugo typically doesn't require step therapy due to its unique FDA-approved indication for pediatric NF1 with no therapeutic alternatives.

Q: What happens when I turn 18? A: If initially approved before age 18, coverage may continue past your 18th birthday if you maintain clinical benefit. New requests after 18 may be redirected to mirdametinib (Gomekli).

Q: Can my regular pharmacy fill Koselugo? A: No, Florida Blue requires specialty pharmacy dispensing for Koselugo due to its classification as a specialty medication.

Resources and Next Steps

Immediate Action Items

  • Schedule baseline echocardiogram and eye exam
  • Gather all NF1 diagnosis documentation
  • Contact your oncologist or neurologist to initiate PA
  • Enroll in Alexion OneSource for support
  • Verify your Florida Blue plan's specific formulary status

Key Contacts

  • Florida Blue Member Services: Number on back of insurance card
  • Florida Blue Provider Portal: Availity.com
  • Alexion OneSource: alexiononesource.com
  • Florida Insurance Consumer Helpline: 1-877-MY-FL-CFO (1-877-693-5236)

Getting Additional Help

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating evidence-backed, payer-specific appeal letters. Our platform analyzes denial reasons and drafts targeted rebuttals using FDA labeling, peer-reviewed studies, and plan-specific criteria. If you're facing a Koselugo denial, Counterforce Health can help build a compelling medical necessity case tailored to Florida Blue's requirements.

For complex appeals or if you need additional advocacy support, consider consulting with a patient advocate or healthcare attorney specializing in insurance appeals.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by individual plan. Always consult with your healthcare provider and insurance company for specific coverage details. For assistance with insurance complaints or appeals in Florida, contact the Florida Department of Financial Services Consumer Helpline at 1-877-MY-FL-CFO.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.