By Counterforce Health Team in Koselugo (selumetinib) —

UnitedHealthcare Coverage for Koselugo (Selumetinib) in Florida: Prior Authorization Requirements and Appeal Process

Answer Box: Getting Koselugo Covered by UnitedHealthcare in Florida

UnitedHealthcare requires prior authorization for Koselugo (selumetinib) in Florida, with automatic approval for patients under 19 years old who meet clinical criteria. Your fastest path to approval: (1) Ensure you have a confirmed NF1 diagnosis with symptomatic, inoperable plexiform neurofibromas, (2) Have your specialist submit the UnitedHealthcare prior authorization form with complete documentation, and (3) If denied, file an internal appeal within 180 days using Florida's patient protection laws.

Table of Contents

Policy Overview: How UnitedHealthcare Covers Koselugo

UnitedHealthcare covers Koselugo (selumetinib) through its pharmacy benefit manager OptumRx, but the medication requires prior authorization across all plan types—commercial HMO/PPO, Medicare Advantage, and Medicaid managed care plans in Florida.

Coverage varies by plan type:

  • Commercial plans: Standard prior authorization with 12-month approval periods
  • Medicare Advantage: Similar requirements with expedited review options for urgent cases
  • Medicaid managed care: Prior authorization required with state-specific forms

The medication is typically classified as a specialty tier drug, meaning higher copays and specialty pharmacy dispensing requirements apply.

Medical Necessity Requirements

To meet UnitedHealthcare's medical necessity criteria for Koselugo, patients must have:

Primary Diagnosis Requirements

  • Neurofibromatosis Type 1 (NF1) confirmed by meeting at least two of the NIH diagnostic criteria:
    • Six or more café-au-lait macules
    • Freckling in axillary or inguinal regions
    • Two or more neurofibromas or one plexiform neurofibroma
    • Optic pathway glioma
    • Two or more Lisch nodules or choroidal abnormalities
    • Distinctive osseous lesions
    • First-degree relative with NF1

Tumor-Specific Criteria

  • Symptomatic plexiform neurofibromas that are inoperable
  • Evidence of functional impairment (pain, disfigurement, motor dysfunction)
  • MRI documentation of tumor size and location
  • Documentation that surgical removal would pose significant risk

Age and Performance Status

  • Patient age 2 years or older (FDA-approved indication)
  • Adequate performance status (Karnofsky/Lansky ≥70%)
  • Body surface area typically ≥0.55 m²

Prior Authorization Process

Step-by-Step Approval Process

  1. Prescriber Preparation (1-2 days)
    • Gather all diagnostic documentation
    • Complete baseline safety evaluations (LVEF, ophthalmologic exam)
    • Obtain MRI imaging showing inoperable plexiform neurofibromas
  2. Submit Prior Authorization (Same day)
  3. UnitedHealthcare Review (5-10 business days)
    • Medical director reviews against established criteria
    • May request additional information or peer-to-peer consultation
    • Automatic approval for patients under 19 meeting criteria
  4. Approval and Dispensing (1-3 days)
    • Approved prescriptions route to specialty pharmacy
    • Patient receives medication directly from specialty pharmacy
    • Initial approvals typically granted for 12 months
Tip: Patients under 19 years old often receive automatic approval without detailed coverage review, significantly speeding the process.

Common Denial Reasons & Solutions

Denial Reason How to Fix It Required Documentation
Insufficient NF1 diagnosis Provide complete diagnostic workup Genetic testing, clinical photos, ophthalmology report
Plexiform neurofibroma not documented Submit detailed MRI report Radiologist report confirming PN location/size
Missing safety evaluations Complete baseline assessments ECHO/MUGA showing normal LVEF, eye exam
Age restrictions Confirm pediatric indication Birth certificate, age verification
Missing specialist consultation Obtain specialist evaluation Oncology or neurology consultation note

Appeals Process in Florida

If UnitedHealthcare denies your Koselugo prior authorization, Florida law provides multiple appeal levels:

Internal Appeals (Required First Step)

  • Timeline: 180 days from denial notice to file
  • Process: Submit through UnitedHealthcare member portal or mail
  • Decision timeframe: 30 days for future treatments, 60 days for rendered services
  • Expedited option: 72 hours for urgent medical needs

External Review (After Internal Appeals)

  • Eligibility: Available after exhausting internal appeals
  • Timeline: 4 months from final internal denial
  • Process: File with Florida Department of Financial Services
  • Cost: No charge to consumer
  • Decision: Binding on UnitedHealthcare if overturned

Counterforce Health helps patients and providers navigate this complex appeals process by analyzing denial letters and creating targeted, evidence-backed appeals that address UnitedHealthcare's specific coverage criteria.

Required Appeal Documentation

  • Original denial letter from UnitedHealthcare
  • Complete medical records supporting medical necessity
  • Updated physician letter addressing denial reasons
  • Any new clinical information since original submission

Required Documentation Checklist

Before starting your prior authorization, gather:

Patient Information:

  • UnitedHealthcare member ID and policy details
  • Patient age verification
  • Complete contact information

Clinical Documentation:

  • NF1 diagnosis confirmation (genetic testing or clinical criteria)
  • MRI reports showing plexiform neurofibromas
  • Specialist consultation notes (oncology/neurology)
  • Baseline LVEF assessment (ECHO or MUGA)
  • Ophthalmologic evaluation
  • Documentation of symptoms and functional impairment

Treatment History:

  • Prior therapies attempted (if any)
  • Surgical consultation notes explaining inoperability
  • Current medications and medical history

Costs and Patient Support Options

Koselugo carries significant costs, with annual treatment expenses potentially exceeding $268,000. However, several support options exist:

Manufacturer Support Programs

  • AstraZeneca Patient Assistance: Income-based free drug program
  • Copay assistance: Available for commercially insured patients
  • Information: Visit koselugo.com for current programs

Specialty Pharmacy Benefits

  • UnitedHealthcare routes Koselugo through specialty pharmacies
  • Often includes medication adherence support and clinical monitoring
  • May offer home delivery and packaging services

Foundation Grants

  • Various rare disease foundations offer medication assistance
  • Income and diagnosis requirements vary by program

When to Escalate to State Regulators

Contact Florida insurance regulators if:

  • UnitedHealthcare fails to respond within required timeframes
  • You believe the denial violates Florida insurance laws
  • The appeals process isn't being followed properly

Florida Department of Financial Services

  • Insurance Consumer Helpline: 1-877-MY-FL-CFO (1-877-693-5236)
  • Online complaint system available
  • Free assistance with insurance disputes

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Koselugo? Standard review takes 5-10 business days. Patients under 19 often receive faster approval, while complex cases may require peer-to-peer review extending the timeline.

What if Koselugo isn't on my UnitedHealthcare formulary? Koselugo typically requires prior authorization rather than being non-formulary. If truly non-covered, you can request a formulary exception with supporting medical necessity documentation.

Can I get expedited approval for urgent cases? Yes, UnitedHealthcare offers expedited review for urgent medical situations, typically within 72 hours. Your doctor must document the urgent medical need.

Does step therapy apply to Koselugo? Current UnitedHealthcare policies don't specify step therapy requirements for Koselugo in NF1, as it's the first FDA-approved treatment for this specific indication.

What happens if my appeal is denied? After exhausting UnitedHealthcare's internal appeals, you can request external review through Florida's independent review process, which is binding if decided in your favor.

Are there age restrictions for coverage? Koselugo is FDA-approved for patients 2 years and older. UnitedHealthcare typically auto-approves patients under 19 who meet clinical criteria.

How often do I need reauthorization? Initial approvals are typically for 12 months, with renewal requiring documentation of continued medical necessity and absence of disease progression.

What if I move to another state while on Koselugo? Coverage requirements may change based on state regulations and plan availability. Contact UnitedHealthcare member services before relocating to ensure continued coverage.

From our advocates: We've seen families successfully overturn Koselugo denials by ensuring their MRI reports clearly document both the size and symptomatic nature of plexiform neurofibromas. One key factor is having the radiologist specifically note why surgical removal isn't feasible—whether due to location near vital structures or the extensive nature of the tumors. This detailed imaging documentation, combined with a specialist's letter explaining functional impairment, significantly strengthens the medical necessity case.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer policies and creating targeted rebuttals. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes, increasing approval rates through evidence-based advocacy tailored to each insurer's specific criteria.

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 can change. Always consult your healthcare provider and insurance plan documents for the most current information. For assistance with insurance disputes in Florida, contact the state Insurance Consumer Helpline at 1-877-693-5236.

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