By Counterforce Health Team in Koselugo (selumetinib) —

Work With Your Doctor to Get Koselugo (Selumetinib) Approved by UnitedHealthcare in Ohio: Complete Provider Collaboration Guide

Answer Box: Getting Koselugo Covered by UnitedHealthcare in Ohio

Koselugo (selumetinib) requires prior authorization from UnitedHealthcare for pediatric patients ≥2 years with NF1 plexiform neurofibromas. Your doctor must submit clinical documentation proving NF1 diagnosis, inoperable symptomatic tumors, and baseline safety evaluations. If denied, you have 180 days for internal appeals, then external review through Ohio's Department of Insurance. Start today: Schedule an appointment to review your medical records and discuss the prior authorization requirements with your healthcare team.

Table of Contents

  1. Set Your Goal: Understanding Approval Requirements
  2. Visit Preparation: Building Your Case
  3. Evidence Kit: Essential Documentation
  4. Medical Necessity Letter Structure
  5. Peer-to-Peer Review Support
  6. After-Visit Action Plan
  7. Respectful Persistence Strategy
  8. Appeals Process in Ohio
  9. Cost and Support Programs
  10. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization UnitedHealthcare must approve before prescribing OptumRx PA Guidelines OptumRx
NF1 Diagnosis ≥2 NIH criteria documented Medical records, genetic testing FDA Label
Age Requirement ≥2 years old Birth certificate, medical records FDA Label
Inoperable PN Surgical consult confirming non-resectable Neurosurgery consultation note FDA Label
Baseline LVEF Heart function assessment Echocardiogram or MUGA scan Prescribing Information
Eye Exam Ophthalmologic evaluation Ophthalmology report Prescribing Information

Set Your Goal: Understanding Approval Requirements

Your partnership with your healthcare provider is crucial for Koselugo approval. UnitedHealthcare requires prior authorization for this specialty medication, which means your doctor must prove medical necessity before coverage begins.

What UnitedHealthcare Needs to See:

  • Confirmed NF1 diagnosis using established criteria
  • Documentation of symptomatic, inoperable plexiform neurofibromas
  • Evidence that surgery isn't appropriate or safe
  • Baseline safety evaluations (heart and eye function)
  • Treatment plan with appropriate monitoring
Note: 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 each plan's specific rules.

Visit Preparation: Building Your Case

Before your appointment, gather information that strengthens your case for medical necessity.

Symptom Timeline Documentation

Prepare detailed notes about:

  • When plexiform neurofibromas were first noticed
  • How symptoms have progressed (pain, functional limitations, disfigurement)
  • Impact on daily activities, school, or work
  • Sleep disruption, mobility issues, or other quality of life effects

Previous Treatments and Outcomes

Document everything you've tried:

  • Surgical consultations and why surgery wasn't recommended
  • Pain management approaches and their effectiveness
  • Physical therapy or other supportive care
  • Any other medications attempted

Functional Impact Assessment

Be specific about how NF1 affects your life:

  • Activities you can no longer do or find difficult
  • Pain levels throughout the day
  • How symptoms affect family dynamics
  • Educational or developmental concerns for pediatric patients

Evidence Kit: Essential Documentation

Work with your healthcare team to compile comprehensive medical evidence.

Required Medical Records

NF1 Diagnosis Documentation:

  • Genetic testing results (if available)
  • Clinical notes documenting ≥2 NIH diagnostic criteria
  • Family history of NF1 (if applicable)
  • Photos of café-au-lait spots or other visible signs

Imaging Studies:

  • Recent MRI scans showing plexiform neurofibromas
  • Radiology reports with measurements and descriptions
  • Comparison studies showing tumor progression
  • Any PET or CT scans if performed

Safety Baseline Studies

Cardiac Evaluation:

  • Echocardiogram or MUGA scan results
  • LVEF (left ventricular ejection fraction) measurement
  • Cardiology consultation if indicated

Ophthalmologic Assessment:

  • Comprehensive eye exam report
  • Slit-lamp examination findings
  • Visual field testing if performed
  • Retinal photography or OCT if available

Surgical Consultation

Neurosurgery or Surgical Oncology Review:

  • Written opinion on surgical feasibility
  • Explanation of risks if surgery were attempted
  • Discussion of why complete resection isn't possible
  • Alternative surgical options considered and rejected

Medical Necessity Letter Structure

Your doctor will need to write a compelling medical necessity letter. Alexion provides an official template that can be customized for your situation.

Key Elements Your Doctor Should Include

Patient Identification:

  • Full name, date of birth, insurance information
  • Policy and group numbers
  • Request for expedited review if clinically urgent

Clinical Justification:

  • NF1 diagnosis with specific criteria met (ICD-10: Q85.00)
  • Detailed description of plexiform neurofibromas
  • Symptom severity and functional impact
  • Why surgery isn't appropriate or feasible

Treatment Plan:

  • Prescribed dose (typically 25 mg/m² twice daily)
  • Monitoring plan for safety and efficacy
  • Expected duration of therapy
  • Plans for dose adjustments if needed

Supporting Evidence:

  • References to FDA approval and prescribing information
  • Relevant clinical studies or guidelines
  • Peer-reviewed literature supporting treatment

Peer-to-Peer Review Support

If UnitedHealthcare initially denies coverage, your doctor can request a peer-to-peer review with a board-certified specialist.

How You Can Help Your Doctor Prepare

Offer Flexible Availability:

  • Provide multiple time windows when your doctor can take the call
  • Understand that peer-to-peer calls happen within 1 business day of request

Prepare a Concise Case Summary:

  • One-page bullet point summary of your case
  • Key points about why alternatives won't work
  • Specific evidence supporting medical necessity

Gather Additional Evidence:

  • Recent literature supporting Koselugo use in NF1
  • Quality of life assessments or functional measures
  • Documentation of failed conservative treatments
From Our Advocates: "We've seen cases where a well-prepared peer-to-peer conversation completely reversed an initial denial. The key is having all the clinical evidence organized and ready to discuss, along with specific references to the patient's unique circumstances that make standard alternatives inappropriate."

After-Visit Action Plan

After meeting with your healthcare team, maintain organized records and clear communication.

Documentation to Save

Keep copies of everything:

  • Prior authorization submission confirmation
  • All medical records submitted
  • Correspondence with UnitedHealthcare
  • Denial letters (if received)
  • Appeal submissions and responses

Portal Communication Strategy

Use your patient portal effectively:

  • Message your care team with questions or updates
  • Upload any additional documentation requested
  • Track the status of your prior authorization
  • Set up notifications for responses

Timeline Management

Stay on top of deadlines:

  • Prior authorization processing (typically 72 hours for standard, 24 hours for expedited)
  • Internal appeal deadlines (180 days from denial)
  • External review deadlines (180 days from final internal denial)

Respectful Persistence Strategy

Advocacy requires persistence while maintaining positive relationships with your healthcare team and insurance company.

Appropriate Follow-Up Cadence

Week 1-2: Allow normal processing time Week 3: Gentle inquiry about status Week 4+: More frequent contact if no response Always: Maintain professional, collaborative tone

Escalation Steps

  1. Provider office follow-up: Check on submission status
  2. Insurance customer service: Verify receipt and processing timeline
  3. Supervisor request: Ask to speak with a case manager
  4. Formal appeal: If denied, immediately begin appeal process
  5. State regulator: Contact Ohio Department of Insurance if needed

Appeals Process in Ohio

Ohio provides strong consumer protections for insurance appeals, including external review through independent medical experts.

Internal Appeals with UnitedHealthcare

Timeline: 180 days from denial notice Process: Submit written appeal with additional evidence Review: Internal medical review by UnitedHealthcare physicians

External Review Through Ohio Department of Insurance

Eligibility: Denials based on medical necessity or experimental/investigational determinations Timeline: 180 days from final internal denial Process: Independent Review Organization (IRO) with ≥3 expert physicians Decision Timeline: ≤30 days standard, ≤72 hours expedited

Contact Information:

Required Documentation for Appeals

Include with your appeal:

  • Original denial letter
  • Medical necessity letter from physician
  • All supporting medical records
  • Relevant clinical studies or guidelines
  • Patient impact statement

Cost and Support Programs

Even with insurance approval, Koselugo can be expensive. Multiple support programs can help reduce out-of-pocket costs.

Manufacturer Support Programs

Alexion Access Navigator:

Foundation Support

Organizations that may help:

  • Patient Advocate Foundation
  • CancerCare Co-Pay Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

State-Specific Resources

Ohio Programs:

FAQ

How long does UnitedHealthcare prior authorization take for Koselugo? Standard reviews take up to 72 hours, expedited reviews take up to 24 hours. Your doctor can request expedited review if delay would harm your health.

What if Koselugo isn't on UnitedHealthcare's formulary? Koselugo typically requires prior authorization but is covered when medical necessity criteria are met. Non-formulary status doesn't prevent coverage with proper documentation.

Can I request an expedited appeal in Ohio? Yes, if delay would seriously endanger your health or if you have a terminal condition. Expedited external reviews are decided within 72 hours.

What counts as medical necessity for Koselugo? NF1 diagnosis with symptomatic, inoperable plexiform neurofibromas in patients ≥2 years old, with appropriate baseline safety evaluations completed.

Does step therapy apply to Koselugo? Current research suggests no specific step therapy requirements for pediatric NF1 plexiform neurofibromas, but verify with your specific plan.

What if my employer plan is self-funded? Self-funded plans follow federal ERISA law rather than Ohio state regulations, but many voluntarily use similar external review processes.

How can Counterforce Health help with my appeal? Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing denial letters and plan policies to create evidence-backed rebuttals aligned with each insurer's specific requirements.

What should I do if UnitedHealthcare delays my appeal? Contact the Ohio Department of Insurance at (800) 686-1526. They can intervene if insurers improperly delay or deny external review requests.

Disclaimer: This information is for educational purposes only and is not medical advice. Always consult with your healthcare provider about treatment decisions. Insurance coverage varies by plan, and requirements may change. Verify current policies with your insurer and check with the Ohio Department of Insurance for the most up-to-date appeal procedures.

Sources & Further Reading

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