By Counterforce Health Team in Koselugo (selumetinib) —

How to Get Koselugo (selumetinib) Covered by Aetna (CVS Health) in Florida: Complete Prior Authorization Guide

Answer Box: Getting Koselugo (selumetinib) Covered by Aetna (CVS Health) in Florida

Koselugo (selumetinib) is typically covered by Aetna (CVS Health) as a specialty medication with prior authorization for pediatric patients ≥2 years with NF1 and symptomatic, inoperable plexiform neurofibromas. The fastest path to approval: 1) Have your pediatric oncologist or neurologist submit a complete PA form with NF1 diagnosis confirmation, baseline LVEF/eye exams, and documentation of inoperable, symptomatic plexiform neurofibromas, 2) Submit via Aetna's specialty PA fax (1-888-267-3277) or provider portal, 3) If denied, file an internal appeal within 180 days citing medical necessity and FDA indication. Start with Aetna's specialty medication precertification form.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Koselugo prescriptions Aetna Specialty Drug List Aetna 2025 Specialty List
Age Requirement Pediatric patients ≥2 years old FDA labeling FDA Access Data
Diagnosis NF1 with symptomatic, inoperable plexiform neurofibromas PA form documentation Specialty PA Form
Baseline Testing LVEF assessment, ophthalmologic exam Clinical monitoring requirements Koselugo Prescribing Info
Specialty Pharmacy Must use CVS Specialty or approved network Limited distribution CVS Specialty
Appeals Deadline 180 days from denial notice Florida insurance law Florida DFS

When Alternatives Make Sense

For pediatric patients with NF1 and plexiform neurofibromas, Koselugo (selumetinib) is the only FDA-approved systemic treatment specifically for this indication. However, alternatives might be considered when:

  • Koselugo is denied or not covered under your specific Aetna plan
  • Intolerable side effects occur (cardiac, ocular, or severe skin reactions)
  • Lack of response after 6-12 months of treatment
  • Age restrictions apply (though FDA approval now extends to ≥2 years)
Note: Unlike many other conditions, pediatric NF1 with plexiform neurofibromas has limited treatment options. Most "alternatives" are either off-label uses of other medications or non-pharmacologic approaches.

Typical Alternatives for Pediatric NF1

1. Newer MEK Inhibitors

Mirdametinib (Gomekli) recently received FDA approval for NF1-associated plexiform neurofibromas in both adults and children ≥2 years. Key differences from Koselugo:

  • Dosing schedule: Intermittent (3 weeks on, 1 week off) vs. continuous
  • Formulation: Available as capsules or tablets for oral suspension
  • Coverage status: May be on different formulary tiers than Koselugo

2. Surgical Options

When plexiform neurofibromas are:

  • Small and discrete
  • Not involving critical structures
  • Causing significant symptoms that could be relieved by resection

Surgery remains the preferred approach. For large or complex tumors, debulking surgery may be combined with MEK inhibitor therapy.

3. Supportive Care Approaches

  • Pain management: Acceptance and Commitment Therapy (ACT) has shown significant benefits for NF1-related pain
  • Physical therapy: For functional improvements and mobility
  • Monitoring: Regular MRI surveillance without active treatment for stable, asymptomatic lesions

Pros and Cons Overview

Approach Pros Cons Access Considerations
Koselugo (selumetinib) Only FDA-approved option; extensive pediatric data; proven PN shrinkage Continuous dosing; cardiac/eye monitoring; high cost PA required; specialty pharmacy only
Mirdametinib Intermittent dosing; potentially better tolerability Newer drug with less long-term data May have different coverage criteria
Surgery Potential for complete local control High morbidity risk for extensive PN; incomplete resection common Covered by most plans when medically necessary
Supportive care Lower risk; addresses quality of life No tumor shrinkage; symptoms may progress Generally well-covered

Exception Strategy: When to Request

Request a formulary exception or step-therapy override when Aetna denies Koselugo coverage. Your strongest arguments include:

Medical Necessity Documentation

  1. Unique FDA indication: Koselugo is the only FDA-approved treatment for pediatric NF1 with symptomatic, inoperable plexiform neurofibromas
  2. No true alternatives: Other MEK inhibitors may not be approved for pediatric use or may have different risk profiles
  3. Clinical urgency: Document symptoms like pain, functional impairment, or risk of complications

Required Evidence

  • NF1 diagnosis confirmation (genetic testing or clinical criteria)
  • Imaging studies showing plexiform neurofibroma location and size
  • Documentation of symptoms and impact on daily functioning
  • Baseline cardiac and ophthalmologic evaluations
  • Specialist consultation notes from pediatric oncology or neurology
Clinician Corner: When writing a medical necessity letter, emphasize that Koselugo targets the specific MEK pathway dysregulated in NF1, cite the SPRINT trial data showing 44-66% objective response rates, and document why surgery is not feasible for this patient's specific tumor location and extent.

Switching Logistics

If Switching FROM Another Treatment TO Koselugo

  1. Coordinate with prescriber to document:
    • Previous treatment failures or intolerances
    • Disease progression despite other therapies
    • Specific reasons why Koselugo is now medically necessary
  2. Gather required documentation:
    • Updated MRI showing PN status
    • Current symptom assessment
    • Baseline LVEF and eye exam (if not done recently)
  3. Submit PA with transition rationale:

Working with CVS Specialty

Koselugo has limited distribution and may require coordination with specific specialty pharmacies. Contact CVS Specialty at 1-800-237-2767 for:

  • Benefit verification
  • Prior authorization status updates
  • Home delivery coordination
  • Financial assistance programs

Counterforce Health specializes in turning insurance denials into targeted appeals for specialty medications like Koselugo. Their platform analyzes denial letters and plan policies to create evidence-backed rebuttals that address specific payer requirements, helping families navigate the complex prior authorization process more effectively.

Re-trying for Koselugo Later

If initially denied or if you start with an alternative, document the following to strengthen a future Koselugo request:

Treatment Response Documentation

  • Objective measures: Regular MRI showing PN volume changes
  • Functional assessments: Pain scores, quality of life measures, physical function tests
  • Adverse events: Any intolerable side effects from alternative treatments

Disease Progression Evidence

  • New symptoms or worsening of existing symptoms
  • Imaging changes showing PN growth or new lesions
  • Functional decline affecting daily activities or development

Clinical Trial Participation

If participating in research studies, document:

  • Trial outcomes and your specific response
  • Any protocol deviations or early discontinuation
  • Investigator recommendations for standard-of-care treatment

Appeals Playbook for Florida

Internal Appeals (First Level)

Timeline: Must file within 180 days of denial notice Process:

  1. Call Aetna member services to request appeal forms
  2. Submit via provider portal or fax additional clinical documentation
  3. Decision timeline: 30 days for standard appeals, 72 hours for urgent

Required documentation:

  • Original denial letter
  • Updated medical records
  • Specialist letter of support
  • Any new clinical evidence

External Review (Independent Review)

If internal appeals are unsuccessful, Florida residents can request external review through the Florida Department of Financial Services.

Timeline: Must request within 4 months of final internal denial Cost: Free to consumers Decision: Binding on the insurance company

How to file:

  • Complete external review request form
  • Submit via Florida DFS website or mail
  • Include all relevant medical records and denial correspondence
Tip: For urgent situations involving immediate health risks, you can request expedited internal and external reviews simultaneously, with decisions often within 72 hours.

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Submit specialist letter emphasizing FDA indication and lack of alternatives Pediatric oncology/neurology consultation, symptom documentation
"Experimental/investigational" Cite FDA approval and published clinical trial data FDA labeling, SPRINT trial results, clinical guidelines
"Step therapy required" Request override citing unique indication and no true alternatives Medical exception form, literature showing no equivalent options
"Age restriction" Provide current FDA labeling showing ≥2 years approval Updated prescribing information, pediatric dosing guidelines
"Insufficient documentation" Submit complete clinical picture with all required elements NF1 diagnosis, imaging, baseline testing, symptom assessment

FAQ

Q: How long does Aetna prior authorization take for Koselugo in Florida? A: Standard PA decisions typically take 15-30 days. Urgent requests may be processed within 72 hours if medical urgency is documented.

Q: What if Koselugo isn't on my Aetna formulary? A: Request a formulary exception using the medical exception form, emphasizing that it's the only FDA-approved treatment for pediatric NF1 with plexiform neurofibromas.

Q: Can I get an expedited appeal if my child's condition is worsening? A: Yes, if delays could seriously jeopardize your child's health, request expedited internal appeal and potentially simultaneous external review in Florida.

Q: Does Aetna require trying other treatments first? A: Step therapy requirements vary by plan, but exceptions are available when alternatives aren't appropriate or effective for the specific condition.

Q: What financial assistance is available for Koselugo? A: AstraZeneca offers copay cards for commercially insured patients and patient assistance programs for those who qualify. Contact Koselugo OneSource for details.

Q: Who should prescribe Koselugo for the best chance of approval? A: Pediatric oncologists or neurologists with NF1 expertise have the best success rates, as they can provide the detailed clinical rationale Aetna requires.

When navigating complex prior authorization requirements, Counterforce Health helps families and clinicians create comprehensive appeals that address payer-specific criteria while incorporating the right clinical evidence and regulatory citations to maximize approval chances.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may vary by specific Aetna plan and can change over time. Always consult with your healthcare provider and insurance company for the most current information regarding your specific situation. For assistance with insurance concerns in Florida, contact the Florida Department of Financial Services at 1-877-MY-FL-CFO (1-877-693-5236).

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