By Counterforce Health Team in Koselugo (selumetinib) —

Get Koselugo (Selumetinib) Covered by Aetna CVS Health in New York: Complete Guide to Prior Authorization and Appeals

Answer Box: Quick Path to Approval

Koselugo (selumetinib) requires prior authorization from Aetna CVS Health for pediatric patients ≥2 years with NF1 and symptomatic, inoperable plexiform neurofibromas. Your prescriber submits the PA with baseline LVEF (echocardiogram) and ophthalmologic evaluation results. Standard decisions take 30-45 days; expedited reviews complete within 72 hours for urgent cases. If denied, you have 180 days to appeal internally, then 4 months for New York's external review. Start today: Ask your clinic to verify your plan's formulary status and gather required baseline testing before PA submission.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Clinical Criteria and Requirements
  5. Costs and Financial Assistance
  6. Denials and Appeals
  7. Renewals and Ongoing Coverage
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Koselugo Covered by Aetna CVS Health?

Koselugo appears on Aetna's specialty drug list, meaning it requires prior authorization and is filled through specialty pharmacy channels. Coverage applies to FDA-approved indications: pediatric patients ≥2 years with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas.

Which Aetna Plans Cover Koselugo?

Most Aetna commercial, Medicare, and Medicaid plans in New York include Koselugo coverage with prior authorization. However, specific formulary status varies by plan type:

  • Commercial/Exchange plans: Specialty tier with PA
  • Aetna Better Health NY (Medicaid): Covered with state Medicaid PA requirements
  • Medicare plans: Check your specific plan's formulary using Aetna's drug search tool
Note: Formularies change during the year. Always verify current status through your member portal or by calling the number on your ID card.

Prior Authorization Process

Who Submits the Prior Authorization?

Your prescribing physician or their staff submits the PA request to Aetna CVS Health. The process typically involves:

  1. Baseline testing completion (LVEF assessment and ophthalmologic evaluation)
  2. PA form submission via Aetna's provider portal or fax
  3. Clinical documentation including diagnosis confirmation and treatment history
  4. Specialty pharmacy coordination through Onco360 (Koselugo's exclusive distributor)

Required Documentation

Clinical Requirements:

  • Confirmed NF1 diagnosis (genetic testing or clinical criteria)
  • Imaging documentation of symptomatic, inoperable plexiform neurofibromas
  • Baseline echocardiogram showing LVEF above institutional lower limit
  • Ophthalmologic evaluation results
  • Prior treatment history and failures/contraindications

Administrative Requirements:

  • Complete Aetna PA form (verify current version)
  • Patient demographics and insurance information
  • Prescriber attestation for ongoing monitoring

Timing and Urgency

Standard Review Timeline

  • Initial PA decision: 30-45 days for most commercial plans
  • Medicaid plans: Up to 30 days with acknowledgment within 15 days
  • Medicare plans: Typically 72 hours to 14 days depending on plan type

Expedited Review Process

For urgent cases where delay could seriously jeopardize health, request expedited review:

Criteria for Expedited Review:

  • Progressive tumor growth causing functional impairment
  • Risk of permanent neurologic damage
  • Severe, unmanaged symptoms affecting quality of life

Timeline: 72 hours for expedited decisions across most Aetna plan types.

How to Request: Mark PA form as "EXPEDITED" and include physician statement explaining urgency.

Clinical Criteria and Requirements

FDA-Approved Indication

Koselugo is approved for pediatric patients ≥2 years with NF1 who have symptomatic, inoperable plexiform neurofibromas. Key criteria include:

Requirement Documentation Needed Source
Age ≥2 years Birth certificate or medical record FDA Label
NF1 diagnosis Genetic testing or clinical criteria FDA Label
Symptomatic PN Clinical notes documenting symptoms FDA Label
Inoperable status Surgeon evaluation or imaging report FDA Label
Baseline LVEF Echocardiogram above institutional LLN Koselugo HCP Site
Eye exam Ophthalmologic evaluation Koselugo HCP Site

Safety Monitoring Requirements

Aetna PA approval includes prescriber agreement to monitor:

  • LVEF: Every 3 months in year 1, then every 6 months
  • Ophthalmologic exams: Regular monitoring for retinal toxicity
  • Other: CPK levels, dermatologic reactions, GI adverse events

Costs and Financial Assistance

Typical Out-of-Pocket Costs

Koselugo's retail cost approaches $270,000 annually. Your actual cost depends on:

  • Specialty tier coinsurance: Often 20-50% up to monthly maximum
  • Annual out-of-pocket maximum: After reaching this limit, Aetna pays 100%
  • Copay assistance: Manufacturer programs can significantly reduce costs

Financial Support Options

Manufacturer Assistance:

  • OneSource patient support program through AstraZeneca
  • Copay cards for commercially insured patients
  • Patient assistance programs for uninsured/underinsured

Specialty Pharmacy Support:

  • Onco360 provides financial assistance coordination
  • Payment plans and flexible billing options
Tip: Don't authorize shipment until you know your final out-of-pocket cost after all assistance programs are applied.

Denials and Appeals

Common Denial Reasons

Denial Reason How to Address
Missing baseline LVEF Submit echocardiogram results showing LVEF above LLN
Insufficient NF1 documentation Provide genetic testing or detailed clinical criteria
Age restrictions Confirm patient is ≥2 years with documentation
Lack of symptom documentation Submit detailed clinical notes describing PN symptoms
Missing ophthalmologic evaluation Provide complete eye exam results

Internal Appeal Process

Timeline: 180 days from denial notice to file internal appeal

Standard Appeals: 30 days for decision Expedited Appeals: 72 hours for urgent cases

Required Elements:

  • Original denial letter
  • Additional clinical documentation addressing denial reasons
  • Medical necessity letter from prescriber
  • Supporting literature and guidelines

New York External Review

After internal appeal denial, New York residents can request external review through the NY Department of Financial Services.

Timeline: 4 months from internal appeal denial Decision: Up to 30 days (72 hours for expedited) Cost: $25 maximum (waived for financial hardship)

When External Review Overturns Denial: Aetna must cover the service and refund the appeal fee.

Renewals and Ongoing Coverage

Reauthorization Requirements

Koselugo typically requires annual reauthorization with:

  • Updated clinical assessment
  • Imaging studies showing response or stability
  • Continued prescriber attestation for monitoring
  • Documentation of ongoing medical necessity

Monitoring for Continued Coverage

Maintain coverage by ensuring:

  • Regular LVEF monitoring per protocol
  • Ophthalmologic evaluations as required
  • Clinical documentation of benefit or stable disease
  • Adherence to safety monitoring requirements

Specialty Pharmacy Requirements

Exclusive Distribution

Koselugo is distributed exclusively through Onco360 Specialty Pharmacy, not CVS Specialty. This limited distribution network:

  • Verifies insurance benefits and PA status
  • Coordinates financial assistance programs
  • Provides 24/7 oncology pharmacy support
  • Manages refills and adherence monitoring

Patient Support Services

Onco360 provides:

  • Insurance benefit validation
  • Prior authorization support
  • Financial assistance coordination
  • Clinical monitoring and education
  • Refill reminders and adherence tools

Troubleshooting Common Issues

PA Portal Problems

If Aetna's provider portal is down:

  • Use backup fax submission (verify current fax number)
  • Call provider services for alternative submission methods
  • Request expedited processing if delay affects patient care

Missing Forms or Documentation

Common missing items:

  • Baseline LVEF results
  • Ophthalmologic evaluation
  • Complete NF1 documentation
  • Prior treatment history

Solution: Create a checklist before PA submission and verify all requirements are met.

Communication Gaps

Between prescriber and specialty pharmacy:

  • Ensure Onco360 has complete PA approval documentation
  • Verify patient contact information is current
  • Confirm shipping address and timing preferences

Frequently Asked Questions

How long does Aetna CVS Health PA take in New York?

Standard PA decisions take 30-45 days. Expedited reviews for urgent cases complete within 72 hours. Medicaid plans acknowledge requests within 15 days and decide within 30 days.

What if Koselugo is non-formulary on my plan?

Request a formulary exception with medical necessity documentation. If denied, appeal with supporting clinical evidence and guidelines. New York's external review process provides additional recourse.

Can I request an expedited appeal?

Yes, if delay would seriously jeopardize health or cause severe unmanaged pain. Include physician documentation explaining why expedited review is medically necessary.

Does step therapy apply to Koselugo?

Step therapy requirements vary by plan. For pediatric NF1 with plexiform neurofibromas, Koselugo is often first-line given limited alternatives. Check your specific plan's PA criteria.

What happens during pediatric to adult transition?

Coverage may change when transitioning from pediatric to adult plans. Request continuity of care review 3-6 months before age cutoff. Consider mirdametinib (Gomekli) as an alternative if adult coverage differs.

How do I appeal if my child's coverage is denied?

File internal appeal within 180 days, requesting expedited review for pediatric urgency. If denied, use New York's external review within 4 months. For Medicaid, you can also request a state fair hearing.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with payer requirements and improve approval rates.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements change frequently. Always verify current information with your insurance plan and consult your healthcare provider for medical decisions. For personalized assistance with insurance appeals in New York, contact Community Health Advocates at 888-614-5400.

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