By Counterforce Health Team in Koselugo (selumetinib) —

The Requirements Checklist to Get Koselugo (Selumetinib) Covered by Cigna in Michigan: Forms, Appeals, and Clinical Criteria

Answer Box: Quick Path to Koselugo Coverage

Cigna requires prior authorization (PA) for Koselugo (selumetinib) in pediatric NF1 patients with symptomatic, inoperable plexiform neurofibromas. Initial approvals last 1 year with reauthorization requiring evidence of benefit. Key requirements: confirmed NF1 diagnosis (ICD-10 Q85.01), baseline LVEF evaluation, ophthalmologic exam, and MRI documenting inoperable plexiform neurofibromas. Submit PA through Cigna provider portal with complete documentation packet. If denied, Michigan patients have 127 days to file external review with DIFS.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Requirements
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: What to Expect
  9. Common Denial Reasons & Prevention
  10. Appeals Process in Michigan
  11. Quick Reference Checklist

Who Should Use This Checklist

This comprehensive guide is designed for patients, caregivers, and healthcare providers navigating Cigna's prior authorization process for Koselugo (selumetinib) in Michigan. You'll find this particularly useful if:

  • Your child has been diagnosed with NF1 and symptomatic plexiform neurofibromas
  • Your doctor has recommended Koselugo but you're facing insurance hurdles
  • You've received a denial and need to understand your appeal options
  • You're a clinician preparing a prior authorization submission

Expected outcome: Following this checklist increases your chances of initial approval and provides a clear roadmap for appeals if needed. Michigan's robust external review process means many denials can be successfully overturned with proper documentation.

Member & Plan Basics

Verify Active Coverage

Before starting the PA process, confirm:

  • Your Cigna plan is active and covers specialty medications
  • Koselugo requires prior authorization under your specific plan
  • Whether your plan uses Express Scripts/Accredo for specialty pharmacy services

Plan Type Considerations

Commercial Plans: Standard PA requirements apply with 1-year initial approval periods.

Medicare Advantage: Age restrictions may apply - typically requires therapy initiation before age 19 for continuation coverage.

Deductible and Cost-Sharing

Koselugo is typically classified as a Tier 5 specialty medication. In Michigan, specialty medications are limited to 30-day supplies. Contact Accredo at 877-826-7657 to discuss copay assistance programs.

Clinical Criteria Requirements

FDA-Approved Indication

Koselugo is FDA-approved for adults and pediatric patients ≥1 year with NF1 who have symptomatic, inoperable plexiform neurofibromas. However, many payer policies still reference the original pediatric ≥2 years criteria.

Cigna's Specific Requirements

According to Cigna's PA policy, patients must meet ALL of the following:

Requirement Details Documentation Needed
Age 1-18 years OR ≥19 if started before age 19 Birth certificate, medical records
NF1 Diagnosis Confirmed neurofibromatosis type 1 Clinical criteria or genetic testing
Plexiform Neurofibromas Symptomatic and inoperable MRI/imaging, specialist assessment
Prescriber Oncologist or specialist recommended Provider credentials

Baseline Safety Evaluations

Cardiac Function: Baseline LVEF evaluation required due to cardiomyopathy risk. The FDA label specifies monitoring for LVEF decline ≥10% below baseline.

Ophthalmologic Exam: Comprehensive eye exam to exclude retinal vein occlusion, retinal pigment epithelial detachment, or uncontrolled glaucoma.

Laboratory Studies: Baseline liver function tests and CPK levels per institutional practice.

Coding and Billing Requirements

ICD-10 Diagnosis Codes

Primary: Q85.01 - Neurofibromatosis, type 1

Alternative: Q85.00 - Neurofibromatosis, unspecified (when documentation is less specific)

NDC and HCPCS Information

Koselugo is an oral medication billed using product-specific NDCs. Consult the manufacturer's coding resource for current NDC numbers by strength and package size.

HCPCS: No specific J-code exists for Koselugo. If billed under medical benefit, use J3490 (unclassified drugs) with NDC details.

Dosing Specifications

Standard dosing: 25 mg/m² orally twice daily, adjusted for body surface area and hepatic function per FDA prescribing information.

Documentation Packet Essentials

Provider Note Elements

Your specialist's documentation should include:

  • Confirmed NF1 diagnosis with clinical criteria or genetic testing results
  • Detailed description of plexiform neurofibroma symptoms (pain, functional impairment, disfigurement)
  • Assessment of inoperability due to location, vascularity, or risk of major morbidity
  • Treatment goals and monitoring plan

Medical Necessity Letter Components

A strong letter of medical necessity should address:

  1. Patient's condition: NF1 diagnosis and symptomatic plexiform neurofibromas
  2. Treatment rationale: Why Koselugo is medically necessary
  3. Lack of alternatives: No equally effective treatments for pediatric NF1 plexiform neurofibromas
  4. FDA approval status: Reference the specific indication
  5. Monitoring plan: Cardiac, ophthalmologic, and laboratory surveillance
From our advocates: We've seen successful appeals when providers include specific symptom descriptions and quality-of-life impacts in their letters. Rather than just stating "symptomatic," describe how the tumors affect daily activities, school attendance, or physical function. This composite approach has helped demonstrate medical necessity more effectively.

Required Attachments

Essential Documents:

  • Recent MRI or CT scan showing plexiform neurofibromas
  • Echocardiogram with LVEF results
  • Ophthalmology consultation report
  • Previous treatment history (if any)
  • Genetic testing results (if available)

Submission Process

Correct Form and Portal

Submit through the Cigna provider portal or use the Koselugo-specific PA form available through CoverMyMeds.

Required Fields That Commonly Cause Rejections

  • Complete patient demographics including correct member ID
  • Accurate ICD-10 coding (Q85.01 preferred)
  • Specific symptom documentation beyond just "symptomatic"
  • Clear statement of inoperability with clinical rationale
  • Prescriber signature and credentials

Timeline Expectations

Standard PA: Response within 72 hours of complete submission Urgent/Expedited: Response within 24 hours when delay would jeopardize health

Specialty Pharmacy Routing

Preferred Vendors

Cigna typically requires Koselugo to be dispensed through Accredo specialty pharmacy. Call 877-826-7657 to initiate enrollment.

Transfer Steps

  1. Verify plan requirements through myCigna app or website
  2. Contact Accredo for new patient enrollment
  3. Provide prescription directly from prescriber to Accredo
  4. Complete enrollment forms and insurance verification
  5. Schedule delivery to home or provider office

Shipment Verification

Koselugo requires proper storage and handling. Accredo provides:

  • Temperature-controlled shipping at no extra cost
  • Delivery confirmation and tracking
  • 24/7 pharmacist support for questions

After Submission: What to Expect

Confirmation and Tracking

Record these details:

  • PA submission date and confirmation number
  • Case reference number from Cigna
  • Contact information for follow-up
  • Expected decision timeline

Status Check Schedule

  • Day 3: Check status if no response received
  • Day 7: Follow up on any missing documentation requests
  • Day 14: Escalate if no decision rendered

Common Denial Reasons & Prevention

Top 5 Denial Reasons and Solutions

Denial Reason Prevention Strategy Required Documentation
Incomplete documentation Submit all required attachments upfront Complete checklist verification
Age non-compliance Verify age criteria and continuation rules Birth records, treatment history
Missing medical necessity Provide detailed symptom description Specialist letter with specific impacts
Inadequate baseline testing Complete all safety evaluations Echo, eye exam, lab results
Off-label use concerns Emphasize FDA-approved indication Reference prescribing information

Appeals Process in Michigan

Internal Appeal Rights

If denied, you have 180 days to file an internal appeal with Cigna. Submit additional documentation addressing the specific denial reasons.

External Review Process

Michigan offers robust external review rights through the Department of Insurance and Financial Services (DIFS). After final internal denial, you have 127 days to request external review.

How to File:

  • Use DIFS online External Review Request form
  • Submit via email, fax, or mail to DIFS
  • Include all relevant medical records and denial letters

Timelines:

  • Standard review: Decision within 60 days
  • Expedited review: Decision within 72 hours (requires physician letter stating delay would harm patient)

Contact DIFS: 877-999-6442 for questions about the appeal process.

When to Escalate

Consider filing a complaint with DIFS if:

  • Cigna fails to meet response timelines
  • Denial appears to contradict their own policy
  • You encounter procedural violations

Quick Reference Checklist

Before You Start

  • Verify active Cigna coverage
  • Confirm NF1 diagnosis and symptomatic plexiform neurofibromas
  • Complete baseline LVEF evaluation
  • Obtain ophthalmologic clearance
  • Gather recent imaging studies

Documentation Packet

  • Completed PA form with all required fields
  • Medical necessity letter from specialist
  • MRI/CT showing plexiform neurofibromas
  • Echocardiogram results
  • Ophthalmology consultation
  • Previous treatment history
  • Insurance card copy

Submission

  • Submit through correct portal/form
  • Record confirmation number
  • Set follow-up reminders
  • Contact Accredo for specialty pharmacy setup

If Denied

  • Review denial reasons carefully
  • Gather additional supporting documentation
  • File internal appeal within 180 days
  • Consider external review with DIFS (127 days)

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed responses. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with each payer's specific requirements, significantly improving approval rates for complex medications like Koselugo.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan directly for specific coverage decisions. Insurance policies and procedures may change; verify current requirements with your plan. For assistance with complex appeals, consider consulting with Counterforce Health or other advocacy services.

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