By Counterforce Health Team in Koselugo (selumetinib) —

How to Get Koselugo (Selumetinib) Covered by Humana in Michigan: Complete Appeals Guide with Forms and Timelines

Answer Box: Fast Track to Koselugo Coverage

Koselugo (selumetinib) requires prior authorization from Humana for pediatric NF1 patients with symptomatic, inoperable plexiform neurofibromas. Your fastest path: Have your specialist submit a complete PA request with NF1 diagnosis confirmation, MRI showing inoperable tumors, baseline cardiac evaluation (LVEF), and comprehensive eye exam. If denied, file an internal appeal within 65 days, then request Michigan DIFS external review within 127 days. Start today: Contact your prescriber to gather baseline safety evaluations and imaging documentation.

Table of Contents

Understanding Koselugo Coverage Requirements

Koselugo (selumetinib) is an oral MEK1/2 inhibitor approved by the FDA in 2020 for pediatric patients aged 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas. At approximately $268,677 per year, it requires careful documentation to secure coverage.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all pediatric NF1 patients Humana PA Lists
Age Restriction Patients ≥2 years only FDA Label
Diagnosis Requirement Confirmed NF1 with inoperable plexiform neurofibromas Humana Coverage Policy
Baseline Safety Tests LVEF assessment, eye exam Koselugo HCP Site
Authorization Period 12 months with reauthorization Humana PA Process

Reading Your Denial Letter

When Humana denies Koselugo coverage, your explanation of benefits (EOB) or denial letter will include specific reason codes. Common denial reasons include:

  • Missing NF1 confirmation: Genetic testing or detailed clinical criteria documentation required
  • Inadequate imaging: Need MRI evidence showing inoperable plexiform neurofibromas
  • Missing safety evaluations: Baseline cardiac (LVEF) and ophthalmologic assessments required
  • Age restriction: Patient must be ≥2 years old
  • Non-formulary status: Drug may require formulary exception request
Tip: Look for the appeal deadline on your denial letter—you have 65 days from the denial date to file an internal appeal with Humana.

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Week 1)

Who: Your specialist and care team
Documents needed:

  • Confirmed NF1 diagnosis (genetic testing or clinical criteria)
  • MRI imaging showing plexiform neurofibromas
  • Surgical consultation confirming inoperability
  • Baseline echocardiogram (LVEF assessment)
  • Complete ophthalmologic evaluation Timeline: 1-2 weeks to compile

2. Submit Prior Authorization (Week 2)

Who: Prescribing physician
How: Humana provider portal or fax
Timeline: Humana responds within 72 hours for standard requests, 24 hours for expedited

3. If Denied: File Internal Appeal (Within 65 days)

Who: Patient or authorized representative
Documents: Original denial letter, updated medical records, specialist letter of medical necessity
Timeline: 7-30 days for Humana's response depending on plan type

4. Request Michigan External Review (Within 127 days of final denial)

Who: Patient
Form: DIFS Form FIS 0018
Timeline: Up to 60 days for standard review, 72 hours for expedited

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
"Not medically necessary" Submit comprehensive letter of medical necessity with FDA approval documentation Specialist letter, clinical guidelines, peer-reviewed studies
"Missing baseline tests" Complete all required safety evaluations Echocardiogram results, ophthalmology report, lab work
"Unconfirmed NF1 diagnosis" Provide genetic testing or detailed clinical criteria Genetic test results or comprehensive clinical assessment
"Non-formulary drug" Request formulary exception with medical necessity justification Prescriber statement explaining why alternatives are inappropriate
"Age restriction" Verify patient meets FDA-approved age criteria Birth certificate showing patient ≥2 years old

Humana Appeals Process in Michigan

Internal Appeal (Level 1)

  • Deadline: 65 days from denial notice
  • Response time: 7 days for Medicare Part D, 30 days for Medicare Advantage
  • How to file: Online through Humana member portal, phone, or mail
  • Required: Original denial letter, supporting medical documentation

Expedited Appeal

If your child's condition could worsen without treatment, request an expedited appeal:

  • Timeline: 24-72 hours for decision
  • Requirement: Physician statement confirming medical urgency
  • How to request: Mark all submissions as "expedited" and provide clinical justification
From our advocates: We've seen successful Koselugo appeals when families worked closely with their NF specialist to document functional impairment and quality of life impacts. The key is showing how plexiform neurofibromas specifically affect daily activities, mobility, or cause significant pain—not just that they exist.

Michigan DIFS External Review

If Humana's internal appeal process doesn't result in approval, Michigan's Department of Insurance and Financial Services (DIFS) provides an independent external review.

Eligibility and Timeline

  • Filing deadline: 127 days after receiving Humana's final denial
  • Standard review: Up to 60 days for decision
  • Expedited review: 72 hours (requires physician statement of medical urgency)
  • Cost: Free to patients

Required Forms and Documents

How to Submit

  • Online: michigan.gov/difs
  • Phone: 877-999-6442 (Monday-Friday, 8 a.m. to 5 p.m.)
  • Email, fax, or mail: Contact information available on DIFS website

Medical Necessity Documentation

A strong medical necessity letter should include:

Clinical Rationale Checklist

  • NF1 diagnosis confirmation with ICD-10 code (Q85.00)
  • Imaging evidence showing symptomatic plexiform neurofibromas
  • Functional impairment assessment using validated tools like PedsQL™ NF1 Module
  • Inoperability statement from surgical consultation
  • Treatment goals and expected outcomes
  • Safety monitoring plan including cardiac and ophthalmologic follow-up

Supporting Evidence

  • FDA approval documentation for NF1-related plexiform neurofibromas
  • Peer-reviewed clinical trial data demonstrating efficacy
  • Specialty guidelines from organizations like the Children's Tumor Foundation
  • Documentation that no therapeutic alternatives exist for this FDA-approved indication

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and drafting evidence-backed appeals that align with payer-specific policies. Their platform identifies the specific denial basis and creates targeted rebuttals using the right clinical evidence and procedural requirements.

Cost Savings and Support Programs

Manufacturer Support

  • AstraZeneca Patient Access Program: Financial assistance for eligible patients
  • Information: Koselugo patient support (verify current eligibility criteria)

Copay Assistance

  • Commercial insurance patients may qualify for copay support programs
  • Contact: Koselugo patient support team for current program details

Foundation Grants

  • Children's Tumor Foundation may offer resources for NF1 families
  • State-specific assistance programs through Michigan Department of Health and Human Services

When to Escalate

File a Complaint with Michigan Regulators

If you believe Humana improperly denied coverage or violated Michigan insurance regulations:

  • Michigan DIFS Complaint Process: File online or call 877-999-6442
  • Required information: Policy details, denial letters, correspondence with Humana
  • Timeline: DIFS typically responds within 30 days

Contact Federal Agencies

For Medicare-related issues:

  • Medicare Rights Center: 1-800-MEDICARE
  • Centers for Medicare & Medicaid Services: File complaints through Medicare.gov

Frequently Asked Questions

How long does Humana prior authorization take for Koselugo in Michigan?
Standard PA requests receive responses within 72 hours. Expedited requests (when delay could harm the patient) are decided within 24 hours.

What if Koselugo is non-formulary on my Humana plan?
Request a formulary exception by having your prescriber submit a supporting statement explaining why covered alternatives would be less effective or cause adverse effects.

Can I request an expedited appeal if my child's condition is worsening?
Yes, if waiting for a standard appeal decision could seriously harm your child's health, you can request expedited review with a physician's supporting statement.

Does step therapy apply to Koselugo for NF1?
Koselugo is the first and primary FDA-approved treatment for pediatric NF1 plexiform neurofibromas. Mirdametinib (Gomekli) was approved in 2025 as an alternative MEK inhibitor, which may affect step therapy requirements.

What happens if both internal and external appeals fail?
Consider requesting a second opinion, exploring clinical trials, or working with patient advocacy organizations. Counterforce Health can help identify alternative coverage strategies or procedural issues that may warrant additional appeals.

How do I prove my child's plexiform neurofibromas are "symptomatic"?
Document functional impairment, pain levels, mobility restrictions, or cosmetic disfigurement affecting quality of life. Use validated assessment tools and maintain detailed symptom logs.

Can I appeal if we've moved to Michigan from another state?
Yes, but ensure you understand Michigan-specific appeal timelines and procedures. Previous denials from other states may still be relevant to your medical necessity documentation.

What if my child turns 18 during treatment?
Koselugo remains FDA-approved for pediatric patients who began treatment before age 18. For new adult patients, mirdametinib may be the preferred option under some payer policies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may change. Always consult your healthcare provider for medical decisions and contact Humana directly or Michigan DIFS for the most current procedural requirements and forms.

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