How to Get Koselugo (selumetinib) Covered by Aetna (CVS Health) in Michigan: Complete Decision Tree and Appeals Guide
Quick Answer: Aetna (CVS Health) covers Koselugo (selumetinib) for pediatric patients ≥2 years with NF1-related plexiform neurofibromas, but requires prior authorization with strict documentation. Submit requests via the Availity portal or fax to 1-866-249-6155. If denied, you have 180 days to appeal internally, then 127 days to file for Michigan external review through DIFS. Start by gathering your NF1 diagnosis, baseline LVEF results, and ophthalmologic evaluation. Submit your PA request here.
Table of Contents
- How to Use This Decision Tree
- Eligibility Triage: Do You Qualify?
- If "Likely Eligible": Your Fast-Track Checklist
- If "Possibly Eligible": Tests and Documentation Needed
- If "Not Yet": Alternative Paths Forward
- If Denied: Michigan Appeals Roadmap
- Coverage Requirements at a Glance
- Common Denial Reasons & How to Fix Them
- FAQ: Your Top Questions Answered
How to Use This Decision Tree
This guide helps you navigate Aetna (CVS Health)'s prior authorization process for Koselugo (selumetinib) in Michigan. Whether you're a parent, patient, or clinician, follow the eligibility questions below to find your fastest path to coverage.
Start here: Answer the triage questions honestly based on your current medical records. Each section includes specific next steps and required documentation. If you get stuck, Michigan's Department of Insurance and Financial Services (DIFS) offers free consumer assistance at (877) 999-6442.
Eligibility Triage: Do You Qualify?
Step 1: Confirm Your Diagnosis
Question: Do you have a confirmed diagnosis of neurofibromatosis type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas?
- ✅ Yes: Continue to Step 2
- ❌ No: Koselugo is only FDA-approved for this specific indication. Discuss alternatives with your oncologist or neurologist.
Step 2: Check Age Requirements
Question: Are you between 2-17 years old?
- ✅ Yes: Continue to Step 3
- ❌ No, I'm an adult: As of 2025, adults now have mirdametinib (Gomekli) as an FDA-approved option for NF1-PN
Step 3: Safety Prerequisites
Question: Have you completed baseline LVEF assessment and comprehensive eye exam?
- ✅ Yes, both done: You're likely eligible—go to the Fast-Track section
- ⚠️ Partially: You're possibly eligible—see Tests and Documentation section
- ❌ Neither done: Start with safety evaluations before submitting PA
Step 4: Prior Therapy Status
Question: Has Aetna (CVS Health) required you to try other treatments first?
- ✅ No step therapy required: Proceed with PA submission
- ⚠️ Step therapy applies: Document any prior failures or contraindications
- ❓ Unsure: Check your Aetna drug formulary or call member services
If "Likely Eligible": Your Fast-Track Checklist
You meet the basic criteria. Here's your submission roadmap:
Document Checklist
Required for every PA request:
- NF1 diagnosis with genetic testing or clinical criteria documentation
- MRI or CT imaging showing symptomatic, inoperable plexiform neurofibromas
- Baseline LVEF assessment (echocardiogram) showing normal function
- Comprehensive ophthalmologic evaluation results
- Prescriber agreement to monitor LVEF every 3 months (first year)
- Patient weight and body surface area for dosing calculation
Submission Path
- Provider submits via Availity portal (fastest)
- Alternative: Fax to CVS Specialty at 1-866-249-6155
- Timeline: Submit at least 2 weeks before planned start date
- Decision: Expect response within 30-45 days for standard review
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform can help identify denial reasons and draft point-by-point rebuttals aligned to Aetna's specific policies.
Expected Approval Duration
- Initial approval: 6-12 months
- Renewals: Require updated progress notes showing tumor response or symptom improvement
- Monitoring: Ongoing LVEF and eye exams per protocol
If "Possibly Eligible": Tests and Documentation Needed
Missing some requirements? Here's what to request from your care team:
Missing Safety Evaluations
If you need baseline LVEF assessment:
- Request echocardiogram from cardiology or your primary oncologist
- Ensure report documents ejection fraction ≥institutional lower limit
- FDA labeling requires this before treatment start
If you need ophthalmologic evaluation:
- Schedule comprehensive eye exam with ophthalmologist
- Must document baseline retinal status (watching for future RPED/RVO)
- Include results in PA submission
Incomplete Diagnosis Documentation
If NF1 diagnosis needs strengthening:
- Genetic testing confirming NF1 mutation (gold standard)
- Clinical criteria documentation (café-au-lait spots, neurofibromas, family history)
- Imaging clearly showing plexiform neurofibromas with measurements
Timeline to Reapply
- Complete missing tests within 30-60 days
- Submit new PA request with all documentation
- Note any symptom progression during waiting period
If "Not Yet": Alternative Paths Forward
Don't meet standard criteria? You still have options:
Medical Exception Requests
When to request:
- Age outside pediatric range but compelling clinical need
- Contraindications to step therapy requirements
- Urgent medical necessity (progressive symptoms)
How to submit:
- Include detailed medical necessity letter from specialist
- Document why alternatives are inappropriate or have failed
- Request expedited review if clinically urgent
Alternative Treatment Discussion
FDA-approved options to discuss:
- Mirdametinib (Gomekli): Now approved for adults and children ≥2 with NF1-PN
- Clinical trials: Search ClinicalTrials.gov for NF1 studies
- Symptomatic management: Pain control, physical therapy, surgical consultation
Prepare for Future Eligibility
- Monitor tumor growth with serial imaging
- Document symptom progression
- Maintain relationship with NF1 specialist
- Consider second opinion if treatment urgency increases
If Denied: Michigan Appeals Roadmap
Aetna (CVS Health) denied your request? Michigan offers strong consumer protections:
Level 1: Internal Appeal
Timeline: File within 180 days of denial Process:
- Submit appeal via Aetna member portal
- Include all supporting documentation
- Request peer-to-peer review with Aetna medical director
- Decision: Within 30 days (72 hours if expedited)
Level 2: Michigan External Review
Timeline: File within 127 days of final internal denial Process:
- Submit Request for External Review (FIS 0018) to Michigan DIFS
- Include denial letters, medical records, physician support letter
- Decision: Within 60 days (72 hours if expedited)
- Binding: If approved, Aetna must provide coverage
Michigan DIFS Contact:
- Phone: (877) 999-6442
- Email: [email protected]
- Online: External Review Request Form
Expedited Review Criteria
Request expedited review if:
- Delay would seriously jeopardize your health
- You need urgent treatment (physician letter required)
- Standard timeline could worsen your condition
Companies like Counterforce Health can help draft compelling appeals that address Aetna's specific denial reasons with targeted medical evidence and policy citations.
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Must get approval before filling | Aetna Precertification List | Aetna PA Requirements |
| Age Restriction | Pediatric patients ≥2 years | FDA labeling | FDA Label |
| Diagnosis Code | NF1 with symptomatic, inoperable PN | Medical records | FDA Access Data |
| Safety Monitoring | Baseline LVEF + eye exam | Provider documentation | Koselugo HCP Site |
| Specialty Pharmacy | CVS Specialty required | Plan formulary | CVS Caremark |
| Appeal Deadline | 180 days internal, 127 days external | Plan documents + state law | Michigan DIFS |
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| "Not medically necessary" | Submit medical necessity letter with clinical evidence | Tumor measurements, symptom impact, specialist recommendation |
| "Missing safety evaluations" | Complete baseline testing | LVEF assessment, ophthalmologic exam results |
| "Age outside indication" | Request medical exception | Compelling clinical rationale, specialist support |
| "Experimental/investigational" | Cite FDA approval | FDA labeling, indication-specific evidence |
| "Step therapy not completed" | Document contraindications or failures | Prior treatment records, adverse event documentation |
| "Non-formulary status" | Request formulary exception | Medical necessity, lack of alternatives |
FAQ: Your Top Questions Answered
How long does Aetna (CVS Health) prior authorization take in Michigan? Standard PA decisions take 30-45 days. Expedited reviews (for urgent cases) are completed within 72 hours. Submit requests at least 2 weeks before your planned start date.
What if Koselugo (selumetinib) is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Include evidence that formulary alternatives are inappropriate, contraindicated, or have failed.
Can I request an expedited appeal in Michigan? Yes, if your physician certifies that a delay would seriously jeopardize your health. Include a supporting letter with your appeal to Michigan DIFS.
Does step therapy apply if I've tried treatments outside Michigan? Yes, prior treatment history from any state counts. Document all previous therapies, outcomes, and reasons for discontinuation in your PA request.
What's the cost of Koselugo (selumetinib) without insurance? Cash prices range from approximately $2,651 (28×10mg) to $6,617 (28×25mg) per month. Annual costs can exceed $250,000. Check AstraZeneca's patient assistance programs for copay support.
How often do I need monitoring while on Koselugo? LVEF monitoring every 3 months during the first year, then every 6 months. Regular ophthalmologic evaluations are also required per FDA safety requirements.
What happens if my appeal is denied by Aetna? You can file for Michigan external review within 127 days. The independent review organization's decision is binding—if they approve, Aetna must provide coverage.
Can adults get Koselugo (selumetinib) covered? As of 2025, mirdametinib (Gomekli) is FDA-approved for adults with NF1-PN. Some insurers may prefer this option for adult patients.
Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult your healthcare provider for treatment decisions. Coverage policies change frequently—verify current requirements with Aetna (CVS Health) and your care team.
Need Help? Contact Michigan DIFS at (877) 999-6442 for free insurance assistance, or visit Counterforce Health for specialized appeals support.
Sources & Further Reading
- Aetna Prior Authorization Requirements (PDF)
- Koselugo FDA Labeling
- Michigan DIFS External Review Process
- Koselugo Healthcare Professional Information
- Aetna External Review Program
- CVS Caremark Prior Authorization
- Mirdametinib FDA Approval
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