How to Get Evrysdi (Risdiplam) Covered by Humana in North Carolina: Complete Prior Authorization and Appeals Guide
Answer Box: Getting Evrysdi Covered by Humana in North Carolina
Humana requires prior authorization for Evrysdi (risdiplam) with genetic confirmation of SMA, motor function assessments, and specialist documentation. Submit via Humana's provider portal with complete clinical records for 72-hour standard review (24-hour expedited if urgent). If denied, you have 65 days to appeal internally, then can request external review through North Carolina's Smart NC program within 120 days. Start today: Gather genetic testing results, recent motor assessments, and contact your prescriber to initiate the prior authorization request through Humana's provider portal.
Table of Contents
- Who Should Use This Guide
- Member & Plan Basics
- Clinical Criteria for Approval
- Required Documentation Packet
- Submission Process
- Specialty Pharmacy Requirements
- After Submission: What to Expect
- Appeals Process in North Carolina
- Common Denial Reasons & How to Fix Them
- Quick Reference Checklist
Who Should Use This Guide
This guide helps patients with spinal muscular atrophy (SMA) and their healthcare providers navigate Humana's prior authorization process for Evrysdi (risdiplam) in North Carolina. You'll need this if:
- Your doctor has prescribed Evrysdi for confirmed SMA
- You have Humana Medicare Advantage, Medicare Part D, or commercial insurance
- You're facing a prior authorization requirement or denial
- You need to understand North Carolina's external review rights
Expected outcome: With complete documentation, Humana approves most medically necessary requests. Their Medicare Advantage denial rate is approximately 3.5%—among the lowest of major insurers—when proper documentation is provided.
Member & Plan Basics
Coverage Requirements
Prior Authorization: Required for all Humana plans covering Evrysdi. The medication typically appears on Humana's Prior Authorization and Notification List as a Tier 5 specialty drug.
Plan Types Covered:
- Humana Medicare Advantage (Part C)
- Humana Medicare Part D stand-alone plans
- Humana commercial plans (employer-sponsored)
Cost Considerations: Evrysdi's list price approaches $340,000 annually, making it subject to highest-tier cost-sharing. Medicare Part D beneficiaries may qualify for catastrophic coverage after reaching the annual out-of-pocket threshold.
Note: New Humana members have a 90-day grace period for ongoing treatments started before enrollment, but prior authorization is still required for continued coverage.
Clinical Criteria for Approval
Primary Requirements
| Requirement | Documentation Needed | Source |
|---|---|---|
| SMA Diagnosis | Genetic testing showing SMN1 gene deletion | ICD-10: G12.0, G12.1 |
| Age Eligibility | Pediatric and adult patients | FDA labeling |
| Motor Function | Baseline assessments (CHOP INTEND, HFMSE) | Clinical documentation |
| Specialist Care | Neurologist or SMA specialist involvement | Provider notes |
Genetic Testing Requirements
Medicare covers SMN1 deletion confirmation testing without prior authorization under CPT codes 81329 (dosage analysis) and 81320 (targeted mutation). The test must show:
- Homozygous deletion of SMN1 gene exon 7 (with or without exon 8 deletion)
- SMN2 copy number if available (affects prognosis but not coverage)
- Genetic counseling documentation recommended
No Step Therapy Required
Unlike some insurers, Humana doesn't mandate trying Spinraza or Zolgensma first if Evrysdi is clinically appropriate as initial therapy. However, document any prior SMA treatments and outcomes.
Required Documentation Packet
Medical Necessity Letter Components
Your prescriber should include these elements in the letter of medical necessity:
Patient Information:
- Current age and weight (for dosing calculations)
- SMA type and severity
- Current motor function status
- Functional decline or stability goals
Clinical Justification:
- Genetic testing results confirming SMA
- Motor assessments (baseline and recent)
- Why Evrysdi is preferred over alternatives
- Treatment goals and monitoring plan
Supporting Evidence:
- FDA prescribing information
- Clinical trial data (FIREFISH, SUNFISH studies)
- Relevant treatment guidelines
Required Attachments
- Genetic testing report (SMN1 deletion confirmation)
- Recent motor function assessments
- Specialist consultation notes
- Prior treatment records (if applicable)
- Current weight documentation (for dosing)
- Pregnancy test results (females of reproductive age)
Submission Process
Step-by-Step Submission
- Gather Documentation (1-2 days)
- Collect all required clinical records
- Ensure genetic testing is complete and recent
- Complete Prior Authorization Form
- Access through Humana's provider portal
- Use current form version (verify date)
- Include all required fields to prevent automatic rejections
- Submit Complete Package
- Standard review: 72 hours from complete submission
- Expedited review: 24 hours if urgent medical need
- Request confirmation number and save it
- Verify Submission
- Check portal status within 24 hours
- Confirm all documents were received
- Note any missing information requests
Tip: Submit early in the week (Tuesday-Thursday) for faster processing, as weekends can delay review timelines.
Specialty Pharmacy Requirements
Network Requirements
Evrysdi must be dispensed through Humana's specialty pharmacy network. CenterWell Specialty Pharmacy (formerly Humana Specialty Pharmacy) is the preferred vendor, but other network options may be available.
Services Provided:
- Home delivery coordination
- Clinical monitoring support
- Financial assistance program navigation
- Dosing and administration education
Prescription Transfer Process
- Verify network status of chosen specialty pharmacy
- Transfer prescription from retail pharmacy if needed
- Coordinate delivery to preferred location
- Confirm receipt and proper storage instructions
Using an out-of-network specialty pharmacy will result in automatic coverage denial.
After Submission: What to Expect
Timeline Expectations
- Standard Prior Authorization: 72 hours from complete submission
- Expedited Review: 24 hours for urgent medical situations
- Missing Information Requests: Additional 72 hours after providing documents
Status Tracking
Monitor your request through:
- Humana provider portal (real-time updates)
- Phone: Number on insurance card
- Confirmation number from initial submission
Approval Outcomes
If Approved:
- Initial authorization: 6 months
- Renewal authorization: 12 months
- Coordinate with specialty pharmacy for fulfillment
If Denied:
- Review denial letter carefully
- Identify specific reasons for denial
- Prepare appeal within 65 days
Appeals Process in North Carolina
Internal Appeals (First Level)
Timeline: File within 65 days of denial notice Process: Submit additional clinical documentation addressing denial reasons Duration: Standard appeals decided within 30 days; expedited within 72 hours
External Review Through Smart NC
North Carolina offers robust external review rights through the Smart NC program, administered by the NC Department of Insurance.
Eligibility:
- State-regulated insurance plan (not self-funded employer plans)
- Completed internal appeals process
- Denial based on medical necessity or experimental treatment determination
Process:
- File Request: Submit external review form within 120 days of final internal denial
- Review Assignment: Smart NC assigns Independent Review Organization (IRO)
- Decision Timeline: 45 days for standard review; 72 hours for expedited
- Binding Decision: IRO decision is final and binding on insurer
Contact Smart NC:
- Phone: 1-855-408-1212
- Free advocacy and form assistance available
- Additional documentation accepted up to 7 days after case acceptance
From our advocates: We've seen several North Carolina patients successfully overturn Evrysdi denials through Smart NC's external review process, particularly when the initial denial cited "experimental" status despite FDA approval. The key was submitting comprehensive clinical trial data and FDA prescribing information to demonstrate established efficacy.
Common Denial Reasons & How to Fix Them
| Denial Reason | Solution | Documentation Needed |
|---|---|---|
| Missing genetic confirmation | Submit SMN1 deletion test results | Lab report showing homozygous SMN1 exon 7 deletion |
| Inadequate motor assessment | Provide baseline and recent scores | CHOP INTEND, HFMSE, or other validated scales |
| Dosing documentation gaps | Include current weight and calculation | Recent clinic visit with weight documentation |
| "Experimental" designation | Challenge with FDA approval evidence | FDA prescribing information and clinical trial data |
| Duplicate therapy concern | Clarify treatment history | Records showing Spinraza/Zolgensma discontinuation or rationale |
When to Request Peer-to-Peer Review
If initial documentation doesn't resolve the denial, request a peer-to-peer review between your prescribing physician and Humana's medical director. This is particularly effective for:
- Complex cases with multiple comorbidities
- Unusual dosing requirements
- Questions about treatment sequencing
Quick Reference Checklist
Before Starting
- Confirm active Humana coverage
- Verify Evrysdi requires prior authorization
- Identify specialty pharmacy network options
- Gather insurance card and member information
Clinical Documentation
- Genetic testing report (SMN1 deletion)
- Recent motor function assessments
- Specialist consultation notes
- Current weight documentation
- Prior treatment history (if applicable)
- Pregnancy test (females of reproductive age)
Submission Process
- Complete current prior authorization form
- Submit through Humana provider portal
- Request confirmation number
- Choose standard (72h) or expedited (24h) review
- Track status within 24 hours
If Denied
- Review denial letter thoroughly
- File internal appeal within 65 days
- Contact Smart NC for external review assistance
- Consider peer-to-peer review request
- Gather additional supporting documentation
About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by analyzing denial letters, identifying specific coverage criteria, and drafting evidence-backed rebuttals. The platform streamlines the appeals process for complex medications like Evrysdi, helping families navigate insurance requirements while focusing on their health.
For additional support with Humana appeals or complex prior authorization cases, Counterforce Health provides specialized assistance in developing targeted, evidence-based appeals that address payer-specific requirements.
Sources & Further Reading
- Humana Prior Authorization Lists and Forms
- North Carolina Smart NC External Review Program (verify current contact information)
- Evrysdi Prescribing Information and Access Resources
- Medicare Coverage Database - Genetic Testing
- CenterWell Specialty Pharmacy Services
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For official North Carolina insurance assistance, contact Smart NC at 1-855-408-1212.
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