How to Get Gamifant (Emapalumab-lzsg) Covered by Cigna in North Carolina: Complete Prior Authorization and Appeals Guide
Answer Box: Getting Cigna to Cover Gamifant in North Carolina
Cigna requires prior authorization for Gamifant (emapalumab-lzsg) with specific documentation: confirmed HLH diagnosis (5 of 8 HLH-2004 criteria or genetic testing), evidence of conventional therapy failure/intolerance, and concurrent dexamethasone use. Submit through CoverMyMeds or call 1-800-882-4462 for urgent cases. If denied, North Carolina residents can appeal through Smart NC external review (1-855-408-1212) within 120 days for a binding decision.
Table of Contents
- Coverage at a Glance
- Cigna's Policy Requirements
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & How to Fix Them
- Appeals Playbook for North Carolina
- Clinician Corner: Medical Necessity Documentation
- Cost Assistance Options
- FAQ
Coverage at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required for all Cigna plans | Cigna provider portal | Cigna PA Policy |
| Formulary Tier | Specialty tier (highest cost-sharing) | Plan formulary documents | Express Scripts |
| Step Therapy | Must try conventional HLH therapy first | Medical records of failed treatments | Cigna Coverage Criteria |
| Quantity Limits | 6-month authorization periods | Renewal required every 6 months | Cigna PA Form |
| Site of Care | Specialty pharmacy (Accredo) | Must use designated network pharmacy | Cigna Specialty Pharmacy |
| Appeals Deadline | 120 days for NC external review | From final internal denial date | Smart NC |
Cigna's Policy Requirements
Diagnosis Confirmation
Cigna requires documented evidence of primary hemophagocytic lymphohistiocytosis (HLH) through one of the following:
Genetic Testing Results: Mutations in PRF1, UNC13D, RAB27A, STX11, or STXBP2 genes that cause primary HLH.
Clinical Diagnosis: At least 5 of these 8 HLH-2004 criteria:
- Fever (≥38.5°C)
- Splenomegaly
- Two cytopenias (hemoglobin <9 g/dL, platelets <100×10⁹/L, or neutrophils <1×10⁹/L)
- Hypertriglyceridemia (fasting triglycerides ≥265 mg/dL) or hypofibrinogenemia (fibrinogen ≤1.5 g/L)
- Hemophagocytosis in bone marrow, spleen, or lymph nodes
- Low or absent natural killer cell activity
- Ferritin ≥500 mcg/L
- Soluble CD25 ≥2,400 U/mL
Step Therapy Requirements
Patients must have refractory, recurrent, or progressive disease, or intolerance to conventional HLH therapy. Required documentation includes trials of:
- Etoposide
- Corticosteroids (dexamethasone or prednisolone)
- Cyclosporine
- Anti-thymocyte globulin (if applicable)
- Methotrexate (if applicable)
Additional Coverage Criteria
- Concurrent dexamethasone therapy is mandatory
- FDA-approved dosing must be followed
- Infection screening completed (tuberculosis testing required)
- Authorization duration: Maximum 6 months per approval
Step-by-Step: Fastest Path to Approval
1. Gather Required Documentation
Who does it: Patient and clinic staff
What's needed: Insurance card, complete medical records, lab results, genetic testing (if available)
Timeline: 1-2 days
2. Complete HLH Diagnosis Confirmation
Who does it: Hematologist/oncologist
What's needed: Document 5+ HLH-2004 criteria or genetic test results
Timeline: May require additional testing
3. Document Conventional Therapy History
Who does it: Prescribing physician
What's needed: Records of etoposide, steroids, cyclosporine trials with outcomes
Timeline: Review existing records or obtain from previous providers
4. Submit Prior Authorization
Who does it: Prescriber or clinic staff
How to submit: CoverMyMeds portal or SureScripts
Expected timeline: 5 business days (standard), call for urgent cases
Source: Cigna PA Process
5. Follow Up on Status
Who does it: Clinic staff
How: Check portal or call 1-800-882-4462
Timeline: Daily until decision received
6. If Approved: Coordinate Specialty Pharmacy
Who does it: Patient and Accredo
What's needed: Enrollment with Accredo Specialty Pharmacy
Timeline: 3-5 business days for first shipment
7. If Denied: Initiate Appeal Process
Who does it: Patient or prescriber
Next steps: See Appeals Playbook below
Timeline: Must act within appeal deadlines
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Documents Needed |
|---|---|---|
| "HLH diagnosis not confirmed" | Provide complete HLH-2004 criteria documentation | Lab results, bone marrow biopsy, genetic testing |
| "No evidence of conventional therapy failure" | Submit detailed treatment history with outcomes | Previous medical records, response assessments |
| "Missing infection screening" | Complete tuberculosis testing | IGRA or PPD results, chest imaging |
| "Concurrent dexamethasone not documented" | Confirm dexamethasone will be given with Gamifant | Treatment protocol from prescriber |
| "Dosing not per FDA label" | Adjust dosing to match approved labeling | Updated prescription with correct dosing |
From our advocates: We've seen cases where patients had all the right clinical criteria but submitted documentation from different time periods. Organizing labs, imaging, and clinical notes chronologically with clear dates helped reviewers see the complete HLH picture and led to faster approvals.
Appeals Playbook for North Carolina
Internal Appeals with Cigna
First Level Internal Appeal
- Timeline: Must file within 180 days of denial
- How to file: CoverMyMeds, ExpressPAth, or call 1-800-882-4462
- Decision timeline: 15 days (standard), 72 hours (expedited)
- Required: Additional clinical documentation supporting medical necessity
Second Level Internal Appeal
- Timeline: Available if first appeal denied
- Process: Automatic review by different clinical team
- Decision timeline: 15 days (standard), 72 hours (expedited)
External Review Through Smart NC
If Cigna denies your internal appeals, North Carolina residents have access to binding external review through Smart NC.
Contact Information:
- Phone: 1-855-408-1212
- Website: NC Department of Insurance
Eligibility Requirements:
- Must have completed Cigna's internal appeals process
- Request must be filed within 120 days of final internal denial
- Denial must be based on medical necessity or experimental treatment determination
Timeline:
- Standard external review: 45 days for decision
- Expedited external review: 72 hours (for urgent cases)
How It Works:
- Submit external review request form to Smart NC
- Independent Review Organization (IRO) assigned
- IRO reviews all medical records and makes binding decision
- If overturned, Cigna must provide coverage within 3 business days
Counterforce Health helps patients navigate complex prior authorization and appeals processes by turning insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals using the right medical evidence and payer-specific requirements.
Clinician Corner: Medical Necessity Documentation
Essential Elements for PA Submission
Patient History Section:
- Primary HLH diagnosis with specific criteria met
- Previous conventional therapies tried with dates, doses, and outcomes
- Current clinical status and disease progression
- Contraindications to standard therapy (if applicable)
Clinical Rationale:
- Why Gamifant is medically necessary for this patient
- Expected treatment goals and monitoring plan
- Concurrent dexamethasone therapy protocol
- Infection screening results
Supporting Evidence:
- FDA prescribing information for approved indication
- Relevant clinical guidelines from hematology societies
- Published literature supporting use in refractory HLH
Medical Necessity Letter Template
"This [age]-year-old patient has confirmed primary HLH based on [specific criteria/genetic testing]. Despite treatment with conventional therapy including [list specific agents, doses, duration], the patient has [refractory/recurrent/progressive] disease evidenced by [specific clinical/laboratory findings]. Gamifant (emapalumab-lzsg) is FDA-approved for this indication and represents the appropriate next step in treatment. The patient will receive concurrent dexamethasone therapy as required, and appropriate infection monitoring will be performed."
Cost Assistance Options
Manufacturer Support
- Gamifant Co-pay Program: May reduce out-of-pocket costs for eligible patients
- Patient Assistance Program: For uninsured or underinsured patients
- Information: Visit Gamifant.com or call manufacturer
Foundation Grants
- National Organization for Rare Disorders (NORD)
- Patient Advocate Foundation
- HealthWell Foundation
- Good Days (formerly Chronic Disease Fund)
State Resources
- North Carolina pharmaceutical assistance programs
- Medicaid expansion (effective 2024) may provide additional coverage options
FAQ
How long does Cigna prior authorization take for Gamifant in North Carolina? Standard review is 5 business days. For urgent cases, call 1-800-882-4462 to request expedited review, which can be completed in 24-72 hours.
What if Gamifant is non-formulary on my Cigna plan? You can request a formulary exception by providing medical necessity documentation. The appeals process is the same as for prior authorization denials.
Can I request an expedited appeal if my condition is worsening? Yes, both Cigna internal appeals and Smart NC external review offer expedited timelines (72 hours) for urgent medical situations where delays could jeopardize health.
Does step therapy apply if I failed conventional therapy outside North Carolina? Yes, medical records from any provider can document conventional therapy failure. Ensure records clearly show treatment attempts and outcomes.
What happens if Smart NC overturns Cigna's denial? The decision is binding. Cigna must provide coverage within 3 business days of the external review decision.
How much does external review cost in North Carolina? Smart NC external review is completely free to consumers. There are no fees for filing or processing your case.
Can my doctor request a peer-to-peer review with Cigna? Yes, prescribers can request to speak directly with Cigna's medical director. Call the PA number and ask for peer-to-peer review scheduling.
What if I need Gamifant while my appeal is pending? For urgent situations, request expedited review at each level. Your doctor may also prescribe bridge therapy or contact Counterforce Health for assistance with urgent appeals.
Sources & Further Reading
- Cigna Gamifant Prior Authorization Form (PDF)
- Cigna Coverage Position Criteria for Emapalumab (PDF)
- Smart NC External Review Program
- FDA Gamifant Prescribing Information
- HLH-2004 Diagnostic Criteria
- Cigna Prior Authorization Process
- Express Scripts Coverage Reviews
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for specific coverage questions. For additional assistance with North Carolina insurance appeals, contact Smart NC at 1-855-408-1212.
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