How to Get Qalsody (Tofersen) Covered by Cigna in Georgia: Complete PA Guide, Appeals Process & Approval Scripts
Answer Box: Fast Track to Qalsody (Tofersen) Approval
Eligibility: Cigna covers Qalsody for SOD1-mutation ALS with prior authorization under Coverage Policy IP0567. Fastest path: (1) Confirm your Cigna plan type and whether you need a PCP referral to neurology, (2) Have your ALS neurologist submit complete PA via CoverMyMeds Cigna portal with SOD1 genetic test and ALS documentation, (3) Request expedited review if urgent. Start today: Call the number on your Cigna card to verify formulary status and referral requirements for your specific Georgia plan.
Table of Contents
- Cigna Plan Types & Referral Requirements
- Qalsody Formulary Status & Coverage Policy
- Prior Authorization Requirements & Submission
- Specialty Pharmacy Setup with Accredo
- Cost-Share Considerations
- Common Denial Reasons & Quick Fixes
- Appeals Process: Internal & External Review
- Patient & Clinician Scripts
- FAQ: Cigna Qalsody Coverage in Georgia
Cigna Plan Types & Referral Requirements
Your path to Qalsody approval starts with understanding whether your Cigna plan requires a PCP referral to see an ALS neurologist in Georgia.
Referral Rules by Plan Type
| Plan Type | Referral Required? | Network Rules | Source |
|---|---|---|---|
| HMO / Network | Yes - PCP referral needed | In-network only | Cigna referral policy |
| PPO | No referrals required | In/out-network (higher costs OON) | Plan comparison guide |
| EPO | No referrals required | In-network only | EPO plan details |
| Open Access | No referrals required | Varies by specific plan | Member guide |
Tip: Check your ID card for terms like "HMO," "EPO," "Open Access," or call 1-800-88-CIGNA to confirm your exact plan type and referral requirements.
Finding an ALS Neurologist in Georgia
Use Cigna's Find a Doctor tool to locate in-network neurologists who treat ALS. When calling practices, ask specifically:
- "Are you in-network with Cigna [your exact plan name]?"
- "Does your neurologist treat ALS and prescribe Qalsody/tofersen?"
- "Can you handle intrathecal injections on-site?"
Qalsody Formulary Status & Coverage Policy
Cigna covers Qalsody under its dedicated Neurology – Qalsody Coverage Policy IP0567, effective September 2025. Unlike standard formulary tiers, Qalsody requires clinical prior authorization regardless of your specific drug list.
Coverage Requirements
Indication: Amyotrophic Lateral Sclerosis (ALS) associated with SOD1 mutation only
Key Criteria:
- Documented SOD1 pathogenic mutation via genetic testing
- ALS diagnosis per El Escorial or revised criteria
- Prescription by or consultation with neurologist
- Age ≥18 years
- Approval periods: 6-month increments with renewal requirements
Note: Cigna removed the previous "≤2 years from ALS diagnosis" requirement in their July 2025 policy updates, broadening access.
Prior Authorization Requirements & Submission
Complete PA Checklist
Required Documentation:
- Cigna Qalsody CCRD Prior Authorization form
- SOD1 genetic test report (pathogenic or likely pathogenic variant)
- ALS diagnosis note referencing El Escorial/Airlie House criteria
- ALSFRS-R baseline score
- Prescriber NPI, DEA, specialty verification
- Site of care plan (in-office, hospital, or home infusion)
Submission Methods
- Electronic (Recommended): CoverMyMeds Cigna portal
- Fax: Use form-specific fax number on PA document
- Phone (Urgent): Call 1-800-88-CIGNA for expedited review
Timeline: Standard review within 5 business days; expedited review within 72 hours for urgent cases.
Specialty Pharmacy Setup with Accredo
Cigna routes Qalsody through Accredo, its preferred specialty pharmacy partner.
Dual Enrollment Process
Step 1: Biogen Support Services
- Complete Qalsody Start Form
- Patient section: demographics, insurance cards, signatures
- Prescriber section: select "Specialty Pharmacy" option
- Submit via fax to 1-888-538-9781 or email to [email protected]
Step 2: Accredo Enrollment
- Prescriber submits Accredo referral form after PA approval
- Include Cigna ID, administration site details, and infusion scheduling
- Patient receives intake call for shipment coordination
From our advocates: Many ALS families find success by having their neurologist's office coordinate both the Cigna PA and Accredo enrollment simultaneously, rather than waiting for PA approval first. This parallel approach can reduce delays once approval comes through, though the prescription won't ship until coverage is confirmed.
Cost-Share Considerations
Understanding Your Costs
Qalsody typically costs $14,230-$14,754 per vial (100mg/15mL), with first-year treatment around $200,000-$220,000. Your out-of-pocket costs depend on:
- Deductible: Whether you've met your annual deductible
- Coinsurance: Percentage you pay after deductible (often 10-40% for specialty drugs)
- Out-of-pocket maximum: Annual cap on your total costs
Financial Assistance Options
- Biogen Patient Support: Copay assistance and financial counseling through Qalsody Start Form enrollment
- Georgia foundations: Check Patient Advocate Foundation for ALS-specific grants
- Manufacturer support: Qalsody patient resources
Common Denial Reasons & Quick Fixes
| Denial Reason | How to Fix | Required Documentation |
|---|---|---|
| "No SOD1 mutation documented" | Submit genetic test report | Lab report showing pathogenic SOD1 variant |
| "Not prescribed by neurologist" | Add specialist consultation | Neurology consult note or co-signature |
| "Experimental/investigational" | Cite FDA approval & CMS guidance | FDA label, CMS Dec 2024 directive |
| "Lacks medical necessity" | Strengthen clinical rationale | Updated ALSFRS-R, treatment goals, prognosis |
| "Step therapy required" | Request exception or document failures | Prior riluzole/edaravone trials and outcomes |
Appeals Process: Internal & External Review
Cigna Internal Appeals
Level 1 Appeal:
- Deadline: 180 days from denial notice
- Submit to: Cigna National Appeals Unit, P.O. Box 188011, Chattanooga, TN 37422
- Timeline: 30 days for pre-service decisions
- Include: Denial letter, medical records, peer-reviewed literature, physician letter
Level 2 Appeal:
- Deadline: 60 days from Level 1 denial
- Review: Different medical director/committee
- Timeline: Same as Level 1
Georgia External Review
After exhausting internal appeals, Georgia residents can request external review through the Georgia Department of Insurance.
Process:
- Deadline: 120 days from final internal denial
- Timeline: 20-45 days for decision (20 days for investigational claims)
- Cost: Free to consumers
- Decision: Binding on Cigna if approved
Note: Georgia's external review applies to fully insured plans and covers medical necessity disputes. Call 1-800-656-2298 for Consumer Services assistance.
Patient & Clinician Scripts
Patient Script for Cigna Member Services
"Hi, I'm a Cigna member in Georgia with [plan name] calling about coverage for Qalsody, also called tofersen, for my ALS. Can you tell me: Is Qalsody on my formulary? Do I need a PCP referral to see a neurologist? What's my specialty drug cost-share? And can you transfer me to the prior authorization department?"
Clinician Peer-to-Peer Request Script
"I'm requesting a peer-to-peer review for Qalsody denial [reference number]. My patient has genetically confirmed SOD1-ALS with progressive functional decline. Qalsody is the only FDA-approved therapy targeting their specific mutation. I'm available for physician-to-physician discussion at [phone/email]. Please expedite given the progressive nature of ALS."
FAQ: Cigna Qalsody Coverage in Georgia
Q: How long does Cigna prior authorization take for Qalsody? A: Standard review is 5 business days; expedited review for urgent cases is completed within 72 hours. Request expedited if waiting could harm your health.
Q: What if Qalsody isn't on my Cigna formulary? A: Request a formulary exception through your neurologist, providing medical necessity documentation and evidence that formulary alternatives are ineffective for SOD1-ALS.
Q: Can I get Qalsody if I haven't tried riluzole first? A: Cigna doesn't require step therapy failure for Qalsody, but document any contraindications or clinical reasons why standard ALS therapies aren't appropriate.
Q: Does my neurologist need special credentials to prescribe Qalsody? A: Cigna requires prescription by or consultation with a neurologist. The prescriber should have experience with ALS care and intrathecal injections.
Q: What happens if Cigna denies my appeal? A: You can request external review through Georgia's Department of Insurance within 120 days of the final internal denial. This independent review is free and binding on Cigna.
Q: How much will Qalsody cost me with Cigna coverage? A: Costs vary by plan design. Expect to pay your deductible plus coinsurance (typically 10-40% for specialty drugs) until you reach your out-of-pocket maximum. Ask about manufacturer copay assistance.
How Counterforce Health Can Help
When insurance companies deny coverage for life-saving medications like Qalsody, the appeals process can feel overwhelming for patients and families already dealing with ALS. Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, point-by-point rebuttals that address each payer's specific criteria. Our platform analyzes denial letters, plan policies, and clinical notes to identify exactly why coverage was denied and crafts targeted appeals using the right medical literature, FDA guidance, and clinical evidence that Cigna's reviewers need to see.
For Qalsody appeals, this means pulling together SOD1-ALS research, FDA labeling details, and specialty neurology guidelines while ensuring all procedural requirements are met for Georgia's appeal timelines. Whether you're a patient navigating your first denial or a clinician seeking to strengthen your prior authorization submissions, Counterforce Health provides the specialized support that can make the difference between a sustained denial and approved coverage.
Sources & Further Reading
- Cigna Qalsody Coverage Policy IP0567 (PDF)
- Cigna Prior Authorization Forms & CoverMyMeds Portal
- Qalsody Start Form - Biogen (PDF)
- Georgia Department of Insurance External Review Process
- Cigna Appeals & Grievances Process
- Cigna Specialty Pharmacy (Accredo) Information
- FDA Qalsody Label and Approval Information
Disclaimer: This guide provides educational information about insurance coverage and is not medical or legal advice. Coverage policies and requirements may change. Always verify current information with Cigna member services, your healthcare provider, and official policy documents. For personalized assistance with appeals or coverage issues, consult with patient advocacy organizations or legal professionals familiar with insurance law in Georgia.
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