By Counterforce Health Team in Qalsody (tofersen) —

How to Get Qalsody (Tofersen) Covered by Cigna in New York: Complete Appeals Guide with Templates

Answer Box: Getting Qalsody (Tofersen) Covered by Cigna in New York

Qalsody (tofersen) requires prior authorization from Cigna, with documented SOD1 mutation and step therapy completion. If denied, you have 180 days for internal appeals and 4 months for New York's external review through the Department of Financial Services.

Fastest path to approval:

  1. Confirm SOD1 genetic testing is documented
  2. Complete step therapy with riluzole/edaravone if required
  3. Submit comprehensive medical necessity letter from neurologist

First step today: Call Cigna at the number on your card to request prior authorization forms, or contact Community Health Advocates at 888-614-5400 for free appeal assistance.

Table of Contents

Understanding Cigna's Qalsody Coverage Requirements

Cigna covers Qalsody (tofersen) for adults with ALS due to confirmed SOD1 mutations, but prior authorization is mandatory. The drug is included in Cigna's 2024 formulary for both commercial and Medicare Advantage plans.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Must be approved before dispensing Cigna PA Portal
SOD1 Mutation Genetic test confirming SOD1 variant Lab report from certified genetics lab
Step Therapy Trial of riluzole ± edaravone first Medical records showing prior treatment
Neurologist Prescriber ALS specialist preferred Provider credentials and referral
Formulary Tier Specialty tier (high copay) Cigna Formulary
Appeals Deadline 180 days from denial Denial letter date stamp
Note: Following CMS guidance from December 2024, Cigna cannot automatically deny Qalsody as "experimental" for SOD1-ALS patients. If you received this denial reason, reference the updated policy in your appeal.

Reading Your Denial Letter

Your Cigna denial letter contains critical information for your appeal. Look for these key elements:

Essential Details to Extract:

  • Denial reason code (medical necessity, step therapy, non-formulary)
  • Appeal deadline (typically 180 calendar days)
  • Required documentation for reconsideration
  • Reference number for tracking
  • Contact information for appeals

Common Cigna Denial Language:

  • "Does not meet medical necessity criteria" → Need stronger clinical justification
  • "Step therapy required" → Must try alternatives first
  • "Experimental/investigational" → Cite CMS coverage directive
  • "Insufficient documentation" → Submit complete medical records

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documents
No SOD1 mutation documented Submit genetic test results Certified lab report with SOD1 variant
Step therapy not completed Show prior treatment failures Medical records of riluzole/edaravone trials
Non-neurologist prescriber Get specialist referral Neurologist evaluation and prescription
Insufficient clinical documentation Comprehensive medical file ALSFRS-R scores, progression notes, imaging
"Experimental" designation Cite FDA approval and CMS guidance FDA label, CMS coverage memo

From Our Advocates

We've seen successful appeals when families gather comprehensive documentation upfront. One case involved a patient initially denied for "insufficient evidence" who was approved after submitting three months of ALSFRS-R scores showing rapid progression despite standard therapy. The key was demonstrating urgent medical need with objective measures.

Step-by-Step: Internal Appeal Process

Step 1: Gather Required Documents (Day 1-7)

Who does it: Patient/caregiver with clinic support

  • Insurance card and policy information
  • Complete denial letter
  • All medical records related to ALS diagnosis
  • SOD1 genetic testing results
  • Documentation of prior ALS treatments

Step 2: Request Appeal Forms (Day 1-3)

Who does it: Patient or clinic staff

  • Call Cigna customer service (number on insurance card)
  • Request "Request for Health Care Provider Payment Review" form
  • Ask for specific prior authorization appeal process
  • Timeline: Forms typically provided within 2-3 business days

Step 3: Complete Medical Necessity Letter (Day 7-14)

Who does it: Prescribing neurologist

  • Detail SOD1-ALS diagnosis with genetic confirmation
  • Document progression despite standard therapy
  • Justify Qalsody as only SOD1-targeted treatment
  • Include literature citations and guideline references

Step 4: Submit Complete Appeal (Day 14-21)

Who does it: Clinic or patient

  • Use certified mail or confirmed fax receipt
  • Include all supporting documentation
  • Reference denial letter and provide point-by-point rebuttal
  • Timeline: Cigna has 30 days to respond (15 for urgent cases)

Medical Necessity Letter Template

Your neurologist should include these elements in the appeal letter:

Patient Information Section

Patient: [Name]
Policy #: [Number]
Denial Date: [Date]
Diagnosis: ALS with SOD1 mutation (ICD-10: G12.21)

Clinical Justification Framework

1. Diagnosis Confirmation

  • "Patient has clinically definite ALS confirmed by [El Escorial criteria/other]"
  • "Genetic testing performed on [date] confirmed SOD1 mutation: [specific variant]"
  • "Disease onset: [date] with [initial symptoms]"

2. Disease Progression Documentation

  • Current ALSFRS-R score and decline rate
  • Functional impairments and progression timeline
  • Objective measures (FVC, grip strength, etc.)

3. Prior Treatment History

  • "Patient has tried and failed/cannot tolerate riluzole due to [specific reasons]"
  • "Edaravone was [tried/contraindicated] with [outcome]"
  • Document any adverse reactions or lack of efficacy

4. Qalsody Medical Necessity

  • "Qalsody is the only FDA-approved therapy specifically targeting SOD1-ALS pathogenesis"
  • Reference pivotal trial data and FDA approval basis
  • Explain why continued progression necessitates SOD1-targeted intervention

Supporting Literature to Reference

Peer-to-Peer Review Strategy

If your initial appeal is denied, request a peer-to-peer review where your neurologist speaks directly with Cigna's medical director.

Scheduling the Call

  • Contact Cigna utilization management department
  • Request neurologist-to-neurologist review
  • Provide 2-3 preferred time slots
  • Confirm the reviewing physician's ALS expertise

Call Preparation Checklist

For your neurologist:

  • Patient's complete clinical timeline
  • Specific SOD1 mutation details
  • Progression rate calculations
  • Literature supporting Qalsody efficacy
  • Clear statement of medical necessity

Key talking points:

  • Emphasize SOD1-ALS as distinct disease subset
  • Highlight lack of alternative SOD1-targeted therapies
  • Reference FDA accelerated approval rationale
  • Discuss patient's rapid progression despite standard care

New York External Review Process

If Cigna upholds its denial after internal appeals, New York law provides robust external review rights through the Department of Financial Services.

External Review Eligibility

  • Final adverse determination from Cigna
  • Medical necessity or experimental/investigational denials
  • Must file within 4 months of final internal denial
  • $25 filing fee (waived for Medicaid or financial hardship)

How to File

  1. Complete DFS External Appeal Application
  2. Submit through DFS Online Portal
  3. Include all documentation:
    • Cigna denial letters (initial and appeal responses)
    • Complete medical records
    • Prescriber support letter
    • Relevant medical literature

Timeline and Process

  • Standard review: Decision within 45 days
  • Expedited review: 72 hours for urgent cases
  • Independent medical expert reviews case
  • Decision is binding on Cigna
  • Success rate: Approximately 50% of specialty drug appeals are overturned
Tip: Community Health Advocates provides free assistance with external appeals at 888-614-5400. They can help navigate DFS requirements and strengthen your submission.

Cost Savings and Support Programs

Even with Cigna coverage, Qalsody's specialty tier placement means high out-of-pocket costs. Explore these support options:

Manufacturer Support

  • Biogen Support Services: Coverage verification and appeals assistance
  • Patient assistance programs: Income-based support for eligible patients
  • Copay assistance: May reduce monthly costs significantly

Independent Foundations

  • Patient Advocate Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

State Programs

  • New York State Department of Health may have additional ALS support programs
  • Medicaid secondary coverage for dual-eligible patients

When to Escalate and File Complaints

If standard appeals fail, consider these escalation options:

New York Department of Financial Services

  • File insurance complaint for improper denials
  • Particularly effective for procedural violations
  • Contact: DFS Consumer Hotline

Federal Agencies (for Medicare Advantage)

  • CMS Medicare.gov complaint system
  • Reference CMS guidance on Qalsody coverage
  • Document any "experimental" denial language
  • Consider consulting healthcare law attorney for complex cases
  • New York has strong consumer protection laws
  • Class action opportunities may exist for systematic denials

Frequently Asked Questions

How long does Cigna prior authorization take in New York? Standard PA decisions are made within 15 business days. Expedited reviews for urgent cases are completed within 72 hours. You can track status through Cigna's provider portal.

What if Qalsody isn't on my specific Cigna formulary? Request a formulary exception with medical necessity documentation. Cigna must provide coverage for medically necessary non-formulary drugs when no suitable alternatives exist.

Can I get an expedited appeal if my ALS is progressing rapidly? Yes. Document rapid functional decline with ALSFRS-R scores and request expedited review. Both Cigna internal appeals and New York external reviews offer expedited pathways.

Does step therapy apply if I tried riluzole in another state? Medical records from any location should satisfy step therapy requirements. Ensure complete documentation is transferred to your New York neurologist.

What counts as medical necessity for Qalsody? According to Cigna's coverage policy, medical necessity requires confirmed SOD1-ALS diagnosis, appropriate prescriber, and clinical documentation of disease progression.

How much does Qalsody cost with Cigna coverage? Costs vary by plan, but specialty tier copays can range from $100-500+ per month. With list prices around $14,000 per dose, insurance coverage is essential for access.

For patients and families navigating insurance denials for critical ALS treatments like Qalsody, having expert support can make the difference between approval and continued delays. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with payer requirements. Their platform helps identify the specific denial basis and drafts comprehensive appeals with the right clinical documentation and literature citations that payers expect to see.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Appeal deadlines and requirements may change; verify current information with official sources.

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