By Counterforce Health Team in Qalsody (tofersen) —

How to Get Qalsody (tofersen) Covered by Aetna (CVS Health) in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Qalsody (tofersen) Covered by Aetna in New York

Aetna requires prior authorization for Qalsody with five key criteria: age 18+, ALS diagnosis, documented SOD1 mutation, pulmonary function ≥45% predicted, and no tracheostomy. Fastest path: Have your neurologist submit the Aetna Qalsody precertification form with SOD1 genetic testing results and ALSFRS-R scores. Start today: Call (866) 752-7021 to request the PA packet. If denied, New York's external appeal through DFS can overturn the decision within 30 days.

Table of Contents

  1. Set Your Goal: Understanding Aetna's Qalsody Requirements
  2. Visit Prep: Gathering Your Medical Evidence
  3. Evidence Kit: Essential Documentation
  4. Medical Necessity Letter Structure
  5. Peer-to-Peer Review Support
  6. After Your Visit: Tracking and Follow-Up
  7. Appeals Process in New York
  8. Common Denial Reasons & Solutions
  9. Cost Assistance Programs
  10. FAQ

Set Your Goal: Understanding Aetna's Qalsody Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Timeline
Prior Authorization Required before first dose Aetna PA form 10 business days
SOD1 Mutation CLIA-certified genetic test Neurologist orders via Mayo, Invitae, or similar 1-3 weeks
Neurologist Prescriber Board-certified preferred ALS specialist or neuromuscular physician N/A
Pulmonary Function FVC/SVC ≥45% predicted Recent PFT results Same day
No Tracheostomy Current status documented Medical records N/A

Partnership Strategy: Your neurologist will handle the clinical documentation, but you'll need to ensure all supporting evidence is complete and submitted together. Missing pieces cause delays or denials.

Visit Prep: Gathering Your Medical Evidence

Before Your Appointment

Document your symptom timeline with specific dates:

  • When did you first notice weakness, muscle twitching, or speech changes?
  • How has your function declined (walking, speaking, swallowing, breathing)?
  • What daily activities have become difficult?

List all treatments tried:

  • Riluzole (dose, duration, why stopped if applicable)
  • Edaravone (response, side effects, current status)
  • Physical therapy, speech therapy, respiratory therapy
  • Any other medications or interventions

Functional impact notes:

  • Current ALSFRS-R score if known (scale 0-48, higher is better)
  • Breathing difficulties or need for assistance
  • Weight loss or swallowing problems
  • Mobility aids currently used
Tip: Bring a written summary to your appointment. This ensures nothing important gets missed and helps your neurologist document medical necessity accurately.

Evidence Kit: Essential Documentation

Required Labs and Testing

SOD1 Genetic Testing:

  • Must be from CLIA-certified laboratory
  • Mayo Clinic SOD1Z test is commonly accepted
  • Results must show pathogenic or likely pathogenic variant
  • Family history documentation supports medical necessity

Baseline Assessments:

  • ALSFRS-R score (functional rating scale)
  • Neurofilament light chain (NfL) levels if available
  • Recent pulmonary function tests showing FVC/SVC ≥45%
  • EMG/nerve conduction studies confirming ALS diagnosis

Prior Treatment Documentation:

  • Prescription history for riluzole, edaravone
  • Documentation of therapeutic trials, responses, or contraindications
  • Any adverse reactions or reasons for discontinuation

Medical Necessity Letter Structure

Clinician Corner: Key Elements for Approval

Your neurologist's letter should include these specific components:

1. Patient Demographics and Diagnosis

  • Age, diagnosis date, ICD-10 codes
  • ALS phenotype (limb-onset, bulbar-onset, etc.)
  • Disease progression rate and current functional status

2. SOD1 Mutation Documentation

  • Specific genetic variant identified
  • Laboratory that performed testing
  • Clinical significance and pathogenicity

3. Clinical Rationale

  • Why Qalsody is appropriate for this patient
  • Expected benefits based on FDA approval data
  • Risks of delaying treatment given disease progression

4. Prior Therapies

  • Standard ALS treatments tried (riluzole, edaravone)
  • Response to previous therapies
  • Contraindications to other treatments if applicable

5. Supporting References

Note: CMS issued guidance in December 2024 directing Medicare Advantage plans to cover Qalsody for FDA-approved indications. This strengthens appeals for patients with SOD1-ALS.

Peer-to-Peer Review Support

Preparing for Medical Director Review

If Aetna requests a peer-to-peer review, help your neurologist prepare:

Availability Windows:

  • Offer 2-3 specific time slots when your doctor is available
  • Peer-to-peer calls typically last 10-15 minutes
  • Medical director will focus on clinical appropriateness

Case Summary for Your Provider:

  • One-page summary of key clinical points
  • Emphasis on SOD1 mutation and rapid progression risk
  • Clear statement of medical necessity

Documentation Ready:

  • Have all supporting documents immediately available
  • SOD1 test results, ALSFRS-R scores, PFT results
  • Prior therapy history and outcomes

Script for Requesting Peer-to-Peer

"We'd like to request a peer-to-peer review with your medical director. Dr. [Name] is available [specific times] and can discuss the clinical rationale for Qalsody in this SOD1-positive ALS patient. Can you schedule this within the next 48 hours given the progressive nature of the condition?"

After Your Visit: Tracking and Follow-Up

What to Save

Documentation from your visit:

  • Copy of completed PA form
  • Medical necessity letter
  • All lab results and reports submitted
  • Submission confirmation or reference number

Communication records:

  • Phone calls to Aetna PA department: (866) 752-7021
  • Fax confirmations: (888) 267-3277
  • Portal messages and responses

Follow-Up Timeline

Day Action Contact
1-2 Confirm PA submission Provider office
5-7 Check status with Aetna (866) 752-7021
10 Standard decision deadline Request update if no response
11+ File appeal if denied Internal appeal process

Portal Messaging Tips

When communicating through Aetna's member portal:

  • Include your member ID and PA reference number
  • Be specific about what information you need
  • Request written confirmation of verbal communications
  • Save all portal messages and responses

Appeals Process in New York

Internal Appeal (Required First Step)

Timeline: File within 180 calendar days of denial notice Decision time: 30-60 days for standard review; 72 hours for expedited How to file: Aetna member portal, phone, or written appeal

Required documents:

  • Copy of denial letter
  • Updated medical necessity letter
  • Any new clinical evidence
  • Request for expedited review if clinically urgent

External Appeal Through New York DFS

When to use: After Aetna's internal appeal is denied Timeline: File within 4 months (120 days) of internal denial Decision time: 30 calendar days (72 hours if expedited) Cost: Up to $25 (waived for financial hardship or Medicaid)

How to file:

  1. Download NYDFS External Appeal Form
  2. Include physician statement on medical necessity
  3. Attach all denial letters and supporting documentation
  4. Submit to assigned Independent Consumer Review Organization (ICRO)
Important: NYDFS external appeal decisions are binding on Aetna. If approved, they must authorize coverage and refund your filing fee.

Expedited Appeals

When to request: If delay in treatment could seriously jeopardize your health Timeline: 72 hours for internal; 72 hours for external Documentation needed: Physician attestation of urgency

ALS progression can be rapid, making expedited review often appropriate for SOD1-positive patients.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Documents Needed
No SOD1 mutation documented Submit CLIA-certified genetic test Mayo SOD1Z report or equivalent
Non-neurologist prescriber Add neurologist consultation Referral to ALS specialist
Insufficient pulmonary function Update PFT if condition changed Recent spirometry showing ≥45%
"Experimental" designation Cite FDA approval and CMS guidance FDA approval letter
Missing baseline assessments Complete required testing ALSFRS-R, NfL levels if available
Step therapy not completed Document contraindications or failures Riluzole/edaravone trial history

Sample Appeal Language

"This denial incorrectly characterizes Qalsody as experimental. The FDA granted accelerated approval in April 2023 for ALS patients with SOD1 mutations. CMS guidance from December 2024 specifically directs Medicare Advantage plans to cover FDA-approved indications. Our patient meets all clinical criteria outlined in Aetna's own policy."

Cost Assistance Programs

Manufacturer Support

Biogen Free Drug Program:

Commercial Insurance Copay Assistance:

  • Reduces out-of-pocket costs up to program limits
  • Cannot be used with government insurance
  • Apply through Qalsody patient website

Foundation Grants

ALS Association:

Patient Advocate Foundation:

  • Copay relief and case management
  • Insurance appeals assistance
  • Phone: (800) 532-5274

Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Qalsody. Their platform analyzes denial letters, identifies specific policy gaps, and generates evidence-backed appeals that address payers' exact criteria—helping patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements more effectively.

FAQ

How long does Aetna prior authorization take for Qalsody in New York? Standard decisions are made within 10 business days. Expedited reviews (for urgent cases) are completed within 72 hours. If Aetna needs additional information, they have up to 14 additional days.

What if Qalsody is not on Aetna's formulary? You can request a formulary exception through the same PA process. Emphasize that there are no therapeutic alternatives for SOD1-ALS and cite FDA approval for this specific indication.

Can I request an expedited appeal if denied? Yes, if your neurologist attests that delay in treatment could seriously harm your health. ALS progression often qualifies for expedited review given the neurodegenerative nature of the disease.

Does step therapy apply if I haven't tried riluzole or edaravone? Aetna may require documentation of standard ALS therapies first. However, if you have contraindications or have failed these medications, document this clearly in your appeal.

What happens if both internal and external appeals are denied? You may have additional options through state insurance regulators or legal counsel. Contact the New York State Department of Financial Services consumer helpline at (800) 342-3333 for guidance.

How much does Qalsody cost without insurance? The list price is approximately $14,230-$14,754 per vial. First-year costs typically range from $200,000-$220,000 depending on start timing, with subsequent years around $170,000-$180,000 annually.

Can I continue current treatment during the appeal process? For ongoing treatments, you can request continuation of services in writing within 10 days of the internal denial. This maintains coverage during the appeal process under New York regulations.

Do I need to see an ALS specialist for approval? While not strictly required, having a board-certified neurologist or ALS specialist as your prescriber significantly improves approval chances. Many PA policies prefer specialist prescribers for complex treatments like Qalsody.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and coverage criteria can change. Always consult with your healthcare provider and insurance company for the most current information regarding your specific situation. For free assistance with insurance appeals in New York, contact Community Health Advocates at (888) 614-5400.

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