By Counterforce Health Team in Qalsody (tofersen) —

Getting Qalsody (Tofersen) Covered by UnitedHealthcare in New Jersey: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Qalsody (Tofersen) Covered by UnitedHealthcare in New Jersey

UnitedHealthcare covers Qalsody (tofersen) for adults with ALS and confirmed SOD1 mutations, requiring prior authorization through OptumRx. In New Jersey, if denied, you can appeal through UnitedHealthcare's internal process, then file for external review with New Jersey's Independent Health Care Appeals Program (IHCAP) within 180 days. First step today: Have your neurologist gather SOD1 genetic test results, baseline ALSFRS-R score, and ALS diagnosis documentation to submit a complete PA request via the UHC Provider Portal or by calling OptumRx at 1-800-711-4555.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Approval
  4. Documentation Requirements
  5. Submission Process
  6. Specialty Pharmacy Network
  7. After Submission: What to Expect
  8. Common Denial Reasons & How to Fix Them
  9. Appeals Process in New Jersey
  10. Cost and Financial Assistance
  11. Frequently Asked Questions

Who Should Use This Guide

This guide is for patients with ALS caused by SOD1 mutations who have UnitedHealthcare coverage in New Jersey, along with their caregivers and healthcare providers. You should use this if:

  • You've been diagnosed with ALS and tested positive for a SOD1 gene mutation
  • Your neurologist has recommended Qalsody (tofersen) treatment
  • You have UnitedHealthcare commercial, Medicare Advantage, or Medicaid coverage
  • You're facing a prior authorization requirement or have received a denial

Expected outcome: With complete documentation and proper submission, most eligible patients receive approval within 1-15 business days. If denied, New Jersey's robust external review process provides an additional pathway to coverage.

Member & Plan Basics

Coverage Verification

Before starting the prior authorization process, confirm your UnitedHealthcare plan details:

  • Plan type: Commercial, Medicare Advantage, or Medicaid (check your member ID card)
  • Active coverage: Verify your enrollment is current and premiums are paid
  • Specialty pharmacy requirement: Most UHC plans require specialty pharmacy dispensing for Qalsody
Tip: Call the member services number on your ID card to confirm your plan covers specialty medications and ask about your specific prior authorization requirements.

Deductible and Cost-sharing

Qalsody typically falls under UnitedHealthcare's specialty tier with:

  • Commercial plans: 30-50% coinsurance after deductible (varies by employer plan)
  • Medicare Advantage: Varies by plan; 2025+ Medicare Part D has a $2,000 annual out-of-pocket maximum
  • Medicaid: Minimal or no cost-sharing for covered services

Clinical Criteria for Approval

UnitedHealthcare's medical policy for Qalsody requires all of the following criteria to be met:

Requirement Specific Details Documentation Needed
Age 18 years or older Date of birth verification
ALS Diagnosis Confirmed ALS per medical records Neurologist notes, EMG, nerve conduction studies
SOD1 Mutation Pathogenic SOD1 gene mutation Genetic testing lab results
Baseline Function ALSFRS-R score within past 12 months Functional assessment documentation
Ventilation Status Not dependent on invasive ventilation Clinical notes confirming non-invasive status
Prescriber Neurologist or ALS specialist Provider credentials and treatment plan
Dosing FDA-approved dosing (100 mg intrathecal) Prescription matching label requirements

FDA Approval Status

Qalsody received FDA accelerated approval in April 2023 for adults with ALS associated with SOD1 mutations, based on reduction in plasma neurofilament light chain (NfL) levels—a biomarker of nerve damage.

Documentation Requirements

Medical Necessity Letter Components

Your neurologist should include these elements in the medical necessity letter:

Patient Information:

  • Full name, date of birth, UnitedHealthcare member ID
  • ALS diagnosis with ICD-10 code G12.21 (SOD1-related ALS)
  • Date of symptom onset and progression timeline

Clinical Justification:

  • SOD1 genetic test results showing pathogenic mutation
  • Current ALSFRS-R score and functional status
  • Prior treatments tried (riluzole, edaravone) and outcomes
  • Evidence of disease progression despite standard therapies
  • Rationale for Qalsody as the only SOD1-targeted therapy

Treatment Plan:

  • Dosing schedule: 3 loading doses (days 1, 15, 29), then monthly maintenance
  • Monitoring plan: ALSFRS-R assessments, NfL biomarker tracking
  • Administration site and qualified personnel

Required Attachments

Submit these documents with your prior authorization request:

  • Complete medical necessity letter from neurologist
  • SOD1 genetic testing lab report
  • Recent ALSFRS-R assessment (within 12 months)
  • ALS diagnostic workup (EMG, clinical notes)
  • Documentation of prior ALS treatments and responses
  • Current medication list and allergies

Submission Process

Primary Submission Methods

1. Online Portal (Recommended)

  • UHC Provider Portal: Prior Auth → Pharmacy & Specialty Drug
  • professionals.optumrx.com for pharmacy benefits
  • CoverMyMeds integration for streamlined submission

2. Phone Submission

  • OptumRx: 1-800-711-4555 for criteria and forms
  • Available 24/7 for urgent cases

3. Fax Submission

  • Verify current fax number with OptumRx (numbers vary by region)
  • Include cover sheet with member ID and urgency level

Step-by-Step Submission Process

  1. Gather Documentation (Days 1-3)
    • Neurologist compiles all required documents
    • Patient provides insurance information and consent
  2. Submit Complete Request (Day 4)
    • Use online portal or fax all documents together
    • Request expedited review if clinically urgent
  3. Track Status (Days 5-7)
    • Check portal for status updates
    • Respond promptly to any requests for additional information
  4. Receive Decision (Days 8-15)
    • Standard review: up to 15 business days
    • Expedited review: within 72 hours

Specialty Pharmacy Network

Preferred Vendors

UnitedHealthcare requires dispensing through approved specialty pharmacies:

  • Optum Specialty Pharmacy: Primary network pharmacy (1-855-427-4682)
  • Metro Infusion Center: Approved for Qalsody in some regions
  • Other approved pharmacies: Verify network status via member services

Distribution Process

Qalsody follows a "white bagging" model:

  1. Specialty pharmacy receives prescription and PA approval
  2. Pharmacy ships drug directly to certified infusion center
  3. Treatment center bills separately for administration
  4. Patient receives treatment at approved facility
Note: Use the Qalsody Treatment Center Locator to find certified administration sites near you in New Jersey.

After Submission: What to Expect

Timeline and Communication

  • Confirmation: Receive submission confirmation within 24-48 hours
  • Status checks: Monitor via online portal or call member services
  • Additional information: Respond within 5 business days if requested
  • Decision notification: Sent via portal, phone, and mail

Approval Process

If Approved:

  • Coordinate with specialty pharmacy for first shipment
  • Schedule initial treatment at certified facility
  • Set up ongoing monitoring with neurologist

If Pending:

  • Provide any requested additional documentation promptly
  • Consider peer-to-peer review if available
  • Track deadlines to avoid automatic denials

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
No SOD1 mutation documented Submit genetic testing results Lab report showing pathogenic SOD1 variant
Experimental/investigational Cite FDA approval and CMS guidance FDA approval letter, CMS Dec 2024 directive
Missing baseline assessments Provide functional evaluations ALSFRS-R score, NfL levels if available
Non-neurologist prescriber Transfer prescription or consultation Neurologist prescription or co-signature
Incomplete prior therapy documentation Document standard ALS treatments Records of riluzole/edaravone trials

Key Appeal Arguments

When appealing denials, emphasize:

  • FDA accelerated approval based on biomarker evidence
  • No alternative SOD1-targeted therapies available
  • CMS December 2024 guidance directing Medicare Advantage coverage
  • Rapid ALS progression requires timely intervention

Appeals Process in New Jersey

Internal Appeals (UnitedHealthcare)

First Level Appeal:

  • Timeline: 180 days from denial date
  • Method: Online portal, phone (member services number), or mail
  • Required: Original denial letter, additional medical evidence
  • Decision: Within 30 days (expedited: 72 hours if urgent)

Second Level Appeal:

  • Automatic if first level denied
  • Timeline: Additional 30 days for decision
  • May include peer-to-peer review with medical director

External Review (New Jersey IHCAP)

If UnitedHealthcare denies both internal appeals, New Jersey offers robust external review through the Independent Health Care Appeals Program (IHCAP).

Eligibility:

  • Completed UnitedHealthcare's internal appeal process
  • New Jersey-regulated health plan
  • Denial based on medical necessity or similar coverage issue

How to File:

  • Submit directly to Maximus Federal Services (contracted review organization)
  • Timeline: 180 days from final internal denial
  • Cost: Free to patients (insurer pays all fees)

Process:

  1. Preliminary Review: 5 business days to confirm eligibility
  2. Full Review: Independent physician panel with ALS expertise
  3. Decision: Within 45 days of complete submission
  4. Binding Result: Insurer must comply if overturned
Contact IHCAP: Call 1-888-393-1062 for guidance or visit the New Jersey Department of Banking and Insurance website for forms and detailed instructions.

From Our Advocates

We've seen several cases where patients initially faced "experimental" denials for Qalsody, but successful appeals highlighted the FDA's accelerated approval and the December 2024 CMS guidance requiring Medicare Advantage coverage. The key was submitting complete genetic testing documentation upfront and emphasizing that no other SOD1-targeted treatments exist. New Jersey's external review process has been particularly helpful when internal appeals focused too narrowly on cost rather than medical necessity.

Cost and Financial Assistance

Manufacturer Support

Biogen offers comprehensive support services:

  • Benefits investigation: Coverage verification and PA assistance
  • Copay assistance: May reduce out-of-pocket costs for eligible patients
  • Patient support: 1-877-725-7639 or 1-833-777-7266

Additional Resources

  • ALS Association: Financial assistance and advocacy support
  • Patient advocate organizations: Help with appeals and documentation
  • Counterforce Health: Specialized service that helps turn insurance denials into targeted, evidence-backed appeals for complex medications like Qalsody

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take in New Jersey? A: Standard review takes up to 15 business days. Expedited review (for urgent cases) typically completes within 72 hours.

Q: What if Qalsody isn't on my UnitedHealthcare formulary? A: Request a formulary exception with medical necessity documentation. Emphasize FDA approval and lack of alternatives for SOD1-ALS.

Q: Can I request an expedited appeal if I'm rapidly progressing? A: Yes. Document rapid functional decline with ALSFRS-R scores and request expedited review due to irreversible disease progression.

Q: Does step therapy apply to Qalsody? A: Generally no, due to its genetic specificity. However, some plans may require documentation of standard ALS therapies (riluzole, edaravone).

Q: What happens if UnitedHealthcare denies my external review in New Jersey? A: New Jersey's IHCAP decision is binding on the insurer. If overturned, UnitedHealthcare must provide coverage.

Q: Can my doctor file appeals on my behalf? A: Yes. New Jersey allows providers to file external appeals with patient consent, and many neurologists are experienced with ALS medication appeals.

At Counterforce Health, we specialize in helping patients navigate these complex approval processes by analyzing denial letters and crafting targeted appeals that address payer-specific concerns with the right clinical evidence and regulatory citations.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may change. Always verify current requirements with UnitedHealthcare and consult with your healthcare provider for medical decisions. For questions about New Jersey insurance regulations, contact the NJ Department of Banking and Insurance at 1-800-446-7467.

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