By Counterforce Health Team in Qalsody (tofersen) —

Getting Qalsody (Tofersen) Approved by UnitedHealthcare in Washington: Complete Prior Authorization and Appeals Guide

Answer Box: Quick Path to Qalsody Coverage

UnitedHealthcare covers Qalsody (tofersen) for ALS patients with confirmed SOD1 mutations, but requires prior authorization with specific documentation. First step: Have your neurologist gather your genetic test showing pathogenic SOD1 mutation, baseline ALSFRS-R score, and ALS diagnosis notes. Submit through UnitedHealthcare's provider portal or call OptumRx at 1-800-711-4555 for drug-specific criteria. If denied, you have 180 days to file internal appeals and can request external review through Washington's Independent Review Organization process. Most common approval barrier: missing SOD1 genetic documentation or incomplete neurologist notes.

Table of Contents

  1. Is Qalsody Covered by UnitedHealthcare?
  2. Prior Authorization Requirements
  3. How to Submit and Check Status
  4. Timeline and Urgency Options
  5. Step Therapy and Lab Requirements
  6. Understanding Your Costs
  7. Why Denials Happen and How to Fix Them
  8. Renewal and Reauthorization
  9. Specialty Pharmacy Requirements
  10. Troubleshooting Common Issues
  11. Washington Appeals Process
  12. Frequently Asked Questions

Is Qalsody Covered by UnitedHealthcare?

Yes, UnitedHealthcare covers Qalsody (tofersen) for adults with ALS caused by SOD1 mutations, but coverage requires prior authorization through OptumRx. The drug is typically covered under the medical benefit for intrathecal administration rather than the pharmacy benefit.

Which UnitedHealthcare Plans Cover Qalsody?

  • Commercial plans: Covered with prior authorization
  • Medicare Advantage: Covered following CMS directive (December 2024) requiring MA plans to cover FDA-approved SOD1-ALS treatments
  • Medicaid (Apple Health in Washington): Coverage varies by managed care plan
Note: Coverage criteria can vary by employer group. Always verify your specific plan's formulary and requirements.

Prior Authorization Requirements

UnitedHealthcare requires all of the following documentation for Qalsody approval:

Essential Documentation Checklist

Requirement What You Need Where to Get It
ALS Diagnosis Chart notes from neurologist with clinical details Neurology clinic
SOD1 Mutation Genetic test report showing pathogenic variant Genetic testing lab
Baseline ALSFRS-R Functional assessment score (0-48 scale) Neurologist visit
Prescriber Qualification Neurologist or specialist consultation ALS clinic referral
Treatment Plan Dosing schedule and administration site Neurology team

Critical Details for SOD1 Documentation

Your genetic test report must include:

  • Patient identifiers matching insurance
  • SOD1 gene specifically tested
  • Pathogenic or likely pathogenic variant classification
  • Specific mutation details (e.g., c.272A>C, p.Asp90Ala)
Important: "Variant of uncertain significance (VUS)" typically does not qualify for coverage.

Baseline ALSFRS-R Requirements

Unlike some other payers, UnitedHealthcare does not require baseline neurofilament light chain (NfL) testing, but you should document:

  • Complete 12-item ALSFRS-R score
  • Date of assessment
  • Clinical context (symptom onset, progression rate)

How to Submit and Check Status

For Prescribers

  1. Get drug-specific criteria: Call OptumRx at 1-800-711-4555 to request current Qalsody prior authorization guidelines
  2. Submit through UnitedHealthcare provider portal: Use the online PA system for fastest processing
  3. Include complete documentation: Attach all required records in initial submission to avoid delays

For Patients

  1. Verify coverage: Call the member services number on your UnitedHealthcare card
  2. Confirm specialty pharmacy: Ask which pharmacy network is required for Qalsody
  3. Track status: Use UnitedHealthcare member portal or call customer service for updates

Timeline and Urgency Options

Standard Timeline

  • Initial review: 7-15 business days
  • Expedited review: 72 hours (if delay jeopardizes health)
  • Peer-to-peer review: Available within 1 business day if requested

When to Request Expedited Review

Request urgent processing if:

  • ALS progression is rapid (ALSFRS-R declining >1 point/month)
  • Respiratory function declining (FVC <65%)
  • Patient experiencing significant functional deterioration
Tip: Document urgency with specific clinical metrics and timeline in your request.

Step Therapy and Lab Requirements

Step Therapy Considerations

Qalsody is typically not subject to traditional step therapy since it's the only SOD1-targeted ALS treatment. However, UnitedHealthcare may require documentation of:

  • Current or previous use of standard ALS therapies (riluzole, edaravone)
  • Rationale for SOD1-specific treatment vs. general ALS care

Required Laboratory Work

Mandatory:

  • Genetic testing confirming SOD1 mutation
  • Baseline ALSFRS-R functional assessment

Recommended but not required by UnitedHealthcare:

  • Neurofilament light chain (NfL) levels
  • Forced vital capacity (FVC) measurements
  • EMG/nerve conduction studies

Understanding Your Costs

Typical Cost Structure

  • List price: ~$14,500 per vial
  • Annual cost: $200,000-220,000 first year; ~$170,000-180,000 ongoing
  • Your cost: Depends on plan design (copay vs. coinsurance)

Financial Assistance Options

  1. Manufacturer support: Contact Biogen for patient assistance programs
  2. Specialty pharmacy financial counseling: Available through Optum Specialty Pharmacy
  3. ALS foundations: May provide grants for treatment costs
  4. State programs: Washington has additional resources for rare disease patients
Note: Ask about copay accumulator policies that may affect how manufacturer assistance applies to your deductible.

Why Denials Happen and How to Fix Them

Common Denial Reasons and Solutions

Denial Reason How to Fix Required Documentation
No SOD1 mutation documented Submit complete genetic report Lab report with pathogenic variant
Non-neurologist prescriber Get neurologist consultation Specialist referral or co-signature
Missing baseline assessment Complete ALSFRS-R evaluation Functional assessment form
Insufficient ALS documentation Provide comprehensive workup EMG, imaging, clinical notes
"Experimental" designation Cite FDA approval and CMS guidance FDA label, CMS December 2024 directive

Peer-to-Peer Review Strategy

If initially denied, request a peer-to-peer review where your neurologist can discuss the case directly with UnitedHealthcare's medical reviewer. Key points to emphasize:

  • Confirmed pathogenic SOD1 mutation
  • Clinical progression consistent with SOD1-ALS
  • Lack of alternative targeted therapies
  • Urgency based on functional decline

Renewal and Reauthorization

When Reauthorization is Needed

UnitedHealthcare typically requires reauthorization every 6-12 months for Qalsody. The exact timeline should be confirmed in your initial approval letter.

Documentation for Renewal

  • Updated ALSFRS-R scores: Showing stabilization or slowed decline
  • Tolerance assessment: Any side effects or complications
  • Continued eligibility: Confirmation of ongoing SOD1-ALS diagnosis
  • Clinical benefit: Evidence of treatment response or disease stabilization

Preparing for Renewal

Start the reauthorization process 30-60 days before your current approval expires to avoid treatment interruptions.

Specialty Pharmacy Requirements

UnitedHealthcare's Specialty Network

Qalsody is typically dispensed through Optum Specialty Pharmacy or other approved specialty pharmacies in UnitedHealthcare's network.

Key Steps

  1. Verify required pharmacy: Check if your plan mandates a specific specialty pharmacy
  2. Coordinate with prescriber: Ensure prescription is sent to the correct pharmacy
  3. Arrange administration: Confirm intrathecal administration site and scheduling
Important: Some plans require "white bagging" where the specialty pharmacy ships directly to your infusion center.

Washington Appeals Process

If UnitedHealthcare denies your Qalsody prior authorization, Washington state provides strong consumer protections through its appeals process.

Internal Appeals (First Step)

  1. File within 60 days of denial notice
  2. Submit additional documentation addressing denial reasons
  3. Request expedited review if clinically urgent (72-hour response)

External Review (Independent Review Organization)

After exhausting internal appeals, you can request external review through Washington's Office of the Insurance Commissioner:

  • Filing deadline: 180 days from final internal denial
  • Review timeline: 30 days standard, 72 hours expedited
  • Decision: Binding on UnitedHealthcare if overturned

How to File External Review

  1. Contact your insurer to request external review
  2. UnitedHealthcare forwards your case to Washington OIC
  3. Independent medical experts review your case
  4. Decision is based on medical necessity and current standards
Resources: Call Washington OIC Consumer Advocacy at 1-800-562-6900 for assistance with appeals.

Troubleshooting Common Issues

Portal Access Problems

  • Solution: Call UnitedHealthcare provider services for password reset or technical support
  • Alternative: Submit via fax or phone if portal is unavailable

Missing Forms or Documentation

  • Solution: Contact your neurologist's office for medical records
  • Timeline: Allow 5-10 business days for medical record requests

Specialty Pharmacy Coordination

  • Solution: Have your prescriber coordinate directly with the assigned specialty pharmacy
  • Follow-up: Confirm prescription receipt and processing timeline

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Qalsody?

Standard review takes 7-15 business days. Expedited review for urgent cases is completed within 72 hours.

What if Qalsody is not on my formulary?

Request a formulary exception with medical necessity documentation. Emphasize that Qalsody is the only SOD1-targeted ALS therapy available.

Can I request an expedited appeal in Washington?

Yes, both internal appeals and external review can be expedited if delay would seriously jeopardize your health.

Does step therapy apply if I've tried treatments outside Washington?

Documentation of prior therapy trials from any location should count toward step therapy requirements. Provide complete records with dates and outcomes.

What if my employer plan is self-funded?

Self-funded ERISA plans may not be subject to Washington state appeal laws, but many voluntarily use similar processes. Contact the U.S. Department of Labor for ERISA plan appeals if needed.

How much will Qalsody cost me?

Your out-of-pocket cost depends on your specific plan design. Contact UnitedHealthcare member services for exact copay or coinsurance amounts and annual maximums.

When to Get Help

Counterforce Health specializes in helping patients navigate complex prior authorization and appeals processes for specialty medications like Qalsody. Their platform analyzes denial letters and creates targeted, evidence-backed appeals that align with payer-specific requirements. This can be particularly valuable for rare disease medications where standard appeals templates may not address the specific clinical criteria insurers use.

If you're facing repeated denials or complex appeals, consider working with patient advocates who understand both UnitedHealthcare's review processes and Washington's consumer protection laws. Professional advocacy can significantly improve your chances of approval while reducing the administrative burden on your medical team.

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 determinations. Coverage criteria and processes may change; verify current requirements with UnitedHealthcare and Washington state regulators before making treatment decisions.

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