By Counterforce Health Team in Qalsody (tofersen) —

Qalsody (Tofersen) Approval with UnitedHealthcare in Michigan: Answers to the Most Common Questions

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

Yes, UnitedHealthcare covers Qalsody (tofersen) for ALS patients with confirmed SOD1 mutations, but requires prior authorization through OptumRx. Key requirements: SOD1 genetic testing, neurologist prescription, baseline ALSFRS-R score, and no invasive ventilation. If denied, Michigan residents have 127 days to file external review with DIFS. Start today: Have your neurologist gather SOD1 mutation documentation and submit PA through UnitedHealthcare's provider portal.

Table of Contents

Coverage Basics

Is Qalsody (Tofersen) Covered by UnitedHealthcare?

UnitedHealthcare recognizes Qalsody as a specialty medication covered under its medical benefit for patients with ALS caused by SOD1 gene mutations. However, all requests require prior authorization managed through OptumRx, UnitedHealthcare's pharmacy benefit manager.

The drug is classified as a Specialty Tier medication, meaning it carries the highest cost-sharing amounts—typically 30-50% coinsurance after deductible for commercial plans. Medicaid members may have minimal or zero cost-sharing.

Which UnitedHealthcare Plans Cover Qalsody?

Coverage applies across UnitedHealthcare's Michigan offerings:

  • Commercial employer plans
  • Individual/Exchange plans
  • Medicare Advantage
  • Medicaid managed care plans

Important: Coverage specifics vary by plan type and formulary. Always verify your exact benefits through your Summary of Benefits or by calling member services.

Prior Authorization Process

Who Submits the Prior Authorization?

Your prescribing neurologist or their staff submits the PA request through:

  • UnitedHealthcare Provider Portal (preferred)
  • OptumRx specialty pharmacy system
  • Fax submission with required forms

Required Documentation Checklist

✅ SOD1 genetic testing results confirming mutation
✅ ALS diagnosis with clinical documentation
✅ Baseline ALSFRS-R score (functional assessment)
✅ Neurologist prescription or consultation notes
✅ Ventilation status confirmation (must not be invasively ventilated)
✅ FDA-compliant dosing plan (100mg loading doses, then monthly maintenance)

Tip: Incomplete documentation is the #1 reason for PA delays. Ensure all items are submitted together.

Timing and Urgency

Standard Prior Authorization Timeline

  • Initial review: 30 calendar days maximum
  • Expedited review: 72 hours (for urgent cases)
  • Medicare Part D: 7 calendar days

When to Request Expedited Review

Request expedited processing if:

  • Patient's condition is rapidly deteriorating
  • Delay would seriously jeopardize health
  • Current treatment is failing

Your neurologist must provide written certification of urgency for expedited review.

Clinical Criteria

Step-by-Step: Fastest Path to Approval

  1. Confirm SOD1 mutation - Order genetic testing if not already done
  2. Document baseline function - Complete ALSFRS-R assessment
  3. Verify prescriber qualification - Must be neurologist or in consultation with one
  4. Check ventilation status - Patient cannot be invasively ventilated
  5. Submit complete PA - Use provider portal with all documentation
  6. Follow up in 48-72 hours - Track status and respond to requests quickly
  7. Prepare for renewal - Schedule monitoring labs 6-8 weeks before expiration

Medical Necessity Requirements

Requirement Documentation Needed Source
SOD1 mutation Genetic lab results UHC Policy
ALS diagnosis Neurologist notes, EMG results UHC Policy
Functional baseline ALSFRS-R score within past 12 months UHC Policy
Age requirement Adult (≥18 years) FDA labeling
Ventilation status Not invasively ventilated UHC Policy

Costs and Financial Assistance

Understanding Your Out-of-Pocket Costs

Qalsody's list price is approximately $14,230-$14,754 per vial. With typical specialty tier coinsurance of 30-50%, monthly out-of-pocket costs can range from $4,000-$7,000 before reaching annual out-of-pocket maximums.

Financial Assistance Options

  • Biogen Patient Support - Manufacturer copay assistance program
  • ALS Association - Financial assistance for treatment costs
  • State pharmaceutical assistance programs - Michigan-specific options
  • Medicare Extra Help - For Medicare beneficiaries with limited income
Note: Copay assistance eligibility varies by insurance type. Medicare and Medicaid patients may have different options available.

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Overturn
No SOD1 mutation documented Submit genetic testing results with clear mutation identification
Non-neurologist prescriber Obtain neurologist consultation or prescription
Missing baseline ALSFRS-R Complete functional assessment and submit score
Experimental/investigational Reference FDA approval and CMS coverage determination
Invasive ventilation Document current ventilation status; consider appeal if status changed

UnitedHealthcare Internal Appeals Process

Timeline: File within 180 days of denial notice

Process:

  1. Gather documentation - Original denial, clinical records, supporting literature
  2. Submit appeal - Via provider portal, mail, or fax
  3. Request peer-to-peer - Allow your neurologist to speak with UHC medical director
  4. Track status - Monitor through OptumRx portal
  5. Escalate if denied - Proceed to external review

Michigan External Review Rights

If UnitedHealthcare's internal appeal is denied, Michigan residents can request external review through the Department of Insurance and Financial Services (DIFS).

Key Details:

  • Deadline: 127 days from final denial
  • Standard review: Up to 60 days for decision
  • Expedited review: 72 hours with physician certification
  • Binding decision: Insurer must comply with favorable ruling

Contact DIFS: 877-999-6442 or online portal

Important: Michigan's 127-day deadline is strictly enforced. Don't wait—file promptly after receiving your final denial.

Renewal Requirements

Annual Reauthorization Process

UnitedHealthcare requires annual renewal of Qalsody prior authorization. Begin the renewal process 6-8 weeks before your current approval expires.

Required for Renewal:

  • Updated ALSFRS-R score (within past 12 months)
  • Neurofilament light chain (NfL) biomarker levels
  • Provider attestation of continued benefit
  • Confirmation of SOD1 mutation status
  • Current ventilation status

Monitoring Schedule

Assessment Frequency Purpose
ALSFRS-R score Every 3-6 months Track functional status
NfL biomarker Every 6-12 months Monitor treatment response
Clinical evaluation Monthly (with infusions) Overall disease progression

Specialty Pharmacy

Why Was My Prescription Transferred?

Qalsody requires specialty pharmacy dispensing due to:

  • Complex storage and handling requirements
  • Intrathecal administration coordination
  • Patient monitoring and support services
  • Insurance authorization management

Working with Specialty Pharmacies

Your specialty pharmacy will:

  • Coordinate with your neurologist's office
  • Handle insurance authorizations and appeals
  • Arrange delivery to your treatment center
  • Provide injection supplies and support

Common UnitedHealthcare specialty pharmacy partners:

  • OptumRx Specialty Pharmacy
  • Accredo Specialty Pharmacy
  • CVS Specialty

Troubleshooting Common Issues

Provider Portal Problems

Issue: Can't access UnitedHealthcare provider portal
Solution: Contact provider services at 1-800-842-3211

Issue: PA request shows "pending" for weeks
Solution: Call OptumRx specialty pharmacy line to check status

Issue: Missing required forms
Solution: Download current forms from UHC provider website

Communication Breakdowns

Issue: Specialty pharmacy says PA is approved, but UHC says it's denied
Solution: Request written confirmation from both parties with reference numbers

Issue: Neurologist office hasn't submitted PA after multiple requests
Solution: Offer to help gather documentation or contact patient advocate

When traditional channels fail, Counterforce Health specializes in turning insurance denials into successful appeals by creating targeted, evidence-backed submissions that align with each payer's specific requirements.

Frequently Asked Questions

Q: How long does UnitedHealthcare PA take in Michigan?
A: Standard review takes up to 30 days, but expedited review (with physician certification of urgency) is completed within 72 hours.

Q: What if Qalsody is non-formulary on my plan?
A: Non-formulary doesn't mean no coverage. Your neurologist can request a formulary exception with medical necessity documentation.

Q: Can I request an expedited appeal if my PA is denied?
A: Yes, if delay would seriously jeopardize your health. Your physician must certify the urgency in writing.

Q: Does step therapy apply to Qalsody?
A: UnitedHealthcare may require documentation of prior ALS treatments (riluzole, edaravone), but Qalsody targets a specific genetic mutation, making traditional step therapy less applicable.

Q: What happens if I move to another state while on Qalsody?
A: Coverage continues under the same UnitedHealthcare plan, but appeal rights and external review processes will follow your new state's regulations.

Q: Can my caregiver file appeals on my behalf?
A: Yes, with proper authorization forms. UnitedHealthcare accepts appeals from designated representatives.

Q: How much will Qalsody cost with UnitedHealthcare?
A: Costs vary by plan, but expect specialty tier coinsurance of 30-50% until you reach your annual out-of-pocket maximum. Manufacturer assistance may be available.

Q: What if my neurologist isn't familiar with the PA process?
A: Share UnitedHealthcare's Qalsody policy document and consider connecting them with Biogen's medical affairs team for support.

From our advocates: We've seen cases where patients received faster approvals by having their neurologist submit a comprehensive medical necessity letter alongside the PA request, rather than waiting for UnitedHealthcare to request additional information. The key is anticipating what reviewers need and providing it upfront—SOD1 genetic testing, detailed ALS progression notes, and clear documentation that the patient meets all FDA labeling criteria.

Getting Qalsody covered requires patience and persistence, but Michigan patients have strong appeal rights and multiple pathways to access this important treatment. When facing denials or delays, remember that Counterforce Health helps patients and clinicians navigate complex prior authorization and appeal processes by creating evidence-backed submissions tailored to each payer's specific requirements.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and appeal processes. It is not medical advice, legal advice, or a guarantee of coverage. Always consult with your healthcare provider and insurance plan directly for medical decisions and coverage determinations. Coverage policies and appeal procedures may change; verify current requirements with official sources.

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