By Counterforce Health Team in Qalsody (tofersen) —

How to Get Qalsody (Tofersen) Approved by UnitedHealthcare in Ohio: Complete Guide with Forms and Appeals

Answer Box: Getting Qalsody Covered by UnitedHealthcare in Ohio

UnitedHealthcare requires prior authorization through OptumRx for Qalsody (tofersen) in Ohio. You need: confirmed ALS diagnosis, documented SOD1 mutation, baseline ALSFRS-R score, and neurologist prescription. Submit via UHC Provider Portal or fax to 1-844-403-1027. If denied, Ohio residents get two internal appeals plus external review through Ohio Department of Insurance within 180 days. Start today: Call UHC Member Services (number on your card) to request case management for ALS and confirm your PA requirements.

Table of Contents

  1. Verify Your Plan and Find the Right Forms
  2. Required Forms and Documentation
  3. Submission Portals and Online Tools
  4. Fax Numbers and Mailing Addresses
  5. Specialty Pharmacy Requirements
  6. Support Phone Lines and Case Management
  7. Ohio Appeals and External Review
  8. Common Denial Reasons and Solutions
  9. Costs and Financial Assistance
  10. FAQ

1. Verify Your Plan and Find the Right Forms

Before starting, confirm your exact UnitedHealthcare plan type—the forms and processes differ significantly:

Ohio Medicaid (Community Plan): Uses Ohio-specific Qalsody policy with InterQual criteria Commercial/UMR Plans: Follow UMR medical drug policy (effective June 2025) Medicare Advantage: Standard OptumRx prior authorization requirements

Tip: Check your ID card for "Community Plan" or "UMR" designations. This determines which policy applies to your Qalsody request.

2. Required Forms and Documentation

Core Clinical Requirements

UnitedHealthcare's Qalsody Commercial Medical Benefit Policy requires all of the following for initial authorization:

  • ALS diagnosis confirmation with medical records (chart notes, EMG, imaging)
  • SOD1 mutation genetic test report showing specific mutation
  • Adult patient (18+ years)
  • Baseline functional documentation (ALSFRS-R score preferred)
  • Ventilation status confirming patient is not invasively ventilated
  • Neurologist prescription or consultation documentation
  • FDA-compliant dosing plan (100 mg intrathecal: 3 loading doses at 14-day intervals, then monthly maintenance)

Documentation Checklist

For Initial PA Request:

  • Neurologist consultation note confirming ALS diagnosis
  • SOD1 genetic testing lab report
  • Current ALSFRS-R score (within 12 months)
  • Ventilation assessment (not dependent on invasive ventilation)
  • Treatment plan with dosing schedule
  • Insurance card and member ID

For Renewal (after 12 months):

  • Updated ALSFRS-R score showing stabilization or slower decline
  • Neurofilament light chain (NfL) levels if available
  • Provider attestation of continued benefit
  • Current ventilation status confirmation

3. Submission Portals and Online Tools

Primary Submission Methods

UnitedHealthcare Provider Portal (Medical Benefit)

  • Navigate to: Prior Auth & Notification → Pharmacy & Specialty Drug
  • Upload supporting documents directly
  • Track PA status in real-time
  • Access Provider Portal

OptumRx Electronic PA (Pharmacy Benefit)

Note: Qalsody appears on UnitedHealthcare's Specialty Pharmacy Requirements list, requiring dispensing through designated specialty providers like Metro Infusion Center.

4. Fax Numbers and Mailing Addresses

OptumRx Prior Authorization

Ohio Medicaid Community Plan Appeals

  • Member Appeals Fax: 1-866-713-1891
  • Provider Appeals Fax: 866-449-6843 (pre-claim appeals)
  • Mailing Address: UnitedHealthcare Grievances and Appeals P.O. Box 31364 Salt Lake City, UT 84131-0364

Cover Sheet Tips

  • Include member name, ID number, and date of birth
  • Reference "Qalsody (tofersen) Prior Authorization" in subject line
  • Mark as "URGENT" if delay could jeopardize health
  • Include provider NPI and contact information

5. Specialty Pharmacy Requirements

Qalsody must be obtained through UnitedHealthcare's contracted specialty pharmacy network in Ohio:

Designated Specialty Providers

  • Metro Infusion Center (primary UHC specialty provider for Qalsody)
  • Other UHC-contracted specialty pharmacies as listed in current formulary

Coordination Steps

  1. Confirm treatment center using Qalsody Treatment Center Locator
  2. Verify UHC network status of chosen Ohio treatment facility
  3. Coordinate drug shipment from specialty pharmacy to treatment center
  4. Billing arrangement: Specialty pharmacy bills UHC for drug; treatment center bills for administration only
From our advocates: One Ohio family found success by calling Biogen Support Services (1-877-725-7639) first to coordinate between UnitedHealthcare, the specialty pharmacy, and their local ALS clinic. This prevented delays when the initial treatment center wasn't familiar with UHC's specialty pharmacy requirements.

6. Support Phone Lines and Case Management

UnitedHealthcare Contact Numbers

General Provider Services: 877-842-3210

  • Request case management for ALS patients
  • Coordinate complex care authorization

Member Services: Number on your ID card

  • Ask for "case management for ALS/neurological condition"
  • Request assignment of nurse case manager

Community Plan (Ohio Medicaid): 800-600-9007

  • Provider services for Medicaid members
  • Expedited review requests

What to Ask For

When calling, specifically request:

  • Complex case management for ALS
  • Nurse case manager assignment
  • Care coordination for equipment and services
  • Expedited review if clinically urgent

Biogen Support Services

  • Phone: 1-877-725-7639 (Mon-Fri, 8:30 AM-8:00 PM ET)
  • Services: Benefits investigation, PA support, financial assistance coordination
  • Coverage: Helps with insurance appeals and specialty pharmacy coordination

7. Ohio Appeals and External Review

Internal Appeals Process

Timeline: File within 180 days of denial Levels: Typically 2 internal appeal levels with UnitedHealthcare

Ohio External Review

After exhausting internal appeals, Ohio residents can request external review through the Ohio Department of Insurance:

Ohio Department of Insurance Consumer Services

  • Phone: 1-800-686-1526 (toll-free in Ohio)
  • Local: 614-644-2673
  • Fax: 614-728-1280 (verify current form requirements)
  • Mailing Address: Ohio Department of Insurance Consumer Services Division 50 West Town Street, Third Floor Columbus, OH 43215

External Review Timeline:

  • Standard: 30 days for decision
  • Expedited: 72 hours if delay could seriously endanger health
  • Filing deadline: 180 days from final UHC denial

Required Documents for External Review

  • Completed Ohio External Review Request form
  • All UHC denial letters and internal appeal responses
  • Supporting medical records and provider letters
  • Copy of insurance card and member information

8. Common Denial Reasons and Solutions

Denial Reason Solution Documentation Needed
No SOD1 mutation documented Submit genetic test report Lab report showing specific SOD1 mutation
Non-neurologist prescriber Add neurologist consultation Referral letter or co-signature from ALS specialist
Missing baseline function Provide ALSFRS-R score Current functional assessment within 12 months
Ventilator dependency Clarify ventilation status Note confirming non-invasive ventilation only
Step therapy not met Request exception Document contraindications to riluzole/edaravone

Key Appeal Arguments

  • CMS guidance (December 2024): Medicare Advantage plans directed to cover Qalsody for on-label SOD1-ALS
  • FDA accelerated approval: Based on biomarker evidence of efficacy
  • No alternatives: Only SOD1-targeted therapy available for this patient population

9. Costs and Financial Assistance

Expected Costs

  • List price: ~$14,230-$14,754 per 100 mg vial
  • Annual cost: $200,000-$220,000 first year; $170,000-$180,000 ongoing
  • UHC coverage: Typically specialty tier with 30-50% coinsurance after deductible

Financial Support Options

  • Biogen Support Services: Copay assistance and patient support programs
  • Ohio Medicaid: Minimal cost-sharing for eligible members
  • Nonprofit foundations: ALS Association, Patient Access Network Foundation

10. FAQ

How long does UnitedHealthcare PA take in Ohio? Standard PA decisions typically take up to 30 days. Expedited reviews (for urgent cases) are decided within 72 hours. OptumRx electronic PAs may be approved within minutes if all criteria are clearly met.

What if Qalsody is non-formulary on my plan? Request a formulary exception through the standard PA process. Include documentation that no formulary alternatives are appropriate for SOD1-ALS, as Qalsody is the only targeted therapy for this genetic form.

Can I request an expedited appeal in Ohio? Yes, if delay would seriously jeopardize your health or ability to regain maximum function. Your treating neurologist must certify the urgent medical need. Both UHC internal appeals and Ohio external reviews offer expedited tracks.

Does step therapy apply if I haven't tried riluzole or edaravone? UHC may require documentation of why standard ALS therapies aren't appropriate. However, riluzole and edaravone work differently than Qalsody and may be used concurrently. Request an exception if contraindicated.

What happens if my Ohio treatment center isn't in UHC's network? You may need to transfer care to a network provider or request an exception. Call UHC Member Services to identify in-network ALS treatment centers in Ohio, or ask for a network gap exception if no suitable alternatives exist nearby.

How often do I need to renew Qalsody authorization? Initial approvals are typically for 12 months. Renewals require updated ALSFRS-R scores, provider attestation of continued benefit, and confirmation of ventilation status. Start the renewal process 6-8 weeks before expiration.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address specific payer requirements and clinical criteria.

This guide provides general information and should not replace professional medical or legal advice. For personalized assistance with your specific situation, consult your healthcare provider or contact Counterforce Health for specialized appeals support.

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider regarding treatment decisions. Insurance coverage and requirements may change; verify current policies with your plan.

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