Qalsody

Indicated For

SOD1-ALS, amyotrophic lateral sclerosis

About This Medication

# Biogen Support Services Patient Guide: How to Get QALSODY® (tofersen) at Low or No Cost QALSODY® (tofersen) is the first FDA-approved treatment targeting a genetic cause of amyotrophic lateral sclerosis (ALS) in adults with a superoxide dismutase 1 (SOD1) gene mutation.[7] Biogen Support Services offers financial assistance through copay programs that can reduce your costs to $0 for the medication and some administration expenses if eligible, plus help with insurance navigation and free medication options for uninsured patients.[1][3] ## About QALSODY and Who It Helps **QALSODY (tofersen)** is an intrathecal injection given every 4 weeks to adults with ALS caused by an SOD1 gene mutation. ALS, also known as Lou Gehrig's disease, progressively affects nerve cells controlling voluntary muscles, leading to weakness and loss of function. This drug is unique because it targets the root genetic cause, reducing neurofilament light chain (NfL) levels—a marker of nerve damage—in clinical trials. It's approved under accelerated approval, meaning ongoing studies will confirm long-term benefits.[7][8] Your doctor must confirm you have the SOD1 mutation via genetic testing before prescribing. Biogen Support Services helps from diagnosis through treatment, including education on how QALSODY is administered via lumbar puncture by a healthcare professional.[1] ## Who Qualifies for Biogen Support Services? Biogen doesn't publish strict income thresholds publicly, but their programs assist commercially insured, uninsured, underinsured, and some government-insured patients (with exceptions). Key eligibility factors include: - **Diagnosis**: Confirmed SOD1-ALS in adults. - **U.S. residency**: Services are for U.S. residents only.[8] - **Insurance status**: - Commercially insured: Eligible for $0 copay program (annual cap applies; excludes Medicare, Medicaid, VA/DoD, federal plans).[5] - Uninsured/underinsured: Free medication and charitable assistance options.[3] - Government insured: Help finding alternatives like Medicaid.[5] Two separate copay programs exist: one for QALSODY drug costs, another for administration (enroll in both if needed).[1] Biogen Support Coordinators assess your situation individually—no fixed Federal Poverty Level (FPL) cutoff is specified.[1][3] ## Income Eligibility Breakdown Specific income limits aren't detailed online, as eligibility is case-by-case. However, Biogen emphasizes help for those facing high out-of-pocket costs. Contact coordinators for personalized review. Here's a general guide based on similar Biogen programs: | Household Size | Estimated Income Threshold | Notes | |---------------|----------------------------|--------| | Individual | Case-by-case | Focus on affordability, not strict FPL% | | Couple | Case-by-case | Annual copay cap applies for commercial insurance | | Family of 3 | Case-by-case | Uninsured may get free drug | | Family of 4+ | Case-by-case | Excludes federal plans like Medicare Part D | Call 1-877-725-7639 for exact qualification.[1][5] ## Insurance Requirements **Commercial insurance** is ideal for the $0 copay program, covering copays and some procedure costs (up to annual limits). Biogen handles prior authorizations (PA), benefits investigations, and appeals.[2][5] **Medicare/Medicaid/VA patients** are ineligible for copay assistance but may qualify for free drug or other aid.[3][5] Uninsured patients get direct medication support. Coordinators explain coverage, help with Medigap/COBRA/Medicaid applications, and navigate ACA options.[3] ## Step-by-Step Application Process 1. **Get Prescribed**: Your doctor confirms SOD1 mutation and prescribes QALSODY. 2. **Call Biogen**: Dial **1-877-725-7639** (Mon-Fri, 8:30 AM–8:00 PM ET) for a Support Coordinator. They'll assign a Lead Case Manager (LCM).[1][2] 3. **Complete Start Form**: Doctor fills out the 'Starting QALSODY' form (includes diagnosis ICD-10 code, treatment setting like outpatient infusion). Fax to 888-538-9781 or email StartForm@biogen.com.[6][8] 4. **Benefits Investigation**: Biogen contacts your insurer for coverage details, PA if needed. 5. **Enroll in Assistance**: Separately enroll in copay programs for drug and administration. Provide insurance/proof of residency as requested.[1] 6. **Approval**: Coordinators guide through any denials or appeals. Your LCM supports you throughout.[8] ## Timeline and Delivery Processing varies: benefits investigation is quick (days), PA may take 1-2 weeks. Once approved, medication ships to your infusion center. Treatments occur outpatient (e.g., infusion suite) every 4 weeks. Biogen coordinates delivery—no set processing time listed, but coordinators provide updates. Refills require reauthorization (see FAQ).[1][2][8] ## Alternatives if Denied or Ineligible - **Appeals**: Biogen helps with insurer appeals/PA resubmissions.[3] - **Free Medication**: Uninsured/underinsured may get QALSODY at no cost.[3] - **Charitable Aid**: Connections to organizations for premiums/copays.[3] - **Government Programs**: Medicaid/Medicare extras, ACA marketplace.[5] - **No Biosimilars**: QALSODY has no alternatives listed.[ ] Discuss with your doctor; Biogen explores all options.[1] ## Important Disclaimer This guide summarizes publicly available info as of 2026. Eligibility, benefits, and terms change—federal/state laws apply. Biogen $0 copay has limits/caps; not for federal plans. Always consult your healthcare provider, Biogen Support (1-877-725-7639), or insurer. Not medical/financial advice. Continued QALSODY approval depends on confirmatory trials.[7][8]

Program information last verified: March 30, 2026