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Biogen Support Services
for your patients

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Monday–Friday, 8:30 AM to 8:00 PM ET

Our Support Coordinators are committed to:

Answering general disease and product questions, as well as questions about Biogen Patient Support Services

Assisting with access to treatment and removal of nonclinical barriers

Resources to support your patients’ journey on QALSODY
Patient brochure

Information on how QALSODY works, clinical trial results, and more

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Getting started brochure

Your patients’ guide to how QALSODY is administered

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Dosing and administration brochure

Provides the recommended dosing for QALSODY, preparation instructions, an overview of administration, and guidelines for storage and handling

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Copay reimbursement form

For patients going through the QALSODY Copay Assistance program

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Resource Guide for Practices and Facilities

Download this guide for support with navigating QALSODY treatment access and procurement processes for your patients with ALS

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Sample Letter of Medical Necessity/Appeal Template

In the event you need to obtain approval or appeal a denial, you can leverage this sample letter to support communication with your patient’s health plan

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Start Form (English)

Download this form to help patients start treatment with QALSODY and enroll in Biogen Support Services

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Start Form (Spanish)

Download this form to help patients start treatment with QALSODY and enroll in Biogen Support Services

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Find a treatment center

INDICATION

QALSODY® (tofersen) is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Myelitis and/or Radiculitis

Serious adverse reactions of myelitis and radiculitis have been reported in patients treated with QALSODY. Six patients treated with QALSODY experienced myelitis or radiculitis in the clinical studies. Two patients discontinued treatment with QALSODY and required symptomatic management with full resolution of symptoms. In the remaining 4 patients, symptoms resolved without discontinuation of QALSODY. If symptoms consistent with myelitis or radiculitis develop, diagnostic workup and treatment should be initiated according to the standard of care. Management may require interruption or discontinuation of QALSODY.

Papilledema and Elevated Intracranial Pressure

Serious adverse reactions of papilledema and elevated intracranial pressure have been reported in patients treated with QALSODY. Four patients developed elevated intracranial pressure and/or papilledema. All patients received treatment with standard of care with resolution of symptoms, and no events led to discontinuation of QALSODY. If symptoms consistent with papilledema or elevated intracranial pressure develop, diagnostic workup and treatment should be initiated according to the standard of care.

Aseptic Meningitis

Serious adverse reactions of aseptic meningitis (also called chemical meningitis or drug-induced aseptic meningitis) have been reported in patients treated with QALSODY. One patient experienced a serious adverse reaction of chemical meningitis, which led to discontinuation of QALSODY. One patient experienced a serious adverse reaction of aseptic meningitis, which did not lead to discontinuation of QALSODY. In addition, nonserious adverse drug reactions of CSF white blood cell increased, and CSF protein increased have also been reported with QALSODY. If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care.

Adverse Reactions

The most common adverse reactions (≥10% of patients treated with QALSODY and greater than placebo) were pain, fatigue, arthralgia, cerebrospinal fluid white blood cell increased, and myalgia.

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