Your first 90 days
Your first 90 days on Qalsody for ALS with a SOD1 mutation
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Qalsody is not a pill and not a pharmacy pickup. Every dose is a spinal injection at a clinic, and the first 3 come only 2 weeks apart. That makes the first 90 days the busiest stretch of treatment for the person with ALS and for the caregivers who come along. This page lays out that stretch from the FDA label, Biogen's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Qalsody has no REMS, but every dose is given in a clinic. The first one waits on a genetic test result, an insurance approval and a lumbar puncture appointment. These are the 5 things in the way, in order.
A genetic test showing a SOD1 mutation
The label approves Qalsody only for adults with ALS who have a mutation in the SOD1 gene.
- The Cigna policy on this page asks for documentation of a confirmed SOD1 disease-causing variant.
- Your neurologist orders the test or sends a result you already have.Cigna policy
A clinic that gives spinal injections
The label says Qalsody is given through a lumbar puncture by, or under the direction of, healthcare professionals experienced in that procedure.
- Ask the neurologist where your doses will be given and who performs them.FDA label
A check on breathing and the procedure itself
The label asks the care team to check for conditions related to the lumbar puncture before and after each injection.
- It allows sedation or imaging guidance when the person's condition calls for it, so ask the team which they plan to use.FDA label
Biogen Support Services and the insurance approval
Biogen Support Services helps with financial, insurance and treatment questions as soon as Qalsody is prescribed.
- Most plans need prior authorization, and the usual criteria are further down this page.Qalsody patient brochure
A word about pregnancy
Biogen asks patients to tell their provider before starting if they are pregnant, plan to become pregnant, or are breastfeeding or plan to.
- The rules section below says what the label adds on both.Qalsody patient brochure
The days that matter
Counted from the first injection, with the 3 loading doses 2 weeks apart, then the 28-day rhythm that follows. Days before the first dose are estimates, because test results and insurance set the pace. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.SOD1 genetic test result in hand
Plans such as Cigna ask for proof of a SOD1 mutation before they approve Qalsody.
- The neurologist's office keeps the genetic report ready to send.
Call Biogen Support Services
A Biogen Support Coordinator offers one-on-one phone support and help understanding your insurance and financial options.
- The line is open weekdays, 8:30 AM to 8 PM Eastern.
Prior authorization
The office sends the plan the genetic report, notes on weakness from ALS, and the neurologist's view on breathing.
- Cigna approves Qalsody for 6 months at a time, then reviews it again.
Book the first 3 visits
The loading doses fall 14 days apart, so all 3 can go on the calendar at once.
- Biogen's guide suggests asking whether to plan time to rest after the injection.
Dose 1, the first loading dose
About 10mL of spinal fluid is removed, then 15mL of Qalsody is injected over 1 to 3 minutes.
- The team checks you before and after the lumbar puncture.
The days after a dose
In the main study, pain including back pain occurred in 42% of people on Qalsody against 22% on placebo.
- Tell the team about any pain, tiredness or new symptom.
Dose 2, the second loading dose
This second loading dose comes 14 days after dose 1.
- If it is missed, the label says it is given as soon as possible, with dose 3 coming 14 days later.
Dose 3, the last loading dose
This dose comes 14 days after dose 2, and the label says spinal fluid levels between doses were highest at the third dose, which ends the loading period.
Dose 4, then every 28 days
Maintenance doses start 28 days after dose 3 and repeat every 28 days.
- A missed one is given as soon as possible, and the next falls 28 days after it.
Dose 4, number 2
Dose 5
The second maintenance dose, and the last one inside the first 90 days.
- The label says the blood marker of nerve damage kept falling until about day 113, then held steady.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Qalsody label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Label dated October 23, 2026, read on DailyMed. FDA label
- October 2026
As of November 9, 2026, Drugs@FDA lists only the April 2023 approval for Qalsody, with no letter for the November 2025 revision.Drugs@FDA
- November 2025
The myelitis and radiculitis warning now counts 8 patients instead of 6, with 6 recovering without stopping Qalsody. The label added the final results of the long-term extension study, with longer exposure and updated antibody figures, while the dose stayed the same.FDA label
- November 2024
Version 3 of the label took effect on November 13th. Its text matched the April 2023 label in the sections compared for this page, including 6 patients with myelitis or radiculitis.openFDA label record
- April 2023
Accelerated approval on April 25th for adults with ALS and a SOD1 mutation, based on lower neurofilament light chain. The FDA required the ATLAS trial to confirm the benefit and asked Biogen to report on myelitis and radiculitis twice a year.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Given by a provider through a lumbar puncture
The label calls for an injection into the spinal fluid through a lumbar puncture, by or under a provider experienced in the procedure.
- Each dose uses one single-dose vial, which is stored in a refrigerator, with limited time allowed at room temperature.FDA label
- One fixed dose
Every dose is 100mg in 15mL, and the label says age does not call for a different dose.
- Only the spacing changes, from 14 days during loading to 28 days after.FDA label
- If a dose is missed
The label says a missed second loading dose is given as soon as possible, with the third 14 days later.
- A missed third or maintenance dose is given as soon as possible, with the next 28 days later.FDA label
- Other ALS medicines
In the main study, 62% of people were taking riluzole and 8% edaravone at the start, which the study allowed.
- The label has no drug interaction section, and says Qalsody does not use or affect the CYP liver enzymes behind many interactions.
- Your neurologist decides which ALS medicines you take alongside it.FDA label
- Symptoms are reported, not waited out
The label tells patients and caregivers to contact their healthcare provider if signs of spinal cord inflammation, optic nerve swelling or meningitis appear.
- The watch list below says what those signs look like.FDA label
- Pregnancy and breastfeeding
The label says there are no adequate data on risk in pregnancy, and none on whether tofersen passes into human milk.
- It asks that the benefits of breastfeeding be weighed against the mother's need for Qalsody.FDA label
- A caregiver at every visit helps
Biogen's guide suggests asking about clothing, warm layers, music during the injection, instructions for before and after, and rest time.
- It also suggests asking whether to bring breathing equipment or a ventilator to the lumbar puncture.Getting started guide
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Pins and needles, numbness or weakness that is new
Biogen lists these as common signs of inflammation of the spinal cord or nerve roots, called myelitis and radiculitis.
- Weakness is also part of ALS, which is why anything that feels different from your usual pattern is worth reporting.Qalsody patient brochure
How often spinal cord inflammation happened
The current label counts 8 patients with myelitis or radiculitis in the studies.
- Two stopped Qalsody and recovered with treatment, and the other 6 recovered while staying on it.FDA label
Blurred vision, double vision or vision loss
Biogen lists these as signs of swelling of the optic nerve.
- Headache, vomiting, numbness or weakness can signal raised pressure inside the skull.
- Four patients in the studies had one or both problems, and all recovered with treatment.Qalsody patient brochure
Headache with fever, a stiff neck, nausea or vomiting
Biogen lists these as signs of aseptic meningitis, an inflammation of the brain's lining also called chemical or drug-induced meningitis.
- Two people had a serious case in the studies, and one of them stopped Qalsody.Qalsody patient brochure
The most common side effects
In the main study, pain occurred in 42% of people on Qalsody against 22% on placebo, and tiredness in 17% against 6%.
- Joint pain and muscle pain each occurred in 14% against 6%.
- The label also reports fever with repeat doses in the long-term study.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- No SOD1 genetic result on fileCigna asks for documentation of a confirmed SOD1 disease-causing variant before the first approval. The neurologist's office fixes this by sending the genetic test report to the plan.Cigna policy
- Questions about breathing or ventilationCigna asks the prescriber to state that breathing is adequate and that invasive ventilation is not needed. Renewal asks again about invasive ventilation, and the neurologist's notes usually answer both.Cigna policy
- The prescriber is not the right kind of specialistCigna requires a neurologist, a neuromuscular disease specialist or a physician who treats ALS, either prescribing or consulted. A referral to one of these specialists, or a consult note from one, fixes this.Cigna policy
- The 6-month approval ran outCigna approves Qalsody for 6 months at a time before it reviews the case again. Renewal asks the prescriber to say the patient still benefits, so the office should file before the last approved dose.Cigna policy
- A copay you cannot payNon-government insurance: Biogen's Copay Program may help with the cost of Qalsody itself, whatever your income. Medicare, Medicaid, VA, DoD, TRICARE or other government or drugmaker assistance may make you ineligible. Our help paying page lists the charity funds that are open to people with ALS.Qalsody patient brochure
- Bills for the spinal injection itselfBiogen's separate Administration Copay Program covers approved codes for anesthesia, imaging and the injection procedure. It excludes lab work, observation, supplies and facility or room costs. Residents of Massachusetts, Minnesota and Rhode Island cannot use it.Qalsody patient brochure
Cigna prior authorization policy, June 15, 2026
- Age 18 or older
- A confirmed SOD1 disease-causing variant, with documentation
- Weakness caused by ALS
- Adequate breathing and no need for invasive ventilation, according to the prescriber
- Prescribed by or with a neurologist, a neuromuscular disease specialist or a physician who treats ALS
- A dose of 100mg into the spinal fluid no more often than every 14 days for 3 doses, then every 28 days at most
Approval length. Six months at a time, renewed when the prescriber says the patient still benefits, invasive ventilation is not needed, and the SOD1 result and specialist requirements still hold.
This policy was reviewed in April 2026 and took effect June 15, 2026. It cites the April 2023 label, so it predates the label revised in November 2025 and posted in October 2026. The June 2026 update dropped several earlier demands, such as a list of specific SOD1 variants and a fast decline on the ALS function scale. It also dropped a raised nerve damage marker, a breathing test of 65% or more and riluzole use, which other plans may still ask for. It is here as an example of what a plan asks for, not as a rule. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- Biogen Support Coordinators who give one-on-one phone support, resources and information as soon as Qalsody is prescribed
- Help understanding insurance coverage and exploring financial assistance options
- A Copay Program for the drug itself, for people with non-government insurance regardless of income; Medicare, Medicaid, VA, DoD, TRICARE or other government help may rule you out
- A separate Administration Copay Program for approved anesthesia, imaging and injection codes, not lab work, observation, supplies or facility costs, and closed to Massachusetts, Minnesota and Rhode Island residents
- Copay reimbursement paid to the physician or treatment site on the patient's behalf, filed by fax or mail with the itemized explanation of benefits Copay reimbursement form
Details as the drugmaker publishes them. Qalsody patient brochure
Five questions for the pharmacist or the support line
- Where will each dose be given, and who performs the lumbar puncture?
- Will the injection use imaging or sedation, and should we bring breathing equipment?
- How long should we plan to stay after each dose, and who should drive?
- Is Qalsody billed under my medical benefit, and what will I owe for the drug and the procedure?
- Are all 3 loading doses booked, and who calls if one has to move?
- Which new symptoms should we call about, and what number do we use after hours?
Questions people ask in the first weeks
How is Qalsody given?
As an injection of 100mg in 15mL into the spinal fluid, through a lumbar puncture. The label says it is given by, or under the direction of, healthcare professionals experienced in that procedure. About 10mL of spinal fluid is removed first, and the injection takes 1 to 3 minutes.
How often is Qalsody given?
Three loading doses come 14 days apart, on days 1, 15 and 29. After that, the label calls for one maintenance dose every 28 days, starting with dose 4 on day 57.
Do I need a genetic test before Qalsody?
Yes, because the label approves Qalsody only for adults with ALS who have a SOD1 mutation. Insurers such as Cigna ask for documentation of a confirmed SOD1 variant. The neurologist orders the test or sends a result you already have.
What if a Qalsody dose is missed?
The label says to give it as soon as possible. A late second loading dose is followed by the third 14 days later. A late third or maintenance dose is followed by the next one 28 days later.
What side effects should caregivers watch for on Qalsody?
New pins and needles, numbness or weakness, which can signal spinal cord or nerve root inflammation. Blurred or double vision, or headache with vomiting, can signal optic nerve swelling or pressure in the skull. Headache with fever, a stiff neck or vomiting can signal meningitis. The label says to contact the healthcare provider if these appear.
Does Qalsody need blood tests or a REMS?
No REMS, and the label requires no lab test before a dose. The care team checks for problems related to the lumbar puncture before and after each injection. The neurologist will still follow the ALS itself in the usual way.
Is Qalsody fully approved?
Not yet, because the FDA gave it accelerated approval in April 2023, based on a drop in a blood marker of nerve damage called neurofilament light chain. The FDA required Biogen to complete the ATLAS trial in people with a SOD1 mutation who have no symptoms yet, with completion due December 2027.
Why was Qalsody denied by my insurance?
Plans such as Cigna ask for the SOD1 genetic report, weakness from ALS, the right kind of specialist, and the prescriber's word that breathing is adequate without invasive ventilation. Cigna also approves only 6 months at a time, so renewals come up often. The neurologist's records usually settle it, and Biogen Support Services can explain what the plan is asking for.
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Sources
- DailyMed - QALSODY- tofersen injection (prescribing information, Revised: 11/2025, SPL version 4), Biogen, via DailyMed, October 23, 2026.
- QALSODY (tofersen) injection, for intrathecal use, prescribing information, Revised: 4/2023, FDA, April 25, 2023.
- NDA 215887 corrected accelerated approval letter, Qalsody (tofersen) injection, FDA, April 25, 2023.
- openFDA drug label record for QALSODY (tofersen), set id 81356b45-1cb7-4eef-88ea-e44cc18b47c5, version 3, effective November 13, 2024, FDA, openFDA, November 13, 2024.
- Drugs@FDA: FDA-Approved Drugs, New Drug Application (NDA) 215887, FDA, November 9, 2026.
- Treatment that targets a genetic cause of ALS is here, QALSODY patient brochure with Support and resources (QAL-US-0157v2 01/24), Biogen, November 9, 2026.
- Getting started with QALSODY, your guide to how QALSODY is administered (QAL-US-0158v2 01/24), Biogen, November 9, 2026.
- QALSODY Copay Reimbursement Form (QAL-US-0299 5/23), Biogen, November 9, 2026.
- The Journal of the American Medical Association (JAMA) Neurology Publishes Long Term Results from the QALSODY Phase 3 VALOR Study and its Open-Label Extension in SOD1-ALS, Biogen, December 22, 2025.
- Neurology – Qalsody, Drug Coverage Policy IP0567, Cigna, June 15, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing neurologist. Found an error? Use the report link in the footer and it will be checked against the source.