Prescribing guide
Qalsody (tofersen)Intrathecal dosing, neurological warnings, coding and prior authorization criteria for SOD1-ALSFor prescribers and their offices treating ALS with a SOD1 mutation: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS and no lab gate; a documented SOD1 mutation, a site with clinicians experienced in lumbar puncture, prior authorization, and pre- and post-procedure evaluation at each dose.
Example PA threshold
Cigna IP0567 example: age 18 or older, documented SOD1 pathogenic variant, weakness attributable to ALS, adequate respiratory function without invasive ventilation, neurologist, neuromuscular specialist or ALS physician; 6-month approvals.
Monitoring
No required labs; monitor for myelitis or radiculitis, papilledema or raised intracranial pressure, and aseptic meningitis, with workup per standard of care; evaluate for lumbar puncture complications before and after each dose.
Support line
Biogen Support Services, 1-877-725-7639, Monday to Friday 8:30 AM to 8 PM Eastern; Support Coordinators, insurance and financial help, a drug Copay Program and a separate Administration Copay Program for non-government insurance.
Give your patient their plan
A one-page handout for starting Qalsody, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/qalsodyBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Confirm the indication | ALS in adults with a mutation in SOD1, under accelerated approval based on reduction in plasma NfL. Continued approval may depend on verification of clinical benefit in confirmatory trials. | FDA label |
| Document the SOD1 variant | Cigna requires a confirmed SOD1 pathogenic variant with documentation at initial review. | Cigna policy |
| Arrange the procedure | Administer by, or under the direction of, healthcare professionals experienced in lumbar puncture. Consider sedation or imaging guidance if indicated by the patient's clinical condition. Confirm patient readiness before removing the vial cap; an unopened vial can return to the refrigerator. | FDA label |
| Respiratory equipment | Biogen's patient guide prompts patients to ask whether to bring respiratory equipment or a ventilator to the lumbar puncture. Payer respiratory criteria are under documentation below. | Getting started guide |
| Enroll in Biogen Support Services | Support Coordinators provide phone support, insurance and financial assistance from the time of prescription. The line is 1-877-725-7639, which the label also gives for adverse event reports. | Qalsody patient brochure |
| Copay programs | Two separate enrollments for non-government insurance: one for the drug and one for administration. Medicare, Medicaid, VA/DoD, TRICARE or other government or pharmaceutical assistance may make the patient ineligible. Administration copay covers only Biogen-approved anesthesia, imaging, surgical procedure or drug administration codes, not labs, observation, supplies or facility costs, and excludes Massachusetts, Minnesota and Rhode Island residents. | Qalsody patient brochure |
| Copay reimbursement | Payments go to the physician or site of care on the patient's behalf. Submit the claim form with an itemized EOB or remittance advice and a summary of billed charges by fax to 1-908-809-6244 or by mail to Biogen Claims, PO Box 2355, Morristown, NJ 07962. | Copay reimbursement form |
| Pregnancy and lactation | No adequate human data; animal studies at up to about 20 times human exposure showed no embryofetal effects. Tofersen was detected in mouse milk; weigh breastfeeding benefits against the mother's need. | FDA label |
Prior authorization criteria and what to document
One public policy as the example: Cigna, June 15, 2026. Approval 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age | 18 or older at initial review | Date of birth on the request | Cigna policy |
| Genetics | Confirmed SOD1 pathogenic variant [documentation required]; the June 2026 revision dropped the list of specific variants | Genetic test report | Cigna policy |
| Clinical status | Weakness attributable to ALS | Neurology note with examination findings | Cigna policy |
| Respiratory | Adequate respiratory function and no invasive ventilation, according to the prescriber; no invasive ventilation at renewal | Statement in the note; the policy no longer requires SVC of 65% or more | Cigna policy |
| Prescriber | Neurologist, neuromuscular disease specialist or physician specializing in ALS, prescribing or in consultation | Specialty on the request, or the consult note | Cigna policy |
| Dose | 100mg (15mL) intrathecally no more often than every 14 days for 3 doses, then no more often than every 28 days | Order and administration record | Cigna policy |
| Renewal | Every 6 months; the prescriber states continued benefit, plus SOD1 variant, no invasive ventilation and specialist | A dated note on benefit; documentation need not be resubmitted at reauthorization | Cigna policy |
| Dropped criteria | Effective June 15, 2026, Cigna removed ALSFRS-R slope thresholds, elevated baseline NfL, SVC of 65% or more and prior riluzole; other plans may still ask | Check the plan's current policy before filing | Cigna policy |
| Drug code | HCPCS J1304, injection, tofersen, 1mg, in Cigna's coding table | Listed in the policy's coding table as covered when criteria are met | Cigna policy |
| Procedure codes | Biogen's May 2023 copay form lists unclassified drug codes J3490, J3590 or C9399, NDC 64406-0109-01, CPT 62272 and 96450, and imaging 77003, 76942 or 77012 | Codes the form lists for copay reimbursement; the form predates J1304 | Copay reimbursement form |
Qalsody dosing and titration
| When | Label | Source |
|---|---|---|
| Days 1, 15 and 29 | Loading doses, 100mg (15mL) each, at 14-day intervals. Remove about 10mL of CSF with the lumbar puncture needle, then inject as a bolus over 1 to 3 minutes. Do not dilute; no external filter needed. | FDA label |
| Day 57, then every 28 days | Maintenance dose, 100mg (15mL). Maximum CSF trough concentration occurred at the third dose, with little to no accumulation on monthly maintenance; effective CSF half-life about 4 weeks. | FDA label |
| Missed loading dose 2 | Give as soon as possible; give loading dose 3 14 days later. | FDA label |
| Missed dose 3 or maintenance | Give as soon as possible; give the next dose 28 days later. | FDA label |
| Preparation | Warm the refrigerated vial to room temperature, 25°C (77°F), without external heat. Do not shake. Inspect for particles; solution should be clear and colorless to slightly yellow. Single-dose, preservative-free vial; give within 4 hours of drawing into the syringe, otherwise discard. | FDA label |
| Storage | 2 to 8°C (36 to 46°F) in the carton, protected from light, not frozen. Without refrigeration, up to 14 days at or below 30°C (86°F) in the carton; unopened vials out of the carton, up to 6 hours a day at or below 30°C for at most 6 days (36 hours). | FDA label |
| Supply | One single-dose vial of 100mg/15mL per carton, NDC 64406-109-01; discard unused contents. | FDA label |
| Dating period | 18 months from the date of manufacture when stored at 2 to 8°C, per the approval letter. | FDA letter |
| Specific populations | No dose change by age; not established in pediatric patients; renal and hepatic impairment not studied, and tofersen is not expected to be metabolized by hepatic enzymes. | FDA label |
Monitoring the Qalsody label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Each dose | Pre- and post-procedure evaluation | The label asks prescribers to evaluate patients before and after injection for conditions related to lumbar puncture to avoid serious procedural complications | FDA label |
| Any time | Myelitis or radiculitis | 8 patients in clinical studies; 2 discontinued and recovered with symptomatic management, 6 resolved on treatment. Workup per standard of care; may require interruption or discontinuation | FDA label |
| Any time | Papilledema or elevated intracranial pressure | 4 patients; all resolved with standard of care; none discontinued | FDA label |
| Any time | Aseptic or chemical meningitis | 2 serious cases, 1 discontinued; nonserious CSF white cell rise (14% against 0%) and CSF protein rise (8% against 3%) in VALOR | FDA label |
| Counseling | Symptoms Biogen tells patients to report | Pins and needles, numbness or weakness; blurred or double vision or vision loss; headache, vomiting, numbness or weakness; headache, fever, neck stiffness, nausea or vomiting. The label asks prescribers to tell patients and caregivers to contact their provider | Qalsody patient brochure |
| In VALOR | Pain including back and extremity pain, fatigue, arthralgia, myalgia | 42% against 22%, 17% against 6%, 14% against 6%, 14% against 6% in VALOR; pyrexia with repeat dosing in the extension | FDA label |
| Long term | Serious neurological events across VALOR and the extension | Biogen reported on December 22, 2025 that myelitis or radiculitis, papilledema or raised intracranial pressure, and chemical or aseptic meningitis occurred in 9 participants (8.7%), all resolved | Biogen press release |
| Response | Plasma NfL and CSF SOD1 | At week 28, plasma NfL fell 55% against a 12% rise on placebo and CSF SOD1 fell 35%; NfL declined until about day 113 then held. ALSFRS-R change was not statistically significant | FDA label |
| Label history | April 2023 original | Median exposure 119.4 weeks, ADA in 58.4% (97 of 166) and 6 myelitis or radiculitis cases at approval | FDA label, 2023 |
| Current label | Safety population and exposure | 147 patients with SOD1-ALS, median exposure 199.7 weeks (range 4 to 321), in Study 1 and the open-label extension Study 2 | FDA label |
Qalsody drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Contraindications | None | FDA label |
| CYP and transporters | No clinical interaction studies. In vitro, not a substrate, inhibitor or inducer of major CYP enzymes, and not a substrate or inhibitor of major transporters. Expected to be metabolized by exonuclease hydrolysis | FDA label |
| Riluzole and edaravone | Permitted in VALOR; 62% took riluzole and 8% edaravone at baseline | FDA label |
| Immunogenicity | ADA in 66.7% (98 of 147), 55.8% persistent; ADA reduced plasma clearance by 37.9% with no discernible effect on SOD1 or NfL reduction or on safety | FDA label |
| QTc | No clinically relevant prolongation at the approved dosing regimen | FDA label |
| Confirmatory trial | ATLAS (Study 233AS303) in presymptomatic adults with a SOD1 mutation; completion 12/2027, final report 06/2028 per the accelerated approval letter, which also requested twice-yearly myelitis and radiculitis reports | FDA letter |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Biogen Support Services
- 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
Questions prescribers' offices ask about Qalsody
What is the Qalsody dosing schedule?
100mg (15mL) intrathecally per administration, per the label revised November 2025: 3 loading doses at 14-day intervals, then a maintenance dose every 28 days. Remove about 10mL of CSF first and inject as a bolus over 1 to 3 minutes, within 4 hours of drawing from the vial.
What if a Qalsody dose is missed?
A missed second loading dose is given as soon as possible, with the third 14 days later, per the label revised November 2025. A missed third loading dose or maintenance dose is given as soon as possible, with the next 28 days later.
What are the Qalsody warnings?
Three, per the label revised November 2025: myelitis and radiculitis in 8 patients, 2 discontinued; papilledema or elevated intracranial pressure in 4, none discontinued; and aseptic or chemical meningitis, 2 serious cases, 1 discontinued. Monitor for symptoms and work up per standard of care. There is no boxed warning and no REMS.
Does Qalsody require laboratory monitoring?
None is required, per the label revised November 2025, which has no contraindications and no drug interaction section. It asks prescribers to evaluate patients before and after each intrathecal injection for conditions related to lumbar puncture. CSF white cells rose in 14% against 0% on placebo in VALOR (Study 1 Part C).
What do insurers ask for to approve Qalsody?
Cigna IP0567, effective June 15, 2026, asks for age 18 or older, a documented SOD1 pathogenic variant, weakness attributable to ALS, adequate respiratory function without invasive ventilation, and a neurologist, neuromuscular specialist or ALS physician. Approval runs 6 months; the policy cites the April 2023 label.
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Sources
- DailyMed - QALSODY- tofersen injection (prescribing information, Revised: 11/2025, SPL version 4), Biogen, via DailyMed, 2026-10-23.
- QALSODY (tofersen) injection, for intrathecal use, prescribing information, Revised: 4/2023, FDA, 2023-04-25.
- NDA 215887 corrected accelerated approval letter, Qalsody (tofersen) injection, FDA, 2023-04-25.
- openFDA drug label record for QALSODY (tofersen), set id 81356b45-1cb7-4eef-88ea-e44cc18b47c5, version 3, effective November 13, 2024, FDA, openFDA, 2024-11-13.
- Drugs@FDA: FDA-Approved Drugs, New Drug Application (NDA) 215887, FDA, 2026-11-09.
- Treatment that targets a genetic cause of ALS is here, QALSODY patient brochure with Support and resources (QAL-US-0157v2 01/24), Biogen, 2026-11-09.
- Getting started with QALSODY, your guide to how QALSODY is administered (QAL-US-0158v2 01/24), Biogen, 2026-11-09.
- QALSODY Copay Reimbursement Form (QAL-US-0299 5/23), Biogen, 2026-11-09.
- 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, 2025-12-22.
- Neurology – Qalsody, Drug Coverage Policy IP0567, Cigna, 2026-06-15.
A reference drawn from the October 23, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 9, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.