Tofersen (Qalsody) treatment for SOD1-associated MND

Regulatory status and access

The Medicines and Healthcare products Regulatory Agency (MHRA) approved tofersen (Qalsody) on 22 July 2025 for the treatment of adults with amyotrophic lateral sclerosis (ALS) caused by pathological variants in the SOD1 gene. Biogen, the manufacturer of tofersen, has submitted an application to the National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) to determine whether treatment should be commissioned within the NHS.

While NICE and SMC appraisals are ongoing, tofersen treatment is not currently funded by the NHS. Biogen has made the treatment available in the UK free of charge to eligible patients on a “named patient basis” in an Expanded Access Program (EAP). However, centres offering tofersen must then cover all associated service costs, including pharmacy preparation, the clinical staff required for administration and monitoring, including any out-of-hours adverse event management.

Below are sites that have confirmed they are delivering tofersen on a "named patient basis" and their current status:

Locations

• Brighton  Site at capacity - unable to accept new patients

• London - Imperial College Healthcare (Charing Cross Hospital)  providing service to patients covered by their MND Centre 

• London - Royal London (Barts)  providing service to patients covered by their MND Centre 

• London - UCL  Site currently has capacity to accept new patients

• Newcastle  In set-up

• Oxford  Site at capacity - unable to accept new patients

• Sheffield  Site at capacity - unable to accept new patients

• Stoke  Site at capacity - unable to accept new patients