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No UK Approval Filing For Biogen's Tofersen Because Of NICE HTA Decision

 
• By Ian Schofield

England’s health technology assessment body, NICE, says it has suspended the appraisal process for the motor neurone disease treatment while it considers the next steps. No HTA submission for tofersen has been made in Scotland.

Motor neuron connecting to muscle fiber, 3D illustration. A neuromuscular junction allows the motor neuron to transmit a signal to the muscle
Tofersen has been shown to slow the progression of motor neurone disease • Source: Shutterstock

Biogen says it does not plan to seek marketing approval for its motor neurone disease treatment, Qalsody (tofersen), from the UK medicines regulator, the MHRA, because it would be unlikely to receive a positive reimbursement recommendation under the appraisal route chosen by NICE, England’s health technology assessment (HTA) institute.

“It is with regret that Biogen will not be filing for marketing authorization with the MHRA for tofersen at this time,” a

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