The National Institute for Health and Care Excellence (NICE) has recommended funding for Spinraza (nusinersen) on the National Health Service (NHS).
The positive recommendation, subject to a five-year managed access agreement (MAA), is for the treatment of infants, children and adults with 5q spinal muscular atrophy (SMA), including pre-symptomatic and SMA types I, II and III. SMA is a rare, debilitating and life-threatening disease that results in severe progressive muscular atrophy and weakness.
NICE’s evaluation of nusinersen was based on the largest body of clinical evidence currently available across all types of SMA, with six years of data including more than 300 patients treated with pre-symptomatic, infantile (type I) and later-onset (types II and III) SMA. To date, more than 7,500 patients worldwide have been treated with nusinersen, from infants to adults.
The decision of NICE to recommend funding for Spinraza builds on Biogen’s commitment to find solutions to provide broad access to innovative therapies through collaborating closely with governments and communities around the world on new business models. In Europe, a key component of that work is Biogen’s portfolio of biosimilars — cost-saving biologic medicines that are similar to currently available biologic therapies known as originators.
Terry O’Regan, Vice President and Managing Director of Biogen UK and Ireland said, “This positive outcome has been achieved through intensive and collaborative working between the SMA community, NICE, NHS England, and Biogen. We will continue to work with health authorities to ensure this welcome decision translates into access as soon as possible for those awaiting treatment, which includes providing NHS England with access to nusinersen for type I patients immediately.”