Biogen’s expensive spinal muscular atrophy (SMA) treatment Spinraza, is facing tougher competition but the drug maker hoping to cover the market before competitors come about. Now a recommendation from England’s drug-price watchdog may come as another help. UK’s National Institute for Health and Care Excellence (NICE) recommended Spinraza for use on the country's NHS for treatment of presymptomatic, infantile and late-onset SMA after Biogen agreed to a confidential discount.
“We are very pleased that we can now recommend nusinersen for people with SMA. The committee has recognised that nusinersen is a promising treatment that has been shown to improve a range of outcomes important to patients. But it also recognised that there are significant uncertainties, particularly around its long-term benefits. All along we have felt it important to give all parties every opportunity to try to find a way to mitigate these uncertainties in order to make nusinersen available to patients in England." said Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE.
The recommendation makes Spinraza the first and only treatment in the UK for SMA, a rare and often fatal disease that is estimated to affect between 650 and 1,300 patients.
“The NICE recommendation of nusinersen for infants, children, and adults with 5q SMA, including pre-symptomatic, SMA types I, II and III, is a momentous occasion for patients and their families who have fought tirelessly for access to this life-changing medicine. 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.” said Terry O’Regan, Vice President and Managing Director of Biogen UK.
BIOGEN’S SPINRAZA®▼ (NUSINERSEN) RECEIVES RECOMMENDATION FROM NICE FOR THE TREATMENT OF INFANTS, CHILDREN AND ADULTS WITH 5q SPINAL MUSCULAR ATROPHY
May 14, 2019 07:03 PM Eastern Daylight Time
MAIDENHEAD, England--(BUSINESS WIRE)--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.1
Terry O’Regan, Vice President and Managing Director of Biogen UK and Ireland, said:
“The NICE recommendation of nusinersen for infants, children, and adults with 5q SMA, including pre-symptomatic, SMA types I, II and III, is a momentous occasion for patients and their families who have fought tirelessly for access to this life-changing medicine. 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.”
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.2 To date, more than 7,500 patients worldwide have been treated with nusinersen, from infants to adults.2
The decision 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. Biosimilar products are strategically important in creating scope in healthcare budgets for patients to access innovative medicines, as Biogen works with payers and health systems globally to achieve this goal. In Europe, approximately 145,000 patients have been treated with a Biogen biosimilar and, based on internal estimates, Biogen expects the uptake to contribute an estimated healthcare savings of up to 1.8 billion Euros in 2019.2
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