It’s with huge excitement we share the news with you that more people with spinal muscular atrophy (SMA) are now eligible for access to Spinraza (also known as nusinsersen).
This follows NICE’s review of data they’ve collected as part of the Managed Access Agreement (MAA) for this treatment. It also demonstrates the power of partnership. Patient groups – MDUK, SMA UK and TreatSMA – have been working for nearly two years with clinicians and others so that people with SMA Type 3, who are unable to walk, can access nusinersen too.
NICE concluded in its review that it was appropriate to extend the clinical eligibility criteria to allow access to nusinersen for those with SMA Type 3, who aren’t able to walk. The review has also removed the rule that meant those who lost the ability to walk after 12 months of treatment would no longer be eligible for further treatment.
The review, which involved Biogen, patient groups, clinicians, SMA REACH UK and NHS England and NHS Improvement, assessed whether new evidence had become available to support a change in the MAA treatment eligibility criteria. Specifically, it looked at whether people with SMA Type 3, who are unable to walk, could benefit from nusinersen and so should be included in the MAA.
NHS England is developing its service capacity to deliver nusinersen to this wider group and, as COVID-19 restrictions ease, they will be able to expand this capacity further. Where there are already established services, some people will be able to access to the treatment immediately.
SMA UK, MDUK and TreatSMA are working with NICE, NHS England and the Managed Access Oversight Committee to update the MAA document to reflect the changes. We will keep you updated and share further details as they become available. NICE expects to publish the revised MAA document and review documentation by June 2021.
You can find out more about the review here: https://www.nice.org.uk/guidance/TA588