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Update On The Nusinersen (Spinraza) Eligibility Criteria Review

Update on the Nusinersen (Spinraza) Eligibility Criteria Review

The nusinersen clinical eligibility criteria review is progressing as planned to the anticipated timeline.

Patient groups and clinicians met in March 2021 as representatives of the Managed Access Oversight Committee (MAOC) to consider the new evidence and the assessment and recommendations of the External Assessment Centre (EAC). The next step will be for the recommendations of the EAC and the MAOC to be considered by NICE’s Technology Appraisal Committee C in an adjudication step to enable publication of a final decision. NICE’s Technology Appraisal Committee C are an independent advisory committee who worked on the original single technology appraisal of nusinersen.

If the evidence review concludes that the new evidence demonstrates comparable clinical benefits of nusinersen for patients with non-ambulant type III SMA (resulting in a recommendation to revise the MAA eligibility criteria) then the newly eligible group(s) of patients may have access to nusinersen treatment.

If the evidence review concludes there is not enough new information to support revising the MAA eligibility, then patients who are currently ineligible for nusinersen treatment will have access to best supportive care only.

Until the point of a final published decision on the NICE website, NHS England and NHS Improvement has agreed to suspend the stopping criterion for paediatric patients receiving nusinersen under the conditions of the MAA who have not regained independent ambulation after 12 months of treatment. For patients who meet this stopping criterion during the evidence review period, it is recommended that the clinician, patient and/or their family/carer(s) review the benefits of treatment with nusinersen and jointly decide whether to continue or stop treatment. The proposed arrangements ensure that these patients have continuing access to treatment with nusinersen for the duration of the evidence review.

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