BioMarin has requested an extension to the timelines for the re-evaluation for elosulfase alfa to respond to clarification questions on the evidence submitted to NICE. NICE has accepted this request to ensure that BioMarin has the best opportunity to present more complete data on patients receiving treatment with elosulfase alfa. Therefore, the committee meeting on 10 June 2021 has been rescheduled to take place on 6 October 2021.
The revised timelines for publication of guidance will now extend beyond the current end date for the managed access agreement (15 December 2021). In response to the amended timelines for the re-evaluation, NHS England and NHS Improvement will work together with BioMarin on an agreement that ensures continued patient access to treatment while the re-evaluation is undertaken. NICE will provide an update to all stakeholders when further details about the arrangements for the extension period are confirmed.