OP38 Managed (Early) Access In England: The ‘Ins And Outs’

Introduction Managed access approaches have been used by The National Institute for Health and Care Excellence (NICE) in partnership with NHS England since 2015. The Cancer Drugs Fund is an exemplar of this approach which enables earlier patient access to promising new treatments while further real-world data is collected to address evidential uncertainties. Increasingly, this approach is being applied to rare diseases and other conditions to address unmet clinical need with extensive involvement from patient organizations and clinicians. Methods All Managed Access Agreements (MAAs) in development or published in England were reviewed to present data on the number of technologies (i) entering, (ii) in active monitoring, and (iii) exiting managed access, for both cancer and other disease areas. Results After six years since the first MAA (at December 2021), over 73,000 patients have benefited from earlier access to promising new treatments for cancer, genetic and rare diseases, including cystic fibrosis, spinal muscular atrophy and sickle cell disease via managed access. Fifty-eight technologies were commissioned via managed access: thirty technologies in active data collection, eleven technologies being re-evaluated, and seventeen technologies have exited managed access. Patient and clinical engagement have been essential to the successful real-world data collections delivered and underway. Conclusions Managed access is an approach for providing earlier patient access to promising new technologies that would not otherwise be recommended for use in England. The approach to managed access in England is maturing at the same time the volume of topics entering and exiting managed access in England is expected to grow throughout 2022 with the introduction of the Innovative Medicines Fund.