FOCUS-NHS: A Framework for mOnitoring and improving Clinical Use of bioSimilars across the NHS

Research question: What is needed in order to achieve improvements in clinical care via high uptake of future biosimilars? Background: The effectiveness of monoclonal antibodies has led to NICE approval for NHS use across a range of conditions. Biosimilars bring potential to release cost savings for service investment, potentially enabling earlier and wider treatment access. However, natalizumab biosimilar deployment resulted in unanticipated challenges. Take-up has stalled, placing future biosimilar deployment at significant risk. A thorough process evaluation is needed to understand what happened and why, and to prepare NHS systems for future biosimilar deployments across conditions. Any delay runs the risk of loss of institutional memory. If effective support and communication systems are not put in place future biosimilar deployments may fail. Aims and Objectives: We will use outputs from process evaluation (WP1) and quantitative evaluation (WP2) to design inclusive communication tools in collaboration with clinicians, patients, communities, and policy makers (WP3). We will develop and upgrade effective and responsive infrastructure able to inclusively monitor biosimilar deployment (WP2). Our outputs will be evaluated and refined via real-world piloting during ocrelizumab biosimilar deployment (WP4), including data generation via routine care (WP5). We will assess the true costs of biosimilar use in the NHS, accounting for support required for effective deployment across all people (WP6). Methods: We will deliver these objectives via 6 linked workpackages (WP). WP1 will use process evaluation to understand barriers and enablers during natalizumab biosimilar deployment. WP2 will use real world evidence to evaluate natalizumab biosimilar uptake and outcomes across the NHS. WP32 will co-design evidence-informed communication strategies to enable effective discussion around biosimilars, including with the public, policy makers and healthcare professionals, evaluated in WP4. WP5 will evaluate routine data in terms of data quality, inclusion, and representation during ocrelizumab biosimilar deployment. WP6 will develop a framework to assess short- and long-term costs and cost-effectiveness of biosimilar treatments for MS. Research inclusion is integrated throughout all WP. We will deploy and monitor specific strategies to ensure all people have an equitable opportunity to participate in this research, informed by our work with people and communities. We will refer to the Government Digital Inclusion strategy to mitigate digital exclusion, and participant information will be available in both written and video format to support those with lower literacy levels. Timeline: Activities during y1-2 will focus on learnings from natalizumab deployment (WP1&2) and developing effective and sustainable systems to support (WP3,4) and monitor (WP4,5) ocrelizumab biosimilar deployment during y3-5. Knowledge mobilisation, dissemination and impact: Our partnerships with NHS England, MS services, national neurology infrastructure and third sector organisations provide the collaborations required to deliver and disseminate effectively. Engagement with scientific communities will build on our existing successful scientific outputs, including national and international dissemination activities. Our work with communities will ensure that outputs facilitate wider public conversation about biosimilars and their role in the NHS.