Radioligand therapy is a truly multidisciplinary, multi-sectoral approach, with policies across the health, energy and other sectors directly impacting access and availability. With many new therapies on the horizon, and variable access to existing therapies, an evaluation of the current integration of – and readiness for – radioligand therapy is essential.
The Radioligand Therapy Readiness Assessment Framework is a tool to evaluate the situation within different countries and ultimately provide a clear evidence-base to guide health system readiness and integration into care at the national level.
The framework takes a systems view to analyse integration of radioligand therapy across five domains of a health system: governance, regulation and reimbursement, identified need, service provision and health information.
Governance refers to a range of steering and rule-making functions carried out by decision-makers that directly impact the availability, accessibility and standards of delivery of radioligand therapy. Governance may come from health or energy system decision-makers in the form of policy and plans, but it also includes guidelines and the best practice from the clinical community.
Regulation and reimbursement define why, when and how radioligand therapy should be provided and paid for. This essential component of the health system is led by various national, and sometimes international, organisations and ensures that medicines are delivered safely, effectively and sustainably.
Identified need is the potential need or demand for radioligand therapy among people with cancer. There are many components required to fully understand a need for an intervention, including epidemiological data, levels of patient and healthcare professional awareness, and referral patterns. Such information is essential in planning services.
Service provision encompasses the inputs and outputs required for the provision of radioligand therapy. This includes the healthcare workforce and infrastructure required to ensure radioligand therapy services are delivered effectively and efficiently to the people who need them.
Health information refers to data that are collected, analysed and synthesised to support decision-making around radioligand therapy. Comprehensive data collection efforts spanning clinical, patient, real-world and economic data points are essential to understand how radioligand therapy is used and how services can be improved.
We offer the Radioligand Therapy Readiness Assessment Framework to any interested parties to adapt and apply to their own context. The user guide aims to support new applications of the framework and explains how to prepare, research, validate findings and reach consensus on areas for policy action. It also contains a glossary of the key technical terms used in the framework.
The readiness assessment framework has been piloted in the UK and US, leading to the development of national policy-focused situation analyses, using the five domains of the framework, to inform health system planning in these countries.
The Radioligand Therapy Readiness Assessment Framework aims to identify what is needed to support the integration of radioligand therapy into cancer care. It builds on the research in the European policy report, Radioligand therapy: realising the potential of targeted cancer care, as well as comprehensive scoping research evaluating existing frameworks. A grounded theory approach was adopted to develop the framework further, incorporating findings from UK and US pilot country analyses to refine it over time. The framework was developed by The Health Policy Partnership, an independent research organisation, with input from a multidisciplinary International Expert Advisory Group who had full editorial control over materials.