Bridging affordability and sustainability of health innovations via novel pricing, cost-effectiveness, and reimbursement models to improve patient access: the ASCERTAIN project

Objectives Disparities in access to potential innovative health technologies (pIHTs) persist across Europe due to differing healthcare budgets, pricing policies, and health technology assessment (HTA) practices. The ASCERTAIN project aims to reduce these inequalities by developing integrated pricing, cost-effectiveness, and reimbursement approaches that enhance affordability, long-term sustainability, and timely patient access. Methods The project applies a mixed-methods approach, including literature review, stakeholder surveys, interviews, and focus groups, to ensure relevance across diverse health systems. It integrates access-based pricing, value-driven HTA, and adaptable reimbursement models into a practical, open-access ACCESS2MEDS Toolbox. This includes access-based pricing frameworks, cost-effectiveness models, and budget impact and reimbursement analyses, all adaptable to country-specific conditions to reduce uncertainty and improve transparency. Tools are co-created with patients, developers, clinicians, and policymakers and will be tested and validated using three use cases representing high-impact areas of innovation: precision oncology medicines, cell and gene therapies, and next-generation sequencing tests. Results Outputs will include validated tools enabling improved evaluation of clinical benefit, cost-effectiveness, and financial sustainability, strengthening value-based decision-making across Europe. Innovative access- and outcome-based pricing strategies will support responsible innovation while encouraging fair reimbursement and improved budget control. Policy roadmaps will guide the adoption of equitable access models and support system-level implementation. Conclusions ASCERTAIN will provide a harmonized framework that balances cost control, innovation incentives, and patient-centered care. By facilitating consistent, evidence-based pricing and reimbursement decisions, the project supports fair and sustainable access to pIHTs across Europe, with continued multi-stakeholder collaboration driving its wider adoption and real-world impact. Public interest abstract Many lifesaving medical breakthroughs, like advanced cancer therapies and gene treatments, are becoming available, but not everyone in Europe can access them equally. Differences in healthcare funding and pricing decisions mean that patients in some countries wait much longer for the care they need. The ASCERTAIN project is working to change this. By bringing together patients, health technology developers, clinicians, and policymakers, the project is creating new tools to help health systems decide how to pay for cutting-edge technologies in a fair and affordable way. These tools also make sure that these technologies are paid for based on how well they work for patients in real life. By improving transparency and reducing financial pressure on health services, ASCERTAIN aims to ensure that people across Europe benefit from innovative technologies sooner, supporting healthier lives and a more sustainable future for healthcare.