Optimizing time to access: creating structure in the dynamic European Health Technology Assessment of oncology drugs

On average, it takes 559 days from marketing authorisation to patient access for oncological drugs. This thesis of Sharon Wolters explores how the evaluation of oncology drugs can be optimized with the aim of shortening the time needed for issuing reimbursement recommendations, thereby improving equity across Europe. Four main recommendations are proposed:

• Be prepared: All stakeholders involved should be aware of the evidence requirements when designing clinical trials and seek early scientific advice. Staying informed about methodological developments is essential.
• Collaborate: Effective collaboration between regulatory authorities and HTA bodies through information sharing and parallel assessments is crucial. Collaborations with health technology developers to address challenges together are needed. Including patients and healthcare providers to better understand the medical need and clinical relevance provides valuable insights.
• Streamline processes: Prevent duplication by streamlining processes and clarifying and aligning evidence requirements where possible. The established evidentiary requirements should be periodically reviewed. For economic analyses, the development of standardized economic models with broad stakeholder input may help strike the right balance between accuracy and complexity.
• Acknowledge uncertainty: Early discussions on managed entry agreements and conditional approval reimbursement pathways, followed by real-world evidence collection, can help mitigate initial uncertainties.

Conclusion

The time to patient access to oncology medications can be shortened. With timely and thorough preparation, effective collaboration, streamlined clinical and economic assessment processes, and acknowledging some degree of uncertainty, the time needed for issuing reimbursement recommendations can be shortened, thereby improving equity across Europe.