Real‑World Evidence (RWE) as a component of Health Technology Assessment (HTA) submissions for oncology therapies is playing an increasingly influential role in HTA decision‑making. As evidence requirements evolve, HTA bodies are looking more closely at how RWE can complement randomized clinical trials (RCTs) data, especially where RCTs are unfeasible or limited, and strengthen HTA decision making.

This white paper explores how HTA bodies across key markets are evolving their frameworks to incorporate broader evidence sources, and where expectations differ for the use of RWE in oncology submissions. Drawing on recent guidance, cross‑country HTA analyses, and real‑world case studies, it examines how RWE is being used in practice - particularly in external control arms, comparative effectiveness assessments, and economic modelling.

Crucially, the paper outlines how drug developers can maximise the impact of RWE through a strategic, proactive approach to its generation and use. It highlights common pitfalls, methodological challenges, and the factors that differentiate RWE submissions that influence HTA outcomes from those that fall short.

Whether you are planning an oncology HTA submission, designing an RWE strategy, or addressing evidence uncertainty in innovative or rare indications, this paper provides practical insights to help align evidence generation with evolving HTA and payer expectations.

Download the white paper to learn:

• How RWE is shaping oncology HTA decision‑making across major agencies
• How HTA bodies are adapting their frameworks to broader evidence sources
• When and how RWE adds the most value in oncology submissions
• How a proactive, strategic RWE approach can strengthen HTA outcomes