EXPERT VIEW: Strengthening market access through insight-driven real-world evidence

Growing demand for access to health care alongside advances in science and technology has led to heightened scrutiny of whether or not new medicines provide clinical, economic and patient value, writes Louise Parmenter, global head of operations, Epidemiology and Outcomes Research, Real-World and Late Phase Research, and Anke van Engen, senior consulting director, Practice Leader HTA Solutions at contract research organization Quintiles.

Health Technology Assessment (HTA) is now a common step in a new medicine being made available for patients. Globally there are over 100 HTA agencies, and their role in informing reimbursement and their evidentiary needs continue to evolve.

Real-world evidence (RWE) is increasingly requested by HTA agencies to supplement clinical trials and demonstrate how a product is likely to perform when prescribed to patients. For example, in 2012, the US Food and Drug Administration used evidence from three claims database studies and a randomized controlled trial to expand the indication for Actemra (tocilizumab) – a medicine used to treat rheumatoid arthritis.