Building HTA insights into the drug development plan: Current approaches to seeking early scientific advice from HTA agencies

Abstract

There is a growing trend for pharmaceutical companies to seek scientific advice on drug development from a Health Technology Assessment (HTA) perspective, to improve the efficiency of their studies, enable better trial design, and support the goals of positive HTA recommendation for reimbursement. This study uses information collected directly from companies on individual products to assess their strategies and practices for seeking HTA-related scientific advice in terms of which stakeholders to engage and for what purpose, when to seek scientific advice, and whether to implement that advice within global clinical development.

Keywords: Drug development; Early scientific advice; Health Technology Assessment; Parallel scientific advice; Regulator; Reimbursement.