Impact of HTA (Health Technology Assessment) requirements on SMEs (Small and Medium sized Enterprises) in Europe

27.03.2012

Impact of HTA (Health Technology Assessment) requirements on SMEs (Small and Medium sized Enterprises) in Europe

To evaluate new treatments in a more systematic way, governments increasingly turn to health technology assestment (HTA). Information from HTA, such as clinical effectiveness and cost effectiveness, is used by authorities to take decisions on pricing and reimbursement. Anecdotal evidence indicated that SMEs in particular were finding it challenging to adjust to the increasing use of HTA as they strove to bring their products to the market and gain reimbursement.

In order to better understand how the use of HTA impacts SMEs' R&D efforts and market access opportunities, a survey was conducted by SFL Regulatory Affairs & Scientific Communication Ltd and EuropaBio. The survey looked at how European SMEs consider HTA throughout the different stages of drug development, from the pre-clinical phase through marketing authorisation and to the post-marketing stage. It also aimed to identify potential hurdles that SMEs face when dealing with HTA.