March 2009 Workshop

The current dynamics of bringing new medicines to market are being influenced by conflicts between the agendas of regulators and payers. Historically the regulatory review and the consideration of products for listing and reimbursement by health care providers have been kept as separate exercises. The current situation makes a special case in which better cooperation and coordination of activities could be of significant benefit in making new medicines available to patients.  This Workshop will be will be based on the Workshop held in the UK in 2009, but with a focus on developing the themes raised so as to contribute to the ongoing discussions in the US.

This Workshop will discuss

·         Improving efficiency of requirements: by identifying areas of overlap between the activities of HTA and the FDA in drug assessment and to discuss mechanisms by which dialogue and information sharing may minimise duplication.

·         Identifying mechanisms to mitigate the risk of mismatch of outcomes that can occur when the FDA grants accelerated approvals that are not compatible with current HTA requirements.

·         Developing a white paper: the recommendations of the Workshop and supporting survey will be used to create a white paper that addresses the implications of changing the current model of keeping scientific review separate from discussions of pricing in order to achieve greater efficiency of process and predictability of outcome.