Review and reimbursement: A special case for better co-operation
29-30th September 2009, Surrey, UK
The current dynamics of bringing new medicines to market are influenced by potential conflicts between the agendas of three important stakeholders: the pharmaceutical industry, regulators and payers. Regulators are under pressure to develop methods to speed the approval process through novel mechanisms such as conditional licensing, while maintaining an emphasis on safety, quality and efficacy. By contrast, there is an increasing pressure on payers to control spiralling healthcare costs via the assessment and practical application of clinical and cost-effectiveness. While, historically, the regulatory review and the consideration of products for listing and reimbursement by healthcare providers (health technology assessment – HTA) have been kept as separate exercises, the current approaches to drug development make a special case in which better cooperation and coordination of activities could be of significant benefit in making safe and effective new medicines available to patients in a timely and cost effective manner.
This workshop was jointly developed by the Institute and the Office of Health Economics, UK, to specifically address the related issues of overlap in activities between regulation and HTAs and the potential for mismatch of outcomes. It focused in particular on how consultation and cooperation has the potential to improve the process of bringing a new medicine to market for all three stakeholders.