Review and reimbursement: Aligning the needs and requirements in clinical development
23rd-24th March 2010, Washington DC, USA
The current dynamics of bringing new medicines to market are being influenced by conflicts between the agendas of regulators and payers. Regulators are under pressure to develop methods to speed the approval process, including mechanisms such as accelerated approvals, 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 of clinical and cost-effectiveness. The two processes of licensing and reimbursement continue to add uncertainty to drug development decisions as market approval does not necessarily mean that the product will be reimbursed. While, historically the regulatory review and the consideration of products for formulary listing and reimbursement by healthcare providers (health technology assessment – HTA) have been entirely separate, the current dialogue around comparative effectiveness research (CER) may lead to a closer alignment among the two approaches.
This Workshop was developed to specifically address the related issues of overlap and/or differences in requirements between licensing, HTA, formulary listing and reimbursement, and the potential for mismatch of outcomes, in the multi-payer healthcare system of the US. The current Workshop follows the Institute’s September 2009 Workshop, Review and Reimbursement: a special case for better cooperation, that focussed on the single- payer systems of Australia, Canada, Europe and Switzerland. At the September Workshop, the implications of the current experiments into information sharing, alignment of technical requirements and even joint scientific advice being offered by regulatory authorities and HTA agencies was explored.
Workshop objectives
- Improve efficiency of global development: by identifying areas of overlap between the evidence requirements of HTAs and the regulatory authorities in drug assessment and by discussing mechanisms by which dialogue and information sharing may minimise duplication or divergent requirements.
- Improve the predictability of outcomes: by identifying mechanisms to mitigate the risk of mismatch of outcomes that can occur when a regulatory authority grants an approval that is not compatible with current HTA requirements.
- Develop a white paper: the recommendations of the two Workshops and the supporting survey will be used to create a white paper that addresses the global implications of changes to the current model of separate regulatory and HTA reviews by aligning the evidence needs and requirements for licensure with those of the HTA evaluator in order to achieve greater efficiency of process and predictability of outcome.