Mapping an emerging framework for regenerative medicine reimbursement

The development of regenerative medicines (RMs) carry substantial risks for companies because production costs are often large and products are yet to show effective long-term results. A broad examination of published literature in the field of RM shows there is a growing discussion about policies that aim to encourage the development of RMs through risk-sharing policies. Interviews with numerous organisations in the field of RM showed that trade associations are the most active in considering ways to structure financial reimbursement for the RM industry.

What background and points are discussed?

The authors’ analysis of RM literature shows a growing number of publications on the topic of RM reimbursement and “risk-sharing” policies. Additionally, their work sheds light on who the contributors are, who the audiences are, where publications and authors are from geographically, and where texts are being published. The US had the highest average number of texts per month discussing RM reimbursement for 2015 (416). The next four countries were Japan(239), Germany(237), France(188), the UK(183) and South Korea(56). The authors found that most of the publications appeared in academic journals rather than books, chapters, dissertations or other texts. The literature on RM reimbursement was primarily directed at clinical audiences (46%), followed by social and human sciences (28%), business (10%), economics (8%) and others. Data show that RM literature is widely spread among different journals and publishers. To better understand the current climate and dynamics of the RM reimbursement discussions, the authors interviewed 43 different organisations and stakeholders (national agencies, service providers, trade associations, funding bodies, research institutions, consultancy companies, and others). Of all the interviewees, trade associations appeared to be the most involved and knowledgeable on issues surrounding RM reimbursement. The general message the authors received from trade associations was that there needs to be better collaboration between government agencies and the primary health care agencies in the UK (specifically NICE and the NHS) to reduce the time and costs of developing RM products. The assessment, evaluation and value of RM treatments with a curative nature is another topic also discussed, including calls for greater use of data obtained outside of randomised clinical trials. There was also some interest by trade associations to change the current reimbursement and incentive methodologies, such as establishing government funding initiatives, but associations primarily emphasised better collaboration.