Recent changes to the regulatory landscape of pharmaceuticals may require reimbursement authorities to issue guidance on technologies with an evidence base that is less mature than has previously been the case. The greater uncertainty regarding the clinical and cost-effectiveness of new technologies at the point of decision making in a Health Technology Assessment (HTA) translates into a larger risk to the health-care payer. Decision makers need to be aware of the magnitude of those risks and the potential to manage it through assessment of a broad range of decision options, including so-called Managed Entry Agreements (MEAs).
The aim of this work was to present an analytical framework that can both quantify the need for an MEA, and assess the value of different MEAs for their reduction in the risk to the payer.
Grimm, S.E., Strong, M., Brennan, A. et al. The HTA Risk Analysis Chart: Visualising the Need for and Potential Value of Managed Entry Agreements in Health Technology Assessment. PharmacoEconomics (2017) 35: 1287