Prezzi di riferimento per dispositivi medici: criticità, vantaggi e approcci

Chapter 15 aims at presenting definitions and examples of reference pricing for medical technologies, and critically discussing their application to the medical device sector in Italy, also in light of the ongoing debate on medical technologies’ value. To this purpose, we present an overview of the models developed in recent years, mainly in the United States, for measuring different dimensions of value, so-called value-based frameworks. The research was carried out through a review of the scientific and grey literature. The chapter then moves on to illustrate the origins of reference pricing introduced to set homogeneous reimbursement prices, often for pharmaceuticals products, able to spur competition within the reference market and grant patient’s freedom of choice subject to co-payment if a difference between the selected technology’s price and the reference price exists. In Italy, reference pricing for medical devices were introduced as a cost containment policy or a reimbursement system rather than a pricing system, as it sets the maximum reimbursement level, with no patient’s freedom of choice or co-payment allowed. Value-based frameworks for medical devices might contribute to the definition of reference markets and reference prices. Although value-based frameworks for medical devices are currently under development and implementation, they represent a positive example of multi-stakeholder (e.g., clinicians, patients, policy makers, manufacturers, academia and research institutions) involvement in the evaluation of medical technologies’ value dimensions.