Innovazione e innovatività: definizione e strumenti, applicazioni ed esperienze

Abstract

Reference to ‘innovation’ in the pharmaceutical context has been applied in different settings and by several authors in these last years. All of them had as main scope to improve the methodology (or reduce discreptionality) in decision making. They reported and discussed methods for selecting and prioritizing their development speeding up the R&D process (fast track, innovation path), valuing the drug in comparison to the current therapies (added value) and/or accelerate the access of patients in a reimbursed environment.

The impact generated by the adoption of different methodologies makes the “methodological issue” appealing for HTA agencies, regulators and manufacturers (all of them in clear “conflict of interest” with respect to use of the definition) and seems at the basis of the recent proliferation of several different definitions and processes. Despite these dishomogeneity the core of the evaluations is still represented by the concept of ‘relative therapeutic added value’ and is driven by the choice of comparator or standard of care. A wider approach to ‘pharmaceutical innovation’ should be addressed, trying to match public and private expectations in priority setting for R&D programs, in selecting and weighting the relevant value dimension of new health technologies, managing the issue of how each potential innovation could impact on the sustainability framework and on the social expectation of the society.