Managed Entry Agreements For Pharmaceuticals In The Context Of Adaptive Pathways In Europe

Of the 62% of respondents, 25% represented the public sector, the rest the pharmaceutical industry (pharmaceutical). Only 42% of participants said that MMAs were making their place in their institutions, with the majority representing Lebanon. All interviewees reported the use of financial agreements, most of which referred to “updated treatment” and, to a lesser extent, a “price volume agreement.” Financial agreements were either considered the only species of meA (71.4%) Reported. or use in results-based agreements (28.6%). Most participants assessed the challenges of identifying and measuring relevant data, as well as the lack of expertise in evaluating health economic data. The majority of respondents predicted increased use of AMEs to address budgetary impact while improving access to innovative care. Hoekman et al. (2015) found that, for products with an oncology indication, conditional marketing authorization tended to be used by supervisory authorities as a “rescue option” where the evidence provided was deemed insufficient to warrant a full marketing authorization (Hoekman et al., 2015). Such a “rescue option” clearly departs from the pre-programmed approach recommended as part of the adaptive approach. In addition, the HTA units and payers may have considered that the evidence provided for the marketing authorization of these products was not sufficient to assess the added value of the drug and may therefore have been reluctant to enter into complex results-based agreements in this context. In the context of publicly funded health systems in Europe, the availability and capacity of manufacturers, payers and health technology assessment agencies (HTAs) is a prerequisite for the proper functioning of your system. This has caused hesitation, especially in HTA bodies and paying agencies, as many fear having to pay for poorly tested but expensive treatments (Ermisch et al., 2016). At the same time, manufacturers are not clear as to how HTA positions and payers will evaluate the first data package for products in adaptive channels, and therefore there are uncertainties about possible price entry and management models.