4Seat agreements administered in relation to drug adaptation pathways for patients. Final report November 2016. Available on adaptsmart.eu/wp-content/uploads/2016/12/CRA-MEA-in-the-context-of-MAPPs-Final-Report-16-December-2016-STC.pdf. Despite these challenges, there are also examples of a successful and comprehensive use of results-based entry-level agreements. Italy has invested in comprehensive data collection systems on pharmaceutical use in clinical practices facilitating post-market surveillance and in different types of payment models (Pani, 2016). Several payers stated in interviews that they were considering or had begun to use paid models (a subtype of a results-based market entry agreement) for certain products that have been introduced in recent years or have begun to use performance payment models (a subtype of the results-based entry agreement agreement). In interviews, producers indicated that they were willing to also consider the use of results-based agreements. Interviews showed that manufacturers appeared to be more interested in considering the use of results-based agreements than payers. However, European payers and HTA bodies have little appetite for the use of agreements that collect results data because of their complexity. It is expected that companies will participate, as part of an adaptive approach, in a joint scientific consultation process involving hTA regulators and regulators, which has already been done for some of the impilote products.
This process should lead to an integrated data generator plan, in which regulatory applications are supplemented by hTA applications. These applications would be implemented in relevant national instruments, such as cash entry agreements, in accordance with national procedures and guidelines, as pricing and reimbursement fall within national jurisdiction. The evidence in practice gathered after the first authorization would be used to supplement the initial marketing authorization requirements – without substituting – and to allow a better understanding of the optimal use of the product (for example. B understanding of subgroups of patients and responders) to maximize effects and minimize risk. The questionnaire responses were used to identify payers and HTA agencies that had experience with managed entry agreements for these products. In addition, the manufacturers who marketed these products were identified and invited to participate in semi-structured interviews that were used to answer the same questions as interviews with payers and HTA agencies. The results were presented during a one-day workshop in July 2016. About 30 people participated in the workshop and represented manufacturers, payers, HTA agencies, patient representatives, health professionals and academics. During the workshop, the implications of the results were reviewed and proposals were reviewed. The following section presents the results of the review, interviews and workshop discussions (Figure 11). 3IMI ADAPT SMART Workshop – Introduced managed in the context of adaptive trails (London, July 5, 2016) Brief workshop report. Available on adaptsmart.eu/wp-content/uploads/2016/02/ADAPT-SMART-Managed-entry-short-WS-report.pdf The first objective is to describe the current activities of the Agreement on Managed Entry Agreements (MEA) in the Middle East and North Africa (MENA), as well as the perception and use of these agreements by pharmaceutical decision-makers; The second objective is to describe the issues and reflect on the uncertainty associated with the implementation of AEDs and the future prospects of AED activities in the region.