Interviews showed that in 2006-2016, results-based management agreements were not frequently used for drugs with conditional marketing authorization or were authorised in exceptional circumstances in Europe. These products may have been a natural case study for a results-based agreement on a managed market entry contract, as additional data are needed to refine the benefit-risk ratio after the initial licence is granted. MEA, Managed Entry Agreement; HTA, health technology assessment. – Financial agreements are easier to implement, but miss the opportunity to use evidence generated after approval. A possible agreement could combine financial components with a hovering, taking into account the results of new discoveries from TTS, observational studies, registries or electronic medical records; – regardless of the model used, it would be possible to harmonize stakeholder expectations by looking forward to all the potential results of the data generativeness plan and by clearly defining, at the beginning of the managed market entry agreement, the impact this will have on the state of prices and product coverage for the various scenarios. 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. According to the EMA definition, the adaptive approach is a scientific approach to drug development, which aims to facilitate patients` access to promising drugs that sustainably address needs not met by a prospective approach. This review examines the results of the ADAPT-SMART consortium`s activities in identifying facilitators and studying the adequacy of managed entry-level agreements for adaptive route products in Europe. We found that in 2006-2016, results-based cash entry agreements were not frequently used for products with conditional marketing authorization or approved in exceptional circumstances. Barriers and opportunities to develop practical models for managed access agreements for adaptive route products were discussed in interviews and a multi-party workshop, along with a series of recommendations contained in this document. 3IMI ADAPT SMART workshop – Introduced managed in the context of adaptive trails (London, 5 July 2016) Brief workshop report.
Available on adaptsmart.eu/wp-content/uploads/2016/02/ADAPT-SMART-Managed-entry-short-WS-report.pdf For a payer, the success of a results-based agreement is determined by its ability to reduce uncertainty about the (cost) effectiveness of a product, reduce budgetary impact, improve the efficient use of a product or combine a combination of it. In addition, in light of the new evidence, the reversal of a refund decision must be feasible in practice. During the talks, HTA bodies and payers expressed their reluctance to conclude results-based agreements due to the complexity and lack of easily accessible administrative infrastructure in most countries, which would facilitate their implementation (Table 1).1).