What Are Managed Entry Agreements

Managing multiple agreements in a health care system or beyond health care providers could be untenable for the payer/supplier or manufacturer. Once an agreement is reached in a hospital, others may require identical or different agreements, which would increase the burden on the manufacturer. However, if the supplier operates multiple systems for different products, this can cause confusion. Overall, the pros and cons of MEAs differ among stakeholders, as shown in Table 2. Cooperation between the manufacturer and the payer requires early cooperation on the form and details of the MEA. It is necessary to set up electronic medical records or data management systems to evaluate the data generated. If necessary, there must be a good research policy, including consideration of patient issues, such as data protection and informed consent. These agreements must be time-limited, while respecting a pre-agreed timetable to assess whether the concerns or problems concerned have been resolved, including the need to provide robust surveillance data (Reference Frénsdal, Facey and Klemp8). When an agreement is reached to address uncertainties in the clinical and/or cost-effectiveness (DCE) relationship, all stakeholders should be involved in the development of clear protocols, with well-defined research questions and definitions, on the results to be measured and on how to measure them.

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. At present, many people remain concerned about standards of evidence for adaptive products (Ermisch et al., 2016; Vella Bonanno et al., 2017). This is a key challenge that needs to be addressed. In the end, patients` access to medicines in the European environment will only be achieved once the products have followed the pricing and reimbursement procedures in the different countries. Without the assistance of HTA bodies and payers in these countries, the introduction of adaptive pathways and viable models for results-based entry-level agreements may be limited. 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.

– the complexity of results-based agreements could be mitigated by the use of existing data infrastructure to avoid long periods of study, and by the use of simple outcome measures (e.g. B dropout time, hospitalization) easier to follow in clinical practice; In Australia, a number of controlled access agreements have been developed to allow national coverage of new drugs.