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Managed Entry Agreements Italy

van de Vooren, K., Curto, A., Freemantle, N., and Garattini, L. (2015). Market access agreements for anti-cancer drugs. J. R. Soc. Med. 108, 166-170 doi: 10.1177/0141076814559626 Managed Entry Agreements (MEAS) are agreements between companies and healthcare organizations that allow the coverage of new medicines while facing uncertainty about their financial implications or benefits. Financial agreements are used in at least two-thirds of OECD countries and EU Member States. Many of these countries also use performance-based agreements that condition coverage, payments to companies, or discounts paid by companies on product performance, but these MEAs are less prevalent. With the support of the European Commission, the OECD has reviewed countries` experience so far with ITA on a performance basis to identify best practices and ways to improve the use of these agreements in the future. Toumi, M., Jaroslawski, S., Sawada, T., and Kornfeld, Å. (2017).

The use of surrogate and patient assessment points in outcome-based market access agreements: ongoing discussion. Health Policy 15, 5-11 doi: 10.1007/s40258-016-0274-x Ferrario, A., and Kanavos, P. (2015). Managing uncertainty and high prices of new medicines: a comparative analysis of the use of entry-into-hand agreements in Belgium, England, the Netherlands and Sweden. Ploughshare. Sci. Med. 124, 39-47 doi: 10.1016/j.socscimed.2014.11.003 Morel, T., Arickx, F., Befrits, G., Siviero, P., van der Meijden, C., Xoxi, E., et al. (2013). Reconciling uncertainty about costs and outcomes with the need for access to orphan medicines: a comparative study of entry agreements managed in seven European countries. Orphanet J. Rare Dis.

8:198. doi: 10.1186/1750-1172-8-198 Despite the lack of evidence, the experience gained so far with performance-based agreements indicates a series of good practices. These cover four main themes: Pauwels, K. (2016). Financial agreements and defined benefit agreements: the Belgian experience. J. Pharm. Practi Politics.

8 (supply 1): O1. doi: 10.1186/2052-3211-8-S1-O1 Confidentiality of information on performance-based MEAs and interest in such informationThe number of countries where information is not confidential and which are interested in such information from other countries, based on interviews with experts from 12 OECD countries (1) using performance-based MEAs Managed Entry Agreement.- Published: The information is readily available in the public domain (z.B. on the Internet).- Unpublished: The information is not in the public domain, but is not confidential and can be transmitted to 3 parties upon request.1. Australia, Belgium, Czech Republic, Estonia, France, Hungary, Italy, Korea, Lithuania, Netherlands, Sweden, United Kingdom (England only) – Information on Australia relates only to ad hoc agreements. The information for England relates only to managed access agreements (31 agreements under the Cancer Drugs Fund and 4 for other OECD-controlled diseases) that are publicly available; No to other patient access systems. Source: Authors of the study based on interviews with OECD experts. It is difficult to assess the extent to which performance-based MEAS have been successful so far. Few countries have formally evaluated their experience. The confidentiality of agreements remains an obstacle to independent evaluation and little evidence is public.

However, information from expert interviews and previous studies indicates that coverage of Evidence Development Agreements (EDAs) has so far had a poor record in reducing uncertainty about drug performance. . . .