In Sweden, the two DECs discussed above allowed the payer to collect evidence that allowed the actual cost-effectiveness of the drugs concerned to be reassessed and final decisions on reimbursement and price to be made. As a result of these decisions, the drugs were funded without any other AMA. The aim of this discussion paper is to contribute to the general debate on market access schemes, based on information published by competent national cost recipients in Europe. We used a review paper written by public health beneficiaries to identify the European Union countries in which the MAA was implemented (United Kingdom, France, Italy and Denmark) [3]. This document was chosen because it was a literary critique supplemented by unpublished references or “grey literature” known to 16 European co-authors, mainly health authorities and health insurance staff, who evaluate and implement such systems [3]. For the purposes of this document, we excluded price volume agreements and market capitalizations, as well as systems that were directly intended for customer awareness/marketing campaigns and not maa with health authorities (i.e. the “140-90” initiative for Novartis`s valsartan [4] and the Bayer system for vardenafil [5] in Denmark). In addition, we found through personal communication that MAA was launched in Sweden [6]. That is why we are on the websites of the national control and reimbursement authorities in Great Britain (England and Wales) (National Institute for Health and Clinical Excellence (NICE) and Department of Health (DoH), Italy (Agenzia Italiana del Farmaco (AIFA), France (High Health Authority (HAS)) and Sweden (The Dental and Pharmaceutical Benefits Agency (TLV)) containing the following keywords: “risk sharing,” “patient access,” “conditional/refund coverage,” “result guarantee,” “observation study” or “payment by benefit.” Non-English documents and sites have been translated by native speakers.

For recovered documents, we have tried to identify additional information in general web resources, and we offer a reference for each. All searches were conducted between September and December 2010. As this document is a “debate message,” we have not used the standard method for literary review and research has been done by an author. However, both authors were independently involved in the analysis and abstraction of the data. Fojo, T., and Lo, A. W. (2016). The price, value and cost of cancer drugs. Lancet Oncol.

17, 3-5. doi: 10.1016/S1470-2045 (15)00564-1 Pauwels, K., Huys, I., Casteels, M., and Simoens, p. (2016). Industry perspectives for access to innovative drug markets: relevance for oncology drugs. Up front. Mr. Pharmacol. 7:144. doi: 10.3389/fphar.2016.00144 Both countries have gained experience in market access agreements, but their practical application has changed dramatically over time. AIFA began primarily with financial contracts and then moved to results-based systems, whereas in recent years DH has only agreed to financially-based systems.

The English NHS seems to have opted for a minimization of the costs of its management, the simplicity of the systems that predominate over the additional clinical information that could be collected by PAS. However, the Italian NHS insisted on investing in performance-based MEAs, despite the lack of clinical added value. Apart from the above MAA developed as part of the NICE drug evaluation process, the British DoH in 2002 developed a MAA for interferons β and glatiramer in the treatment of multiple sclerosis (SS).

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