Innovative Medicines And Market Access Agreements

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Access to new medicines is essential for their manufacturers. The reason is that the high price itself might not directly generate high revenues: the volume of sales could be significantly reduced if an expensive drug was examined by health care recipients and the reimbursement was denied or was not recommended for use in the Health Technology Assessment (HTA). While cost-benefit analysis is primarily used to support decision-making in the UK or Sweden, other countries (such as France or Germany) might talk more about „economic use of resources“ than a specific mode of analysis [1]. Many innovative agreements – often initiated by the pharmaceutical industry – can potentially be used to ensure that hospitals get the best value for money, lose risk uncertainties by gathering evidence of real value and/or reducing the budgetary impact of buying innovative therapy. We have divided these innovative agreements into 3 „archetypes“ to highlight differences from traditional agreements (see Table 1). Jommi C: central and regional policy that affects access to the drug market in Italy. 2010, Bocconi University Other examples of MAA, which we identified in Italy, were indicated for drugs indicated in chronic angina (ivabradine) [17] and type 2 diabetes (sitagliptin, vilagliptin and exenatide) [14, 18]. These provisional MAAs have been set up to monitor practical use, collect epidemiological data as well as new efficacy and safety data for the rehabilitation of prices and/or conditions of reimbursement of medicines by the Italian Agency. The systems were carried out by limiting treatment induction to specialized centres, monitoring clinical practices, adverse events and withdrawal due to treatment failure [19]. The Italian AIFA announced that, according to an analysis of patient registries that were part of the P4P and CA agreements for expensive cancer drugs, it would reduce its list price by 30 to 40% in 2011 [47]. Although a price review was adopted at the introduction of these P4P systems, they were not designed to address uncertainty about the efficacy (costs) of drugs and it is unlikely that the registration data will have sufficient quality to provide more robust estimates than those available at the time of the introduction of the drugs. Payers are in favour of innovative price agreements.

The challenge is to find new ways to pricing and awarding innovative drug contracts, particularly in oncology and rare diseases, that benefit health outcomes, innovation and sustainability of the health system, while meeting the direct needs of stakeholders. Towse A: value-based pricing, research and development and patient access systems. Will the UK do it right or wrong?. Br J Clin Pharmacol. 70: 360-366. In a recent review paper, European payers distinguished two types of agreements: financial and payment means [3]. We felt that there had been little discussion among European health care consumers about the motivations they had for implementing different types of systems in their respective countries and the impact this could have on prices in EU Member States.

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