Risk-Sharing Agreements Pharma

Garattini L, Motterlini N, Cornago D: Price and distribution margins of patented medicines in pharmacies: A comparison in seven European countries. Health policy. 2008, 85: 305-13. 10.1016/j.healthpol.2007.08.005. One of the conclusions of the economic crisis was that many countries quickly implemented a multitude of cost-control strategies to reduce pharmaceutical spending [1]. These cost control strategies have been more reactive than proactive responses to the crisis and are aimed at reducing the upfront costs of new drugs [1]. Cost reduction has been tempted by the introduction of international benchmark prices (PRIs), price reductions, mandatory rebates, the promotion of generic drugs, an increase in co-payments, a more centralized public procurement system and, finally, a reduction in the scope by excluding certain drugs from reimbursement [1]. For the most part, the 2008 economic crisis contributed to catalyzing the implementation of BPVs. The new Pharmaceutical Price Regulation Scheme (PPRS), adopted in the United Kingdom, officially introduced the PAS in 2009 as part of its legal framework and made a significant change to the UK price and refund framework [ 33]. The United Kingdom has encouraged its NHS to take into account the social value of medical treatment in order to solve the problem of injustice and promote innovation and focus on under-represented patient groups [34]. Similarly, in 2011, Germany approved the Pharmaceutical Market Sanitation Act (AMNOG), which made it mandatory to reimburse an early performance assessment.

This can be considered a formal switch to VBP [35]. The political changes in the pricing and repayment practices of these two countries marked the end of the era of free pricing in some of Europe`s largest markets [36]. Current rules to limit the increase in pharmaceutical spending, to guarantee health gains in finite budgets, or both, include limiting the „off-label” prescription and prescribing outside identified subpopulations where the value of technology is most important. These include price volume agreements (VAPs), patient access systems that typically provide free drugs for a period of time, „evidence development coverage” systems, and payment of results systems based on results achieved in practice. These latter systems are also called results-related contracts, efficiency objectives or efficiency guarantee systems [13, 19-22, 24-35].

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