Working Group on Pricing and Reimbursement
The key task of this Working Group was to examine pricing and reimbursement mechanisms to support Member States fulfilling their commitment towards the G10 recommendations, as well as towards the public health objectives of offering an equal access to medicines at an affordable overall cost.
Several factors have generated significant changes in the pricing and reimbursement mechanisms of most Member States during the last years: raising expenditure on medicines, inequity of access to medicines in Europe, the call for early access to innovative medicines. This Working Group aims to identify, explore and exchange alternative mechanisms that can help Member States answer these different challenges. It will be up to each Member State to see how to apply these mechanisms.
The Pricing and Reimbursement Working Group has developed and agreed on a number of documents :
Guiding principles for good practices implementing a pricing and reimbursement policy [23 KB]
With decisions on pricing and reimbursement of pharmaceuticals, Member States aim to achieve 3 overall objectives of (1) finding the optimal use of resources to maintain a sustainable financing of healthcare, (2) ensuring access to medicines for patients and (3) rewarding valuable innovation. Each Member State has its specific approach for balancing these 3 overall objectives. The guiding principles and ideas in the document aim to help Member States obtain such a balance, through implementation of national pricing and reimbursement practices.
Ensuring availability to medicines in small national markets in Europe [25 KB]
The issue of sustainable availability and delivery of medicines is in particular important for the smaller national markets, where some important medicines are not available. The production and supply of medicines is usually undertaken by economic operators (manufacturers, wholesalers and pharmacists) that are driven by economic incentives. This paper aims to understand these economic factors, and bring forward some potential solutions to ensure availability of supply. It should be noted that a parallel and separate effort is ongoing from a regulatory perspective, driven by the Heads of Medicines Agencies.
Improving access to orphan medicines for all affected EU citizens [40 KB]
Orphan medicines amplify the common tensions in the field of pricing and reimbursement: assessing and rewarding innovation is difficult, budget optimisation is challenged and access for patients is limited in several countries. In spite of many policy initiatives increasing the number of newly developed orphan medicines, many of these are not available for all EU citizens. This paper aims to identify the main bottlenecks not only related to (1) development, but also to (2) assessment, to (3) pricing and reimbursement practices by companies and by national authorities and to (4) awareness raising. Consequently this paper puts forward some ideas that should be seriously explored in order to ensure timely and equitable access for all EU citizens to orphan medicines.
Characterisation of the value of innovative medicines [34 KB]
This report is a bottom-up exercise, based on discussions and collection of views from the relevant Member State authorities on how to recognise, assess and reward valuable innovative medicines. However, it does not aim to identify and implement an EU-wide definition of "valuable innovation". This exercise identifies some common ground between individual Member States, in addition to setting out more different and optional views on what constitutes valuable innovation. This exercise covers valuable innovation in 3 main areas: (1) therapeutic/clinical benefits regarding the disease, (2) quality-of-life benefits for the patient and (3) broader socio-economic benefits.
From assessing innovative value of pharmaceuticals to pricing and reimbursement decisions [31 KB]
This paper aims to clarify how some European Member States use assessments of innovative medicines in their pricing and reimbursement decisions. Such decisions drive the expenditure for the authorities as well as the revenue for companies, the basic incentive for further research and development. Hence this paper aims to understand the mechanics behind the incentive for companies to risk investing in R&D. This information is valuable (1) for countries that in their pricing/reimbursement decisions refer to prices in Member States that assesses innovative medicines, to ensure an understanding of the rationale behind the reference price. Moreover, (2) it will benefit Member States that search for experiences and good practices to develop their own value-based pricing systems and (3) for pharmaceutical companies that need to know what revenue can be expected for the value of their medicines.
The Toolbox exercise [60 KB]
Member States increasingly look to the same range of practices to balance budgets with access and reward for innovation. Nevertheless there is need for more evidence of the benefits and risks of different practices. This increases the interest of the Member State participants in sharing their experiences and evidence on different practices. The aim of the toolbox exercise is therefore, for six selected practices, to collect expertise from Member States and stakeholders and to provide answers to questions like: real benefit(s), potential risks and interferences with other practices, driving factors of such risks or successes, practical set-up.
Risk-Sharing practices and Conditional Pricing of pharmaceuticals [27 KB]
An increasing number of Member States have set-up risk sharing practices and conditional pricing and reimbursement practices. These practices allow competent authorities and pharmaceutical companies to build clinical experience on medicines which might normally not be eligible for reimbursement. Such practices allow at the same time budget-control and the identification and reward of valuable innovative medicines. Furthermore, they provide access for patients to highly innovative treatments. This paper describes how these practices are set-up in different Member States and draw some common findings.
For more information about the G10 process, please consult the report "High level group on innovation and provision of medicines in the EU [503 KB] "