On 14 February 2014, the London School of Economics and Political Science hosted a Summit to discuss Risk Sharing and Managed Entry Agreements (MEA). Programme Director, Panos Kanavos (Reader in International Health Policy and Development), brought together a diverse range of stakeholders from across Europe to consider current practice and the future of MEAs.
The European Medicine Agency’s (EMA) Road Map to 2015 was discussed as providing a Europe-wide impetus towards a ‘staggered approach’ to the licensing of products. Under this approach, which includes MEAs, initial approval is limited to a well-defined/restricted population until real-world data is available to support a broadening of the approved population. Such progressive licensing of products can mitigate the financial risks of adopting new products for healthcare systems, while still enabling access to treatment for the patients with the highest unmet need.
MEAs in Europe
Within the scope of MEAs, European countries have applied a number of different methods. In England and Wales, Belgium and Lithuania for example, ‘financially based’ mechanisms are typically utilised (for example price-volume agreements, discounts and rebates). Other countries may prefer ‘health based’ mechanisms (such as the Netherlands, Sweden and the Czech Republic), where registries and payment by results are more commonly used. Dr Paolo Siviero, Head of Economic Strategy and Pharma Policy at the Agenzia Italiana del Farmaco (AIFA), described how the Italian system uses a mixture of financial and health-based schemes. Dr Siviero also provided an overview on how improving information technology is enabling the development of a patient registry which will allow the constant production of real-world data from the Italian healthcare system as a whole, thus giving a complete overview of a disease and its treatment costs/efficacy.
Key learnings from the MS Risk Sharing Scheme
Jackie Palace, who leads the Multiple Sclerosis (MS) and Neuromyelitis Group at Oxford University, shared key learnings from the UK’s MS risk-sharing scheme, one of the more controversial and well known MEAs. The need to validate and improve MEAs continuously was highlighted as a particularly important lesson, as unexpected results and environmental changes can create a need to modify MEAs once they are set up.
Future prospects
MEAs were expected to continue to be used as a way to make financing work so that the right patients achieve access to the innovative treatments which they need. However, it was noted that not every access hurdle can be handled with an MEA. Tailoring of approaches to specific situations should include consideration of: the strength of clinical evidence, value for money and willingness to pay. It was also noted confidence in MEAs could be enhanced by giving the patient’s perspective greater prominence in the design and running of these schemes.