Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future

Abstract

Objectives: The aim of this study is to conduct an analysis on the regulation and application of managed entry agreements (MEA) for oncology drugs across different European countries.Methods: Literature search and document analysis were performed between September 2015 and June 2016 to collect information on the regulatory framework and practice of MEA in Belgium, The Netherlands, Scotland, England and Wales, Sweden, Italy, Czech Republic and France. An overview of the content and typology of MEA applied for oncology drugs between 2008 and 2015 was generated based on publically available sources and contributions by national health authorities. Semi-structured interviews were conducted with representatives of national health authorities involved in the management or negotiation of MEA.Results: The application of MEA differs across countries and across different indications for the same drug. Financial based agreements are prevailing due to their simplicity compared to performance-based agreements. Performance-based agreements are less commonly applied in the European countries except for Italy. In the Netherlands, application of performance-based agreements was stopped due to their inability to deal with dynamics in the market, which is highly relevant for oncology drugs.Conclusions: MEA constitute a common policy tool that public payers in European countries use to ensure early access to highly priced oncology drugs. In light of strengths and weaknesses observed for MEA and the expected developments in the oncology area, the importance of MEA is likely to grow in the future.

Perspectives to mitigate payer uncertainty in health technology assessment of novel oncology drugs

“…It is important that we avoid unnecessary and obstructive complication of the HTA process. However, changes to the cancer treatment landscape, and the uncertainty about the risk-benefit profile of many new treatments, may necessitate alternative financing models, such as performance-linked, managed entry agreements [38]. Implementing performance-related schemes will require a broad spectrum of evidence from randomised controlled trials and post-licensing registry studies.…”

Impact of changes in the methodology of external price referencing on medicine prices: discrete-event simulation

“…The extent of discounts granted by industry to the payers, and thus the actual net prices are, as a rule, kept confidential in the MEA (14). This has an impact on other EPRapplying countries which, due to non-disclosure of discounts, have to refer to the officially published, thus higher, list prices for their EPR calculations (15,16).…”

Affordability of oncology drugs: accuracy of budget impact estimations

“…The accuracy of BI estimates for oncology is however unknown, potentially hampering decision-makers in considering the uncertainty in BI outcomes. Especially in the oncology field, various schemes have been implemented by decision-makers to manage affordability and BI, such as the Cancer Drug Fund in the UK, and various managed entry schemes frequently used for oncology drugs in, for example, Sweden, Belgium and Italy [19][20][21]. In order to provide more insight into this source of uncertainty and to allow for a better appraisal of BI, this study aims to quantify CONTACT Olaf H. Klungel o.h.klungel@uu.nl PO Box 80082, TB, Utrecht, 3508 The Netherland the accuracy of BI estimations using Dutch reimbursement decisions on oncology products as an example.…”