Integrative Review of Managed Entry Agreements: Chances and Limitations

Abstract

Introduction: Managed Entry Agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high-and middle-income countries. Methods: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior level co-authors including key South American markets. Afterall, involved senior level decision makers and advisers providing guidance on potential advantages and disadvantages of MEAs and ways forward. Results: 25 studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%), and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. Conclusion: We are likely to see a growth in MEAs with the continual launch of new high priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome based MEAs could be an important tool to improve access to new innovative medicines there are critical issues to address. Comparing knowledge, experiences and practices across countries is crucial to guide high-and middle-income countries when designing their future MEAs.

The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy

“…The literature about challenges with MEA in different jurisdictions is relatively large ( Stafinski et al, 2010 ; Puig-Peiró et al, 2011 ; Wonder et al, 2012 ; Ferrario and Kanavos, 2013 ; Ferrario and Kanavos, 2015 ; Ferrario et al, 2017 ; Kanavos et al, 2017 ; Breccia et al, 2020 ; Zampiroli Dias et al, 2020) but there is a lack of published information about the factors that contribute to successful MEA systems and the constructs of MEA for individual products. Confidentiality clauses often drive the absence of published data in many countries ( Stafinski et al, 2010 ; Wonder et al, 2012 ), however there is important information about the constructs of MEA that could be shared, including core data sets and aggregated analyses. Hence AIFA has an important opportunity to continue its new program of publishing reports of its closed registries and reflecting on the lessons learnt in the Italian context.…”

Revision of Ireland’s Cost-Effectiveness Threshold: New State-Industry Drug Pricing Deal Should Adequately Reflect Opportunity Costs

“…Furthermore, this cost-effectiveness summary information is only published for those interventions subject to a full assessment by the NCPE, not those solely subject to the Rapid Review pathway [ 6 ]. Further transparency concerns arise when we consider the potential application of managed-entry agreements that may condition aspects of reimbursement with price-volume agreements, budget caps or agreements based on observed treatment effectiveness [ 47 ]. Such mechanisms may make it uncertain what the effective price per QALY achieved is, even to those privy to confidential pricing information.…”

Efficacy, Safety, and Economics of Innovative Medicines: The Role of Multi-Criteria Decision Analysis and Managed Entry Agreements in Practice and Policy

“…Nevertheless, a recent study brings to attention that the increased availability of innovative medicines is in line with the increased number of MEA, giving real-world evidence from around the globe ( 61 ).…”