Managed Entry Agreements
Managed Entry Agreements
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Managed entry agreements (MEAs) describe a range of mechanisms by which pharmaceutical firms and payers share some of the financial and clinical risk associated with the introduction of a new medicine.
Publisher: Datamonitor Healthcare
- Description
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Managed entry agreements (MEAs) describe a range of mechanisms by which pharmaceutical firms and payers share some of the financial and clinical risk associated with the introduction of a new medicine. When facing squeezed budgets, payers demand proof of superior outcomes at the lowest possible cost, but since neither they nor the manufacturers want to restrict access to new treatments, MEAs – including coverage-with-evidence development set-ups, pay-for-performance deals, or simply price-volume agreements or discounts – have multiplied, especially in Europe. Most are discount-only or price-volume deals, and do not directly help determine a drug’s value. This analysis focuses primarily on outcomes-based MEAs, which are far trickier to design and execute but which generate evidence of a treatment’s real-world effectiveness. Drug firms seeking an alternative to deep discounting and payers seeking value for money should heed the lessons learned from current and past outcomes-based MEAs.
Table of Contents
5 EXECUTIVE SUMMARY
5 Risk-sharing deals: the past and the present
5 Lessons from key case studies
5 Measuring outcomes: will this hurdle lower?
6 The future MEA landscape
7 RISK-SHARING DEALS: THE PAST AND THE PRESENT
9 Bibliography
10 LESSONS FROM KEY CASE STUDIES
12 Case study 1: Johnson & Johnson’s Velcade Response Scheme
13 Case study 2: fixed-per-patient price – Iressa in oncology
15 Case study 3: try before you buy – Cimzia in rheumatoid arthritis
15 Case study 4: Revlimid deal piggybacks on pharmacovigilance set-up
16 Case study 5: beware the complexity of long-term efficacy data – the multiple sclerosis riskshare
17 Case study 6: proactive pharma-payer engagement – Xolair in asthma
18 Case study 7: can Xolair improve the Netherlands’ experience of risk-shares?
19 Case study 8: no response, no pay – Esbriet in idiopathic pulmonary fibrosis in Italy
20 Case study 9: signaling more risk-shares in Spain – ChondroCelect
21 Case study 10: outcomes rule in the US – was Merck-Cigna deal ahead of its time?
23 Bibliography
27 MEASURING OUTCOMES: WILL THIS HURDLE LOWER?
27 Improved data systems necessary, but not sufficient
27 PASLU resistance to MEAs looks set to remain
28 Italy redesigns registries for outcomes
29 Catalonia claims existing data systems fit new outcomes policy
30 Sweden shuns outcomes-based deals for simplicity’s sake
30 US government boosts healthcare IT
30 Bibliography
33 THE FUTURE MEA LANDSCAPE
33 Broader healthcare trends point to more outcomes-based MEAs
33 US healthcare landscape’s focus shifting to outcomes so deals may follow
34 Some pharma warming to MEAs, if only to avoid discounts
36 Bibliography
37 APPENDIX
37 About the author
37 Scope
37 Methodology
LIST OF TABLES
7 Table 1: Drivers and hurdles for outcomes-based MEAs
10 Table 2: Summary of key general takeaways for pharma from past and current MEAs
11 Table 3: Summary of selected geographical outcomes-based MEAs and takeaways
Table 1: Drivers and hurdles for outcomes-based MEAs
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