The Use of Managed Entry Agreement in National Reimbursement Decisions of New Drugs.
Author(s)
ABSTRACT WITHDRAWN
OBJECTIVES: Managed Entry Agreements (MEA, also called risk-sharing agreements) between pharmaceutical companies and payers are used to reduce the clinical uncertainty associated to innovative medicines (when full evidence on clinical benefit is not available) and to ensure the drug budgetary control. The aim of this study was to describe the use of MEAs in the reimbursement of new drugs in three European countries. METHODS: Review of publicly available data on MEA as part of the funding conditions of new drugs and new reimbursed indications for existing products was carried out for Italy, Spain and the UK. The type of MEA (i.e. whether if it is based on financial or clinical results) and group of drugs (e.g., orphan drugs, oncology drugs and others) was determined for each drug/indication. Simple discounts (e.g., simple patient access schemes based on confidential discounts established in the UK) were not considered. The analysis was carried out for all drugs commercialized between January 2015 and June 2020 in the included countries and for which MEAs were established at national level for pricing and reimbursement purposes. RESULTS: Between 2015 and 2020, 63, 60 and 34 MEAs were associated to the reimbursement of new drugs/indications in Italy, UK and Spain respectively. Financial MEAs were the most frequent type of agreement in Spain and Italy (77% and 75%), whilst outcomes-based agreements were more frequent in the UK, where 37 drugs included in the CDF were assumed to be reimbursed under a conditional evidence generation agreement. In fact, oncology drugs accounted for 62% of MEAs in the UK and just 32-35% in Spain and Italy. CONCLUSIONS: The use of MEA as part of pricing and reimbursement at national level has increased in the latest 5 years in Italy, Spain and the UK, with financial agreements being the most common.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PNS111
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes, Public Spending & National Health Expenditures, Reimbursement & Access Policy, Risk-sharing Approaches
Disease
No Specific Disease