MANAGED ENTRY AGREEMENTS IN THE ITALIAN MARKET BETWEEN JUNE 2005 AND JUNE 2015
Author(s)
Tettamanti A, Urbinati D, Noble M
IMS Health, Milano, Italy
Presentation Documents
OBJECTIVES: Managed entry agreements (MEAs) are vital to access the Italian Market. MEAs, monitored by an AIFA registry, are divided into outcome based (cost-sharing) and non-outcome based (risk-sharing and payment by results) agreements. The objective is to understand the MEA adoption, evolution and utilization variability among Therapeutic Areas and Antineoplastic Drugs. METHODS: The desk-based research was carried out by integrating different information sources, from AIFA and Gazzette Ufficiali to Regional HTA studies. Data were gathered for all the 82 products/indications belonging to an open registry associated to a MEA since June 2005 up until April 2015. RESULTS: Sixty six % products/indications have an outcome based MEA, 32% a non-outcome based and 2% both. A third of outcome based and a quarter of non-outcome based MEAs have an additional volume agreement or spending cap. A maximum peak of 30 products/indications with MEA is recorded in 2014, compared to an annual average of 8. In 2006-2007 cost-sharingMEAs were predominantly adopted; in 2008-2011, outcome based MEAs were negotiated in approximately half of the cases (57%), becoming since 2012, the preferred conditional reimbursement scheme (78%). Focusing on Antineoplastic products, Leukemia drugs have only non-outcome based agreements, Lymphoma, Melanoma, Breast, Colorectal and Ovary Cancer drugs have a prevalence of outcome based, whereas Renal Cell and Lung Cancer drugs have both. CONCLUSIONS: Throughout the years there has been an increase in the adoption of a MEAs as they are considered a valuable strategy to manage payer budget impact and drug clinical benefit uncertainties. Since their introduction, the choice of MEA schemes adopted has witnessed an evolution, with an increasing preference for outcome based MEAs, though often applied together with additional financial saving schemes. Due to the model adoption variability of MEAs within the Therapeutic Areas, the study of their structure plays a key role in accessing the Italian Market.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PHP220
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy, Risk-sharing Approaches
Disease
Multiple Diseases