MANAGED ENTRY AGREEMENTS- PORTUGUESE EXPERIENCE

Author(s)

Gonçalves L, Teixeira M, Caldeira S, Ramos R
INFARMED, I.P., Lisbon, Portugal

OBJECTIVES:   Managed Entry Agreements (MEA) are well established mechanisms for managing the uncertainty around the clinical evidence, eligible patient population, cost-effectiveness and budget cap. Building on this experience, this research aimed to characterise the several MEA applied in the Portuguese Health Technology Assessment System (SiNATS) and monitored by INFARMED, I.P., namely describe their main objectives, instruments, benefits and the criteria underlying its implementation. Simultaneously, this study intended to describe utilization variability among Therapeutic Areas. METHODS:   The analysis begins by identifying the positive decisions of medicines reimbursement by National Health Service (NHS), in both inpatient and outpatient settings, and for which there was MEAs approved between 2005 and 2015. Following, we classified the MEAs, based on the European Taxonomy defined by Ferrario & Kanavos (2013). RESULTS:   Research indicated that Portugal focused on MEA that are financial schemes, performance-based agreements (recently implemented) or both. In the study period it was celebrated more than 140 MEAs (more than 80 MEAs approved between 2010 and 2015), of which approximately 60% were for inpatient setting and 40% were for outpatient setting. In inpatient setting more than 40% of MEAs are antineoplastic and immunomodulating agents while in outpatient setting about 30% of MEAs are from nervous system group. To date, the MEA instrument most used is the price-volume agreement (PVA), followed up by outcome-guarantee and coverage with evidence development (CED) agreements. CONCLUSIONS:   This study confirmed that a variety of MEAs were increasingly used in Portugal to manage aspects of uncertainty associated with the introduction of medicines in the NHS. Therefore, MEAs represent a valuable strategic tool for overcoming these challenges and ensuring the sustainability of NHS.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PHP341

Topic

Health Policy & Regulatory

Topic Subcategory

Risk-sharing Approaches

Disease

Multiple Diseases

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×