PCN394 DETERMINANTS OF MANAGED ENTRY AGREEMENTS IN THE CONTEXT OF HTA; EMPIRICAL EVIDENCE FROM ONCOLOGY MEDICINES IN FOUR COUNTRIES.

Abstract

Managed Entry Agreements (MEAs) are increasingly used in HTA to address decision-making uncertainties due to immature evidence submitted by manufacturers. Literature has suggested that countries implement MEAs differently for the same drugs; however, the determinants of this variation remain unknown. We aimed to examine the extent to which MEA outcomes differ across settings, and understand the HTA decision-making factors that drove divergent outcomes. A retrospective analysis of HTA appraisals for oncology medicines approved since 2009 in Australia, England, Scotland and Sweden. Data was collected on; 1)Social value judgements (SVJs), 2a)The evidence appraised, 2b)Interpretation of this evidence and 3)Final HTA/MEA decision outcome. Restricted HTA outcomes were coded as Listed With Criteria (LWC) excluding a MEA or LWC including a MEA (LWCMEA). χ2 and k-scores were used to measure country differences in their MEA decision-outcomes. Descriptive statistics and ANOVA were used to identify the HTA decision-making variables driving such differences. 60%(n=201) of drug-indication pairs studied were restricted (LWC or LWCMEA), of which 75%(n=150) were LWCMEA. In terms of their MEA outcomes, countries differed significantly (χ2=8.3,p<0.05) and had a poor to moderate inter-rater agreement (−0.53< κ <0.2). Cross-country differences were somewhat underpinned by clinical uncertainties; i.e.“Relevance to clinical practice” (p<0.05) and “Clinical benefit” (p<0.05) and to a larger extent by economic ones; i.e. "Cost effectiveness” (p<0.01), "Clinical evidence” and "costs” included in the model(p<0.001 and p<0.05 respectively), and” Modelling” (p<0.05). The greatest country variation was driven by SVJs, with "Unmet need", "Severity", "Innovation", "Administration advantage” and "Impact on QoL", all highlighting significant cross-country differences (p<0.05). Despite providing some transparency around the criteria influencing MEAs’ implementation across settings, there are still barriers to overcome before they can be implemented more efficiently; i.e. their increased administrative burden, the absence of outcomes evaluation processes and the confidentiality around the prices/discounts negotiated under these agreements.