Determinants of Managed Entry Agreements in the context of Health Technology Assessment: a comparative analysis of oncology therapies in four countries

Abstract Background Managed Entry Agreements (MEAs) are increasingly used to address uncertainties arising in the Health Technology Assessment (HTA) process due immature evidence of new, high-cost medicines on their real-world performance and cost-effectiveness. The literature remains inconclusive HTA decision-making factors that influence utilization MEAs. We aimed assess if uptake MEAs differs between countries so, understand which criteria play a role determining such differences. Methods All oncology approved since 2009 Australia, England, Scotland, Sweden were studied. Four categories variables collected from publicly available reports above drugs: (i) Social Value Judgments (SVJs), (ii) Clinical/Economic submitted, (iii) Interpretation this evidence, (iv) Funding decision. Conditional/restricted decisions coded as Listed With Conditions (LWC) other than an MEA or LWC including (LWCMEA). Cohen's κ -scores measured inter-rater agreement LWCMEA outcomes Pearson's chi-squared tests explored association outcomes. Results A total 74 drug-indication pairs found resulting n = 296 observations; 8 percent ( 23) 55 163) LWCMEA. poor-to-moderate existed (−.29 < .33) decisions. Cross-country differences within sample partly driven by economic largely SVJs considered across agencies. Conclusions set HTA-related driving was identified. These findings can be useful future research at informing country-specific, “best-practice” guidelines for successful implementation.