Health technology assessment criteria as drivers of coverage with managed entry agreements: a case study of cancer medicines in four countries.

Background: Managed entry agreements (MEAs) continue to emerge in health technology assessment (HTA)-based decision-making, to address evidentiary uncertainties arising therein. Evidence on the HTA criteria that influence MEAs' uptake remains scarce. This study explores the HTA criteria that determine (i) if an HTA funding decision will be listed with conditions (LWC) other than a MEA, or with a MEA as a condition (LWCMEA), and ii) the MEA type implemented (i.e., financial, outcomes based, or combination).

Methods: HTA reports of all oncology medicines approved since 2009 in Australia, England, Scotland, and Sweden were searched to capture the clinical/economic evidence uncertainties raised in the decision-making process, the Social Value Judgements (SVJs) considered therein and the final coverage decision. Binary and multinomial logit models captured the probability (odds ratio (OR)) of a coverage decision being LWCMEA vs. LWC, and of the MEA being financial, outcomes based, or combination, based on the HTA criteria studied.

Results: 23 (12%) LWC and 163 (88%) LWCMEA decisions were identified; 136 (83.4%) comprised financial, 10 (6.2%) outcomes based and 17 (10.4%) combination MEAs. LWCMEA decisions were driven by economic model utilities' uncertainties (7.16 < OR < 26.7, p < .05), and the innovation (8.5 < OR < 11.7, p < .05) SVJ. Outcomes based contracts were influenced by clinical evidence (OR = 69.2, p < .05) and relevance to clinical practice (OR = 26.4, p < .05) uncertainties, and rarity (OR = 46.2, p < .05) and severity (OR = 23.3, p < .05) SVJs. Financial MEAs were influenced by innovation (8.9 < OR < 9.3, p < .05) and societal impact (OR = 17.7, p < .0001) SVJs.

Conclusions: This study provides an empirical framework on the HTA criteria that shape payers' preferences in funding with MEAs, when faced with uncertainty.