Determinants of managed entry agreements in the context of Health Technology Assessment: a comparative analysis of oncology therapies in four countries

Efthymiadou, Olina and Kanavos, Panos ORCID: 0000-0001-9518-3089 (2021) Determinants of managed entry agreements in the context of Health Technology Assessment: a comparative analysis of oncology therapies in four countries. International journal of technology assessment in health care, 37 (1). ISSN 1471-6348

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Abstract

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

Item Type:	Article
Official URL:	https://www.cambridge.org/core/journals/internatio...
Additional Information:	© 2021 The Authors
Divisions:	?? MTRG ??
Subjects:	R Medicine > RA Public aspects of medicine
Date Deposited:	31 Jan 2022 10:24
Last Modified:	17 Apr 2024 04:57
URI:	http://eprints.lse.ac.uk/id/eprint/113577

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