Stakeholder views of managed entry agreements: A literature review of national studies

Thanimalai, Subramaniam; Choon, Wai Yee; Lee, Kenneth Kwing-Chin

doi:10.1016/j.hpopen.2021.100032

Cited by 6 publications

(2 citation statements)

References 24 publications

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“…As the real prices of medicines under MEAs were not disclosed, we could not measure the impact of MEAs accurately. The confidentiality that is a part of MEAs impedes the transparency of policy process, which is the intrinsic goal of public policy ( Carlson et al, 2010 ; Ferrario and Kanavos, 2013 ; Department of Health DoH, 2014 ; Ferrario et al, 2017 ; Sabine and Kenneth, 2017 ; Christiane and Soumana, 2018 ; Luzzatto et al, 2018 ; Park, 2018 ; Subramaniam et al, 2021 ). In particular, information regarding the benefits and risks associated with the MEA contracts should be clearly disseminated to all key stakeholders.…”

Section: Discussionmentioning

confidence: 99%

Introduction of managed entry agreements in Korea: Problem, policy, and politics

et al. 2023

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Objectives: This study aimed to understand Managed Entry Agreements (MEAs) in Korea through the framework of three streams of the policy window model and its practical management and impact on pricing and reimbursement scheme.Methods: An extensive literature review based on Kingdon’s model was conducted. We also performed descriptive analyses of MEA implementation using data on medicines listed in Korea and compared its MEA scheme with four different countries.Results: As per problem streams, patients with rare disease or cancers have considerable difficulties in affording their medicines and this has challenged the drug benefit system and raised an issue of patient’s access. Policy streams highlighted that MEAs were introduced as a benefit enhancement plan for four major diseases since January 2014. MEAs have also been strengthened as a bypass mechanism to expand the insurance coverage especially for new premium-priced medicines under Moon Care (Listing all non-listed services). In descriptive analysis of MEAs, a total of 48 medicines were contracted as MEAs from January 2014 to December 2020, accounting for 73.4% of listed medicines for cancer or rare diseases and 97.9% of the cases were finance-based contracts. Meanwhile, outcome-based contracts such as CED accounted for only 2.1%. The application of MEAs differs across countries, resulting in a kappa coefficient of 0.00–0.14 (United Kingdom 0.03, Italy 0.00, Australia 0.14), indicating a lack of consistency compared to South Korea.Conclusion: MEAs, which were introduced as a bypass mechanism, have now superseded the standard process for anticancer agents or orphan drugs. Further studies are needed to evaluate the impact of the confidential agreements and effectiveness of new high-priced medicines with limited clinical data at launch.

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Section: Discussionmentioning

confidence: 99%

Introduction of managed entry agreements in Korea: Problem, policy, and politics

et al. 2023

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“…It has been suggested that MEAs can improve access to innovative medicines by addressing decision-making related uncertainties and hence, preventing rejection from reimbursement due to uncertain clinical and cost-effectiveness evidence [6][7][8]. Nevertheless, these agreements have not yet gained widespread acceptance primarily because their sustainability is unclear and their effectiveness in meeting their objectives has yet to be evaluated [9].…”

Section: Introductionmentioning

confidence: 99%

Impact of Managed Entry Agreements on availability of and timely access to medicines: an ex-post evaluation of agreements implemented for oncology therapies in four countries

Efthymiadou

Kanavos

2022

BMC Health Serv Res

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Background Despite the increased utilisation of Managed Entry Agreements (MEAs), empirical studies assessing their impact on achieving better access to medicines remains scarce. In this study we evaluated the role of MEAs on enhancing availability of and timely access to a sample of oncology medicines that had received at least one prior rejection from reimbursement. Methods Funding decisions and their respective timelines for all oncology medicines approved between 2009 and 2018 in Australia, England, Scotland and Sweden were studied. A number of binary logit models captured the probability (Odds ratio (OR)) of a previous coverage rejection being reversed to positive after resubmission with vs. without a MEA. Gamma generalised linear models were used to understand if there is any association between time to final funding decision and the presence of MEA, among other decision-making variables, and if so, the strength and direction of this association (Beta coefficient (B)). Results Of the 59 previously rejected medicine-indication pairs studied, 88.2% (n = 45) received a favourable decision after resubmission with MEA vs. 11.8% (n = 6) without. Average time from original submission to final funding decision was 404 (± 254) and 452 (± 364) days for submissions without vs. with MEA respectively. Resubmissions with a MEA had a higher likelihood of receiving a favourable funding decision compared to those without MEA (43.36 < OR < 202, p < 0.05), although approval specifically with an outcomes-based agreement was associated with an increase in the time to final funding decision (B = 0.89, p < 0.01). A statistically significant decrease in time to final funding decision was observed for resubmissions in Australia and Scotland compared to England and Sweden, and for resubmissions with a clinically relevant instead of a surrogate endpoint. Conclusions MEAs can improve availability of medicines by increasing the likelihood of reimbursement for medicines that would have otherwise remained rejected from reimbursement due to their evidentiary uncertainties. Nevertheless, approval with a MEA can increase the time to final funding decision, while the true, added value for patients and healthcare systems of the interventions approved with MEAs in comparison to other available interventions remains unknown.

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A Systematic Review of Challenges and Opportunities in the Implementation of Managed Entry Agreements for Advanced Therapy Medicinal Products

Greco,

Frederix,

Hooft

et al. 2024

Clinical Therapeutics

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Stakeholder views of managed entry agreements: A literature review of national studies

Cited by 6 publications

References 24 publications

Introduction of managed entry agreements in Korea: Problem, policy, and politics

Introduction of managed entry agreements in Korea: Problem, policy, and politics

Impact of Managed Entry Agreements on availability of and timely access to medicines: an ex-post evaluation of agreements implemented for oncology therapies in four countries

A Systematic Review of Challenges and Opportunities in the Implementation of Managed Entry Agreements for Advanced Therapy Medicinal Products

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