ArticlePharmacoEconomics2017
The HTA Risk Analysis Chart: Visualising the Need for and Potential Value of Managed Entry Agreements in Health Technology Assessment.
Article in PharmacoEconomics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Mapping the landscape of managed entry agreements: a systematic review of global frameworks, system-level components, and implementation challenges.Frontiers in pharmacology · 2026Pooled it
- Psychological interventions to improve self-management of type 1 and type 2 diabetes: a systematic review.Health technology assessment (Winchester, England) · 2020Pooled it
- Evaluating the Role and Policy Implications of Using External Evidence in Survival Extrapolations: A Case Study of Axicabtagene Ciloleucel Therapy for Second-Line DLBCL.PharmacoEconomics · 2025Article
- Cost-effectiveness of ceftolozane/tazobactam compared to meropenem in ventilator-associated pneumonia.Cost effectiveness and resource allocation : C/E · 2025Article
- Managed Entry Agreements for Pharmaceutical Products in Three Maghreb Countries: Payer and Supplier Perspectives.Journal of market access & health policy · 2025Article
- Alternative Payment Models for Innovative Medicines: A Framework for Effective Implementation.Applied health economics and health policy · 2025Article
- Modeling First-Line Daratumumab Use for Newly Diagnosed, Transplant-Ineligible, Multiple Myeloma: A Cost-Effectiveness and Risk Analysis for Healthcare Payers.PharmacoEconomics - open · 2024Article
- Cost-effectiveness of linezolid to ventilator-associated pneumonia in Colombia.BMC infectious diseases · 2024Article
- Response to "UNCERTAINTY MANAGEMENT IN REGULATORY AND HEALTH TECHNOLOGY ASSESSMENT DECISION-MAKING ON DRUGS: GUIDANCE OF THE HTAi-DIA WORKING GROUP".International journal of technology assessment in health care · 2023Article
- Application of Artificial Intelligence or machine learning in risk sharing agreements for pharmacotherapy risk management.Journal of integrative bioinformatics · 2023Article
- Comprehensive Review of Methods to Assess Uncertainty in Health Economic Evaluations.PharmacoEconomics · 2023Review
- Coverage with evidence development for medical devices in Europe: Can practice meet theory?Health economics · 2022Article
- Implications of Oncology Trial Design and Uncertainties in Efficacy-Safety Data on Health Technology Assessments.Current oncology (Toronto, Ont.) · 2022Review
- An Efficient Method for Computing Expected Value of Sample Information for Survival Data from an Ongoing Trial.Medical decision making : an international journal of the Society for Medical Decision Making · 2022Article
- Article
- Simulating Study Data to Support Expected Value of Sample Information Calculations: A Tutorial.Medical decision making : an international journal of the Society for Medical Decision Making · 2022Article
- Prioritisation and design of clinical trials.European journal of epidemiology · 2021Article
- A Review of Web-Based Tools for Value-of-Information Analysis.Applied health economics and health policy · 2021Review
- How Managed Entry Agreements can improve allocation in the public health system: a mechanism design approach.The European journal of health economics : HEPAC : health economics in prevention and care · 2021Article
- A MEA is a MEA is a MEA? Sequential decision making and the impact of different managed entry agreements at the manufacturer and payer level, using a case study for an oncology drug in England.The European journal of health economics : HEPAC : health economics in prevention and care · 2021Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
backgroundRecent changes to the regulatory landscape of pharmaceuticals may sometimes require reimbursement authorities to issue guidance on technologies that have a less mature evidence base. Decision makers need to be aware of risks associated with such health technology assessment (HTA) decisions and the potential to manage this risk through managed entry agreements (MEAs).
objectiveThis work develops methods for quantifying risk associated with specific MEAs and for clearly communicating this to decision makers.
methodsWe develop the 'HTA risk analysis chart', in which we present the payer strategy and uncertainty burden (P-SUB) as a measure of overall risk. The P-SUB consists of the payer uncertainty burden (PUB), the risk stemming from decision uncertainty as to which is the truly optimal technology from the relevant set of technologies, and the payer strategy burden (PSB), the additional risk of approving a technology that is not expected to be optimal. We demonstrate the approach using three recent technology appraisals from the UK National Institute for Health and Clinical Excellence (NICE), each of which considered a price-based MEA.
resultsThe HTA risk analysis chart was calculated using results from standard probabilistic sensitivity analyses. In all three HTAs, the new interventions were associated with substantial risk as measured by the P-SUB. For one of these technologies, the P-SUB was reduced to zero with the proposed price reduction, making this intervention cost effective with near complete certainty. For the other two, the risk reduced substantially with a much reduced PSB and a slightly increased PUB.
conclusionsThe HTA risk analysis chart shows the risk that the healthcare payer incurs under unresolved decision uncertainty and when considering recommending a technology that is not expected to be optimal given current evidence. This allows the simultaneous consideration of financial and data-collection MEA schemes in an easily understood format. The use of HTA risk analysis charts will help to ensure that MEAs are considered within a standard utility-maximising health economic decision-making framework.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.