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The HTA Risk Analysis Chart: Visualising the Need for and Potential Value of Managed Entry Agreements in Health Technology Assessment

Author

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  • Sabine Elisabeth Grimm

    (Maastricht University Medical Center)

  • Mark Strong

    (University of Sheffield)

  • Alan Brennan

    (University of Sheffield)

  • Allan J. Wailoo

    (University of Sheffield)

Abstract

Background Recent 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). Objective This work develops methods for quantifying risk associated with specific MEAs and for clearly communicating this to decision makers. Methods We 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. Results The 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. Conclusions The 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.

Suggested Citation

  • Sabine Elisabeth Grimm & Mark Strong & Alan Brennan & Allan J. Wailoo, 2017. "The HTA Risk Analysis Chart: Visualising the Need for and Potential Value of Managed Entry Agreements in Health Technology Assessment," PharmacoEconomics, Springer, vol. 35(12), pages 1287-1296, December.
    • Handle: RePEc:spr:pharme:v:35:y:2017:i:12:d:10.1007_s40273-017-0562-9
    DOI: 10.1007/s40273-017-0562-9
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    References listed on IDEAS

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    1. Claire Rothery & Karl Claxton & Stephen Palmer & David Epstein & Rosanna Tarricone & Mark Sculpher, 2017. "Characterising Uncertainty in the Assessment of Medical Devices and Determining Future Research Needs," Health Economics, John Wiley & Sons, Ltd., vol. 26, pages 109-123, February.
    2. Simon Walker & Mark Sculpher & Karl Claxton & Steve Palmer, 2012. "Coverage with evidence development, only in research, risk sharing or patient access scheme? A framework for coverage decisions," Working Papers 077cherp, Centre for Health Economics, University of York.
    3. Briggs, Andrew & Sculpher, Mark & Claxton, Karl, 2006. "Decision Modelling for Health Economic Evaluation," OUP Catalogue, Oxford University Press, number 9780198526629.
    4. Simon Eckermann & Andrew R. Willan, 2007. "Expected value of information and decision making in HTA," Health Economics, John Wiley & Sons, Ltd., vol. 16(2), pages 195-209, February.
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    1. Michael Drummond & Carlo Federici & Vivian Reckers‐Droog & Aleksandra Torbica & Carl Rudolf Blankart & Oriana Ciani & Zoltán Kaló & Sándor Kovács & Werner Brouwer, 2022. "Coverage with evidence development for medical devices in Europe: Can practice meet theory?," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 179-194, September.
    2. Nasuh C. Buyukkaramikli & Peter Wigfield & Men Thi Hoang, 2021. "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, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 22(1), pages 51-73, February.
    3. Shuli Brammli-Greenberg & Ira Yaari & Elad Daniels & Ariella Adijes-Toren, 2021. "How Managed Entry Agreements can improve allocation in the public health system: a mechanism design approach," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 22(5), pages 699-709, July.

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