The NICE Decision Support Unit has just published a report titled “Framework for analysing risk in Health Technology Assessments and its application to Managed Entry Agreements”. Written by Sabine Grimm, Mark Strong, Alan Brennan and Allan Wailoo, an abridged abstract is below…..
Background: Recent changes to the regulatory landscape of pharmaceuticals may require reimbursement authorities to issue guidance on technologies with an evidence base that is less mature than has previously been the case. The greater uncertainty regarding the clinical and cost-effectiveness of new technologies at the point of decision making in a Health Technology Assessment (HTA) translates into a larger risk to the health-care payer. Decision makers need to be aware of the magnitude of those risks and the potential to manage it through assessment of a broad range of decision options, including so-called Managed Entry Agreements (MEAs).
Objective: The aim of this work was to present an analytical framework that can both quantify the need for an MEA, and assess the value of different MEAs for their reduction in the risk to the payer.
Methods: We developed the MEA risk analysis framework, an updated taxonomy of MEA schemes and the MEA design guidance questionnaire. Within this framework, we developed the concepts of Payer Uncertainty Burden (PUB), a measure of the risk associated with decision uncertainty in a HTA; and the Payer Strategy Burden (PSB) which quantifies the additional risk linked to each strategy in the HTA, given the proposed price and available evidence. We called the sum of the two the Payer Strategy and Uncertainty Burden (P-SUB). Both can be calculated with commonly used cost-effectiveness models, probabilistic sensitivity analyses (PSA) and the Sheffield Accelerated Value of Information (SAVI) online tool. We applied the MEA risk analysis framework to eight past NICE technology appraisals.
Results: The application of the framework in past NICE technology appraisals confirmed its feasibility within relatively short timelines. The value of different price reduction and evidence collection schemes depended on the uncertainties present in the appraisal and the magnitude of the PSB.
Conclusion: This report concludes that coherent, consistent and transparent assessments of proposed MEA schemes are critical. The MEA risk analysis framework proposed to routinely evaluate the decision risk in terms of Payer Uncertainty Burden and Payer Strategy Burden in HTA offers a consistent and transparent method of assessing the need for and the value of MEA schemes that is feasible within standard HTA timelines.
