A Pilot Study of Value of Information Analysis to Support Research Recommendations for the National Institute for Health and Clinical Excellence

Background - This project developed as a result of the activities of the Research Teams at the Centre for Health Economics, University of York, and ScHARR at the University of Sheffield in the methods and application of decision analysis and value of information analysis as a means of informing the research recommendations made by NICE, as part of its Guidance to the NHS in England and Wales, and informing the deliberations of the NICE Research and Development Committee. Objectives - The specific objectives of the pilot study were to: • Demonstrate the benefits of using appropriate decision analytic methods and value of information analysis to inform research recommendations. • Establish the feasibility and resource implications of applying these methods in a timely way, to inform NICE. • Identify critical issues and methodological challenges to the use of value of information methods for research recommendations (with particular regard to the new reference case as a suitable basis for this type of analysis).

The HTA risk analysis chart: visualising the need for and potential value of managed entry agreements in health technology assessment

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

Cost-effectiveness and value of information analyses of neuraminidase inhibitors for the treatment of influenza

Objectives: To assess the cost-effectiveness of alternative strategies for the treatment of suspected influenza in otherwise healthy adults and to identify future research priorities using value of information analysis.Methods: A decision model was used to estimate the costs and effects, in terms of quality-adjusted life-years (QALYs) of amantadine, zanamivir, and oseltamivir for the treatment of influenza in otherwise healthy adults using data predominantly from meta-analysis of randomized controlled trials. Probabilistic sensitivity analysis using Monte Carlo simulation was conducted. The expected value of perfect information for the entire model and for individual parameters was calculated.Results: Based on mean costs and effects, zanamivir is dominated by oseltamivir. The incremental cost-effectiveness ratio for amantadine (compared with no treatment) is £11,000 and £44,000 for oseltamivir (compared with amantadine). The probability that amantadine is cost-effective at a willingness to pay of £30,000 per QALY is 0.74, falling to 0.49 at £20,000 per QALY. Global expected value of perfect information (EVPI) is £2 m over 15 years if a willingness to pay threshold of £30,000 per QALY is assumed rising to £9.6 m at £45,000 per QALY. EVPI for only one parameter exceeds £500,0000 at £30,000 per QALY: the quality of life for untreated influenza.Conclusions: At traditionally accepted values of willingness to pay for health benefits, it is unlikely that additional research would be an efficient use of scarce resources. The only exception to this would be to examine the health-related quality of life impact of influenza in an untreated patient group. If a higher threshold value were acceptable, there are a small group of parameters that may warrant further investigation. These would, however, require comparative, potentially expensive, research studies.<br/