An Analysis of Uncertainties and Data Collection Agreements in the Cancer Drugs Fund

Laura A. Trigg, Maxwell S. Barnish, Samuel Hayward, Naomi Shaw, Louise Crathorne, Brad Groves, John Spoors, Thomas Strong, G. J. Melendez-Torres and Caroline Farmer ()
Additional contact information
Laura A. Trigg: Peninsula Technology Assessment Group (PenTAG)
Maxwell S. Barnish: Peninsula Technology Assessment Group (PenTAG)
Samuel Hayward: Peninsula Technology Assessment Group (PenTAG)
Naomi Shaw: Peninsula Technology Assessment Group (PenTAG)
Louise Crathorne: Peninsula Technology Assessment Group (PenTAG)
Brad Groves: National Institute for Health and Care Excellence
John Spoors: NHS England
Thomas Strong: National Institute for Health and Care Excellence
G. J. Melendez-Torres: Peninsula Technology Assessment Group (PenTAG)
Caroline Farmer: Peninsula Technology Assessment Group (PenTAG)

PharmacoEconomics - Open, 2024, vol. 8, issue 2, No 11, 303-311

Abstract: Abstract Background Managed Access Agreements (MAAs) are a commercial arrangement that provide patients earlier access to innovative health technologies while uncertainties in the evidence base are resolved through data collection. In the UK, data collection agreements (DCAs) outline the evidence that will be collected during the MAA period and are intended to resolve uncertainties in the clinical- and cost-effectiveness of a technology sufficient for the National Institute of Health and Care Excellence (NICE) committee to make a final decision on reimbursement. Objective The aim of this study was to identify the primary uncertainties leading to a recommendation for entry to the Cancer Drugs Fund (CDF) and evaluate how the corresponding DCAs attempt to address these. Methods A database of MAAs agreed within the CDF was compiled with coverage between July 2016 and December 2020 (the time during which evidence generation was routinely collected within the CDF up until the time of analysis). Uncertainties in the evidence base for technologies entering the CDF were analysed alongside the outcomes planned for data collection during the MAA. These data provide an overview of the key uncertainties surrounding health technologies in the CDF on entry and the types of evidence targeted by DCAs. Results In the assessment of 39 Cancer Drugs Fund (CDF) cases, NICE committees identified a total of 108 key uncertainties in cost-effectiveness estimates. Overall survival was the most commonly identified uncertainty, followed by generalisability of the evidence to the target population. DCAs specified a range of outcomes relevant to understanding the clinical effectiveness of the technology, though fewer than half (43.6%) of the DCAs addressed all the key uncertainties identified by the NICE committee. Conclusion The analysis indicated that data collection within the CDF is not sufficient to resolve all the uncertainties identified by the NICE committee, meaning that other approaches will be needed at re-appraisal to ensure that the NICE committee can reach a final decision on reimbursement.

Date: 2024
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DOI: 10.1007/s41669-023-00460-9

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