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The Role of Measurement Uncertainty in Health Technology Assessments (HTAs) of In Vitro Tests.

ABSTRACT: INTRODUCTION:Numerous factors contribute to uncertainty in test measurement procedures, and this uncertainty can have a significant impact on the downstream clinical utility and cost-effectiveness of testing strategies. Currently, however, there is no clear guidance concerning if or how such factors should be considered within Health Technology Assessments (HTAs) of tests. OBJECTIVE:The aim was to provide an introduction to key concepts in measurement uncertainty for the HTA community and to explore, via systematic review, current methods utilised within HTAs. METHODS:HTAs of in vitro tests including a model-based economic evaluation were identified via the Centre for Reviews and Dissemination (CRD) HTA database and key reimbursement authority websites. Data were extracted to explore the specific components of measurement uncertainty assessed and methods utilised. The findings were narratively synthesised. RESULTS:Of 107 identified HTAs, 20 (19%) attempted to assess components of measurement uncertainty: 15 did so via some form of pre-model assessment (such as a literature review or laboratory survey); four also included components within the economic model; and one considered measurement uncertainty within the model only. One study quantified the impact of measurement uncertainty on cost-effectiveness and found that this parameter significantly changed the results, but did not impact the overall decision uncertainty. CONCLUSION:A minority of HTAs identified from this review used various approaches to assess and/or incorporate the impact of measurement uncertainty, indicating that these assessments are feasible. Uncertainty remains around best practice methodology for conducting such analyses; further research is required to ensure that future HTAs are fit for purpose.

SUBMITTER: Smith AF

PROVIDER: S-EPMC5999143 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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The Role of Measurement Uncertainty in Health Technology Assessments (HTAs) of In Vitro Tests.

Smith Alison F AF Messenger Mike M Hall Peter P Hulme Claire C

PharmacoEconomics 20180701 7

<h4>Introduction</h4>Numerous factors contribute to uncertainty in test measurement procedures, and this uncertainty can have a significant impact on the downstream clinical utility and cost-effectiveness of testing strategies. Currently, however, there is no clear guidance concerning if or how such factors should be considered within Health Technology Assessments (HTAs) of tests.<h4>Objective</h4>The aim was to provide an introduction to key concepts in measurement uncertainty for the HTA commu ...[more]

PMID: 29502176

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Project description:BackgroundIn some jurisdictions, patients and patient groups may be invited to provide input when Health Technology Assessment (HTA) is used to inform decisions about which medicines should be subsidised or funded. This input can help frame the evidence from a patient perspective, address uncertainties in the evidence and interpret it for the local setting. However, there is currently no evidence linking patient involvement with positive reimbursement decisions.AimWe aimed to understand the expectations of patient involvement in the reimbursement process, especially among cancer patient advocacy groups (PAGs) in New Zealand (Aotearoa), South Korea and Taiwan.MethodsWe developed an online survey to help understand the role that cancer PAGs play in reimbursement processes and identify knowledge gaps about the processes that might impact the efforts of PAGs. The survey elicited the views of staff and patients affiliated with PAGs (n = 43) on current practices and how the assessment and reimbursement of new cancer drugs might be improved.ResultsThere was variability in knowledge of the HTA assessment processes and in experience of being involved in them. Those with HTA experience were more likely to have confidence in the process. Those who had not been involved tended to have little awareness of, or frustration with, decision-making processes. Most identified cost, finances and economic assessments as key considerations in current processes. Some respondents had clear ideas about how their knowledge and involvement could improve processes to determine the value of new medicines. However, for many, a lack of information about the basis for decision making and opportunities to be involved was a barrier to identifying process improvement.ConclusionsHTA is implemented primarily in countries seeking to have fair and equitable processes for funding medicines. PAGs often recognise the financial challenges of funding new medicines and share the desire for procedural fairness. The connection PAGs make between patient involvement and improved access to new medicines may be based on the belief they can add information to the evidence base, help solve problems, ensure fairness through transparency and/or influence the culture towards increased access to medicines they value.

Project description:ObjectivesTo examine the validity and statistical limitations of exploratory analyses of clinical trial data commonly requested by agencies responsible for determining which medical products may be financed or reimbursed by a healthcare system.DesignThis was a retrospective review of efficacy and safety analyses conducted for German Health Technology Assessment (HTA) evaluations with a decision date between 2015 and 2020, and an illustrative safety-related exploratory analysis of data from two phase III clinical trials of verubecestat (an anti-amyloid drug whose development was stopped for lack of efficacy) as would be mandated by the German HTA agency.ResultsWe identified 422 HTA evaluations of 404 randomised controlled clinical trials. For 140 trials (34.7%), the evaluation was based on subpopulations of participants in the originating confirmatory trial (175 subpopulations were assessed). In 57% (100 of 175), the subpopulation sample size was 50% or less of the original study population. Detailed analysis of five evaluations based on subpopulations of the original trial is presented. The safety-related exploratory analysis of verubecestat led to 206 statistical analyses for treatments and 812 treatment-by-subgroup interaction tests. Of 31 safety endpoints with an elevated HR (suggesting association with drug treatment), the HR for 81% of these (25 of 31) was not elevated in both trials. Of the 812 treatment-by-subgroup interactions evaluated, 26 had an elevated HR for a subgroup in one trial, but only 1 was elevated in both trials.ConclusionsMany HTA evaluations rely on subpopulation analyses and numerous post hoc statistical hypothesis tests. Subpopulation analysis may lead to loss of statistical power and uncontrolled influences of random imbalances. Multiple testing may introduce spurious findings. Decisions about benefits of medical products should therefore not rely on exploratory analyses of clinical trial data but rather on prospective clinical studies and careful synthesis of all available evidence based on prespecified criteria.

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The Role of Measurement Uncertainty in Health Technology Assessments (HTAs) of In Vitro Tests.

Publications

The Role of Measurement Uncertainty in Health Technology Assessments (HTAs) of In Vitro Tests.

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