Abstract
Clinical practice guidelines (CPGs) on screening, surveillance, and treatment of several diseases recommend the selective use of biomarkers with central role in clinical decision-making and move towards including patients in this process. To this aim we will clarify the multidisciplinary interactions required to properly measure the cost-effectiveness of biomarkers with regard to the risk-benefit of the patients and how Health Technology Assessment (HTA) approach may assess value of biomarkers integrated within the decision-making process. HTA through the interaction of different skills provides high-quality research information on the effectiveness, costs, and impact of health technologies, including biomarkers. The biostatistical methodology is relevant to HTA but only meta-analysis is covered in depth, whereas proper approaches are needed to estimate the benefit-risk balance ratio. Several biomarkers underwent HTA evaluation and the final reports have pragmatically addressed: 1) a redesign of the screening based on biomarker; 2) a de-implementation/replacement of the test in clinical practice; 3) a selection of biomarkers with potential predictive ability and prognostic value; and 4) a stronger monitoring of the appropriateness of test request. The COVID-19 pandemic has disclosed the need to create a robust and sustainable system to urgently deal with global health concerns and the HTA methodology enables rapid cost-effective implementation of diagnostic tests allowing healthcare providers to make critical patient-management decisions.
Highlights
The pipeline of the biomarkers in routine clinical practice comprises several specific steps, from the discovery to the translational phase, and is aimed at the most effective clinical implementation [1, 2]
The COVID-19 pandemic has disclosed the need to create a robust and sustainable system to urgently deal with global health
We clarify the multidisciplinary efforts and interactions required to properly assess the value of biomarkers integrated within decision-making process and how Health Technology Assessment (HTA) methodology may deal with regulatory, ethics, and scientific aspects to measure the cost-effectiveness of biomarkers after the regulatory authorizations issued by the FDA and other regulatory Agencies
Summary
Ferraro et al.: Health Technology Assessment to assess value of biomarkers and not patient oriented screening programs based on biomarkers measurement have been associated with an unfavorable benefit-risk balance at the individual level [4, 7]. In the context of breast cancer promising positive PVs (i.e., minimal threshold of 80% for rule in) estimated across the early stages of the biomarkers pipeline development are crucial to give impulse to their introduction into the clinical setting, where the appropriate biomarker request has to be pursued to preserve the promising positive PVs of the validation phase [1] To this aim, with the first clinical introduction of the biomarker, the clinical research should optimize the application of the test (i.e., ordering PSA in patients at risk of advanced prostate cancer) and outcomes (i.e., identification of advanced prostate cancer) there are several examples in the current literature showing that the estimated PVs of biomarkers have been strongly compromised by methodological weakness (i.e., design limitations) and poor statistical modeling of the results [1, 8]. We clarify the multidisciplinary efforts and interactions required to properly assess the value of biomarkers integrated within decision-making process and how Health Technology Assessment (HTA) methodology may deal with regulatory, ethics, and scientific aspects to measure the cost-effectiveness of biomarkers after the regulatory authorizations issued by the FDA and other regulatory Agencies (i.e., www.lawinsider.com/dictionary/ regulatory-authorizations regulatory authorizations)
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