Abstract
Molecular diagnostic tests drive the scientific and technological uplift in the field of predictive, preventive, and personalized medicine offering invaluable clinical and socioeconomic benefits to the key stakeholders. Although the results of diagnostic tests are immensely influential, molecular diagnostic tests (MDx) are still grudgingly reimbursed by payers and amount for less than 5 % of the overall healthcare costs. This paper aims at defining the value of molecular diagnostic test and outlining the most important components of “value” from miscellaneous assessment frameworks, which go beyond accuracy and feasibility and impact the clinical adoption, informing healthcare resource allocation decisions. The authors suggest that the industry should facilitate discussions with various stakeholders throughout the entire assessment process in order to arrive at a consensus about the depth of evidence required for positive marketing authorization or reimbursement decisions. In light of the evolving “value-based healthcare” delivery practices, it is also recommended to account for social and ethical parameters of value, since these are anticipated to become as critical for reimbursement decisions and test acceptance as economic and clinical criteria.
Highlights
Molecular diagnostic tests drive the scientific and technological uplift in the field of predictive, preventive, and personalized medicine offering invaluable clinical and socioeconomic benefits to the key stakeholders
Unlike therapeutics (Rx), which undergo three phases of clinical trials prior to marketing authorization and Akhmetov and Bubnov The EPMA Journal (2015) 6:19 whose effect on patients can be quite straightforwardly demonstrated by patient-reported outcome measures, there is no clarity in the molecular diagnostics field on how much evidence is required to prove the value of a test
In view of the multi-parameter nature of value, it is recommended thereby to facilitate discussions with various stakeholders throughout the assessment process in order to arrive at a consensus about the depth of evidence required for positive regulatory or reimbursement decisions
Summary
Molecular diagnostic tests drive the scientific and technological uplift in the field of predictive, preventive, and personalized medicine offering invaluable clinical and socioeconomic benefits to the key stakeholders. This paper aims at defining the value of molecular diagnostic test and outlining the most important components of “value” from miscellaneous assessment frameworks, which go beyond accuracy and feasibility and impact the clinical adoption, informing healthcare resource allocation decisions. Acceptance and adoption of personalized medicine by wider community within the global health system requires that all major stakeholders understand and are able to measure value offered by this practice, which is a herculean task considering the diversity of stakeholders’ needs, lack of a uniform assessment criteria, and often intangible multiparameter nature of “value.”. Unlike therapeutics (Rx), which undergo three phases of clinical trials prior to marketing authorization and Akhmetov and Bubnov The EPMA Journal (2015) 6:19 whose effect on patients can be quite straightforwardly demonstrated by patient-reported outcome measures, there is no clarity in the molecular diagnostics field on how much evidence is required to prove the value of a test. Most of diagnostic studies focus on accuracy and feasibility, which is a hardly enough prerequisite for better patient health or other downstream improvements [6, 7]
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