Promises and Drawbacks of Health Technology Assessment (HTA) in Laboratory Medicine
By Giuseppe Lippi January 15, 2020
The increasing integration of diagnostic tests into clinical practice has historically relied on the expertise of “expert groups” or “expert panels.” These bodies were responsible for reviewing new applications and updating the list of available tests, based on discoveries, technology advancements, or changes in disease patterns.
This approach has led to the development of highly specific test panels, tailored to local factors like disease prevalence, economic resources, healthcare sustainability, and reimbursement policies, as well as patient needs. However, the use of arbitrary criteria when evaluating test performance, costs, and healthcare outcomes has significantly weakened this strategy. This often resulted in the approval of diagnostic tests for use in some areas while other – even neighboring – regions overlooked them.
Basic Concepts of Health Technology Assessment
Determining whether a diagnostic test is both sustainable and clinically useful is a complex process. This challenge stems from translating basic research into practical daily application. It takes many years and involves a series of steps, including assay development, validation, commercialization by in vitro diagnostics (IVD) companies, and a thorough understanding of an assay’s analytical and clinical performance. The test must be positioned within an appropriate care pathway and then monitored for performance and failures. Many tests are “lost in translation” during these steps.
To mitigate some of these shortcomings, most global healthcare models are increasingly adopting health technology assessment (HTA). HTA is precisely defined as a thorough and evidence-based evaluation of medical and diagnostic technology to determine its safety, efficacy, and cost-effectiveness, as well as ethical and legal implications. Thus, HTA aims to provide an evidence-based input for healthcare decisions. In the context of laboratory medicine, HTA should be a multidisciplinary enterprise, assessing laboratory technology from the basic reagents to instrumentation, as well as redesigning care pathways and healthcare structures.
The main objectives of the HTA process are partnership, scientific credibility, independence, accountability, responsiveness, effectiveness, visibility, and accessibility. HTA domains are multi-faceted (clinical, social, organizational, economic, ethical, legal), along with the outcomes (assessment of efficacy, safety, costs, and social/organizational impact). Essential criteria characterize a HTA process. An evaluation of health technology should include all stakeholders, including patients and their families, healthcare professionals, scientific organizations, citizen representatives, volunteering organizations, and commercial partners, among others. The HTA should also consider building structures (hospitals, outpatient clinics), instrumentation, technological systems, and reagents. The systematic literature analysis should be conducted using validated methods.
Aims, Scope, and Advantages of Health Technology Assessment in Laboratory Medicine
The goal of HTA is to assess innovative medical technologies and allocate resources while improving the efficiency and effectiveness of healthcare delivery by national systems. The HTA addresses four primary questions: Does the test work? Is it sustainable for the healthcare system? Is it cost-effective? Does it favorably affect existing care pathways? If the answers are affirmative, the test can be introduced into clinical practice.
Importantly, HTA encompasses all management levels of healthcare systems and structures including general, intermediate, and professional levels. The outcome of HTA will impact political/clinical choices at various levels, including legislative decisions, management choices at individual facilities, and choices made in daily care practice. Then, HTA involves assessment before clinical implementation to evaluate efficacy, and after to ensure its positive impact and adaptability despite any changes. The ultimate goal is providing a reliable decision-making process on IVD technologies to various decision-makers. The process needs to identify the most efficient healthcare settings, types of patients for whom the test is appropriate, positioning within laboratory networks, any impact on organizational structure, and reimbursement policies.
The Potential Drawbacks
While HTA offers significant benefits, some drawbacks are important: Despite its prevalence, HTA in laboratory diagnostics is relatively limited: a search of popular scientific search engines such as PubMed reveals that a search for “health technology assessment” yields 4490 documents, but combining ‘health technology assessment’ AND ‘laboratory medicine’ dramatically reduces the number to 20 (0.4%). The impact of innovation isn’t fully realized with diagnostics tests since reliable evaluations are hard to find.
The growing influence of personalized medicine is another key point. With the HTA approach, new tests are based on firm scientific evidence, mainly derived from patient studies. However, medicine is not an exact science, where one test can be helpful in one population, but not in another. This may result in some patients missing out on chances. The rules of the game can be questioned: Who is nominated by whom? Written rules about how multidisciplinary HTA team members are chosen are infrequent. A recent WHO survey found that while many countries gather scientific data to support assessments, few define how HTA should be integrated into healthcare and only half have guidelines on how it should be done. Policymakers can nominate members who may support decisions based on healthcare economics without evidence-based scientific information. The rules on conflicts of interest must be clearly defined to ensure decisions are not biased.
Conclusions
It is undeniable that HTA’s wider use in laboratory medicine will bring significant benefits for both national healthcare systems and the general population. Some potential drawbacks should be recognized. The establishment of “working groups” or “task forces” for HTA in laboratory medicine by accredited scientific organizations such as the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is an imperative need. This will help establish the assessment of diagnostic tests as a reliable and clinically useful endeavor.
