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The introduction of diagnostic tests in clinical practice has been for long based on the work of so-called “expert groups” or “expert panels”, which were in duty of revising applications and updating the list of clinically available tests according to recent biological discoveries, technological developments or changes of disease epidemiology. This has led the way to generating highly specific panels of tests, dependent upon local epidemiology, economic resources, healthcare sustainability, reimbursement policies and, last but not least, patients’ demands. The use of arbitrary criteria for evaluating test performance, costs and healthcare outcomes is the major weakness of this strategy, which has often led to approving diagnostics tests for clinical use in some geographical areas, which have been then overlooked in other, even neighbouring regions.
Basic concepts of Heath Technology Assessment
The process of establishing whether or not a certain diagnostic test may be considered both sustainable and clinically useful is not an easy task. This is mostly due to the fact that translating basic research assays in daily practice is a challenging enterprise, needing many years and involving many sequential processes, such as assay development and validation, commercialisation of reagents and/or diagnostic platforms by in vitro diagnostics (IVD) companies, thoughtful analysis of analytical and clinical performance, positioning the test at the right place within an appropriate care pathway, monitoring outcomes, performance and failures. Throughout these steps, the vast majority of tests may be literally “lost in translation”
To overcome some of these shortcomings, most healthcare models around the world are increasingly committing to health technology assessment (HTA), which can be conventionally defined as the accurate evaluation of medical and diagnostic technology for evidence of safety, efficacy, cost-effectiveness, ethical and legal implications. HTA is hence mainly aimed to provide an evidence-based, reliable and possibly foolproof input into a healthcare strategy or policy decision. In a broader sense, HTA in laboratory medicine should hence be considered a multi-professional and multidisciplinary enterprise aimed at assessing laboratory technology from basic reagents and instrumentation, up to rearranging care pathways and redesigning complex healthcare structures around the new diagnostic test.
The main operating paradigms of HTA include partnership, scientific credibility, independence, accountability, responsiveness, effectiveness, visibility and accessibility. Therefore, HTA domains are many (i.e., clinical, social, organisational, economic, ethical, legal), as highly multifaceted are the outcomes (e.g., assessment of efficacy, safety, costs, social and organisational impact). There are many essential criteria characterising a HTA process. First, the evaluation of health technology, and thereby the multidisciplinary team, shall involve all stakeholders, thus including the patients and their families, healthcare professionals and scientific organisations, citizens
representatives and volunteering associations, health and social-sanitary facilities, commercial and no-profit partners, industries, universities. The process of HTA should then consider a number of aspects that contribute to care delivery, thus including material sanitary technologies (e.g., building structures such as hospitals, outpatient clinics and patients’ homes), instrumentation and technological systems, reagents and consumables, test complexity, workload, but should also be designed around organisational and care models, clinical guidelines and regulatory systems. The systematic literature analysis should then be conducted using validated methodologies, such as that described in the Cochrane Handbook for Systematic Reviews of Interventions.
Aims, scope and advantages of Health Technology Assessment in Laboratory Medicine
The concept of HTA can be summarised as a valuable tool for evaluating innovative medical technologies, better allocating resources, improving both efficiency and efficacy of care delivery by national healthcare systems. To put it simply, the HTA process shall actually answer to four major questions, which are: Does the test work? Is it sustainable for the healthcare system? Is it cost-effective? Does it favorably impact existing care pathways? When all four answers are expectantly “yes”, then the test can be introduced in clinical practice.
Importantly, HTA shall cover all management levels of healthcare systems and their structures. Therefore, the outcome of HTA is aimed to impact political and clinical choices taken at different decision-making levels: (i) general level (i.e., legislative decisions and choices of national and regional regulatory bodies including the Ministry of Health, Medicines Agencies, Regional Health Service Agencies, Health Institutes, Regional Health Departments and Regional Agencies); (ii) intermediate level (i.e., management choices specific to individual healthcare facilities such as purchasing equipment, structuring care pathways, adopting specific organisational arrangements, granting assistance or not; and (iii) professional level (i.e., choices made by individuals in daily care practice involving the use of a diagnostic test, the need for medical and/or genetic counselling, the impact on care plans and organisation).
Then, the entire HTA process shall entail assessment before introduction into clinical practice (i.e., for evaluating efficacy and efficiency), but also afterward (i.e., for ensuring that the positive impact will continue despite scientific, technical, organisation and epidemiologic changes). The final purpose is providing a reliable decision-making process about IVD technologies to policymakers, healthcare administrators and laboratory professionals. Importantly, the process shall also clearly define the healthcare settings where the test may express higher efficiency and efficacy, the categories of patients to whom it may be offered, its precise positioning within a network of laboratories, the potential impact on laboratory organisation, as well as prices and reimbursement policies.
The potential drawbacks
Besides the many predictable positive outcomes that HTA may have on diagnostics testing, yet some important shortcomings emerge. First, HTA has now been widely used in many healthcare settings, but its popularity in laboratory diagnostics remains relatively limited. If one enters the keyword “health technology assessment” in one popular scientific search engine such as PubMed, over 4490 documents can be found so far. However, when both keywords “health technology assessment” AND “laboratory medicine” (OR “laboratory diagnostics”) are entered in PubMed, then the number of items dramatically falls to 20 (i.e., 0.4%). Although HTA is an element that more than others may provide an add value to innovation, reliable or published evaluations of diagnostic tests can hardly be found.
The ever growing impact of personalised medicine in laboratory diagnostics is a second important aspect. Inherently to the concept of HTA, the introduction of a new test is based upon solid scientific evidence, which has often been gathered from studies in populations of hundreds, thousands, occasionally millions of patients. With the awareness that medicine in not an exact science, what works in the single patient may not be equally straightforward in the general population. Therefore, when the process of introducing diagnostic tests in clinical practice only relies on HTA, there is a significant risk that a minority of patients, in whom that same test may be helpful, may lose chances and potential benefits.
Another critical issue especially concerns the rules of this game, which can be simply summarised in the concept “who is nominated by whom?”. It may seem awkward or even paradoxical, but written rules on how the members of the HTA multidisciplinary teams shall be selected are not so frequent. Interestingly, a recent survey endorsed by the World Health Organisation (WHO) revealed that although may countries around the world frequently gather and summarise significant information and scientific evidence to support technology assessment, fewer of them developed juridical issues to define how HTA should be incorporated in healthcare decision making, and only half of them have developed guidelines on how HTA should be conducted. Therefore, in a not so unlikely scenario, policymakers or healthcare administrators may arbitrarily decide to nominate members who may finally support decisions based on healthcare economy but not relying on evidence-based scientific information. Laboratory professionals may even be excluded in the evaluation of diagnostics tests, since no standards have been settled about the composition of HTA multidisciplinary teams for IVD technologies.
Finally, clear rules should be defined for unmistakably identifying potential conflicts of interests, thus avoiding that the final decisions of some HTA team members may be biased by personal interests in diagnostic tests or technology being evaluated.
Although it is undeniable that the larger use of HTA in laboratory medicine will bring many clinical and economic benefits for both the national healthcare systems and the general population, some potential drawbacks should be clearly recognised. The establishment of “working groups” or “task forces” for HTA in laboratory medicine by accredited scientific organisations such as the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) shall now be seen as a compelling need for making the assessment of diagnostic tests a liable, reliable and clinically useful endeavour.