Knowledge of health outcomes generated by drugs in the real world: Temporary fashion or real need?

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"tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "535" "paginaFinal" => "538" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Javier Soto Álvarez" "autores" => array:1 [ 0 => array:3 [ "nombre" => "Javier" "apellidos" => "Soto Álvarez" "email" => array:1 [ 0 => "javier.soto.alvarez@pfizer.com" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Departamento de Investigación de Resultados en Salud y Farmacoeconomía, Global Health & Value Unit, Pfizer España, Alcobendas, Madrid, Spain" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Conocimiento de los resultados en salud generados por los medicamentos en el mundo real: ¿moda pasajera o necesidad real?" ] ] "textoCompleto" => "Currently, the National Health Service (NHS) of our country is going through a complex situation, deriving, on the one hand, from a growing need of society in health care, and on the other hand, from a major limitation on available resources as a result of the financial crisis suffered in recent years. This has led to a reduced availability of existing resources to meet the demands of citizens in health care.In this current context, one of the strategies to be implemented in the NHS should be promoting the use of medicinal products that really bring added value to patients and to society in general, both clinical and economic value, in addition to humanistic and social values.<a class="elsevierStyleCrossRef" href="#bib0100">1</a> One of the most important features in defining the value of these drugs is the health outcomes they generate beyond the reported during the program of comparative clinical trials (CCTs). This means how they work and what therapeutic results occur in everyday medical practice in the real world, when they begin to be used in all types of patients according to the instructions on their technical specifications, and not only in the groups of patients enrolled in clinical trials.For many years, due to the movement of evidence-based medicine, therapeutic decisions of health professionals have relied, almost exclusively, on data provided by the CCTs, without having considered the evidence from the studies focused on understanding the health outcomes of routine drugs in the real world, prescribed at the discretion of doctors and taken by patients according to their habits and with the routine checkups carried out by the NHS.<a class="elsevierStyleCrossRef" href="#bib0105">2</a>The CCTs remain the methodological designs with higher quality and credibility in demonstrating the efficacy and safety of a new drug against the existing standard choices in the management of a disease, due to their high internal validity and accuracy. However, they have significant limitations when the results are generalized to all patients susceptible of being treated with the new drug because of the restrictive criteria in the selection of patients who will participate in the CCTs (rarely performed with elderly, children or pregnant patients or polypharmacy or multipathological patients). For this reason, the results obtained in the CCTs cannot be generalized to all patients with the disease (they have limited external validity). Therefore, it is difficult to estimate the behavior of new drugs in real life, when prescribed to all kinds of patients.<a class="elsevierStyleCrossRefs" href="#bib0110">3,4</a>In this situation, outcomes of new drugs are required on health care in the real world. These data are entirely complementary to the data obtained in the CCTs during the clinical research, so that health professionals can make more informed and consistent therapeutic decisions.<a class="elsevierStyleCrossRef" href="#bib0120">5</a> In recent years evidence-based medicine has been moving toward a results based medicine in health care.<a class="elsevierStyleCrossRef" href="#bib0125">6</a> Today, it would be desirable to turn to a medicine based on data from real life, if we want the NHS to start and make more therapeutic decisions with data on what happens in daily medical practice and with the health outcomes achieved from drugs of routine use, prescribed to all patients (not a select group of them) and where key results are assessed to make therapeutic decisions in a day to day basis, beyond efficacy and safety. This includes clinical effectiveness, quality of life and level of patient satisfaction, their compliance and adherence to therapy and the level of efficiency of drugs with real costs.<a class="elsevierStyleCrossRefs" href="#bib0130">7,8</a>What variables should be evaluated when performing projects to be provided with data of daily medical practice with drugs in real life?The routine variables assessed in CCTs are efficacy and safety of new therapeutic alternative versus standard therapies. However, in the studies measuring the health outcomes caused by drugs in real life, the parameters that should be assessed are as follows: (a) clinical effectiveness (data on control of signs and symptoms of the disease and data of morbidity and mortality); (b) results perceived and reported by patients (quality of life, treatment satisfaction, degree of disability, preferences, etc.); (c) efficiency (cost-effectiveness, including actual costs); (d) cost of disease management according to routine medical practice; (e) adherence and compliance with treatment and; (f) data on the use of drugs and compliance with the indications approved in the data sheet.What methodological designs can be used to know the health outcomes caused by drugs in real life?Although little used, pragmatic clinical trials are a methodology with high internal and external validity of the results and these results can be easily generalized, as they will reflect accurately what happens in daily medical practice. The problem is that it takes a long time to obtain results (several years), they are very expensive and require very large sample sizes.<a class="elsevierStyleCrossRef" href="#bib0140">9</a>Other designs more and more used are medical records using prospective observational cohort study methodology, which include patients with a particular disease as soon as they are diagnosed and they are monitored until the final outcome of the disease. The therapies administered and the diverse health outcomes are registered (events, complications, progression, survival, adverse effects, performance, resource consumption, absenteeism, disability, etc.). Today, there are more and more registers in industrialized countries. Most of them have been sponsored by scientific societies and health authorities.<a class="elsevierStyleCrossRef" href="#bib0145">10</a>In addition, observational designs are being more and more used (prospective and retrospective) to conduct studies that reveal data from real life of drugs through administrative databases and computerized medical records of patients, largely due the boom of information technology worldwide in recent years. Another possible design for obtaining real life data of drugs are health surveys, where patients are asked directly about different aspects of their health, resource consumption, pattern of disease treatment, etc.<a class="elsevierStyleCrossRef" href="#bib0150">11</a>To date, the methods most commonly used to provide evidence of drugs in real life are observational designs (registers, databases, medical records, etc.), and these methods are exposed to the emergence of significant biases (selection, analysis, monitoring, etc.) and confounders very difficult to control (because randomization is not being used). Therefore, it is essential to conduct these studies accurately and validly, following the best methodological standards and with maximum scientific rigor in their implementation, so that the results obtained are reliable and relevant to health professionals and other NHS decision-makers.<a class="elsevierStyleCrossRefs" href="#bib0155">12,13</a>What is required to launch a program to provide data on health outcomes of drugs in real life within the National Health System?Within the NHS in our country there is a lot of therapeutic information generated over the years, but not evaluated regularly and continuously, but only discussed occasionally, when it is necessary to have data for some specific reason. The first thing to do is to create a cultural change in all NHS players, so that the programs focused on obtaining data of results in real life are perceived as covering the gap between the data provided by the conventional CCTs and what happens in daily medical practice. Therefore, they will generate evidence that will help make better therapeutic decisions in patients. In addition, the NHS should be instilled the need to invest resources to obtain real-life data of sufficient methodological quality and reliable to health professionals and other decision-makers.Moreover, a progressive expansion of electronic medical records is necessary within the NHS, in regional health services, that integrates primary care and hospital care. This should be interoperative in all Autonomous Communities (currently there are good examples in some of them, but further progress and spread to global geography is necessary). In addition, the medical records of each patient should be standardized on collecting the results relevant to the patient's health, not only clinical outcomes, but also other key results. Therefore, health professionals would be able to make daily therapeutic decisions, as already noted above.What are the advantages of being provided with health outcomes of drugs in real life for society and the National Health System in our country?These data will help health professionals increase awareness of the disease, its evolution and treatment in daily medical practice, as well as better understanding of the health outcomes obtained by the patients after prescription of drugs. Therefore, this will allow them to make better therapeutic decisions in real life. These data will help health decision makers become aware of the extensive information available within the NHS. This information is required to be analyzed in order to know what is happening in real life with drugs and the results they are generating in patients. Additionally, it will allow them to have firm and relevant data for periodic reassessments of drugs after being merchandized, in order to modify their positioning with respect to other therapeutic alternatives to treat various diseases. For pharmaceutical companies, this information will allow to have evidence to help answer questions from health professionals and other NHS decision-makers. These questions are difficult to answer with conventional CCTs. Obtaining data on the operation of the medicines in daily medical practice is also difficult, as well as their adverse effects. This will allow health professionals to have available the medications with best clinical outcomes.The most significant challenge of our NHS is to maintain quality and fair care, while establishing mechanisms to improve efficiency and sustainability in response to the increasing demand of society, the change in the health care profile and the continuous arrival of new innovations. To obtain syncretism between investment and health outcomes achieved in relation to the incorporation of new innovative medicines in the NHS, it is key to have data to know how they work in daily medical practice and what health outcomes are generated in real life, since this evidence will help significantly health professionals to make better therapeutic decisions, which will result in better health care and lower consumption of health resources from other budget items.Currently, there is a lot of information on the treatments received by patients and the results obtained in health institutions (both primary care and hospital), gathered regularly and hardly analyzed and used to make treatment decisions. This is called big data on healthcare, and is one of the existing promises today to try and improve the quality of care of health systems and improve the health outcomes of patients. This is derived from a high technical capacity available in recent years in the scope of information technology and in the ability to analyze these data quickly and reliably for professionals and health decision makers.<a class="elsevierStyleCrossRefs" href="#bib0165">14–16</a> Getting our NHS to implement the culture of real life data collection of drugs used to treat different diseases is a joint work of all those agents involved. To this purpose, it is necessary to change the vision of health administrations and other agents in taking advantage of the existing data with the tools available at the moment (the proposal of Catalonia with the health Big data draft VISC+ is a good start). Moreover, it is necessary to change the conception and perception of health databases and instead of considering them as mere management tools, they should be seen as scientifically valid and credible methods for obtaining data from real life. In addition, a better coordination among the various regional health services of the autonomous communities would also be desirable in order to be more efficient in the analysis and use of all this existing information and establish a national plan to obtain real life data on drugs to promote and provide guarantees and homogenization in using these data evenly across the NHS.Patients in particular and society in general, co-owners of our NHS, deserve the best treatment decisions by health professionals as well as the best health results. This will allow the number of years lived in good quality of life increase. An essential part to achieve this goal is to be provided with the therapeutic benefits of drugs in real life that allows routine use of drugs that generate better results in patients.<a class="elsevierStyleCrossRef" href="#bib0180">17</a> All areas forming the NHS in our country should work together and be generous with society, Therefore, the understanding of the results achieved on drugs in daily medical practice should be mandatory and a necessity, and not a transient trend, as it is expected to happen in the rest of Europe in the early future.<a class="elsevierStyleCrossRef" href="#bib0185">18</a> There are still many things to solve, such as ensuring the safety and protection of health data through proper anonymization, the correct use of the results obtained, the enhanced collaboration between the NHS and pharmaceutical companies, and others. However, it is time for all agents involved in the NHS to work together to achieve that the understanding of behavioral data of medicines in everyday medical practice becomes real.<a class="elsevierStyleCrossRef" href="#bib0190">19</a> The great beneficiary of this strategy will be the patients. The best treatment decisions will be made and the quality of care and the NHS itself will improve, since health costs resulting from better control of patients will be reduced.NoteThe views expressed in this article are those of the author. Therefore, they do not necessarily reflect the view of the company in which the author is working today.Conflict of interestsThe author of this paper is currently an employee of Pfizer Spain S.L.U." 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