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Healthcare Technology Assessments (HTA)are important tools for the (dis)incorporation of technologies and, for this purpose, they make use of various methods of clinical epidemiology and biostatistics to generate scientific evidence, making it possible to offer managers for decision making based on local evidence. In this sense, the so-called Real-world Data (RWD) or “real-life data” is the raw material for the generation of Real-world Evidence (RWE) “real-world evidence”, which will be of great use to various stakeholders of the Marketplace. In this Article, we’ll talk more about RWD/RWE and how it has been used in Brazil and worldwide.

Why use Real-world Evidence (RWE) in HTA?

As the name implies, Real-world Data (RWD) is generated based on data collected in the real-world and therefore outside the context of traditional clinical studies. Among the possibilities of RWD are electronic medical systems records and administrative records. By using a less controlled environment as a basis, the RWE allows working with broader and more diverse populations, which reflect the day-to-day assistance.

It is not, however, a matter of replacing clinical studies, but of complementing them, answering questions that traditional clinical research alone is not capable of answering. The RWE allows you to check, for example, if a certain drug has the same performance in a less controlled environment (on a daily basis).

Specialists believe that the RWE must become increasingly relevant to develop new practices in the healthcare sector, due to the speed with which information is accessed and with which it is possible to form online communities of patients, with clinical data, allowing accelerated studies. In addition, the cost of using RWE is lower than phase 3 clinical trials or multicenter prospective cohorts.

Among the positive results that this can bring are the improvement in health care and the use of new products in a more comprehensive and optimized way. There are different RWE methodologies and designs, which differ according to available information, research question, and other criteria.

RWE in the world

Real World Evidence (RWE) methodologies are already widespread in the United States, especially for private health-insurance companies and clinical practice guides. In some European countries, such as the UK, France, the Netherlands and the Nordic countries, there is also a policy for the use of databases and records considered acceptable for ATS.

RWE in Brazil and Latin America

Today, in developed countries, RWE is used for some clear purposes, such as:

  • Assess the clinical burden of a given disease and potential number of patients;
  • Confirm the results of traditional clinical studies;
  • Adapt economic models to the local reality;
  • Verify the real benefits of a drug based on the patient’s point of view in a less controlled environment;
  • Assess budget impact locally;
  • Check the long-term effect of a given technology, including its safety.

In Latin America, the adoption of studies based on RWE must pay attention to specific aspects of each region. Among them are:

  • There are no consolidated criteria to assess the quality of studies that use administrative databases or secondary databases (secondary data suggest that the database was not designed to answer research questions, but was developed for other purposes, such as reimbursement of procedures);
  • The GRADE (Gradation of Estimation, Development and Evaluation) methodology, which assesses the quality of evidence, may consider RWE as low-quality evidence. Researchers in the field are already developing methodologies compatible with studies that use RWD;
  • RWE studies can be costly for local researchers, which tends to be a problem for the Brazilian and Latin American reality. However, it does not reach the same amounts invested in multicenter clinical trials, making it an accessible investment to the private sector, such as the pharmaceutical industry, clinics, and public managers, among others.

The adoption of RWE in Brazil and Latin America could mean a new, better-informed phase in the decision-making process regarding health technologies. However, this requires that regulatory agencies and ATS assessments understand the value of an RWE’s information and use it to inform decisions that will benefit Brazilian citizens.

To learn more about ATS and the process of incorporating health technologies, download the e-book MAPES: Cases &Soluções.

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