[:pb]Por Bruno Riveros

Durante a ISPOR LATAM em São Paulo, A MAPESOLUTIONS, representada por seu líder de ATS e RWE, Bruno Riveros, PharmD, MSc, participou da mesa Challenges in Latin America Healthcare Systems: What Real World Evidence Is Needed to measure value during a Health Technology Assessment for Devices and Diagnosis Tests? Contando com a participação de Cristina Ferreira (Manager, Reimbursement & Health Economics at Edwards Lifesciences LATAM, São Paulo, Brazil), e Charles Cachoeira (Global Director in Market Access at Roche, Tucson, USA) o painel as dificuldades e possíveis alternativas para execução de estudos de c vida real para avaliação de tecnologia em saúde na região. Leia Mais em:  https://mapesolutions.com/2017/09/21/english-mapesolu…ns-rwe-hta-latam/

 [:en]Written by Bruno Riveros

In the last September 16^th we have attended the Issue Panel entitled Challenges in Latin America Healthcare Systems: What Real World Evidence Is Needed to measure value during a Health Technology Assessment for Devices and Diagnosis Tests? taking place in the 6^th Latin America ISPOR Conference, Sao Paulo, Brazil.

We had the opportunity to review the challenges on how to show value for devices and diagnostic tests in countries as Argentina, Brazil, Chile, Colombia and Mexico and contextualize with the reality of USA, Australia and Europe. Whereas in a few countries in LATAM the process of reimbursement is broadly similar but less stringent than that for drugs, in other countries, as Brazil, Colombia and Mexico, the reimbursement process must follow a specific methodological guideline, which requires description of clinical and economic evidences, technical and operational aspects and the innovative level of the technology. It is expected in the following years, that other LATAM countries start carrying out more thorough assessment for devices and diagnostic tests.

It is notorious that for most of devices and diagnostic tests there is a lack of high-level scientific evidences. In addition, most payers and HTA agencies evaluate devices and diagnostic tests with the mindset of drugs. It was consensus among the speakers that such approach leads to an incomplete assessment and does not take into account the singularities of devices and diagnostic tests. For instance, for devices being used in [or requiring] surgeries, it is hard to conduct blind studies and the efficacy/safety of the technology is directly related to the experience of the physician and the healthcare team and also the quality of the infrastructure. In addition, value dossiers for devices must consider [in most LATAM countries] the kind of procedure irrespective whether there is one single brand in the market or several others. This fact consider that the same device with different brands have similar accuracy/efficacy/safety and efficiency among each other, despite other characteristics as operational functionalities, demand for other equipment and ease on using it. There are several examples showing that different brands of devices to be used in the same procedure differ dramatically between each other. [e.g., remote monitoring of cardiac implanted electronic devices can have daily or weekly data transmission. It was shown that daily transmission decreases mortality compared to weekly transmission].

There are already registries of using Real World Data (RWD) coming from observational studies, electronic medical records or claiming database to show value of devices and diagnostic tests. Overall, measuring outcomes of interest is the most relevant evidence within RWD. With the increase of discussion about adopting Value-Based Competition in healthcare systems, clinic and humanistic outcomes will be more often registered and, therefore, more likely to be used in researches. However, not only health outcomes are being explored and retrieved from RWD. Records showing that a given device is capable to increase the absolute number of surgeries performed by the same team or even decrease the use of secondary products can also show value for the technology under assessment. Finally, it was discussed that a good framework for the value-proposition can be Multi-Criteria Decision Analysis (MCDA). After all, with MCDA other important aspects of devices and diagnostic tests [operational, technical, feasibility given geographic areas] are put in discussion besides clinical and economic findings. There are cases in LATAM in which a technology with poor clinical evidence [but with great value in saving time of healthcare team] was tested in a small environment in order to provide clinical data to justify [or not] the expansion of use.

Finally, there is a trend among HTA agencies in LATAM to promote more stringent assessment of devices and diagnostic tests for reimbursement purposes. Brazil, Colombia and Mexico have already methodological guideline specific for that kind of technology. RWD is a powerful tool for showing value of technologies when high-level evidences are lacking [or even when they are not possible to be generated]. There are cases of success in LATAM using observational studies, EMR and claiming databases to create value proposition. In addition, MCDA has being recognized as an important framework to explore important domains surrounding devices and diagnostic tests besides clinical and economic findings.  

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