Real-World Evidence Offers Important Opportunity for MexicoBy Mario Muniz | Thu, 07/21/2022 - 16:00
One of the lessons learned from the COVID-19 pandemic has to do with the need to access data and generate evidence in record time. The necessity to quickly understand COVID-19’s characteristics, accelerate research and development (R&D) processes and generate and assess new safe and effective vaccines and therapies in a swift manner has undoubtedly resulted in an increasing interest among life science companies to further embrace Real-World Evidence (RWE) studies, to generate insights that inform their strategic or operational decisions.
RWE is defined as healthcare information that is obtained from data not collected in traditional clinical trials. Patient-level data from which RWE is generated are termed Real-Word Data (RWD); these comprise numerous sources, including information from electronic medical records, claims and billing data, clinical registries, surveys, pharmacy data, and data collected through wearables and health applications, among others (Figure 1).
RWE, which is primarily intended to support a claim or hypothesis as published evidence with external stakeholders, is derived from the analysis of RWD by using different analytical techniques (e.g., descriptive analyses, programming, machine learning, artificial intelligence, natural language processing) in so-called RWE studies.
Evidence produced from RWE studies aims to integrate the
insights gained from clinical trials, whose limitations with regard to cost and stricter inclusion criteria make it difficult to generalize findings to larger, more heterogeneous populations of patients, providers, and healthcare delivery systems that reflect real conditions in everyday clinical practice.
RW Studies and Its Uses
Typically, life science companies conduct RWE studies to inform the development of new therapies and medical devices, health outcomes research, safety surveillance, patient care, quality improvement, and effectiveness studies by addressing questions that are mainly associated with seven main topics (Figure 2).
For example, pharmaceutical firms may be interested in understanding the natural history of a disease, conducting longer, more thorough post-authorization safety studies to identify adverse events related to a specific therapy, exploring the characteristics of patients with a disease, and identifying comorbidities and their associated costs.
RWE studies are commonly referred to as low-interventional and non-interventional (observational). They can be based on primary or secondary data collection. The most common types of RWE studies are presented in Figure 3 and Figure 4.
The use of RWE, which nowadays supports almost all phases of a product (i.e., clinical development, growth phase, and mature phase) has increased significantly in recent decades. This has been mainly fueled by healthcare stakeholders’ ever-increasing evidence demands (Table 1).
Table 1: Factors driving global adoption and use of RWE
However, although regulators in developed countries have been gradually incorporating the use of RWE to assess the value of new interventions and monitor their safety and effectiveness in post-authorization studies (e.g., US, Canada, Japan, China, and countries within the European Union), most emerging countries haven’t yet established regulatory frameworks that support RWE. Such is the case of Latin America.
Latin America and Mexico
In a 2019 study that aimed to analyze the characteristics and uses of RWE in Argentina, Brazil, Colombia, and Chile, researchers found that RWE is mostly used for pharmacovigilance and academic purposes; to a lesser degree, it is used to inform health technology assessment decision-making or pricing negotiations; and is not used at all to inform early access decisions.
In Mexico, although RWE has been used in the development of patient registries by academic institutions and pharmacovigilance studies, not much else is known about the utilization of RWE in the country. There is some evidence that suggests that it is used in health technology assessments (HTAs) as a means “to support prioritization and rational use of health resources and to maintain sustainable healthcare budgets”, and to inform clinical decision-making in oncology. Furthermore, several post-authorization safety studies and pharmacovigilance studies have also been reported. However, the extent to which RWE is being applied in Mexico, along with the types and number of real-world studies that are being conducted and quality of the studies remains unclear.
To gain some insight into the trends of RWE utilization in Mexico, we searched for the number of observational studies that have been conducted in Mexico and registered in the ClinicalTrials.gov website from 2004 to 2019 (the last available year). Overall, it seems that the number of registered observational studies in Mexico has increased over the years (Figure 3). However, it is worth noting that there was a consistent increase in the number of registered observational studies between 2004 and 2011 but a rather inconsistent one in more recent years.
RWD Sources in Mexico
In general, RWD availability in Mexico is limited. The main sources of patient-level RWD are national health datasets (e.g., public hospital administrative data, mortality data and the health and nutrition survey). However, one of the major drawbacks of these datasets is the lack of connectivity that exists between them. On the other hand, electronic medical records (EMRs) have not been widely adopted by healthcare institutions (and EMRs from different organizations are usually not integrated: up to 65 different public electronic health record systems have been identified). Access to data from clinical and patient registries is restricted and the lack of regulation and privacy concerns with regard to the analysis of patient-level data from EMRs, wearables, and social media make it difficult to use these data as sources for RWE generation.
Challenges for the Adoption of RWE in Mexico
The lack of knowledge with regard to the definition and concepts related to RWE and RWD, the lack of guidance from regulatory authorities, and the need for greater coordination and incentives to support RWE generation for use in the pharmaceutical, clinical and healthcare settings are among the most important challenges for the adoption of RWE in Mexico. Moreover, although Mexico’s regulatory agency (COFEPRIS) has implemented a registry for both clinical trials and observational studies, it is somewhat unreliable. Hence, monitoring and evaluation of the use and trends of RWE generation in Mexico is difficult to undertake.
From the above, the need for a reliable registry of RWE studies is essential to monitor and evaluate the use of RWE in Mexico and to further enhance the development of RWE utilization. In addition, according to Ida Caterina García-Appendini, Head of the Real-World Insights (RWI) Business Unit in IQVIA Mexico, it is necessary to build awareness about the value of RWE, its sources, and the methods that are used to generate it. This can be done by providing education and training to key stakeholders (i.e., pharmaceutical companies, local payers, healthcare professionals). Furthermore, it is crucial to improve the connectivity between existing RWD sources and promote the design and implementation of additional, comprehensive national healthcare datasets that could be used for RWE studies. Also, local authorities should follow global trends imposed by leading regulatory agencies in developed countries and advocate for RWE generation by developing guidelines for the use of RWE. These guidelines should be aimed at increasing the use of local RWE in payer submissions.
Mexico’s regulatory authorities should take advantage of current opportunities for the expansion of RWE use. Among them:
- Health technology assessments (HTAs) are mandatory in Mexico and require the submission of evidence from randomized clinical trials (RCTs). The design and enactment of new guidelines supporting the use of RWE as a complement to evidence from RCTs is clearly an opportunity to support the adoption of RWE.
- Current guidelines from COFEPRIS drive demand for post-marketing surveillance studies because they require that pharmaceutical companies submit active surveillance plans for all new products prior to receiving authorization. These guidelines encourage the use of pharmacovigilance and post-authorization observational studies.
- Increased mobile adoption. This represents a digital health opportunity for RWE generation (e.g., the use of telemedicine).
- Global increase in funding for RWE within the pharmaceutical industry.
In addition to the publication of new draft guidance documents on RWE utilization by the US Food and Drug Administration (FDA) in 2021, the recent approval of drugs that have undergone evaluation processes in which insights from clinical trials were supplemented with evidence from real-world studies (e.g., the approval of abeparvovec-xioi for the treatment of infants with spinal muscular atrophy and tacrolimus for the prevention of organ rejection in patients receiving lung transplants) is a clear indication of the value of RWE as a tool that supports regulatory decision-making. While there is still much work to be done with regard to the adoption of RWE in Latin America, some countries in the region have made some progress. Mexico should take advantage of these regional efforts and encourage the adoption of RWE as a key tool for the improvement of healthcare in the country.
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 While primary data collection refers to the process of gathering new data in an active manner, secondary data collection strategies involve the use of existing data sources that are routinely collected (i.e., clinical registries, administrative datasets, etc.)
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