In Brazil, the incorporation or disinvestment of health technologies into the Unified Health System (SUS) are advised by the National Committee for Health Technology Incorporation (Conitec). Despite the thorough evaluation carried out by Conitec, the results measured after implementation do not always reflect the economic and clinical impact expected from the incorporation. Thus, real-world evidence (RWE) is essential for monitoring health technologies. The aim of this study was to report how Brazil is using the RWE to obtain additional information about the incorporated technologies.

Actions related to the use of RWE for monitoring of technologies incorporated into the SUS were described. The period evaluated was between 2012 and 2022.

The first Conitec recommendation in which the use of real-life data in the decision-making process was evidenced occurred in 2016. Administrative data from a cohort of patients identified that beta-interferons for Multiple Sclerosis were less effective than the other drugs used in the Brazilian public system. A further eight reports have been published assessing the performance of technologies using administrative data.

Another strategy for RWE generation was through the funding of primary studies, highlighting a study with 21 rare diseases and another one to evaluate Zolgensma gene therapy, acquired through court for Spinal Muscular Atrophy. Both studies are ongoing and aim to evaluate the effectiveness, safety, adherence, and cost of medications in the evaluated diseases. Conitec is also following studies in RWE financed by pharmaceutical companies to evaluate effectiveness for incorporated technologies subject to reassessment. Additionally, managed access arrangements have been promoted for generating RWE when there is uncertainty about outcomes.

Real-world evidence from administrative data and clinical research allows monitoring after the implementation of technologies in the Unified Health System in Brazil. This makes it possible to reallocate resources in health and contribute for the system sustainability, in addition to generating data that reduce the uncertainties assumed at the time of incorporation.

In hospitals with standardized processes of health technology assessment (HTA), clinical studies are usually required to support incorporation requests. Factors such as conflicts of interest and confirmation bias affect the quality of the evidence. The objective of this study was to assess the quality of studies submitted to the university hospital to support the incorporation of non-drugs technologies.

All submissions received from 2017 to 2019 were reviewed. Data about methodological quality of studies sent by requesters and their utilization of final recommendation were collected, as well as about studies retrieved during additional search performed by HTA. The Jadad and Assessing the Methodological Quality of Systematic Reviews (AMSTAR) scales were used for assessing the quality of randomized clinical trials (RCTs) and systematic reviews (SRs), respectively.

Twenty-one requests for incorporation of equipment were analyzed. The average number of studies attached was 4.5. In eight requests (53.3%), both SRs and RCTs were attached. In seven (46.7%) only low quality studies were included were included; additional search identified RCTs and SRs in four of these cases. According to the Jadad and AMSTAR scales, 60 percent of the submitted RCTs showed a high risk of bias, while 57 percent of the SRs showed moderate quality, respectively.

The best evidence is not always submitted during the incorporation request process. Requirements for studies of moderate-to-high quality to accept the incorporation demand could be helpful to avoid inefficiencies in hospital-based HTA.

Clinical practice guidelines (CPGs) are an ideal implementation mechanism for promoting effective clinical practice, but without due consideration of costs they may do more harm than good and become a source of inefficiency. The Alberta Guideline Adaptation Program sought current best practice for incorporating economic information into CPGs to better leverage health technology assessment (HTA) and health economic expertise in its guideline development program.

A comprehensive, systematic review of published and grey literature was undertaken to: (i) catalogue theoretical frameworks and practical methods for incorporating economic information into CPGs and forecasting the post-implementation economic impact of CPGs; (ii) summarize current methods for evaluating the economic impact of CPGs; and, (iii) identify barriers and facilitators to incorporating economic information into CPGs.

Rigorous economic analyses were infrequently incorporated in CPG development. While a selection of guidance documents and CPG manuals published between 2001 and 2017 by leading CPG developers emphasized the health economist's role and the importance of incorporating economic evidence into CPGs, few provided adequate guidance on the best way to do this. There is no agreement on how best to monitor the economic impact of CPGs. Analysis of a sample of over 100 studies published between 2005 and 2013 identified the three main methods currently used to assess the post-implementation economic impact of CPGs: pre-test/post-test cost analyses, mapping studies, and modelled cost-effectiveness studies. The key elements of each study type were summarized and compared.

The review highlighted the under-recognized know-do gap among developers with respect to using health economics information and expertise in CPG development. It identified the advantages and potential limitations of applying health economics to CPG development, as well as areas where developers can better utilize HTA researchers and health economists to improve the quality of guidelines and better document the resource implications and feasibility of the interventions they recommend.

Web-based interventions for the promotion of maternal mental health could represent a cost-effective strategy to reduce the burden associated with perinatal mental illness. This study aimed to evaluate the cost-utility of Be a Mom, a self-guided web-based cognitive behavioral therapy intervention, compared with a waiting-list control.

The economic evaluation alongside a randomized controlled trial was conducted from a societal perspective over a 14-month time frame. Postpartum women presenting low risk for postpartum depression were randomized to the intervention (n = 191) or control (n = 176) group and assessed at baseline, postintervention and 4 and 12 months after postintervention. Data regarding healthcare use, productive losses and quality-adjusted life years (QALYs) were collected and used to calculate incremental cost-effectiveness ratios (ICERs). Uncertainty was accounted for with nonparametric bootstrapping and sensitivity analyses.

At 14 months, and after accounting for a 3.5 percent discount rate, the intervention resulted in a yearly cost-saving of EUR 165.47 (−361.77, 28.51) and a QALY gain of 0.0064 (−0.0116, 0.0244). Bootstrapping results revealed a dominant ICER for the intervention group. Although results were statistically nonsignificant, cost-effectiveness acceptability curves showed that at a EUR 0 willingness to pay threshold, there is a 96 percent probability that the intervention is cost-effective when compared with the control group. The sensitivity analyses generally supported the acceptable likelihood of the intervention being more cost-effective than the control group.

From a societal perspective, the implementation of Be a Mom among low-risk postpartum women could be a cost-effective way to improve perinatal mental health.

Although individual patient data meta-analysis (IPD MA) is considered the gold standard of systematic reviews (SRs), a recent International Network of Agencies for Health Technology Assessment survey indicates that IPD MA is not frequently included in a health technology assessment (HTA), or conducted by HTA researchers. The objective of this presentation is to describe our first experience with including an IPD MA in a HTA report, discuss the added value for an evidence-based decision-making process, and advocate for expanding work in this field.

An overview of SRs on endovascular therapy for acute ischemic stroke included one IPD MA and six study-level SRs/MAs. Methodological quality was appraised by two reviewers independently using the tool recommended by the Cochrane IPD MA working group for the IPD MA, and the AMSTAR (A MeaSurement Tool to Assess systematic Reviews) for the study-level reviews. Pooled results from subgroup analyses based on access to primary patient data were compared to those reported in SRs that conducted subgroup analyses based on the published data to identify patients or clinical factors that would impact clinical outcomes.

The overall findings were similar between the IPD MA and other SRs/MAs. However, when compared to aggregated data used in study-level SRs/MAs, subgroup analyses based on patient data allowed for adjustment of confounders, multiple categories within a subgroup, standardization of outcomes across trials, and detailed data checking. Larger sample sizes of each pre-defined subgroup permitted for more precise estimates of treatment effects. A number of methodological issues in the IPD MA were identified; particularly, no assessment of risk of bias of included trials was conducted.

Access to original patient data is demanding and conducting IPD MA requires extensive resources. The advantages of having an improved quality analysis, an appropriate quantification of the effects in the analyzed subgroups, and precision of results may justify additional efforts, and may increase confidence in the decision-making process.

Multiple databases are often searched in Health Technology Assessment systematic reviews. However in rapid reviews, time and resources are limited and modifications to the search methodology may be necessary. In this retrospective study, the impact of searching fewer databases for three completed rapid reviews (i) Severe Mental Illness (SMI), (ii) Cannabis Cessation (CC), iii) Premature Ejaculation (PE) for the United Kingdom National Institute for Health Research was investigated.

The database coverage and indexing of the study references from the reviews were initially identified. The impact of fewer databases searched was then tested by (i) the number of studies that might be missed, (ii) the number of records for sifting and (iii) the overall rapid review conclusions.

A total of 178 included study references were found in the reviews (SMI n = 14 for 13 studies, CC n = 34 for 33 studies, PE n = 130 for 102 studies). Searching Medline only for SMI, Medline+Embase for CC, Medline+Embase+Cochrane Library for PE, would result in 1902 (74 percent), 466 (43 percent) and 240 (11 percent) fewer records needed to sift, respectively. There would also be a total of ten ‘would be missed’ references (SMI n = 1, CC n = 5 and PE n = 4). However, nine out of the ten references were found to have no or minimal impact on the overall findings of the reviews. The ten references were secondary reports of an included study, papers that lacked sufficient data for meta-analysis such as a conference abstract or an ongoing trial.

From the three reviews examined, limiting the search to fewer databases had no or minimal impact on the review conclusions despite the variable number of studies that would be missed and records needed to sift. More exploration during the scoping search prior to commencing the review will aid the decision on whether to limit the search to fewer databases.

The use of multi-criteria decision analysis (MCDA) in health technology assessment (HTA) studies has become more common due to the fact that MCDA offers a comprehensive technique for decisions that involve multiple criteria and stakeholders. How MCDA contributes to the HTA decision making process is an issue to be investigated. A systematic review was carried out in order to provide an overview of the benefits identified in MCDA applications for the strategic HTA decision making process.

A systematic review developed by Philip Wahlster et al. (2014) was updated. The papers were analyzed in order to determine how MCDA is connected with traditional HTA, and to identify opportunities through the application of MCDA. In total 965 papers were found, and 43 articles were included in the review. The included articles detailed MCDA applications oriented to tactical and strategic decision making processes. The review was conducted by two researchers.

Of the available studies published on MCDA, 76 percent were published between 2014 and 2017, and 24 percent were published prior to 2014. Regarding the MCDA methodology defined in the included studies, 10 used the analytical hierarchy process, four used multi-attribute theory, and others refer the methodology only as “MCDA”. Seventeen studies also included health technology economic analysis, in special cost-effectiveness, safety and technological innovation. The studies suggest MCDA adds value since it allows different stakeholders to be engaged in the decision making process.

The increase in studies on MCDA and healthcare point to the possibility to add different criteria, engage people with different knowledge levels, and make the decision-making process more transparent. In comparison with other technical areas, the use of MCDA in healthcare is more focused on achieving the decision about adding the new technology, and to show how to engage stakeholders than to explain how to develop the algorithms and methodologies.

Cellphones can be used to support treatment and disseminate health information. Literature has shown an unmet need for information for people living with human immunodeficiency virus (PLHIV) and others affected by the epidemic. The World Health Organization (WHO) emphasizes the incorporation of cellphones as a tool to support HIV adherence and information dissemination. We sought to assess rates of utilization of health information provided through the Call for Life Uganda (CFLU) platform among HIV-positive individuals.

CFLU uses the Mobile Technology for Community Health (MoTeCH) software Call for Life™ developed by Janssen and adapted to the Uganda setting in collaboration with Infectious Diseases Institute (IDI). It offers daily pill reminder calls/sms, health info tips; symptom reporting and clinic appointment reminders. CFLU was used in a randomized control trial (RCT) undertaken to improve outcomes in HIV patients providing information categorized into Antiretroviral therapy (ART) and adherence, positive living, general health, pregnancy, breast-feeding, and sexuality. We used data from the RCT between August 2016 to June 2018 to generate frequency distributions and gender differences regarding utilization of health information.

From a total of 300 respondents receiving the CFLU intervention, a majority were: females (70%), aged 16 to 35 years (62%), married (74.7%), had attained secondary and higher education (57.3%); and employed (67.7%). Overall, 255/300 (85%) utilized at least one of the health-tips categories. Participants utilized mostly general health information 211/300 (70%); followed ARTs and adherence 173/300 (57.7%); pregnancy and breast-feeding 137/300 (45.7%), sexuality 113/300 (37.7%), and positive living 98/300 (32.7%). Gender differences were noted regarding ARTs and adherence utilization with higher percentage of females to males (61% vs 50%) and for sexuality, a higher percentage of males to females (41.6% vs 33.3%, p < 0.05).

The findings indicate that when availed with platforms for health-related information, PLHIV populations will utilize them mostly for adherence. We recommend increased incorporation of such technologies to disseminate information in this key population.

Medical devices (MDs) differ regarding their risk class (I to III), operational area (in-, outpatient), intended use (diagnostic, monitoring, intervention), and with regard to available clinical evidence. Therefore, the market access processes as well as the approach of gaining reimbursement differ significantly. From a variety of potential approaches the underlying analysis illustrates five MD-specific processes.

Based on a systematic search of publicly available regulations the main pathways of potential reimbursement for MDs were evaluated.

MDs to be used in the in-patient setting can be divided into three categories: an innovative MD (a) is exceeding a current reimbursement framework (German Operations and Procedures Key (OPS) / diagnosis related groups (DRG)), (b) falls within an existing reimbursement rate, or (c) the MD is based on a known mode of action (MoA) for which already adequate reimbursement exists. Due to less empirical data from MDs for a) and b), a health technology assessment (HTA) is required before inclusion in a DRG, whereas a MD with known concept (c) will be grouped into existing price structures. Initiators of these processes are hospitals through a so-called NUB application. MDs entering the outpatient sector are covered by another reimbursement catalogue (EBM/GOÄ) and have to pass an assessment by the G-BA (rapid HTA) if based on new MoA (d). Such an assessment can only be initiated by respective umbrella organizations of service providers (e.g. KBV (National Association of Statutory Health Insurance Physicians)). MDs not being positively recommended by the G-BA are not reimbursable. For MDs (e) with known MoA no HTA is required.

For a successful market launch including sufficient reimbursement not only the market potential, but also the specific regulatory pathways have to be considered carefully. New and innovative MDs in the outpatient sector may have a longer application process to gain a positive reimbursement decision than MDs used in inpatient setting.