Public hospitals in São Paulo can be held financially responsible for costs related to medications prescribed outside the recommendations of the Brazilian Unified Health System (SUS). The objective of this study was to describe these expenses in a public hospital and the measures implemented and evaluated to reduce this problem.

In January 2023, the Health Technology Assessment Center collected data on legal proceedings filed against a tertiary teaching hospital from January 2021 to November 2023. The data were obtained from monthly reports sent by the São Paulo State Department of Health (SES). The proceedings were categorized according to the type of technology and its availability in the SUS, costs, and the prescribing specialties. The indicators developed were used to plan improvement actions to guide care teams, negotiate with the SES, and resolve current legal proceedings.

The cost of legal proceedings for 136 patients was BRL4,410,278 (USD890,965). Four medicines for six patients constituted 56 percent of the total cost. A group created an informative folder explaining how to access the National List of Essential Medicines, prescribe medicines from the high-cost program, and make administrative requests. Other related actions were the creation of a standardized process for requesting medicines, monthly assessment of judicialization data, clinical discussions with prescribers, and educational activities with residents. The interventions reduced average monthly costs from BRL177,268 (USD35,811) to BRL85,493 (USD17,271) in the last trimester.

Knowledge and measurement of judicialization costs allowed the hospital to implement improvements to help avoid new legal proceedings and to understand the demands of medical specialties regarding situations not covered by SUS guidelines. The Health Technology Assessment Center’s work with managers made it possible to identify opportunities for improving the education of professionals regarding the procedures and technologies available in the SUS.

While implementing an evidence-based guideline for venous thromboembolism (VTE) prophylaxis in a Brazilian tertiary hospital, we identified an unmet need for patients undergoing major orthopedic surgery. The Brazilian Unified Health System (SUS) does not provide access to direct oral anticoagulants (DOACs) or enoxaparin. Therefore, an assessment of the efficacy, safety, and budgetary impact of these medications from a hospital perspective is warranted.

Our Health Technology Assessment Center performed an overview of systematic reviews (SR) to compare the efficacy and safety of DOACs with enoxaparin. The Cochrane Library, Embase, and MEDLINE databases were searched in May 2023. The relative risks of symptomatic VTE, clinically relevant bleeding, and mortality were collected. The AMSTAR-2 tool was used to assess the methodological quality of included SRs. Treatment costs and estimates of the number of patients undergoing knee or hip arthroplasty were derived from historical institutional data.

Of the 32 SRs included in the analysis, seven performed a network meta-analysis. All SRs had at least one flaw in a critical methodological domain, mainly in not providing the list of excluded studies. Regarding mortality rates, most SRs did not detect any differences between the treatments. The risk of experiencing VTE was lower with DOACs in eight SRs for hip arthroplasty and in five SRs for knee arthroplasty. The risk of major bleeding was similar between the treatments in all but two SRs. Substituting enoxaparin for DOACs led to a cost reduction of BRL490 (USD98) per patient, which could save BRL29,890 (USD6,038) per year.

Patients undergoing hip and knee arthroplasties are at high risk for the occurrence of VTE. Our overview of SRs showed that the efficacy and safety of DOACs are well recognized. DOACs reduce the risk of VTE, but to date patients in Brazil do not have access to these medicines through the SUS. By providing DOACs, hospitals could ensure adequate prophylaxis without increasing costs.

The Revised International Staging System (R-ISS) International Myeloma Working Group (IMWG) recommends a minimal panel to detect high-risk cytogenetics (del17p, t[4;14], t[14;16]) for patients with multiple myeloma (MM). In the Brazilian Public Health System, the use of FISH is currently authorized for rare diseases only, not including MM. In 2021, the Brazilian National Committee for Health Technology Incorporation, with the purpose of broadening the use of FISH to MM patients, requested a review to be undertaken by the Health Technology Assessment Center of University of Campinas’ Teaching Hospital. This study presents the results of a meta-analysis comparing FISH vs CC to the detection of the above-mentioned aberrations in MM patients.

On 25 June 2021, a pre-structured search on four databases (Embase, MEDLINE, Cochrane and LILACS) was performed to identify studies comparing FISH and CC results in MM patients for the detection of high-risk cytogenetics (del17p, t[4;14], and t[14;16]) in MM patients’ bone marrow samples. Study selection, risk of bias assessment, data extraction (frequency of positive tests) and quality of evidence assessment were performed by two independent researchers. Conflicts were solved in agreement meetings with a third researcher. Meta-analysis was performed using frequency of positives to obtain Risk Difference (RD), a surrogate measure of the surplus positive tests between FISH and CC.

From a total of 1346 rendered entries, 11 studies were selected. Only observational studies were available. These studies presented an overall high risk of bias (QUADAS-2). A total of 781 patients were assessed (653 evaluated by FISH and 719 by CC). Meta-analysis results showed that, for t(4;14) FISH detected 12 percent more samples (RD:0.12 [95% confidence interval (CI):0.06-0.19]). For t(14;16), FISH detected 0.42 percent more samples (RD:0.00 [95%CI:-0.01-0.02]). And for del17p, FISH detected 1.6 percent more samples (RD:0.12 [95%CI:0.04-0.20]).

FISH appears to be more effective than CC on the detection of t(4;414) and del17p aberrations, and can be a useful tool in hematology practice. The results of t(14;16) presented non-superiority, probably due to the low frequency of this aberration.

The Brazilian health technology assessment (HTA) process includes calls for public consultations, in which society can give its opinion on reports emitted by the National Committee for Health Technology Incorporation (CONITEC). Open and closed queries for public consultation are performed by official formularies and can be accessed online at CONITEC webpage. Queries are divided into two categories of reports: clinical protocols and guidelines, and incorporation/exclusion demands. Incorporation/exclusion queries are subdivided in two additional categories: opinion and experience, or technical. In this study we analyze the weight of patients’ participation in opinion and experience queries and their opinion (pro or con) on inclusion/exclusion of health technologies.

Formularies concerning concluded public consultations on health technology incorporation/exclusion reports were extracted from CONITEC website from 1 January to 26 November 2021. Entries on the opinion and experience formularies included amongst others, a close-ended question about the opinion of participants on health technology incorporation/exclusion reports (“favorable”/“against”/“neither”). In this study, we analyzed patients’ opinion contained within concluded public consultations on incorporation/exclusion of health technologies.

A total of 63 health technology incorporation/exclusion queries were performed in the analyzed period, of which there were only four exclusions. A total of 32,209 contributions were registered. “Patients”, “Health professionals”, “Family or caregivers”, “Interest on the theme”, accounted for 99.4 percent (13.5, 16.7, 32.3, 36.7%, respectively). Patient participation accounted for 4,367 (13.5%) entries. The total number of opinions in favor of the presented documents by the “Patients” was 4,268 (97.7%), 59 (1.4%) disagreed and 40 (0.9%) had no opinion.

Public consultation of official HTA reports is a very useful tool to legitimize decisions through social participation. Although patient participation is not numerically the most important category to contribute on public consultation queries, patients are, if not the most influential stakeholder, the main recipient of decisions concerning health technologies incorporations. Further analyses shall investigate experience narratives included in public consultation queries.

The Brazilian HTA process includes calls for public consultations, in which society can give its opinion on reports emitted by the National Committee for Health Technology Incorporation (CONITEC). Open and closed queries for public consultation are performed by official formularies and are available online at CONITEC webpage. There are two categories of queries: clinical protocols and guidelines, and incorporation/exclusion demands. Incorporation/exclusion queries are subdivided in two additional categories: opinion and experience, or technical. In this study we analyze health professionals’ technical contributions and their opinion (pro or con) on the inclusion or exclusion of health technologies.

On November 26th, 2021, formularies concerning concluded public consultations on health technology incorporation/exclusion reports were extracted from CONITEC website for the period, January 1, 2021 to November 26, 2021. Entries on the technical contributions formularies included a close-ended question about the opinion of participants on health technology incorporation/exclusion reports (“favorable”/“against”/“neither”).

A total of 63 health technology incorporation/exclusion queries were carried out during the study period, of which only 4 were exclusions. A total of 7783 contributions were registered. “Patients”, “Family or caregivers”, “Interest on the theme”, and “Health professionals”, accounted for 96.4% (10.9, 15.2, 17.1 and 53% respectively). Health professionals’ participation alone accounted for 4130 entries. Concerning the category “health professionals”, the total number of favorable opinions on the presented documents was 2740 (66.3%), 1306 (31.6%) disagreed, and 84 (2%) had no opinion.

Health professionals can be considered one of the main stakeholders considering HTA for technology incorporation in public health systems. Brazilian HTA reports are submitted to public consultation through queries, which are available open access at the Brazilian National Committee for Health Technology Incorporation website.

There is a lack of studies evaluating smoking cessation treatment protocols which include people with and without mental and substance use disorders (MSUD), and which allows for individuals with MSUD undergoing their psychiatric treatment.

We compared treatment success between participants with (n = 277) and without (n = 419) MSUD among patients in a 6-week treatment provided by a Brazilian Psychosocial Care Center (CAPS) from 2007 to 2013. Sociodemographic, medical and tobacco use characteristics were assessed at baseline. Tobacco treatment consisted of 1) group cognitive behavior therapy, which included people with and without MSUD in the same groups, and 2) pharmacotherapy, which could include either nicotine patches, nicotine gum, bupropion or nortriptyline. For participants with MSUD, tobacco treatment was integrated into their ongoing mental health treatment. The main outcome was 30-day point prevalence abstinence, measured at last day of treatment.

Abstinence rates did not differ significantly between participants with and without MSUD (31.1% and 34.4%, respectively). Variables that were significantly associated with treatment success included years smoking, the Heaviness of Smoking Index, and use of nicotine patch or bupropion.

The inclusion of individuals with and without MSUD in the same protocol, allowing for individuals with MSUD undergoing their psychiatric treatment, generates at least comparable success rates between the groups. Predictors of treatment success were similar to those found in the general population. Facilities that treat patients with MSUD should treat tobacco use in order to reduce the disparities in morbidity and mortality experienced by this population.

Recent open-label trials show that psychedelics, such as ayahuasca, hold promise as fast-onset antidepressants in treatment-resistant depression.

To test the antidepressant effects of ayahuasca, we conducted a parallel-arm, double-blind randomized placebo-controlled trial in 29 patients with treatment-resistant depression. Patients received a single dose of either ayahuasca or placebo. We assessed changes in depression severity with the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Depression Rating scale at baseline, and at 1 (D1), 2 (D2), and 7 (D7) days after dosing.

We observed significant antidepressant effects of ayahuasca when compared with placebo at all-time points. MADRS scores were significantly lower in the ayahuasca group compared with placebo at D1 and D2 (p = 0.04), and at D7 (p < 0.0001). Between-group effect sizes increased from D1 to D7 (D1: Cohen's d = 0.84; D2: Cohen's d = 0.84; D7: Cohen's d = 1.49). Response rates were high for both groups at D1 and D2, and significantly higher in the ayahuasca group at D7 (64% v. 27%; p = 0.04). Remission rate showed a trend toward significance at D7 (36% v. 7%, p = 0.054).

To our knowledge, this is the first controlled trial to test a psychedelic substance in treatment-resistant depression. Overall, this study brings new evidence supporting the safety and therapeutic value of ayahuasca, dosed within an appropriate setting, to help treat depression. This study is registered at http://clinicaltrials.gov (NCT02914769).