As a step in the process of incorporating technologies, the National Supplementary Health Agency (ANS) prepares critical assessment reports (RACs). The analysis of the RACs can help in understanding the demands in supplementary health. The aim of this work was to characterize the technologies submitted to and incorporated into the ANS with respect to type of intervention, certainty of evidence, and economic aspects.

A descriptive study was conducted in which data from the RACs of the proposals for updating the list of covered procedures, incorporated between October 2021 and December 2023, were analyzed. The extracted data included type of intervention; classification of the disease or condition; level of certainty of the evidence for the main outcome; incremental cost-effectiveness ratio (ICER); and incremental budget impact (IBI) over five years. For the ICER evaluation, the percentage of technologies where the cost exceeded three times the Brazilian gross domestic product (GDP) for 2023 (USD31,103.4557) was considered. Data were presented using descriptive statistics.

Of the 50 incorporated technologies, 96 percent were therapeutic and 4 percent were preventive or prophylactic. Most of the proposals were for oncological conditions (68%). The certainty of the evidence was moderate to high in 52 percent of the incorporations and low to very low in 48 percent. The average IBI was USD32,001,783.74. In 24 percent of the incorporations, the IBI was negative, with 75 percent of these having low to very low evidence certainty. A cost-minimization analysis was conducted for 15 proposals; for the others, the ICER was more than three times the GDP in 54.3 percent of the incorporations.

A relevant percentage of the technologies incorporated by the ANS had low to very low certainty of evidence. Costs exceeded three times the Brazilian GDP in more than half the technologies where the ICER was calculated. The results highlight the need for decisions based on robust evidence and cost effectiveness to ensure the sustainability of the supplementary health system.

Accelerated approval facilitates timely access to innovative drugs in the USA, but confirmatory trials are required for traditional approval. This study evaluated alignment between United States Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines & Healthcare Products Regulatory Agency (MHRA), and National Institute for Health and Care Excellence (NICE) recommendations regarding drugs converted by the FDA from accelerated to traditional approval. This research addresses a gap in the literature by examining drugs across all therapeutic categories converted to traditional approval after 2020.

This retrospective cohort study analyzed drug-indication pairs granted FDA accelerated approval and converted to traditional approval between January 2020 and October 2024. Data from EMA, MHRA, and NICE documents were reviewed to identify decisions regarding market authorization (EMA and MHRA) and coverage recommendation type (NICE). Drug-indication pairs were categorized by FDA therapeutic classification, including infectious diseases (vaccines and non-vaccines), cancer, hematologic, neurological, and other disorders.

From January 2020 to October 2024, 115 drug-indication pairs received FDA accelerated approval. Eight of these were later withdrawn and 78 remain with ongoing confirmatory trials, while 29 successfully verified clinical benefit and were converted to traditional approval. Among these, 25 received EMA market authorization and 21 received MHRA market access after departure from the European Union (EU), with 14 requiring additional monitoring. By October 2024, 14 pairs had not been reviewed by NICE. Eight drug-indication pairs received a “recommended” status, two were “optimized” for smaller populations, and two were recommended for the Cancer Drugs Fund. One appraisal was terminated, and two were not recommended due to insufficient clinical benefits or cost effectiveness.

This study showed that FDA decisions to convert drugs from accelerated to traditional approval do not always align with EMA, MHRA, and NICE recommendations, highlighting potential global differences in regulatory and reimbursement criteria. Next steps will focus on analyzing NICE appraisal rationales, clinical evidence, and cost-effectiveness considerations to better understand these discrepancies, particularly in the post-EU departure period.

Healthcare systems are substantial greenhouse gas emitters, responsible for five percent of emissions worldwide. Inhalers are particularly problematic, and while all inhalers have a negative impact, pressurized metered-dose inhalers (pMDIs) are the worst offenders. With carbon minimal pMDIs in development, this research evaluated the economic value that selected carbon minimal pMDIs could offer and explored how this value can be represented in economic evaluations.

The analysis employed a partial economic evaluation framework. Given the carbon minimal and current standard pMDIs are expected to be clinically equivalent, clinical outcomes and downstream resources offset each other in an incremental analysis. Thus, the evaluation centered around reduction in carbon and incremental costs. Two approaches were undertaken: parallel and integrated evaluation. Environment impact (carbon footprint) was sourced from published life cycle assessments, dosage was based on international guidelines, and costs were taken from the British National Formulary. The cost of carbon used was the UK Treasury’s carbon value of GBP269 (USD370) per ton of carbon dioxide equivalent (CO2e).

Current selected pMDIs produce 103 kg to 150 kg of CO2e per person per year depending on which product is used, whereas the carbon minimal pMDIs produce 13 kg to 18 kg of CO2e per person per year, a reduction of around 88 percent. The undiscounted additional value of the selected carbon minimal pMDIs ranges from GBP776 (USD1,068) to GBP1,134 (USD1,561) per person with asthma over their lifetime. Based on these results, at a population level, if all people currently being prescribed pMDIs moved to a low carbon pMDIs, this could save carbon emissions to the value of GBP112 to 166 million (USD154 to 229 million) annually in the UK alone.

The added value demonstrates the environmental and economic benefits available from switching from existing pMDIs to low carbon pMDIs where clinical outcomes are equivalent. This additional value can be reflected in economic evaluations as part of an HTA process, although challenges remain related to data availability and in the interpretation of environmental impact data in cases of non-dominance.

The National Resources Fund (FNR) is a financing agency for highly complex and high cost services. Among these is mechanical thrombectomy (MT) for acute ischemic stroke (AIS) due to large vessel occlusion. Quantifying access to this technique highlights the importance of continuing to identify and address barriers that limit the number of patients who can benefit from it.

The study involved a retrospective cohort that included all the patients who applied for financing by the FNR from November 2021 to April 2024. It aimed to evaluate access to MT by select candidates for the procedure in accordance with current financial coverage regulations. To estimate the number of expected cases for Uruguay, previous epidemiological figures on the incidence of AIS (national studies) and data on hospital discharges with a diagnosis of AIS (provided by the Population Health Surveillance Area of the Ministry of Public Health of Uruguay for the year 2023) were considered.

In the period considered, 159 candidates for financing applied to FNR. Of these, 132 cases received full financing, five received partial financing, five didn’t meet the criteria for financial coverage, and 17 remained unresolved. Among the cases with full financing, 94 came from private health providers and 38 from public providers. Also, 81 cases originated in the capital’s geographical area and 51 in the interior of the country. Of the estimated annual number of people with AIS in Uruguay, 1.5 percent of them will have access to MT, for a base expected number of at least 3 percent according to real-world data.

Access to MT financed by the FNR was lower than expected. To date, the number of patients that apply for financial coverage by the FNR remains stable at approximately 70 cases per year, with a significant disparity observed in geographical origin (Montevideo versus the interior) and in the patient’s healthcare provider of origin (public versus private).

Globally, knee osteoarthritis (OA) is a prevalent and disabling condition. Intra-articular glucocorticoid injection (IAGI) is widely used to treat knee OA. However, there is conflicting evidence on the benefit-harm profile of IAGI for this indication. This study aimed to determine the clinical effectiveness and safety of IAGI for knee OA.

Systematic literature searches were conducted in three biomedical databases (MEDLINE, Embase, the Cochrane Library) through to 4 October 2023. Randomized controlled trials (RCTs) that compared IAGI with no treatment, sham injection, or oral placebo in patients with knee OA were included. RCTs were appraised using the revised Cochrane risk-of-bias tool. Longitudinal meta-analysis (LMA) was conducted for predetermined outcomes (i.e., pain, function, health-related quality of life [HRQoL], care utilization, adverse events [AEs], and serious adverse events) at one month, three months, six months, and 12 months. Pairwise meta-analyses were conducted at individual time points if there was insufficient evidence to conduct a LMA. The research project was funded by the Swiss Federal Office of Public Health.

In total, 16 RCTs comprising 1,522 patients with knee OA were included. The LMA reported a small reduction in pain at one month (standardized mean difference: −0.30, 95% confidence interval [CI]: −0.52, −0.08), but no clinically or statistically significant differences from three to 12 months. Regarding function, the LMA found no significant differences at any time point. Pairwise meta-analyses at one month showed reduced care utilization favoring IAGI (mean difference −0.43; 95% CI: −0.81, −0.05), but not at other time points, and no differences in HRQoL at any time point. No significant safety concerns were found in relation to AEs and serious AEs.

IAGI provided short-term pain relief for knee OA at one month post-injection, with beneficial effects diminishing by three months and beyond. There were no substantial improvements in function or HRQoL. No significant safety concerns were identified. To guide clinical decision-making, further research should focus on HRQoL as well as potential subgroups of patients that may benefit in the longer term.

In Brazil, approximately 99 percent of malaria cases are concentrated in the Amazon region, 68 percent of which are due to Plasmodium vivax. Tafenoquine, a single-dose drug, should be offered with a glucose-6-phosphate dehydrogenase (G6PD) test because it can cause severe hemolysis in patients with G6PD deficiency. New technologies represent a promising strategy to reduce the burden of malaria in Brazil.

From the perspective of the Unified Health System (SUS), we estimated the incremental budget impact of introducing tafenoquine and the G6PD test for diagnosing and treating Plasmodium vivax malaria in the Brazilian Amazon region over a five-year time horizon. A budget impact model was developed and two scenarios were analyzed: a reference scenario based on current Brazilian national antimalaria guidelines, and an alternative scenario incorporating the novel tafenoquine regimen and G6PD deficiency diagnosis. Face validity was assessed through consensus meetings with policymakers to ensure the model’s accuracy and transparency.

The incremental budget impact of adopting the G6PD test and the novel tafenoquine regimen was estimated at USD6.26 million over five years, assuming full implementation in the Brazilian Amazon region. The model predicted that both technologies would reduce hospitalization costs in approximately 22 percent of cases. The parameter with the greatest effect on the incremental budget impact was the price of the test kit. Additionally, material losses during diagnosis also significantly influenced the results.

The G6PD testing and tafenoquine regimen are valuable strategies for reducing the malaria burden in the Brazilian Amazon Region and could generate potential savings for the SUS. Face validity was a key advantage for ensuring transparency throughout the budget impact development process and for providing an economic evaluation framework to optimize the use of health resources, thereby supporting healthcare decision-making.

Renal stone disease is common, affecting mainly working-age adults, with a lifetime prevalence of 10 percent across the world. Approximately 50 percent of people with renal stones will experience symptoms and 25 percent will require treatment. This study assessed the cost effectiveness of flexible ureterorenoscopy (FURS), compared with extracorporeal shockwave lithotripsy (ESWL) (PUrE-RCT1) and percutaneous nephrolithotomy (PCNL) (PUrE-RCT2) for treating stones in the lower pole of the kidney.

The UK PUrE studies were pragmatic, multicenter, open-label superiority randomized controlled trials recruiting participants with lower pole stones sized 10 mm or less (n=466; PUrE-RCT1), and more than 10 but less than 25 mm (n=159; PUrE-RCT2). Mean costs to the health service and quality-adjusted life years (QALYs) were estimated using generalized linear models by intention-to-treat 12 months after randomization. A Markov model used trial data, combined with longer term data from the literature, for a five-year extrapolation based on the expected recurrence due to residual fragments. Uncertainty around results was characterized by conducting probabilistic and deterministic sensitivity analyses.

For PUrE-RCT 1, FURS was, on average, more costly (GBP1,138 [USD1,536], 95% confidence interval [CI]: GBP646 [USD872], GBP1631 [USD2,202]) and produced 0.017 (95% CI: −0.008, 0.043) additional QALYs with an incremental cost-effectiveness ratio (ICER) of GBP65,163 (USD87,970) per QALY gained. However, ESWL had a 99 percent chance of being cost effective at a GBP20,000 (USD27,000) cost per QALY threshold. For PUrE-RCT2, FURS was, on average, more costly (GBP733 [USD990], 95% CI: −GBP508 [−USD686], GBP1,973 [USD2,664]) when a micro-costing approach was used and produced fewer QALYs (−0.001, 95% CI: −0.044, 0.042). PCNL had an 87 percent chance of being cost effective at a GBP20,000 (USD27,000) threshold value. However, FURS was cost effective when the Healthcare Resource Group (HRG) costing approach was used.

PUrE-RCT1 found that ESWL was cost effective, compared with FURS, with no meaningful difference in QALYs gained, even though stone-free rates were higher after FURS. In PUrE-RCT2, PCNL was cost effective compared with FURS, but the results were sensitive to the costing approach used. Higher transparency in the methods used to derive HRG costing is needed.

Despite being incorporated into the Brazilian Unified Health System (SUS) in 2017 and 2019, insulin analogs are still not well distributed to the populations who need them. These drugs are frequently the target of lawsuits in Brazil, which should be mitigated following the favorable recommendation of the National Committee for Health Technology Incorporation (CONITEC). This study aimed to understand the reasons for this delay in supplying the Brazilian population.

This exploratory, descriptive, and retrospective research collected information from CONITEC’s website, purchases of insulin analogs by the Brazilian Ministry of Health registered in the General Services Administration’s Integrated System (integrated into Brazil’s Federal Purchasing Portal) and dispensing of medicines in the Outpatient Information System between 2011 and 2022. As a key variable, the study focused on the time between the incorporation decree and the first dispensation in the SUS, which should ideally occur within 180 days.

The time between the incorporation decree publication for short-acting insulin analogs and their first dispensation within the SUS was 575 days, 395 days longer than anticipated. In the case of long-acting insulin analogs, there were no scheduled purchases or drug dispensations after the incorporation until December 2024. The possible reasons for these delays include prolonged purchasing processes due to the need to meet specific requirements, shortages of insulin analogs in both national and global markets, conflicts among Brazilian federal entities responsible for financing and purchasing insulin analogs, and a lack of short-acting insulin analogs in the Ministry of Health’s stock, among others.

It is essential to actively monitor the post-incorporation process of insulin analogs in Brazil due to the multiple barriers involved. This is particularly urgent because, as of November 2024, the public incorporation of this drug class, which was previously limited to treating patients with type 1 diabetes mellitus, has been extended to include patients with type 2 diabetes.

Patient involvement is essential for diversifying health technology assessment (HTA) and addressing global healthcare demands. Uruguay’s first national workshop engaged patients and caregivers to develop a consensus on the role and contributions of expert patients in HTA, fostering inclusivity and advancing decision-making processes.

The workshop convened 25 representatives from 17 patient organizations, representing patients (72%) and caregivers (28%) from across Uruguay. Participants shared experiences through surveys and discussions, addressing key challenges, treatment impacts, and expectations. Consensus building activities defined expert patient roles, competencies, and training needs to ensure meaningful contributions to HTA.

The key challenges identified included disease acceptance, family and economic burdens, and treatment accessibility (72%). Participants emphasized the importance of user-friendly, accessible, and affordable health technologies. The essential roles of expert patients included contributing real-world testimonies (88%), creating patient-friendly summaries (76%), and participating in decision-making processes. While 76 percent had communication skills, 52 percent lacked critical analysis training, and 92 percent emphasized the need for education on HTA processes and technical report interpretation. Participants valued structured training and expressed strong motivation (83%) to improve patient representation in HTA.

Uruguay’s workshop demonstrated the value of engaging patients and caregivers in HTA processes. The resulting consensus document highlighted the potential of expert patients to bridge gaps between technical assessments and real-world impact, promoting equity and inclusivity. These findings offer practical insights for strengthening patient involvement in HTA globally.

In India, the Free Diagnostic Service Initiative leverages teleradiology and technology to address the shortage of skilled radiologists, improving healthcare access. X-ray films are digitized for remote reporting, enhancing equitable healthcare delivery. The study explored teleradiology public-private partnership (PPP) models, emphasizing their synergy with artificial intelligence (AI) as a scalable solution to strengthen public health services in low- and middle-income countries.

The study prospectively analyzed telereporting services under PPP models across Indian states and union territories and reviewed literature from January to July 2023. Data from Program Implementation Plans and Records of Proceedings were examined. The study assessed resources, expertise, and accountability using the World Health Organization’s Public-Private Mix Framework, which focused on Enabling Environment, Service Delivery, and Monitoring & Evaluation. It highlighted infrastructure challenges, skilled human resource needs, and impacts on access, equity, regulation, incentives, innovation, and uptake in radiology systems, emphasizing resource-intensive digitization (Digital Imaging and Communications in Medicine; Picture Archiving and Communication System). The findings provide insights into the distribution of responsibilities between public and private entities for effective healthcare delivery.

Teleradiology PPP services in India, implemented in 14 out of 36 states, were categorized into three models: outsourcing X-ray and telereporting, outsourcing digitization and telereporting, and outsourcing human resources and teleradiology services. States like Tamil Nadu and Gujarat used teleradiology for image enhancement and diagnosis. Teleradiology PPPs bridged urban-rural disparities, improving healthcare access for marginalized populations. These models reduced diagnostic costs, enhanced diagnostic accuracy, and improved patient satisfaction and treatment outcomes. They demonstrated scalability, resource optimization, and long-term feasibility. Policymakers are exploring further integration of AI into teleradiology to enhance radiodiagnosis and healthcare delivery across India.

By incorporating evidence from PPP models into the Health Technology Assessment office of the Department of Health Research and the Indian Council of Medical Research under the Ministry of Health, states in India can now make informed decisions regarding the scaling, funding, and optimization of teleradiology services to meet the healthcare needs effectively.

Horizon scanning has become an important global tool to respond to the exponential growth in new health technologies and rapidly evolving health needs. This case study sought to gather core information needed to prioritize new HIV/AIDS technologies that have the potential to improve health system performance and to assess the prospects of using horizon scanning in Ukraine.

The EuroScan Toolkit (2014) and the PRITECTOOLS prioritization tool were employed for horizon scanning. The materials for the study included international and local databases of clinical trials, patents, academic publications; international horizon scanning and early assessment databases; and websites of public and charitable organizations, among others.

Three new health technologies were identified: the Harmony Portable Nucleoside Analog Analyzer based on RESTRICT technology; a machine learning model-based tool for identifying patients at risk of dropping out of HIV treatment; and a messages notification service for HIV-positive people. According to the request, the selected technologies enhance both short-term and long-term adherence to antiretroviral therapy (ART), reduce the risks of ART failure and resistance, and increase the effectiveness of behavioral interventions aimed at improving adherence. These technologies are at the marketing stage, which makes their potential integration into the Ukrainian health system feasible and necessitates informing relevant decision-makers about them.

As a result of using the horizon scanning tool according to the EuroScan Toolkit, new technologies were identified for patients with HIV/AIDS. Information was collected regarding available clinical evidence, expected clinical and organizational changes, legal, ethical, social, and environmental consequences, and economic impact. This makes it especially relevant in the context of developing a health technology assessment guideline for medical devices in Ukraine.

From the 1,255 technologies submitted to Brazil’s National Committee For Health Technology Incorporation (CONITEC) from its creation in 2012 to November 2024, 26 percent were either products or procedures. The specifics of these technologies, from the available evidence to their implementation, have consequences for the health technology assessment (HTA) process. To deal with these, CONITEC was divided into three committees, one of which specializes in health products and procedures, along with a subcommittee to support it.

The aim was to present how the Products and Procedures Subcommittee has contributed to improving CONITEC’s evaluations since its first meeting in May 2023. A qualitative evaluation was conducted using the Subcommittee’s meeting minutes and CONITEC’s recommendation reports to identify technologies reviewed by the Subcommittee and its inputs into the HTA reports. The name of the technology and its indication, evaluation status, and theme were extracted from CONITEC’s website for each of the products or procedures submitted for evaluation.

The subcommittee evaluated 29 topics, including three products and 19 procedures, that were assessed by CONITEC. The remaining seven were conformity analyses, whereby documents are assessed for completeness and the eligibility of the technology for the HTA process is evaluated with respect to the health system’s norms. The most frequent topic areas were oncology (38%), neurology (10.3%) and gastroenterology (10.3%). The subcommittee supported CONITEC by providing data or discussing, for instance the installed capacity of positron emission tomography and computed tomography; potential barriers to implementing cervical cancer screening; the technical specificities of urinary porphobilinogen assay tests; and expanding nomenclature to enable competition on the Rapid Direct Multiplex Polymerase Chain Reaction Test.

The subcommittee has improved the HTA process by bringing together stakeholders from within and outside the Ministry of Health. It enables a broader evaluation of technologies and facilitates technical improvements, corrections, and the incorporation of additional data. This streamlines the HTA process and technology implementation by anticipating challenges and fostering collaboration to articulate effective solutions.

In Brazil, national recommendations on health technology assessment (HTA) are carried out differently in the public and private healthcare domains by the National Supplementary Health Agency (ANS) and the National Committee for Health Technology Incorporation (CONITEC), respectively. Nevertheless, since 2018, the ANS officially began aligning its HTA process with the CONITEC process.

This research employed a qualitative methodology to analyze the ANS and CONITEC HTA processes. Key documents, including laws, guidelines, and policy papers, were gathered from official websites of Brazilian government institutions and national legislation relating to the incorporation process in the period from 2018 to 2024. These texts were subjected to a thematic analysis to identify recurring patterns, discrepancies, and regulatory philosophies. The aim was to compare how different frameworks address common issues such as compliance, enforcement, and stakeholder engagement. The data were analyzed with the support of NVivo software.

The main changes identified involved aligning the incorporation process through standardized evaluation methods, including evidence assessment, economic evaluation, and budget impact analysis. Notably, the analysis deadlines for cancer treatment technologies were shorter in supplementary health (120 days, extendable by 60 days), compared with the public system (180 days, extendable by 90 days). If the supplementary health agency cannot complete the evaluation on time, tacit incorporation occurred. Additionally, technologies recommended by CONITEC were automatically included in the supplementary health framework, ensuring efficient access to effective treatments.

Aligning HTA methods enhances transparency and optimizes analyses. However, certain changes, like mandatory incorporation upon deadline non-fulfillment, were implemented by the legislative branch without comprehensive discussion of their effects on the health system. This lack of dialogue raises concerns about the long-term implications for effective healthcare delivery and stakeholder trust.

Migraine is a neurological condition with significant impacts on quality of life, productivity, and healthcare costs. In Chile, understanding the economic and health burden of migraine in a closed health center, such as the FUSAT hospital, is essential to generate evidence of the burden associated with the pathology and to define effective strategies for its management.

This retrospective study used clinical and claims data collected at the FUSAT Hospital between 2018 and 2023. Patients with diagnosis of migraine were identified and information from outpatient consultations, emergency care, hospitalizations, and sick leave were analyzed. Costs were adjusted to 2023 values and comorbidities were evaluated

Migraine diagnosis was found in 2.8 percent (n=395) of the FUSAT population, predominantly in women aged 45 to75 years. Hypertension (30.1%), anxiety (28.6%), and depression (12%) were frequent among migraine patients. Regarding healthcare costs, the annual expenditure for a patient with migraine was 25 percent higher than the costs reported for patients without migraine. Concerning sick leaves, 12 percent of the migraine population reported at least one sick leave, with an expected cost per patient of CLP2,854,700 (USD2,854), which represents a 20 percent increase in comparison to the average FUSAT patient.

Migraine represents a significant economic and social burden in the FUSAT, mainly affecting women between the ages of 45 and 74 years. The study highlighted the need for specific, tailored interventions focused on optimizing resource usage and health outcomes. Furthermore, a risk-sharing model for rimegepant, based on performance, was proposed for the preventive management of migraine in FUSAT.