The European Health Technology Assessment Network (EUnetHTA) Work Package 5B1, is focused on testing the levels of cross-border collaboration on real world data for supporting reimbursement/pricing decision-making. Within this Work Package, we are conducting a pilot on Left Ventricular Assist Device on destination therapy in collaboration with the National Institute for Health and Care Excellence (NICE, UK), the Belgian Health Care Knowledge Centre (KCE, Belgium) and the Italian National Agency for Regional Health Services (AGENAS, Italy). This pilot aims to define the minimum data set for gathering and sharing high quality registry data on key uncertainties found at the time of the health technology assessment (HTA). Furthermore, the pilot will assess the feasibility of carrying out a common analysis or reusing this data for National or Joint Reassessments.

Evidence gaps were based on the four national assessments. Collaborating partners were responsible for agreeing on the key outcomes and proposing the minimum dataset to be registered. European clinical experts and patients rated and prioritized the dataset using a two round Delphi technique (not relevant, important but not critical; critical). The dataset will confirm the basis for the Spanish LVAD registry, implemented at the national health service level to inform inclusion into the healthcare portfolio.

The key outcomes agreed upon by agencies relate to safety, effectiveness, satisfaction and acceptability of the patient and cost-effectiveness, budget impact and organizational impact. Expert cardiologists and cardiac surgeons representing the European and Spanish Society, among others, participated in the prioritization of basic data. The final dataset is expected by December 2020.

The variation in the quality and definition of outcome measures for measuring key evidence gaps reduces the utility of registries for HTA, making it difficult to compare, link, and aggregate data across countries. The EUnetHTA pilot is intended to offer a model for cross-border collaboration on real world data for supporting the decision-making process for pricing and reimbursement.

Mini health technology assessment (HTA) reports have been used to support policy makers and health systems by providing a timely summary of scientific evidence. The objective of this meta-epidemiologic study was to evaluate the quality of reporting of mini-HTA reports published in Brazil.

An electronic search for all mini-HTA reports published between 2014 and March 2019 was conducted in the SISREBRATS and CONITEC databases. The study selection and data extraction were performed by two independent assessors. The following data were extracted: bibliographic data; research question; characteristics of the population, health technologies and outcomes assessed; eligibility criteria; information about searches and study selection; risk of bias assessment; quality of evidence assessment; synthesis of results; and recommendation about the technology evaluated. A descriptive analysis was used to summarize the information retrieved from all the included mini-HTA reports.

We included 103 mini-HTA reports, the great majority of which (92.3 percent) focused on the coverage of the technologies in the healthcare system, with more than 60 percent being about drugs. Only five mini-HTA reports (4.8 percent) gave reasons for the choice of outcomes, and fifteen (14.5 percent) discriminated between primary and secondary outcomes. All mini-HTAs reported the databases searched and 99 percent of them reported using Medline. Sixty percent of the mini-HTA reported assessing the risk of bias, and 52 percent reported assessing the quality of evidence.

The quality of reporting of the mini-HTA reports performed in Brazil is insufficient and needs to be improved to guarantee transparency and replicability.

Through technological innovations based information and communication technologies (ICT), advantageous telediagnostic systems can be developed to improve the health care of remote populations (1). In the context of universal coverage and the efficient use of available resources, there is a favorable opportunity to develop telemedicine towards an integrated ecosystem to improve health care in remote locations without access to specialists. This study, performed by the Telemedicine Unit (MoH) in collaboration with the Biomedical Engineering Dept (IICS-UNA) and the Basque Country University (UPV/EHU) evaluated a telediagnostic system implemented in 2014 in public health. The results of a cost utility analysis for this telediagnosis project in remote, regional and district hospitals in Paraguay are presented.

This is a prospective study, where the results of using telediagnosis implemented in remote hospitals over three years 2014–16 were evaulated. For these purposes, a utility analysis was carried out by comparing the cost of performing telediagnosis versus performing it “face to face” in a diagnosis center in the capital city.

During the study 182,406 remote diagnoses were performed in the fifty-four remote hospitals using the telediagnosis tool. Of the total, 37.3 percent (68,085) corresponded to tomography (CT), 62.0 percent (113,059) to electrocardiography (ECG), 0.68 percent (1,243) to electroencephalography (EEG) and 0.01 percent (19) to ultrasound studies. The average cost of a tele-tomography, tele-ECG and tele-ultrasound was USD2.6, and USD8.6 for tele-EEG, respectively. The cost reduction through the telediagnosis was 26.4 times for tomography, 4.5 times for ECG, 8.0 times for EEG and 8.3 times for ultrasound. The cost utility analysis performed demonstrates an economic benefit of USD12.9 million to the citizens of the fifty-four communities included in this project.

Despite the potential benefit of the telediagnosis (2) to facilitate the universal coverage, and optimize the use of scarce human and health financial resources shown in this study, other important aspects such as acceptance of the technology, patient satisfaction and a widespread use-assessment should be analyzed (3) before a large diffusion.

To inform the development of a national clinical guideline for Chronic Obstructive Pulmonary Disease (COPD), prioritised by the National Clinical Effectiveness Committee (NCEC) in Ireland, a systematic review was conducted to examine the cost-effectiveness of long-acting beta2-agonists (LABAs) in combination with long-acting muscarinic antagonists (LAMAs) compared with LAMA or LABA monotherapy.

Medline, Embase, the Cochrane Library and grey literature sources were searched up to 19 June 2018. Studies evaluating cost-effectiveness published post-2008 in English were included. Screening, data extraction, and quality assessment using the Consensus Health Economic Criteria (CHEC-list) and International Society for Pharmacoeconomics (ISPOR) questionnaires were conducted independently by two reviewers. Costs were adjusted to 2017 Irish Euro using consumer price indices and purchasing power parity as per national guidelines.

From a total of 8,661 articles identified, nine studies (all cost-utility analyses) were included in the review. Studies ranged from low to high quality and compared LAMA/LABA combination therapy with LAMA monotherapy. The results reported were mixed, ranging from combination therapy being dominated by (that is, more costly and less effective than) LAMA monotherapy to being dominant (that is, less costly and more effective). However, when excluding low quality, less applicable studies, the remaining six studies reported incremental cost-effectiveness ratios (ICERs) of between EUR 2,770 and EUR 26,462 per quality-adjusted life year (QALY) gained. Only one study additionally compared LABA monotherapy as a comparator, reporting combination therapy to be even more cost-effective than in the LAMA monotherapy comparison.

Applying a cost-effectiveness willingness-to-pay threshold of EUR 45,000 per QALY gained, this systematic review found that LAMA/LABA combination therapy is cost-effective compared with LAMA or LABA monotherapy in COPD patients.

The case-mix method involves combining cases with similar complexities and medical services. The process of treating one episode of the disease and receiving treatment is the research unit, thus achieving different medical units. The feasibility of the calculation method is verified by calculating the public hospital consumption ratio, medical income, health materials expenditure indicators, and the differences between the various types of surgical combinations. A decision-making basis can then be provided for the creation of government indicator standards.

Medical records and data on the expenditure of medical consumables for the first and fourth quarters of 2017 were collected from seven third-class provincial hospitals. The medical consumption ratio for different diseases and surgical methods was calculated for the case-mix groups using a weighting method. Data were analyzed by descriptive statistics and the independent samples t-test.

There were significant differences in the proportions of combined use for different types of diseases. The same combination also had significant differences between different hospitals. In the fourth quarter of 2017, the operating group's consumption ratio was significantly lower than in the first quarter (p = 0.000).

It is reasonable to calculate the proportion of consumption by combined weighted analysis, which is also fairer for hospitals with better technical levels. This calculation method can be used by governments to manage the use and cost of medical consumables in hospitals.

In order to facilitate patient information, patient involvement, and to support patient-centered care, healthcare organizations are increasingly offering access to patient data that are stored in the institution-specific electronic health record (EHR). Patients can access these data, read, and print them, or download and integrate them into any type of patient-held record. This EHR access is typically web-based and called “patient portal” allowing the independent access via the Internet from everywhere. A patient portal may also offer additional features such as prescription requests, appointment booking, messaging, personal health-related reminders, individual therapeutic recommendations, personal diaries, and social networking with other patients. In a Cochrane review, we assessed the effects of providing access to EHR for adult patients on patient empowerment and health-related outcomes compared to usual care.

According to the methods of evidence-based medicine, we developed a protocol for a Cochrane review, which is published in the Cochrane database.

We identified ten randomized controlled trials (RCTs) including 6,668 randomized participants. Seven RCTs took place in the USA, two in Canada, and one in Japan. Additional functionalities of interventions and disease conditions were heterogeneous. Three studies (n = 601) reported on patient empowerment. The risk differences reported were neither statistically significant nor clinically relevant. Eight studies (n = 2,070) reported on nine different risk factors (blood pressure, blood glucose, poor asthma control, 10-year Framingham risk score, cholesterol, body mass index, composite score of eight variables, intraocular pressure, composite score of three variables). The results were heterogeneous. Mostly there were no statistically significant risk differences between study groups.

Overall, there is no evidence for a clear positive effect of patient portals on patient empowerment and health related outcomes (mainly risk factors). However, we identified only a small number of studies. The usage of portals was often low and several studies were older.

This article retrospectively examines the evolution of rapid assessments (RAs) produced by the Health Technology Assessment (HTA) Program at the Institute of Health Economics over its 25-year relationship with a single requester, the Alberta Health Ministry (AHM).

The number, types, and methodological attributes of RAs produced over the past 25 years were reviewed. The reasons for developmental changes in RA processes and products over time were charted to document the push–pull tension between AHM needs and the HTA Program's drive to meet those needs while responding to changing methodological benchmarks.

The review demonstrated the dynamic relationship required for HTA researchers to meet requester needs while adhering to good HTA practice. The longstanding symbiotic relationship between the HTA Program and the AHM initially led to increased diversity in RA types, followed by controlled extinction of the less fit (useful) “transition species.” Adaptations in RA methodology were mainly driven by changes in best practice standards, requester needs, the healthcare environment, and staff expertise and technology.

RAs are a useful component of HTA programs. To remain relevant and useful, RAs need to evolve according to need within the constraints of HTA best practice.

The Canadian Agency for Drugs and Technologies in Health (CADTH) Common Drug Review and pan-Canadian Oncology Drug Review programs incorporate perspectives and experiences from patients and family members who might be affected by the resulting funding recommendation. Perspectives are provided by patient groups who use different approaches to gather patient input.

We analyzed a random sample of ninety-three patient input submissions, drawn from a sampling frame of 532 submissions given to CADTH between June 2010 and June 2016. We looked at how groups described their information gathering methods in the original submissions or the published Clinical Guidance Reports.

Approaches were categorized according to whether they involved primary (n = 86) or secondary data collection (n = 130) and further sub categorized according to how data was collected. Primary data included: personal experiences, as described by the submission's author (n = 16); surveys conducted specifically for the submission (n=34); and new interviews of patients and family members on disease and drug experiences (n = 36). Half (forty-seven of ninety-three) of the patient input submissions included experiences of one or more patients who had received the drug under review. Secondary data included: published literature (n = 31); existing surveys (n = 27); past conversations with patients and family members (n = 36); experiences of patient group staff interacting with patients and family members (n = 19); and advice from clinical experts (n = 17). Many patient input submissions (sixty-eight out of ninety-three) reported multiple approaches to collect data. Use of two approaches was most common (thirty-seven out of ninety-three) with five or six approaches used in three of ninety-three submissions.

Despite resource and timing challenges, many patient groups gather primary data to share with CADTH and find individuals with experience of the drug under review.

Most European countries use Health Technology Assessment (HTA) as input for decisions on reimbursement of (new) medicines. In 2018, following the approval of European Social Funding, the Directorate for Pharmaceutical Affairs (DPA) within the Malta Ministry for Health led a specific Work Package aimed at enhancing knowledge, skills and HTA processes to inform reimbursement decisions.

Since the start of the project, the Institute for Medical Technology Assessment (iMTA) and the National Health Care Institute of the Netherlands (ZIN) collaborate in providing guidance and training to DPA on relative effectiveness assessments (REAs) and pharmacoeconomic assessments (PEAs) of pharmaceuticals. Several activities were organized: site visits, face-to face interviews with stakeholders, a qualitative assessment of the core process of the Maltese system, health economics training and tutorials, meetings introducing the European Network for Health Technology Assessment (EUnetHTA) and Dutch HTA processes, development of a new framework for assessment, and a shadow assessment.

Our assessment identified important methodological challenges and crucial processes interdependencies to optimize within the Maltese system. Based on the learnings, DPA created a template based on the EUnetHTA REA assessment format. IMTA created a template to perform PEAs. Currently, a shadow assessment is ongoing in which DPA performs the REA and PEA of a pharmaceutical using the new templates. ZIN and iMTA will provide feedback to DPA on several aspects, including, but not limited to, the PICO, assessment of therapeutic efficacy and safety, identifying uncertainties, input costs and effects, and formulating a clear discussion of the assessment. If necessary, the templates will be adapted during the process. The project will be evaluated and finalized in 2022.

With the guidance and training provided by iMTA and ZIN, DPA structured and aligned their REA and PEA to enhance their assessment process and to improve the presentation of their HTA report to the two appraisal committees. This project emphasizes the importance of international collaboration to enhance HTA processes within the