The Brazilian health system has not been able to enforce the constitutional Right to Health for the entire population, leaving litigation as the last alternative for the fulfillment of the right. In order to harmonize and underpin the decision making of federal judges, an Academic Detailing (AD) program with concepts of evidence-based medicine and health policies for federal judges will be conducted nationwide in Brazil. AD is a strategy to provide information, combining an interactive outreach approach with the best evidence. This study reports the method used to define key messages to be used during visits.

Government, federal judges and academy representatives were invited to a workshop on health litigation in Brazil. They were divided into six groups to discuss five hypothetical scenarios. In each scenario, groups listed two possible key messages to disseminate during AD, addressing the legal, scientific, economic or ethical dimensions. After the definition, a vote was taken, according to the importance that each participant attributed to them (1 to 10), and then a score was generated.

Of the thirty-one participants, five were from the judiciary, three prosecutors, one health insurance representative, nine managers and thirteen from the academy. From the case study presented, fifty-five key messages were suggested. After removing duplicates, twenty-five were selected to assign importance values by each participant. The key messages were sorted from highest to lowest score, the most important being “Explain what evidence-based medicine means and what scientific evidence means”.

Knowledge of theoretical concepts of evidence-based medicine, health policies and the technology incorporation process seem to be of fundamental importance to federal judges. This information will serve as a basis for decision making regarding litigious proceedings involving the constitutional Right to Health in Brazil. From the selected key messages, bulletins to the academic detailing program to federal judges shall be produced.

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.

This study aimed to introduce a pilot program for hospital-based health technology assessment (HB-HTA) in China and present the participants’ experiences based on seven case studies from seven tertiary hospitals.

One-year pilot projects were initiated at the beginning of 2018. Seven pilot hospitals were closely followed from the beginning until the completion of their pilot HTA project. Regular interviews were conducted with the hospital managers leading the HB-HTA projects and key members of the special HTA teams. Observations were made based on field trips and written HTA reports.

Three pilot projects evaluated the use of medical consumables, three evaluated the use of surgical or medical interventions, and one evaluated an innovative management model for ventilators. Real-world data were collected from all the pilot projects to assist with the assessments. Most HB-HTA pilot projects achieved remarkable results such as improvements in economic efficiency; however, there were also obvious deficiencies such as the lack of a necessary cost-effectiveness analysis.

The results varied among the seven HB-HTA pilot projects. The HB-HTA pilot program was implemented to promote the use of HB-HTA in hospital decision making in China. At the same time, HB-HTA in China faces challenges. We have made some policy recommendations based on the findings of the pilot projects.

Consistently high-quality health care is expected throughout Europe while concurrently, financial resources of member states are decreasing. National Health Technology Assessment (HTA) institutes are informing evidence-based reimbursement decisions in the national context, leading to redundancies in HTA production and tying up limited resources. Since 2006, the European Union project, the European Network for HTA (EUnetHTA) is aiming at enhancing the efficient use of HTA resources and facilitating transnational collaboration. Our aim is to present previous experience in joint assessment of medical devices. Furthermore, possible benefits of European collaboration for stakeholders will be discussed.

Processes and challenges of the completed EUnetHTA Joint Action (JA) 2 are summarized and discussed. Benefits, aims and opportunities of the ongoing EUnetHTA JA 3 are described.

Six rapid assessments of medical devices, focusing on the assessment of effectiveness and safety, were published during EUnetHTA JA 2. Challenges in European medical device assessment encompass the choice of topics, the time point of assessments and the lack of European standards for systematic patient involvement. Characteristics of medical devices, like learning curves, call for monitoring them throughout their lifecycle.

The benefit of European collaboration for stakeholders is manifold: uncertainty with regard to actual added value of a technology is minimized through Early Dialogues; harmonized and transparent assessment processes increase the quality of reports; work division among HTA organizations allows a resource-efficient assessment of a bigger amount of technologies; patient involvement ensures consideration of patient relevant endpoints.

The importance of cross-border collaboration in HTA is shown in the continuation of the EUnetHTA project, which aims to sustainably strengthen international collaboration even after expiration of EU-funding.

European collaboration in medical device assessment can ensure cross-border health care and efficient cooperation of national health systems. The focus should be set on a wide implementation of jointly established methods and quality standards. The European collaboration can lead to a concrete benefit for various stakeholders.

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.

The strategic MedTech investment for the expansion of a central London paediatric hospital must sustain its ambitions to remain a state-of-the-art hospital, whilst implementing recent and future MedTech innovations and taking into account spatial and financial limitations. Horizon scanning (HS) is an important health technology assessment (HTA) tool to achieve these goals. To this end, we developed a methodology to help decide the suitability of investing in the following imaging-based MedTech: a hybrid theatre incorporating a biplane, intra-operative MRI (iMRI), multi-detector computed tomography (CT) scanners, and an EOS imaging system and predict the complementary technologies required for the decade to come. These technologies not only require adequate spatial resources but a significant upfront capital investment.

Three sources of information were used: i) a literature search, selected journals and other horizon scanning resources that examined current efficiency, safety, and cost-effectiveness for the proposed technologies, ii) expert elicitation in the form of user-group meetings and one-to-one discussions with clinical and service management teams and iii) hospital data consisting of audit and information from capital equipment bids.

With the exception of limited comparative data on iMRI (mainly including adults), little evidence exists to support investment in the proposed technologies. However, the decision of whether to adopt these technologies was influenced not only by existing evidence on the proposed technologies and associated cost but other factors such as local disease burdens, hospital staff requirements (training, expertise), space requirements for the new MedTech, and its impact on organizing healthcare services and hospital workflows. Complementary technologies associated with radiation monitoring image visualization and control were identified.

Strategic MedTech investment requires a holistic approach that assigns equal weight to information arising by expert elicitation and hospital audit data with existing literature evidence. The decision for adoption is heavily influenced by the clinical expertise and hospital workflows.

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.

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 pan-Canadian Oncology Drug Review (pCODR) evaluates new cancer drugs for public funding recommendations. While pCODR's deliberative framework evaluates overall clinical benefit and includes considerations for exceptional circumstances, rarity of indication is not explicitly addressed. Given the high unmet need that typically accompanies these indications, we explored the impact of rarity on oncology HTA recommendations and funding decisions.

We examined pCODR submissions with final recommendations from 2012 to 2017. Incidence rates were calculated using pCODR recommendation reports and statistics from the Canadian Cancer Society. Indications were classified as rare if the incidence rate was lower than 1/100,000 diagnoses, a definition referenced by the Canadian Agency for Drugs and Technologies in Health. Each pCODR final report was examined for the funding recommendation/justification, level of supporting evidence (presence of a randomized control trial [RCT]), and time to funding (if applicable).

Of the ninety-six pCODR reviews examined, 16.6 percent were classified as rare indications per above criteria. While the frequency of positive funding recommendations were similar between rare and nonrare indication (78.6 vs. 75 percent), rare indications were less likely to be presented with evidence from RCT (50 vs. 90 percent). The average time to funding did not differ significantly across provinces.

Rare indications appear to be associated with weaker clinical evidence. There appears to be no association between rarity, positive funding recommendations, and time to funding. Further work will evaluate factors associated with positive recommendations and the real-world utilization of funded treatments for rare indications.

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.

Various forms of outcomes-based or risk-sharing agreements have been implemented since early 2000s as a way of access to innovative medicinal products. This study aims to summarize the international experience of performance-based risk-sharing arrangements (PBRSAs) and identify the preconditions for a successful implementation of such schemes. Their implications for the Chinese healthcare market are discussed.

A systematic literature review (in PubMed) was conducted to review the evidence on the nature and performance of PBRSAs in the past 10 years. Grey literature was searched for reports in government websites of the countries in scope.

The search identifies 463 records from PubMed and 3 additional records from other sources. Thirty-one publications are included in the final review. The following preconditions were identified to support a successful implementation of PBRSAs: (1) Identify meaningful and feasible outcome measurements; (2) Establish an effective and efficient data collection infrastructure; (3) Control of the implementation costs; (4) Develop governance and administrative infrastructure to allow delisting and rebate/refund; (5) Clarify personal data protection issues.

The implementation of PBRSAs has proven to be challenging. Although the Chinese healthcare system is not yet well equipped to implement such schemes, some recent changes may pave the way to successful PBRSAs for particular innovative products.

Coverage of childhood cancer treatment under the Ghanaian National Health Insurance Scheme (NHIS) has been a policy discussion recently. To improve priority setting, Ghana introduced and used health technology assessment (HTA) processes to guide the resource allocation. To understand the role of stakeholders throughout the HTA lifecycle and for this decision, a stakeholder mapping and engagement was undertaken. We share our results of this mapping and analysis for improving management and financing of childhood cancers in Ghana.

We used two main approaches; first, we undertook a systematic policy documents and literature review of stakeholders relevant in childhood cancer management and financing in Ghana. This was followed by a stakeholder engagement workshop of key stakeholders from the Ministry of Health, Ghana Health Service (GHS), National Health Insurance Authority (NHIA), academia, non-governmental organizations (NGOs), private sector, teaching hospitals, patient groups, and civil society organizations. Participation was done in-person and virtual. Questions were moderated using a focus group discussion approach where responses were recorded. Data were analysed using synthesis and development of themes. Mapping of stakeholders was done using Mendelow’s power-interest grid.

The mapping identified eight key stakeholders in different roles: policy makers (Ministry of Health), payer (NHIA), healthcare providers (teaching hospitals, GHS, private hospitals), pharmaceutical companies, patient group (Ghana Parents Association for Childhood Cancers), and advocacy group (NGOs). Analysis showed that power and interest are concentrated with Ministry of Health and NHIA primarily because of control over resources. Also, while healthcare providers, patient groups, and advocacy groups have high interest, their power ranges from low to moderate. Further analysis of data from the workshop revealed that inability to pay for high cost of treatment leads to treatment abandonment. Payment for treatment was mainly out-of-pocket and by donation from philanthropist.

There was a strong will from stakeholders to extend coverage of the NHIS to childhood cancers in Ghana. Stakeholder engagement is a powerful tool and should be an integral part of every HTA process.