Evidence requirements and assessment methods access differ between health technology assessment (HTA) agencies. The HTA Core Model® provides a standardized approach to HTA, targeting evidence sharing and collaboration between participating HTA bodies. It is fit for purpose from an industry perspective and was used by pharmaceutical company Roche to develop a framework for internal assessment of evidence required for market access and coverage/reimbursement (“access evidence”).

Tools were developed to systematically scope, assess, plan, and summarize access evidence generation. The tools were based mainly on the first four HTA Core Model® domains and rolled-out in selected development teams in 2017. Five months after full implementation, the impact of tools was assessed in an internal survey.

Systematic access evidence generation started with the Access Evidence Questionnaire, to scope evidence requirements and identify evidence gaps. Findings were summarized in the Access Evidence Metric, which assessed the alignment of available/planned evidence against HTA bodies’ requirements and developed scope mitigation strategies. The Access Evidence Plan was then used to plan and document (additional) evidence generation. Once generated, evidence was summarized in the Access Evidence Dossier. A survey of twenty-seven Roche employees involved in evidence generation showed that the tools made discussions around access strategies and evidence more efficient and transparent.

The HTA Core Model® provided a useful framework around which to optimize internal evidence generation and assessment. The benefits of using a standardized HTA approach in industry mirror those expected from implementing the HTA Core Model® in HTA agencies.

The aim of this study was to develop a feasible and effective strategy to involve patients in the Spanish Network of Agencies of Health Technology Assessment (RedETS).

The framework for patient involvement (PI) in the assessment activities and processes of RedETS were developed through a research project that included: (i) a systematic search of the international literature describing a strategy and/or a methodology linking health technology assessment (HTA) and PI; (ii) a qualitative study through interviews with RedETS members to analyze the perceptions of PI among HTA managers in the Spanish context; (iii) a Delphi consultation with three large platforms of patients, carers and consumer organizations in Spain about their perspectives of PI; (iv) a consensus process with the members of the RedETS Governing Council to define the final strategy.

Three main themes were identified in the literature and Web site review: (i) PI methods for the different HTA phases; (ii) Participant definition and selection; (iii) Resources needed. A three-step implementation strategy was proposed: (i) short-term actions: piloting and testing patient participation in HTA and building patients' capacity; (ii) medium-term actions: broadening the participation of patients, and building internal capacity; (iii) long-term actions: consolidating and mainstreaming patient involvement

Patient participation can be incorporated into almost all the HTA phases and products with greater or lesser degrees of difficulty. However, a progressive implementation strategy is suggested for a feasible PI process.

Early assessment can assist in allocating resources for innovation effectively and produce the most beneficial technology for an institution. The aim of the present study was to identify methods and discuss the analytical approaches applied for the early assessment of innovation in a healthcare setting.

Knowledge synthesis based on a structured search (using the MEDLINE, Embase, and Cochrane databases) and thematic analysis was conducted. An analytical framework based on the stage of innovation (developmental, introduction, or early diffusion) was applied to assess whether methods vary according to stage. Themes (type of innovation, study, analysis, study design, method, and main target audience) were then decided among the authors. Identified methods and analysis were discussed according to the innovation stage.

A total of 1,064 articles matched the search strategy. Overall, thirty-nine articles matched the inclusion criteria. The use of methods has a tendency to change according to the stage of innovation. Stakeholder analysis was a prominent method in the innovation stages and particularly in the developmental stage, as the introduction and early diffusion stage has more availability of data and may apply more complex methods. Barriers to the identified methods were also discussed as all of the innovation stages suffered from lack of data and substantial uncertainty.

Although this review has identified applicable approaches for early assessment in different innovation stages, research is required regarding the value of the available data and methods and tools to enhance interactions between different parties at different stages of innovation.

Although self-care can control and prevent complications in hypertensive patients, self-care adherence is relatively low among these patients. Community-based telehealth services through mhealth can be an effective solution.

This study aimed to evaluate the effect and acceptance of an mhealth application as a community-based telehealth intervention on self-care behavior adherence.

This clinical trial included sixty hypertensive patients and their matched controls from two heart clinics affiliated to Shiraz University of Medical Sciences (SUMS). Self-care behaviors were assessed using Hill-Bone questionnaire before and after the intervention. Acceptability was evaluated in the intervention group at the end of the study period. The data were analyzed via SPSS 18 software using descriptive and inferential statistics.

The results showed a significant difference between the intervention and control groups regarding the mean score of self-care behaviors (4.13 ± 0.23 versus 3.18 ± 0.27, p < .001). Additionally, a significant difference was observed between the two groups concerning the mean scores of the two subscales of self-care behaviors, including “medication taking” and “proper diet”. However, no significant difference was observed between the two groups regarding the mean score of “appointment keeping” (p = .075). Overall, the intervention group participants were satisfied (4.27 ± 0.34) with this approach for managing hypertension.

Community-based telehealth services through mhealth had the potential to improve self-care behaviors in hypertensive patients and seemed to be accepted by the patients in the intervention group.

As healthcare decision makers continue to face challenges in health services delivery to their patients, disinvestment programs are being established for a sustainable healthcare system. This study aimed to collect data and information by means of a survey of disinvestment candidates and ongoing disinvestment projects in the health technology assessment (HTA) community.

An online survey was conducted to collect information on disinvestment candidates and activities from members of the Health Technology Assessment International Disinvestment & Early Awareness Interest Group, the EuroScan International Network and International Network of Agencies for Health Technology Assessment.

Among the 362 invitees, twenty-four unique responses were received, and almost 70 percent were involved in disinvestment initiatives. The disinvestment candidates identified represented a range of health technologies. Evidence or signaling of clinical ineffectiveness or inappropriate use typically led to the nomination of disinvestment candidates. Health technology assessments and reassessments were usually conducted to evaluate the technology in question, and decisions usually led to the limited use of the technology. Barriers to disinvestment decisions included the strength of interest and advocacy groups, insufficient data for assessments, a systematic decision process and political challenges, while obstacles to their implementation were clinicians’ reluctance and insufficient funding and incentives.

The survey results suggested that disinvestment activities are occurring in the HTA community, especially in the public sector. Future research can further investigate the processes and methods used to reach and implement disinvestment decisions from our survey respondents and explore to form closer ties between the HTA and clinical communities.

As more health technology assessment (HTA) bodies seek to implement patient involvement, there is a desire to learn from other HTA bodies about their experiences and understand what approaches can be used and which ones make a real difference to HTA. This is difficult, as the impact of patient involvement in HTA is not well documented. This study aims to promote further discussion about the ways in which patient involvement can impact HTAs by studying stories of impact.

In a multi-stakeholder workshop, experts leading patient involvement in four HTA bodies shared examples of HTAs where they believed patient involvement made a difference, then they reflected on these impact stories within the wider context of impact evaluation.

The HTA bodies drew on patient input and patient-based evidence to inform their HTAs. The patient involvement was observed to elucidate patients’ experiences, needs and preferences which, in turn, was observed to influence the HTA recommendations about optimal use of technologies, including taking account of issues for sub-groups, outcomes that matter to patients and educational needs.

Personal stories of patient involvement may enable a wider understanding of different approaches to and impact of patient involvement. The examples relate to both patient input and patient-based evidence and highlight the role that patient involvement can play in reducing uncertainties and complementing the clinical and economic evidence in HTA. They suggest that impact can be seen in recommendations about how and when a technology is used.

Telerehabilitation shows promise in many fields though strong evidence of benefit has been limited. We reviewed progress in the use of telerehabilitation for persons with chronic obstructive pulmonary disease (COPD). A challenge in caring for persons with this condition is the ability to achieve high levels of patient participation and compliance with rehabilitation processes.

Relevant publications were identified through literature searches from November 2009 to May 2018. We selected those that described studies of telerehabilitation in the management of COPD and reported clinical or administrative outcomes. Study quality was assessed using an approach that considers both study performance and study design. Judgments were made on whether the telerehabilitation application had been successful, if reported outcomes were clinically significant, and if further data were needed to establish the application as suitable for routine use.

Twenty-five publications, on 26 studies, were selected. Twelve were of high or good quality. In 11 studies the telemedicine application was successful. Nine studies had unsuccessful applications, and for six studies success was unclear. Further data before routine use would be required or desirable for all successful applications. In many studies there were difficulties associated with availability of skilled mentors, motivational support for patients and access to reliable remote monitoring and communication technology.

Various types of telerehabilitation are potentially helpful in the management of COPD. Availability and access to these technologies should improve. However, in management of this clinically challenging condition their use must be linked to suitable training and education of patients with COPD and timely support for them from healthcare professionals.

Healthcare organizations have invested efforts on hospital-based health technology assessment (HB-HTA) and enterprise risk management (ERM) processes for novel systems to obtain more accurate data on which to base strategic decisions. This study proposes to analyze how HB-HTA and ERM processes can share personal resources and skills to achieve principles with value-oriented results.

Literature on ERM and HB-HTA and data from interviews with healthcare managers compose the research data sources, which were submitted to a qualitative data analysis. It was oriented to identify the association between ERM and HB-HTA application in hospitals and the common principles between both processes, in addition to proposing the capability to share personal resources between both teams in a matrix.

The common principles and personal background suggested for HB-HTA and ERM teams allowed the build of a matrix identifying how both teams can work in an integrated manner being more effective and value-oriented. The shared resource matrix reports how each professional (with a specific background) may interact with each activity associated to HB-HTA or ERM implementation guidelines.

The identification of common principles and capabilities between ERM and HB-HTA suggested advances with the literature from both research areas. The opportunity to share personal resources also contributes to the implementation of those processes in hospitals with less financial resources, approaching its own management to be more efficient with the care chain.

Ethics has been considered among the core domains of health technology assessment (HTA), but there are still disputes regarding ethical analysis. This study aimed to examine full final reports of the European Network for Health Technology Assessment (EUnetHTA) in terms of their compliance with the ethical methodology and ethical perspective of the HTA Core Model®.

The study examines seven full final HTA reports of EUnetHTA written based on the methodology proposed in the HTA Core Model®. The reports were analyzed using the following parameters: competency of the person/group who conducted ethical analysis, assessment elements, and the methodology of ethical analysis.

The results show that, although the HTA Core Model® helped to standardize the final reports of the assessment, there are still concerns regarding the competency of the ethical analysis team, the perspectives on the purpose of ethical analysis, data sources and viewpoints of various stakeholders, use of ethical analysis methodology, and the evaluation of the ethical appropriateness of the entire HTA process.

The HTA Core Model® helped to standardize the final reports on the HTA; however, not all issues with the content and outcomes were solved. The lack of expertise in ethics and insufficiency of the teams regarding ethical analysis are other existing problems. This study also demonstrated that stakeholder viewpoints in general and patient perspectives, in particular, have been overlooked in the HTA process.

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.

Social and cultural aspects are rarely assessed in health technology assessments (HTA), despite being part of most HTA definitions. One hypothesis for the reason why they are hardly considered in HTA is that we lack relevant assessment methods. Accordingly, this review aims at providing an overview of methodological approaches to address social and cultural aspects related to health technologies in HTA.

We conducted a comprehensive literature search by searching fourteen databases and a hand-search of two pertinent journals. Additionally, we sent a query to all member agencies of the International Network of Agencies for Health Technology Assessment (INAHTA) asking them for methods they use to assess social and cultural aspects.

A total of 125 publications met our inclusion criteria. We grouped the methodological approaches into checklists for experts, literature reviews, stakeholder participatory approaches, primary data collection methods, and combinations of methodological approaches.

There is a wide variety of methods available for assessing social and cultural aspects of health technologies, some of which have been applied in HTA. The presented overview of the different approaches and their merits can facilitate the assessment of these aspects, and improve the knowledge regarding (potential) success and failure of the implementation of a health technology.

The aim of this overview was to systematically identify and synthesize existing evidence from systematic reviews on the impact of prehospital physician involvement.

The Medline, Embase, and Cochrane library were searched from 1 January 2000 to 17 November 2017. We included systematic reviews comparing physician-based with non–physician-based prehospital treatment in patients with one of five critical conditions requiring a rapid response.

Ten reviews published from 2009 to 2017 were included. Physician treatment was associated with increased survival in patients with out-of-hospital cardiac arrest and patients with severe trauma; in the latter group, the result was based on more limited evidence. The success rate of prehospital endotracheal intubation (ETI) has improved over the years, but ETI by physicians is still associated with higher success rates than intubation by paramedics. In patients with severe traumatic brain injury, intubation by paramedics who were not well skilled to do so markedly increased mortality.

Current evidence is hinting at a benefit of physicians in selected aspects of prehospital emergency services, including treatment of patients with out-of-hospital cardiac arrest and critically ill or injured patients in need of prehospital intubation. Evidence is, however, limited by confounding and bias, and comparison is hampered by differences in case mix and the organization of emergency medical services. Future research should strive to design studies that enable appropriate control of baseline confounding and obtain follow-up data for the proportion of patients who die in the prehospital setting.

This study sought to explore main barriers and facilitators to implementing health technology assessment (HTA) in Kuwait from the perspective of key stakeholders.

Semi-structured qualitative interviews were conducted with ten key stakeholders: seven healthcare providers working at various departments of the Kuwaiti Ministry of Health (MOH), and three academics with substantial experience in teaching HTA or related fields. Interviews were conducted face-to-face, audio-recorded, and transcribed verbatim. Data were analyzed using an inductive thematic approach.

Participating stakeholders reported several factors that might act as a barrier to building HTA in Kuwait: minimal awareness of HTA, lack of institutional and human capacity, a fragmented healthcare system, poor communication between researchers and policy makers, the country's wealth, politics, as well as data quality, availability, and sharing. Institutionalizing HTA as a politically empowered body, enforcing its recommendation by law, and benefiting from neighboring countries' experiences were suggested as possible ways to move forward.

Studies exploring the unique challenges that high-income developing countries may face in implementing HTA are still scarce. The results of this study are consistent with evidence coming from other developing countries, while also suggesting that the abundance of financial resources in the country is a double-edged sword; it has the potential to facilitate the development of HTA capacity, but also hinders recognizing the need for it.

This study's intent was to determine if a qualitative benefit risk framework could be used or modified to further enable Health Technology Reassessment (HTR) of prescription medicine recommendations. The purpose of this research was to understand Canadian Health Technology Agency assessors past experiences and insights to inform any modifications to the Universal Methodology for Benefit−Risk Assessment (UMBRA) qualitative framework. The UMBRA framework consists of an eight-step process, used during the assessment phase, to aid in decision making and dissemination.

A qualitative descriptive study was conducted and included a purposeful, criterion-based sample of eight assessors who had participated in Health Technology Assessment (HTA) or HTR for prescription medicines or in qualitative decision-making frameworks.

Participant interviews lead to four common themes: “adoption of a qualitative benefit risk framework,” “data (either too much or not enough),” “importance of incorporating stakeholder values,” and “feasibility of the UMBRA framework.” Methodological challenges with HTR were highlighted including the lack of clinical outcome data and the ability to compare clinically relevant meaningful differences. The implementation of a ranking or weighing process found within the UMBRA framework was not favored by half of the participants.

Research participants did not consider all steps of the UMBRA framework to be transferable to the assessment phase of HTR given the need for simplicity, resource efficiency, and stakeholder input throughout the process. The assessor experiences and insights and the resultant key themes can be used in future research to aid in the development of a qualitative recommendation framework for HTR.

There is no established methodology to assess the feasibility of medicine price data sources. Against this backdrop, a framework to guide the selection of most appropriate price data sources for pharmacoeconomic research has been developed.

A targeted literature review was carried out. Dimensions discussed in literature as relevant for medicine price comparisons and practical experience of the authors in medicine price studies informed the conceptional work of the framework development. A draft version of the framework was reviewed by peer pricing experts. The feasibility of the framework was tested in case studies.

According to the developed framework (called Re-ADAPT), a medicine price data source should meet the following criteria: reliability and sustainability; accessibility at a cost that users can afford; provision of medicine price information at the date(s) required; information for the defined geographic area, or at least in a representative way; coverage of the pharmaceuticals and at the price type(s) required. Easy handling and provision of additional information were defined as supportive assets of candidate data sources (secondary criteria). The case studies confirmed the feasibility of the Re-ADAPT framework. In some cases, however, it can be difficult to disentangle assessment criteria (particularly geographic area, scope of pharmaceuticals and price types) for separate consideration, given their interlinkage.

While selection of the most appropriate data sources will remain a challenge, the Re-ADAPT framework aims to provide practical guidance and thus contribute to a more careful, balanced, and evidence-based selection of data sources for medicine price studies.

The need for improving healthcare decision making by implementing health technology assessment (HTA) has been a top priority in Ukraine since 2016. This study sought to provide a tailor-made HTA implementation roadmap, drawing on insights from national stakeholders.

We conducted a survey using a questionnaire already applied in previous HTA research. We assessed the status of HTA when reforms were initiated in 2016 and examined perspectives on possible future developments among policy makers and representatives of pharmaceutical companies and patient organizations.

Thirty-two respondents answered the survey. Forty-eight percent of respondents were not aware of HTA training in Ukraine, but 91 percent preferred having either a graduate or postgraduate training. Experts stated that funding for HTA research and for critical appraisal of HTA submissions was limited, but in the future, they would increase funding mainly from public sources. A public HTA agency with academic support was the most preferred organizational structure. Eighty-eight percent of respondents opted for full transparency, making the HTA agency's recommendations and the related appraisal reports publicly available. A great majority of participants preferred mandating the use of local data in certain categories and indicated the importance of evaluating the transferability of international evidence. Healthcare priority and cost-effectiveness were the most important criteria for decisions, applied with a soft explicit threshold.

Ukraine is in the early phase of implementing HTA and our study provides a clear vision of national stakeholders about the future directions. In addition, learning from the experiences of other countries may help the implementation process.

The aim of this study was to provide an overview of the methodological characteristics and compare the assessment methods applied in health technology assessments (HTAs) of public health interventions (PHIs).

We defined a PHI as a population-based intervention on health promotion or for primary prevention of chronic or nonchronic diseases. HTAs on PHIs were identified by systematically searching the Web pages of members of international HTA networks. We included only full HTA reports published between 2012 and 2016. Two reviewers extracted data on the methods used to assess effectiveness/safety, as well as on economic, social, cultural, ethical, and legal aspects using a-priori standardized tables.

We included ten HTAs provided by four different organizations. Of these, all reports assessed the effectiveness of the interventions and conducted economic evaluations, seven investigated social/cultural aspects, and four each considered legal and ethical aspects, respectively. Some reports addressed applicability, context/setting, and intervention fidelity issues in different ways. We found that most HTAs adapted their methods to some extent, for example, by including nonrandomized studies, expanding the search strategy, involving stakeholders, or applying a framework to guide the HTA process.

Our analysis provides a comprehensive overview of methods applied in HTAs on public health interventions. We found that a heterogeneous set of approaches is used to deal with the challenges of evaluating complex public health interventions.

This study sets an example of an economic evaluation of a model dengue vaccination strategy for Sri Lanka, following a mandatory pre-vaccination screening strategy.

A decision analytic Markov model was developed to estimate the cost-effectiveness of a predicted dengue vaccination strategy over a time horizon of 10 years. The cost effectiveness of dengue vaccination strategy for seropositive individuals was estimated in terms of incremental cost effectiveness ratio (ICER) (cost per additional quality adjusted life-year [QALY]). District-specific ICER values and the budget impact for dengue vaccine were estimated with appropriate sensitivity analyses, also taking the variability of the pre-vaccination screening test performance into consideration.

The ICER for the predicted vaccination strategy following pre-vaccination screening was 4,382 USD/QALY for Sri Lanka. There was a significant regional variation in vaccine cost effectiveness. The disaggregated regional incidence of dengue and the need to perform pre-vaccination screening affects the cost effectiveness estimates significantly, where a safer version of the vaccine has the potential to become cost saving in high incidence districts.

The cost effectiveness of the predicted dengue vaccination strategy following pre-vaccination screening showed a significant regional variation across the districts of Sri Lanka. District-wise disease incidence and the need for pre-vaccination screening was found to be the most significant factors affecting the cost effectiveness of the vaccine.

The aim of this study was to estimate the effectiveness of first-line biologic disease modifying drugs(boDMARDs), and their approved biosimilars (bsDMARDs), compared with conventional (csDMARD) treatment, in terms of ACR (American College of Rheumatology) and EULAR (European League against Rheumatism) responses.

Systematic literature search, on eight databases to January 2017, sought ACR and EULAR data from randomized controlled trials (RCTs) of boDMARDs / bsDMARDs (in combination with csDMARDs, or monotherapy). Two adult populations: methotrexate (MTX)-naïve patients with severe active RA; and csDMARD-experienced patients with moderate-to-severe active RA. Network meta-analyses (NMA) were conducted using a Bayesian Markov chain Monte Carlo simulation using a random effects model with a probit link function for ordered categorical.

Forty-six RCTs met the eligibility criteria. In the MTX-naïve severe active RA population, no biosimilar trials meeting the inclusion criteria were identified. MTX plus methylprednisolone (MP) was most likely to achieve the best ACR response. There was insufficient evidence that combination boDMARDs was superior to intensive (two or more) csDMARDs. In the csDMARD-experienced, moderate-to-severe RA population, the greatest effects for ACR responses were associated with tocilizumab (TCZ) monotherapy, and combination therapy (plus MTX) with bsDMARD etanercept (ETN) SB4, boDMARD ETN and TCZ. These treatments also had the greatest effects on EULAR responses. No clear differences were found between the boDMARDs and their bsDMARDs.

In MTX-naïve patients, there was insufficient evidence that combination boDMARDs was superior to two or more csDMARDs. In csDMARD-experienced patients, boDMARDs and bsDMARDs were comparable and all combination boDMARDs / bsDMARDs were superior to single csDMARD.