This study is an attempt to demystify and clarify the idea of cost in health economics and health technology assessment (HTA).

Its method draws on standard concepts in economics. Cost is a more elusive concept than is commonly thought and can be particularly elusive in multidisciplinary territory like HTA.

The article explains that cost is more completely defined as opportunity cost, why cost is necessarily associated with a decision, and that it will always vary according to the context of that decision: whether choice is about inputs or outputs, what the alternatives are, the timing of the consequences of the decision, the nature of the commitment to which a decision maker is committed, who the decision maker is, and the constraints and discretion limiting or liberating the decision maker. Distinctions between short and long runs and between fixed and variable inputs are matters of choice, not technology, and are similarly context-dependent. Harms or negative consequences are, in general, not costs. Whether so-called “clinically unrelated” future costs and benefits should be counted in current decisions again depends on context.

The costs of entire health programs are context-dependent, relating to planned rates of activity, volumes, and timings. The implications for the methods of HTA are different in the contexts of low- and middle-income countries compared with high-income countries, and further differ contextually according to the budget constraints (fixed or variable) facing decision makers.

With the increase in technologies to support an aging population, health technology assessment (HTA) of aging-related technologies warrants special consideration. At Health Technology Assessment international (HTAi) 2016 and HTAi 2017, an international panel explored interests in HTA focused on aging.

Panelists from five countries shared the state of aging and HTA in their countries. Opportunities were provided for participants to discuss and rate the themes identified by the panelists.

In 2016, the highest ranked themes were: (i) identifying unmet needs of older adults that could be met by technology—how can HTA help?; (ii) differences in assessment of aging-related technologies—what is the scope?; and (iii) involvement of older adults and caregivers. These themes became the starting point for discussion in 2017, for which the highest ranked themes were: (i) identification of challenges in HTA and aging; and (ii) approaches to advancing effectiveness of HTA for aging.

These discussions allowed for examination of future directions for HTA and aging: engagement of older adults to inform the agenda of HTA and the broader public policy enterprise; a systems approach to thinking about needs of older persons should support the type and level of care desired by the individual rather than the health institutions, and HTA should reflect these desires when evaluating technological aides; and there is potential for health information systems and “big data” to support HTA activities that assess usability of technologies for older adults. We hope to build on the momentum of this community to continue exploring opportunities for aging and HTA.

Integration of ethics into health technology assessment (HTA) remains challenging for HTA practitioners. We conducted a systematic review on social and methodological issues related to ethical analysis in HTA. We examined: (1) reasons for integrating ethics (social needs); (2) obstacles to ethical integration; (3) concepts and processes deployed in ethical evaluation (more specifically value judgments) and critical analyses of formal experimentations of ethical evaluation in HTA.

Search criteria included “ethic,” “technology assessment,” and “HTA”. The literature search was done in Medline/Ovid, SCOPUS, CINAHL, PsycINFO, and the international HTA Database. Screening of citations, full-text screening, and data extraction were performed by two subgroups of two independent reviewers. Data extracted from articles were grouped into categories using a general inductive method.

A list of 1,646 citations remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. The social need most often reported was to inform policy decision making. The absence of shared standard models for ethical analysis was the obstacle to integration most often mentioned. Fairness and Equity and values embedded in Principlism were the values most often mentioned in relation to ethical evaluation.

Compared with the scientific experimental paradigm, there are no settled proceedings for ethics in HTA nor consensus on the role of ethical theory and ethical expertise hindering its integration. Our findings enable us to hypothesize that there exists interdependence between the three issues studied in this work and that value judgments could be their linking concept.

The HTA Core Model® was developed to improve the transferability of health technology assessment (HTA) between settings. The model has been used by HTA agencies but is also of interest to manufacturers, for improving internal evidence generation and communicating with other HTA stakeholders. To establish if the model is fit for purpose from an industry perspective, the pharmaceutical company Roche, collaborating with the European Network for HTA (EUnetHTA), conducted an assessment of the model.

A questionnaire was developed to evaluate all assessment elements in the HTA Core Model v2.0 for their usefulness in meeting payers’ evidence needs and demonstrating value. The questionnaire was completed by country affiliate teams working in evidence generation and reimbursement submissions for pharmaceuticals. Survey results were discussed in workshops to ensure consistency and alignment between teams.

The questionnaire was completed by six teams. An additional team from global pricing and market access participated in workshops. Model domains pertaining to the health problem and current technology use, technology description, clinical effectiveness, and economic value were considered most important because they meet payers’ evidence needs. Overall, the model was considered useful to improve the efficiency of HTA evidence generation, share evidence internally, and communicate value to payers and HTA agencies.

From an industry perspective, the HTA Core Model provides a useful framework and common terminology for efficient generation of transferable HTA evidence. The timeliness, efficiency, and transparency of HTA processes could be improved by a more standardized approach to HTA across settings.

To identify and appraise existing evaluation frameworks for mobile medical applications (MMA) and determine their suitability for use in health technology assessment (HTA) of these technologies.

Systematic searches were conducted of seven bibliographic databases to identify literature published between 2008 and 2016 on MMA evaluation frameworks. Frameworks were eligible if they were used to evaluate at least one of the HTA domains of effectiveness, safety, and/or cost and cost-effectiveness of an MMA. After inclusion, the frameworks were reviewed to determine the number and extent to which other elements of an HTA were addressed by the framework.

A total of forty-five frameworks were identified that assessed MMAs. All frameworks assessed whether the app was effective. Of the thirty-four frameworks that examined safety, only seven overtly evaluated potential harms from the MMA (e.g., the impact of inaccurate information). Only one framework explicitly considered a comparator. Technology specific domains were sporadically addressed.

None of the evaluation frameworks could be used, unaltered, to guide the HTA of MMAs. To use these frameworks in HTA they would need to identify relevant comparators, improve assessments of harms and consider the ongoing effect of software updates on the safety and effectiveness of MMAs. Attention should also be paid to ethical issues, such as data privacy, and technology specific characteristics. Implications: Existing MMA evaluation frameworks are not suitable for use in HTA. Further research is needed before an MMA evaluation framework can be developed that will adequately inform policy makers.

Smartphone Apps are one of the tools available to support patients who wish to quit smoking. Content analysis studies have indicated multiple deficiencies within these Apps including minimal use of evidence-based research and Nicotine Dependence Treatment Provider (NDTP) in App development. The aim of this study was to determine quality and features of smoking cessation Apps available on Android® and iOS® platforms.

The first fifty free smoking cessation Apps available for download using the search term smoking cessation on Google Play Store and Apple App Store were chosen. Each of these Apps was analyzed and categorized based on ratings, target audience age, language, and a variety of tracking functionalities noted on the Apps. Indications and suggestions regarding either the use of NDTP or evidence-based behavior change protocols were noted.

There were no significant differences in the features of smoking cessation Apps on Android and iOS. Only 15 percent of all Apps analyzed on both platforms indicated some involvement of NDTP and there was no difference between the two platforms. More than 50 percent of Apps studied were downloaded over half a million times and the average user rating was 3.89/5.00 for Android and 3.72/5.00 for iOS with no significant difference.

Most smoking cessation Apps in both platforms offer basic tracking functionalities with limited motivational tips. Only a handful of Apps have moved beyond this role and while their development is applaudable much innovation remains.

The aim of this study is to review evidence on the cost-effectiveness of exercise-based interventions in the treatment of chronic conditions a decade after the publication of Roine et al. in 2009 (Roine E, Roine RP, Räsänen P, et al. Int J Technol Assess Health Care. 2009;25:427–454).

We carried out a review of published articles in PUBMED and JSTOR between January 1, 2008, and December 31, 2016. Full economic evaluations of exercise programs targeting patients with a chronic condition were eligible for inclusion. Data on program, design, and economic characteristics were extracted using a predefined extraction form. The quality of the economic evaluations was appraised using the adjusted Consensus Health Economic Criteria List.

A total of 426 articles were identified and thirty-seven studies were selected. Eleven studies dealt with musculoskeletal and rheumatologic disorders, ten with cardiovascular diseases, six with neurological disorders, three with mental illnesses, three with cancers, and four with diabetes, respiratory diseases, or pelvic organ prolapse. In total, 60 percent of exercise programs were dominant or cost-effective. For musculoskeletal and rheumatologic disorders, 72 percent of programs were dominant or cost-effective while this was the case for 57 percent of programs for cardiovascular diseases using a nonsurgical comparator.

There is clear evidence in favor of exercise-based programs for the treatment of musculoskeletal and rheumatologic disorders and, to a lesser extent, for the treatment of cardiovascular diseases. More research is needed to evaluate the cost-effectiveness of physical activity in the treatment of neurological disorders, mental illnesses, cancers, respiratory diseases, and diabetes/obesity.

Health-related quality of life (HRQoL) data generated by generic, preference-based instruments (i.e., EQ-5D) are highly demanded in health policy decision making, because they allow for direct comparisons of HRQoL outcomes between disease areas. We aimed to quantify HRQoL outcomes in breast cancer (BC), rheumatoid arthritis (RA), multiple sclerosis (MS), rare cancers (RC), and rare disease (RD) patients and understand the patterns that differentiate HRQoL outcomes between these disease areas, and more specifically between rare and more common disease population groups.

An international, Web survey of patients measured HRQoL (EQ-5D-5L), self-perceived health (EQ-5D-5L Visual Analogue Scale), and additional QoL dimensions, such as patient disability level.

We received 675 completed responses. Average utility loss was 53.5 percent, 32.5 percent, and 33.3 percent for RD, RA, and MS patients, respectively, in contrast to 18.6 percent for BC and RC patients. Statistically significant differences (p < .05) were observed between disease groups in all EQ-5D-5L domain outcomes, apart from that of “Anxiety/Depression.” Severe and/or extreme problems were reported in performing usual activities for RD and RC (34 percent and 13 percent of overall problems reported respectively), mobility for MS (18 percent), pain/discomfort for RA (13 percent), and anxiety/depression for BC (7 percent) patients.

We demonstrated significant differences in the dimensions that drive HRQoL outcomes between rare and more common diseases and showcased that the same EQ-5D utility may reflect very different severities depending on the patient population under investigation. Future research should examine whether outcomes in other, critical HRQoL domains not included in generic measures also highlight significant differences across disease areas.

This study aims to assess how care is mediated through technology by analyzing the interaction between nurses, patients, and a Bar Coded Medication Administration (BCMA) system. The objective is to explore how patients experience care through medication technology, with the main focus of our observations and interviews on nurses rather than patients.

A qualitative ethnographic study was conducted in an orthopedic ward of a Dutch general hospital.

After analyses, the following two themes were discerned: (i) the use of bar code medication technology organizes double institutionalization, and (ii) nurses frequently need to work around the BCMA, as the system is not always supportive of patient needs.

The results of this study indicate that BCMA is not merely a neutral tool, but an active component within the nurse–patient relationship, as it influences medication administration and profoundly affects patient participation in the care process.

This study aims to assess participants’ views on previous experiences, the current situation and future perspectives for early dialogue between the pharmaceutical industry, a regulatory agency and health technology assessment bodies (HTABs) in Europe.

Eleven semi-structured interviews were arranged purposively with experienced people from the pharmaceutical industry, the European Medicines Agency, and an expert in Health Economics. The interview questions focused on the value of early dialogue, the challenges faced during the process of early dialogue, the best time to start an early dialogue, the kind of products most suitable for early dialogue, the current situation, and future perspectives for the early dialogue process. The interviews were recorded and then transcribed for open and axial coding to summarize the findings.

All interviewees agreed that early dialogue is a valuable process that helps to inform the development program and accordingly provide patients with faster access to new medicines. However, at this stage, the pharmaceutical industry acknowledged certain challenges: (i) Finding resources within pharmaceutical companies and HTABs to support early dialogues (ii) Requirements between regulators and HTABs in different countries diverge.

This study revealed that people from the pharmaceutical industry perceive early dialogue as a valuable tool that can bring medicines to patients faster by streamlining development. However, the challenges mentioned above need to be mitigated to build a sustainable mechanism for early dialogue.

The aim of this study was to develop and to assess a specific Multi-Criteria Decision Analysis (MCDA) framework to evaluate new drugs in an hospital pharmacy and therapeutics committee (P&TC) setting.

A pilot criteria framework was developed based on the EVIDEM (Evidence and Value: Impact on DEcisionMaking) framework, together with other relevant criteria, and assessed by a group of P&TC's members. The weighting of included criteria was done using a 5-point weighting technique. Two drugs were chosen by evaluation: an orphan-drug for Gaucher disease, and a nonorphan drug for the treatment of inflammatory bowel disease. Evidence matrices were developed, and value contribution of each drug was evaluated by P&TC's members. An agreed final framework was obtained through a discussion between the P&TC's members.

After criteria assessment, the pilot framework included eight quantitative criteria: “disease severity,” “unmet needs,” “comparative efficacy/effectiveness,” “comparative safety/tolerability,” “comparative patient-reported outcomes,” “comparative cost consequences-cost of treatment,” “comparative cost consequences-other medical costs,” and “quality of evidence”; and one contextual criterion: “opportunity costs and affordability.” The most valued criteria were: “comparative safety/tolerability,” “disease severity,” and “comparative efficacy/effectiveness.” When assessing the drugs most valued characteristics of the MCDA were the possibility that all team may contribute to drug assessment by means of scoring the matrices and the discussion to reach a consensus in drug positioning and value decision making.

The reflective MCDA would integrate quantitative and qualitative criteria relevant for a P&TC setting, allowing reflective discussions based on the criteria weighting score.

The emergence of new medical technologies and budget restrictions has led to a substantial increase in the use of hospital-based health technology assessment (HB-HTA). This qualitative study explores whether there is a possibility and interest to realize the collection and dissemination of HB-HTA reports on an international scale by exploring the opinions from HB-HTA experts.

A survey was designed and sent to an international group of experts knowledgeable in HB-HTA from eighteen different countries. The survey contained questions about their opinions on the collection and distribution of HB-HTA information, and about the meaningful dimensions, barriers and values about a database. The data obtained were analyzed through the method of content analysis.

A total of thirty-six experts (response rate of 18.3 percent) responded to the survey. The obtained data shows that all respondents agree that the collection of HB-HTA reports is useful. Moreover, 41.7 percent of respondents that are in the position of sharing HB-HTA reports (n = 24) mentioned that full HB-HTA reports can be shared. Many other respondents reported that confidentiality (45.7 percent) and investment into a database (40.0 percent) are important barriers for the dissemination of HB-HTA reports.

There seem to be enough demand and willingness to share all or most reports by a large community of HB-HTA producers. Therefore, there is a need for a well-designed database with regular maintenance and complete, comparable, and qualitative HB-HTA reports. The database of the AdHopHTA project could potentially facilitate this process.