Design of a multiple criteria decision analysis framework for prioritizing high-impact health technologies in a regional health service.

OBJECTIVES: This study aims to develop a framework for establishing priorities in the regional health service of Murcia, Spain, to facilitate the creation of a comprehensive multiple criteria decision analysis (MCDA) framework. This framework will aid in decision-making processes related to the assessment, reimbursement, and utilization of high-impact health technologies. METHOD: Based on the results of a review of existing frameworks for MCDA of health technologies, a set of criteria was proposed to be used in the context of evaluating high-impact health technologies. Key stakeholders within regional healthcare services, including clinical leaders and management personnel, participated in a focus group (n = 11) to discuss the proposed criteria and select the final fifteen. To elicit the weights of the criteria, two surveys were administered, one to a small sample of healthcare professionals (n = 35) and another to a larger representative sample of the general population (n = 494). RESULTS: The responses obtained from health professionals in the weighting procedure exhibited greater consistency compared to those provided by the general public. The criteria more highly weighted were "Need for intervention" and "Intervention outcomes." The weights finally assigned to each item in the multicriteria framework were derived as the equal-weighted sum of the mean weights from the two samples. CONCLUSIONS: A multi-attribute function capable of generating a composite measure (multicriteria) to assess the value of high-impact health interventions has been developed. Furthermore, it is recommended to pilot this procedure in a specific decision context to evaluate the efficacy, feasibility, usefulness, and reliability of the proposed tool.

Systematic Review of Health Economic Evaluations Focused on Artificial Intelligence in Healthcare: The Tortoise and the Cheetah.

OBJECTIVES: This study aimed to systematically review recent health economic evaluations (HEEs) of artificial intelligence (AI) applications in healthcare. The aim was to discuss pertinent methods, reporting quality and challenges for future implementation of AI in healthcare, and additionally advise future HEEs. METHODS: A systematic literature review was conducted in 2 databases (PubMed and Scopus) for articles published in the last 5 years. Two reviewers performed independent screening, full-text inclusion, data extraction, and appraisal. The Consolidated Health Economic Evaluation Reporting Standards and Philips checklist were used for the quality assessment of included studies. RESULTS: A total of 884 unique studies were identified; 20 were included for full-text review, covering a wide range of medical specialties and care pathway phases. The most commonly evaluated type of AI was automated medical image analysis models (n = 9, 45%). The prevailing health economic analysis was cost minimization (n = 8, 40%) with the costs saved per case as preferred outcome measure. A total of 9 studies (45%) reported model-based HEEs, 4 of which applied a time horizon >1 year. The evidence supporting the chosen analytical methods, assessment of uncertainty, and model structures was underreported. The reporting quality of the articles was moderate as on average studies reported on 66% of Consolidated Health Economic Evaluation Reporting Standards items. CONCLUSIONS: HEEs of AI in healthcare are limited and often focus on costs rather than health impact. Surprisingly, model-based long-term evaluations are just as uncommon as model-based short-term evaluations. Consequently, insight into the actual benefits offered by AI is lagging behind current technological developments.

Varying Willingness to Pay Based on Severity of Illness: Impact on Health Technology Assessment Outcomes of Inpatient and Outpatient Drug Therapies in The Netherlands.

OBJECTIVES: Since 2015, Zorginstituut Nederland (ZIN) has linked disease severity ranges of 0.10 to 0.40, 0.41 to 0.70, and 0.71 to 1.00 with willingness-to-pay (WTP) reference values of €20 000, €50 000, and €80 000 per quality-adjusted life year gained, respectively. We sought to review whether these changes have affected ZIN health technology assessment (HTA) outcomes for specialist and outpatient drugs. METHODS: ZIN recommendations for specialist and outpatient drugs published between January 1, 2012, and December 31, 2020, that included a pharmacoeconomic report were reviewed. Data were extracted on disease severity, proportional shortfall calculation, reported WTP reference value, outcomes related to the cost-effectiveness of the product, budget impact, and ZIN's recommendation including rationale for their advice. RESULTS: A total of 51 HTAs were included. Of the 20 HTAs published before June 2015, a total of 9 received positive recommendations, 7 were conditionally reimbursed, and 4 received negative recommendations. None reported WTP reference values. Of the 31 evaluations published after June 2015, a total of 4 products received positive recommendations, 1 was conditionally approved, and 26 received negative recommendations initially. Most products (65%) reported disease severity to be >0.70. CONCLUSIONS: Since 2015, most products have fallen within the highest category of disease severity. Although pre-2015 outcomes were varied, post-2015 products overwhelmingly received negative recommendations, and the proportion of products for which price negotiations were recommended has increased. These differences in outcomes may result from the introduction of an explicit WTP reference value, whether or not in combination with the severity-adjusted ranges, but may also reflect other national policy changes in 2015.

Avaliação de tecnologias em saúde na saúde suplementar brasileira: a dualidade entre o público e o privado sob a luz da Política Nacional de Gestão de Tecnologias em Saúde / Health Technologies Assessment in private health insurance sector: the duality between public and private in the light of the National Policy on Health Technologies Management

A Avaliação de Tecnologias em Saúde (ATS) respalda políticas públicas na gestão de tecnologias em diversos países. Sua relevância vem sendo ampliada no atual contexto de custos crescentes e recursos escassos com que os sistemas de saúde convivem. Ao proporcionar decisões embasadas nas melhores evidências disponíveis, centrada nas necessidades dos pacientes e das sociedades, considerando benefícios, riscos e custos das tecnologias a serem incorporadas, favorece a alocação mais racional dos recursos escassos. No Brasil, foi principalmente a partir do ano 2000 que a institucionalização da ATS avançou. Em 2009, foi publicada a Política Nacional de Gestão Tecnologias em Saúde (PNGTS), com os objetivos de maximizar os benefícios de saúde a serem obtidos com os recursos disponíveis, e de promover as diretrizes e orientações a todos os atores que participam das atividades de ATS no País. O Ministério da Saúde (MS) capitaneou esse processo que culminou em 2011 com a promulgação da Lei 12.401/11, que instituiu a Comissão Nacional para Incorporação de Tecnologias no Sistema Único de Saúde (CONITEC). Entre outras instituições, a Agência Nacional de Saúde Suplementar (ANS) participou ativamente dos comitês do MS voltados para implementação da ATS. No entanto, mesmo diante de uma política única, o sistema público e a saúde suplementar trilharam diferentes caminhos nesse processo. O objetivo desta tese consistiu em descrever e analisar a institucionalização da ATS na saúde suplementar brasileira, observando as consonâncias e dissonâncias existentes entre os setores público e privado neste processo e identificando as possíveis consequências para o sistema de saúde. Para tanto, se valeu de método qualitativo, tendo como principais fontes de evidências, a revisão bibliográfica, a análise documental e entrevistas semiestruturadas com atores-chaves, escolhidos por terem participado do processo, ativamente, em diferentes momentos e áreas de atuação. Os resultados indicam que diversos fatores contribuíram para uma maior morosidade na institucionalização da ATS na saúde suplementar, como, por exemplo: questões políticas internas e externas à ANS; o comportamento do mercado das empresas operadoras de planos e seguros privados de saúde; além de interferências diretas dos Poderes Executivo e Legislativo nas atividades de incorporação de tecnologias da ANS. Como consequências da dicotomia público privada na implementação das políticas públicas de ATS foram sinalizadas, principalmente, a ineficiência e retrabalho nos processos de incorporação de tecnologias, e o aumento das inequidades no acesso às tecnologias no sistema de saúde. Conclui-se que muitos são os desafios inerentes a implementação de políticas públicas de ATS nos diversos países, e também aqui, dado que estas perpassam por interesses conflitantes dos diferentes stakeholders que atuam no sistema. Contudo, os resultados dessa tese apontam para as vantagens de se almejar uma política única e sólida de ATS no País, que privilegie o fortalecimento da utilização das evidências científicas nas difíceis escolhas que permeiam a área da saúde.

Health Technology Assessment (HTA) supports public policies in the management of technologies in several countries. Its relevance has been increasing in the current context of rising costs and scarce resources with which health systems coexist. By providing decisions based on the best available evidence, centered on the needs of patients and societies, considering the benefits, risks, and costs of the technologies to be incorporated, it favors a more rational allocation of scarce resources. In Brazil, it was mainly from the year 2000 that the institutionalization of HTA advanced. In 2009, the National Policy on Health Technology Management (PNGTS, in the Portuguese acronym) was published, with the objective of maximizing the health benefits to be obtained with the available resources and promoting guidelines to all actors who participate in the activities of HTA in the country. The Ministry of Health (MS) led this process that culminated in 2011 with the enactment of Law 12,401/11, which established the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC, in the Portuguese acronym). Among other institutions, the National Regulatory Agency for Private Health Insurance (ANS) actively participated in the MS committees focused on the implementation of HTA. However, even in the face of a single policy, the public system and the private health insurance sector followed different paths in this process. The objective of this thesis was to describe and analyze the institutionalization of HTA in Brazilian private health insurance sector, observing the existing consonances and dissonances between the public and private sectors in this process and identifying the possible consequences for the health system. For that, it used a qualitative method, using as main sources of evidence, the bibliographic review, document analysis and semi-structured interviews with key actors, chosen for having participated in the process, actively, at different times and areas of activity. The results indicate that several factors contributed to a greater delay in the institutionalization of HTA in the private health insurance sector, such as: internal and external political issues to the ANS; the market behavior of companies operating private health plans and insurance; in addition to direct interference by the Executive and Legislative Powers in the activities of incorporation of technologies by ANS. As a consequence of the public-private dichotomy in the implementation of public HTA policies, the inefficiency and rework in the technology incorporation processes, and the increase in inequities in access to technologies in the health system, were signaled. It is concluded that there are many challenges inherent to the implementation of public HTA policies in different countries, and also here, given that they permeate conflicting interests of the different stakeholders that work in the system. However, the results of this thesis point to the advantages of aiming for a single and solid HTA policy in the country, which privileges the strengthening of the use of scientific evidence in the difficult choices that permeate the healthcare area.

Health technology assessment applied to emergency preparedness: a new perspective.

Emergency preparedness is a continuous quality improvement process through which roles and responsibilities are defined to effectively anticipate, respond to, and recover from the impact of emergencies. This process results in documented plans that provide a backbone structure for developing the core capacities to address health threats. Nevertheless, several barriers can impair an effective preparedness planning, as it needs a 360° perspective to address each component according to the best evidence and practice. Preparedness planning shares common principles with health technology assessment (HTA) as both encompass a multidisciplinary and multistakeholder approach, follow an iterative cycle, adopt a 360° perspective on the impact of intervention measures, and conclude with decision-making support. Our "Perspective" illustrates how each HTA domain can address different component(s) of a preparedness plan that can indeed be seen as a container of multiple HTAs, which can then be used to populate the entire plan itself. This approach can allow one to overcome preparedness barriers, providing an independent, systematic, and robust tool to address the components and ensuring a comprehensive evaluation of their value in the mitigation of the impact of emergencies.

The representation of public values in health technology assessment to inform funding decisions: the case of Australia's national funding bodies.

Over the past few years, there has been an increasing recognition of the value of public involvement in health technology assessment (HTA) to ensure the legitimacy and fairness of public funding decisions [Street J, Stafinski T, Lopes E, Menon D. Defining the role of the public in Health Technology Assessment (HTA) and HTA-informed decision-making processes. Int J Technol Assess Health Care. 2020;36:87-95]. However, important challenges remain, in particular, how to reorient HTA to reflect public priorities. In a recent international survey of thirty HTA agencies conducted by the International Network of Agencies for HTA (INAHTA), public engagement in HTA was listed as one of the "Top 10" challenges for HTA agencies [O'Rourke B, Werko SS, Merlin T, Huang LY, Schuller T. The "Top 10" challenges for health technology assessment: INAHTA viewpoint. Int J Technol Assess. 2020;36:1-4].Historically, Australia has been at the forefront of the application of HTA for assessing the effectiveness and cost-effectiveness of new health technologies to inform public funding decisions. However, current HTA processes in Australia lack meaningful public inputs. Using Australia as an example, we describe this important limitation and discuss the potential impact of this gap on the health system and future directions.

GRADE Guidelines 30: the GRADE approach to assessing the certainty of modeled evidence-An overview in the context of health decision-making.

OBJECTIVES: The objective of the study is to present the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) conceptual approach to the assessment of certainty of evidence from modeling studies (i.e., certainty associated with model outputs). STUDY DESIGN AND SETTING: Expert consultations and an international multidisciplinary workshop informed development of a conceptual approach to assessing the certainty of evidence from models within the context of systematic reviews, health technology assessments, and health care decisions. The discussions also clarified selected concepts and terminology used in the GRADE approach and by the modeling community. Feedback from experts in a broad range of modeling and health care disciplines addressed the content validity of the approach. RESULTS: Workshop participants agreed that the domains determining the certainty of evidence previously identified in the GRADE approach (risk of bias, indirectness, inconsistency, imprecision, reporting bias, magnitude of an effect, dose-response relation, and the direction of residual confounding) also apply when assessing the certainty of evidence from models. The assessment depends on the nature of model inputs and the model itself and on whether one is evaluating evidence from a single model or multiple models. We propose a framework for selecting the best available evidence from models: 1) developing de novo, a model specific to the situation of interest, 2) identifying an existing model, the outputs of which provide the highest certainty evidence for the situation of interest, either "off-the-shelf" or after adaptation, and 3) using outputs from multiple models. We also present a summary of preferred terminology to facilitate communication among modeling and health care disciplines. CONCLUSION: This conceptual GRADE approach provides a framework for using evidence from models in health decision-making and the assessment of certainty of evidence from a model or models. The GRADE Working Group and the modeling community are currently developing the detailed methods and related guidance for assessing specific domains determining the certainty of evidence from models across health care-related disciplines (e.g., therapeutic decision-making, toxicology, environmental health, and health economics).

Development of a decisional flowchart for meaningful patient involvement in Health Technology Assessment.

INTRODUCTION: This paper aims to describe the development of a flowchart to guide the decisions of researchers in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) regarding patient involvement (PI) in Health Technology Assessment (HTA). By doing so, it reflects on current methodological challenges in PI in the HTA field: how best to combine PI methods and what is the role of patient-based evidence. METHODS: A decisional flowchart for PI in HTA was developed between March and April 2019 following an iterative process, reviewed by the members of the PI Interest Group and other RedETS members and validated during an online deliberative meeting. The development of the flowchart was based on a previous methodological framework assessed in a pilot study. RESULTS: The guidelines on how to involve patients in HTA in the RedETS were graphically represented in a flowchart. PI must be included in all HTA reports, except those that assess technologies with no relevant impact on patients' experiences, values, and preferences. Patient organizations or expert patients related to the topic of the HTA report must be identified and invited. These patients can participate in protocol development, outcomes' identification, assessment process, and report review. When the technology assessed affects in a relevant way patient experiences, values, and preferences, patient-based evidence should be included through a systematic literature review or a primary study. CONCLUSIONS: The decisional flowchart for PI in HTA contributes to the current methodological challenges by proposing a combination of direct involvement and patient-based evidence.

Developing recommendations for the diagnosis and treatment of Lyme disease: the role of the patient's perspective in a controversial environment.

CONTEXT: The Ministry of Health in Québec requested the National Institute of Excellence in Health and Social Services to produce clinical and implementation recommendations for the prophylaxis, diagnosis, and treatment of Lyme disease. OBJECTIVES: (i) Describe the process of trialing different modalities of patient engagement as a means to integrate a diversity of patient perspectives and (ii) Describe the learning process of INESSS regarding the integration of the patient perspective. METHODOLOGY: All documents were analyzed, and a survey with all advisory committee members and semi-structured interviews with stakeholders were conducted. Each interview was transcribed verbatim and imported into QDA miner software for the purposes of analysis. Data analysis was carried out concurrently with data collection to allow for an iterative approach between data collection and analysis. RESULTS: Five methods to integrate the perspectives of patients were used: (i) interviews with patients, (ii) inclusion of patient partners within the advisory committee, (iii) literature review, (iv) focus groups with one patient association, and (v) feedback from patient associations on recommendations intended for decision makers and other targeted stakeholders. The patient partners influenced decisions by sharing their experiential knowledge. The patient interviews and the literature review added an in-depth perspective on the disease and experience with the healthcare system. The patient association members shared their perspectives and helped disseminate the recommendation to sustain a practice change. CONCLUSION: The combination of methods to collect and integrate patients' knowledge and patient associations' perspectives helped develop a comprehensive understanding of a controversial object of evaluation.

Role of patients' organizations in Health Technology Assessment: a Habermasian system and lifeworld perspective.

Patient and public involvement in Health Technology Assessment (HTA) is gaining increased interest among research and policy communities. Patients' organizations represent an important link between individual patients and the health system. Social theories are increasingly being used to explain doctor-patient-system interactions, expanding understanding beyond the mere clinical perspective. In this sense, patient involvement in HTA can also be considered through the Habermas's theory of communicative action. From a Habermasian perspective, HTA as part of the instrumental rationality contributes to an increased efficiency of resource use within the system; however, such rationalization threatens to colonize the lifeworld by making it "increasingly state administered with attenuated possibilities for communicative action as a result of the commercialization and rationalization in terms of immediate returns." Using Habermasian system/lifeworld framework, this paper explores opportunities and obstacles to patient involvement in HTA, whereby trying to understand current and possible roles of patients' organizations as a mediating force between HTA as a function of the system and the lifeworld represented by patients.

Toward a common understanding of competencies for health technology assessment: enhancing educational and training programs around the globe.

BACKGROUND: Depending on the health system context and the demands of relevant stakeholders in countries, the need, organizational structure, and prerequisites for enabling capacity building and development in health technology assessment (HTA) will vary. Core competencies are instrumental in this and include essential knowledge, skills, and attitudes (KSAs). They provide building blocks for delivering high-quality and effective practices of HTA. We aimed to systematically explore and develop an overview of the core competencies necessary for HTA. METHODS: This study was conducted during 2016-19 using different methods in a structured manner. We drew concepts of KSAs from various literature sources, surveyed universities and HTA professionals, and conducted expert workshops to arrive at a common understanding of the required competencies. RESULTS: The terminology for KSAs defining competencies in HTA programs has been clarified. In addition, a list of competencies offered through different educational and training programs has been created. The surveys provided clarity on a common understanding of KSAs among HTA stakeholders. Thereafter, a set of competencies was described and classified according to the HTA domains. CONCLUSIONS: Our study shows that there is diversity in HTA programs offered by educational institutions. The content of the programs varies due to differences between countries regarding the level of HTA development and the need for HTA, including the understanding of what HTA is. The preparation of a competency checklist or a "menu" of options mirroring the diversity of HTA will ensure that the specific needs of the HTA community will be covered.

Value assessment of antimicrobials and the implications for development, access, and funding of effective treatments: Australian stakeholder perspective.

BACKGROUND: The frameworks used by Health Technology Assessment (HTA) agencies for value assessment of medicines aim to optimize healthcare resource allocation. However, they may not be effective at capturing the value of antimicrobial drugs. OBJECTIVES: To analyze stakeholder perceptions regarding how antimicrobials are assessed for value for reimbursement purposes and how the Australian HTA framework accommodates the unique attributes of antimicrobials in cost-effectiveness evaluation. METHODS: Eighteen individuals representing the pharmaceutical industry or policy-makers were interviewed. Interviews were transcribed verbatim, coded, and thematically analyzed. RESULTS: Key emergent themes were that reimbursement decision-making should consider the antibiotic spectrum when assessing value, risk of shortages, the impact of procurement processes on low-priced comparators, and the need for methodological transparency when antimicrobials are incorporated into the economic evaluation of other treatments. CONCLUSIONS: Participants agreed that the current HTA framework for antimicrobial value assessment is inadequate to properly inform funding decisions, as the contemporary definition of cost-effectiveness fails to explicitly incorporate the risk of future resistance. Policy-makers were uncertain about how to incorporate future resistance into economic evaluations without a systematic method to capture costs avoided due to good stewardship. Lacking financial reward for the benefits of narrower-spectrum antimicrobials, companies will likely focus on developing broad-spectrum agents with wider potential use. The perceived risks of shortages have influenced the funding of generic antimicrobials in Australia, with policy-makers suggesting a willingness to pay more for assured supply. Although antibiotics often underpin the effectiveness of other medicines, it is unclear how this is incorporated into economic models.

Demonstrating the influence of HTA: INAHTA member stories of HTA impact.

A central function of health technology assessment (HTA) agencies is the production of HTA reports to support evidence-informed policy and decision making. HTA agencies are interested in understanding the mechanisms of HTA impact, which can be understood as the influence or impact of HTA report findings on decision making at various levels of the health system. The members of the International Network of Agencies for HTA (INAHTA) meet at their annual Congress where impact story sharing is one important activity. This paper summarizes four stories of HTA impact that were finalists for the David Hailey Award for Best Impact Story.The methods to measure impact include: document review; claims analysis and review of reimbursement status; citation analysis; qualitative evaluation of stakeholders' views; and review of media response. HTA agency staff also observed changes in government activities and priorities based on the HTA. Impact assessment can provide information to improve the HTA process, for example, the value of patient and clinician engagement in the HTA process to better define the assessment question and literature reviews in a more holistic and balanced way.HTA reports produced by publicly funded HTA agencies are valued by health systems around the globe as they support decision making regarding the appropriate use, pricing, reimbursement, and disinvestment of health technologies. HTAs can also have a positive impact on information sharing between different levels of government and across stakeholder groups. These stories show how HTA can have a significant impact, irrespective of the health system and health technology being assessed.

Expertise, experience, and excellence. Twenty years of patient involvement in health technology assessment at NICE: an evolving story.

From its inception in 1999, the National Institute for Health and Care Excellence (NICE) committed to including the expertise, experiences, and perspectives of lay people, patients and carers, and patient organizations in its health technology assessments (HTAs). This is our story of patient involvement in HTA: from early methods designed for use when assessing medicines, widening to address the different requirements of HTAs for interventional procedures, medical technologies, and diagnostic technologies. We also chart the evolution and development of all our patient involvement methods over the past 20 years through regular evaluation and by responding to external challenge. However, we know that processes and methods alone are not enough. Through case studies we demonstrate the value of patient involvement in HTA and highlight the unique perspectives and experiences that patients bring to HTA committees. Finally, we discuss the underpinning principles and commitments that have made NICE a world leader in delivering meaningful and legitimate patient involvement.

Community engagement in Health Technology Assessment and beyond: from guests in the process to hosts.

In Health Technology Assessment (HTA), clinical and economic evidence are assessed in the regulatory and reimbursement environments, with community input considered as complementary to this. Stakeholders are calling for more meaningful community engagement, but this will not be reached without a significant shift. The Centre for Community-Driven Research (CCDR) is a nonprofit organization bringing much needed change to the way we think about community engagement in health. This article is based on CCDR's experience and outlines three system changes needed to advance community engagement in decisions about health and HTA. This paper comes from the perspective of engaging everyday people in the process as opposed to representation on panels and committees. The three key areas of change that are discussed include building holistic evidence, creating supportive environments, and infrastructure for community engagement, with the term community referring to people affected by disease or health conditions and their carers/families.

How does HTA addresses current social expectations? An international survey.

OBJECTIVES: Integration of ethics into technology assessment in healthcare (HTA) reports is directly linked to the need of decision makers to provide rational grounds justifying their social choices. In a decision-making paradigm, facts and values are intertwined and the social role of HTA reports is to provide relevant information to decision makers. Since 2003, numerous surveys and discussions have addressed different aspects of the integration of ethics into HTA. This study aims to clarify how HTA professionals consider the integration of ethics into HTA, so an international survey was conducted in 2018 and the results are reported here. METHODS: A survey comprising twenty-two questions was designed and carried out from April 2018 to July 2018. Three hundred and twenty-eight HTA agencies from seventy-five countries were invited to participate in this survey. RESULTS: Eighty-nine participants completed the survey, representing a participation rate of twenty-seven percent. As to how HTA reports should fulfill their social role, over 84 percent of respondents agreed upon the necessity to address this role for decision makers, patients, and citizens. At a lower level, the same was found regarding the necessity to make value-judgments explicit in different report sections, including ethical analysis. This contrasts with the response-variability obtained on the status of ethical analysis with the exception of the expertise required. Variability in stakeholder-participation usefulness was also observed. CONCLUSIONS: This study reveals the importance of a three-phase approach, including assessment, contextual data, and recommendations, and highlights the necessity to make explicit value-judgments and have a systematic ethical analysis in order to fulfill HTA's social role in guiding decision makers.

Rapid qualitative evidence syntheses (rQES) in health technology assessment: experiences, challenges, and lessons.

Healthcare decision makers are increasingly demanding that health technology assessment (HTA) is patient focused, and considers data about patients' perspectives on and experiences with health technologies in their everyday lives. Related data are typically generated through qualitative research, and in HTA the typical approach is to synthesize primary qualitative research through the conduct of qualitative evidence synthesis (QES). Abbreviated HTA timelines often do not allow for the full 6-12 months it may take to complete a QES, which has prompted the Canadian Agency for Drugs and Technologies in Health (CADTH) to explore the concept of "rapid qualitative evidence synthesis" (rQES). In this paper, we describe our experiences conducting three rQES at CADTH, and reflect on challenges faced, successes, and lessons learned. Given limited methodological guidance to guide this work, our aim is to provide insight for researchers who may contemplate rQES. We suggest several lessons, including strategies to iteratively develop research questions and search for eligible studies, use search of filters and limits, and use of a single reviewer experienced in qualitative research throughout the review process. We acknowledge that there is room for debate, though believe rQES is a laudable goal and that it is possible to produce a quality, relevant, and useful product, even under restricted timelines. That said, it is vital to recognize what is lost in the name of rapidity. We intend our paper to advance the necessary debate about when rQES may be appropriate, and not, and enable productive discussions around methodological development.

An International Review of Health Technology Assessment Approaches to Prescription Drugs and Their Ethical Principles.

In many countries, health technology assessment (HTA) organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries' methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in (1) the methodologies HTA organizations use to conduct their evaluations and (2) considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy.