Deliberative process of health technology reassessment by health technology assessment agency in Korea.

In 2019, the National Evidence-based Healthcare Collaborating Agency (NECA) in Korea established a health technology reassessment (HTR) system to manage the life cycle of health technologies and develop operational measures promoting the efficient use of healthcare resources. The purpose of this study is to introduce the detailed implementation process and practical functional methods of the HTR implemented by NECA.The HTR is a structured multidisciplinary method for analyzing health technologies currently used in the healthcare system based on the latest information on parameters, such as clinical safety, effectiveness, and cost-effectiveness of optimizing the use of healthcare resources as well as social and ethical issues. All decision-making stages of the HTR are carefully reviewed and transparently managed. The HTR committee makes significant decisions, and the subcommittee decides the details related to the assessment process.Since the pilot began in 2018, 262 cases have been reassessed, of which, 126 cases (48.1 percent) were health services not covered by the National Health Insurance (NHI). Over the past 5 years, approximately 130 recommendations for the in-use technologies were determined by the HTR committee. In the near future, it will be necessary to officially develop and establish a Korean HTR system and a legal foundation to optimize the NHI system.

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.

Are We Making a Difference? A Qualitative Study of Patient Engagement at the pan-Canadian Oncology Drug Review: Perspectives of Patient Groups.

OBJECTIVES: Despite wide support for patient involvement in health technology assessments (HTA), determining meaningful engagement is complex. This article explores experiences and perceptions among patient groups participating in the Canadian Agency for Drugs and Technologies in Health (CADTH)'s pan-Canadian Oncology Drug Review (pCODR) process. METHODS: We created a qualitative interview study comprising 22 semi-structured telephone interviews with individuals representing 21 different patient groups registered with the pCODR process. The analysis used a qualitative descriptive approach employing techniques from grounded theory. RESULTS: Patient groups view the ability to make submissions to the pCODR process as a meaningful activity closely aligned with organizational priorities. Concurrently, they face substantial resource challenges to prepare submissions, including high opportunity costs and difficulty accessing needed literature and finding relevant patients. Although patient groups felt that CADTH is committed to transparency, they expressed considerable uncertainty around the direct impact of their submissions and desired additional avenues for engagement. CONCLUSIONS: This study suggests a strong commitment by patient groups to participate in the pCODR process despite uncertainty about how their submissions are used to inform HTA recommendations. Identifying opportunities to provide both financial and nonfinancial resources to patient groups is crucial to encouraging and supporting their meaningful participation in HTA processes.

Leveraging DICE (Discretely-Integrated Condition Event) Simulation to Simplify the Design and Implementation of Hybrid Models.

OBJECTIVES: Using an example of an existing model constructed by the National Institute for Health and Care Excellence (NICE) to inform a real health technology assessment, this study seeks to demonstrate how a discretely integrated condition event (DICE) simulation can improve the implementation of Markov models. METHODS: Using the technical report and spreadsheet, the original model was translated to a standard DICE simulation without making any changes to the design. All original analyses were repeated and the results were compared. Aspects that could have improved the original design were then considered. RESULTS: The original model consisted of 32 copies (8 risk strata × 4 treatments) of the Markov structure, containing more than 6000 Microsoft Excel® formulas (18 MB files). Three aspects (nonadherence, scheduled treatment stop, and end of fracture risk) were handled by incorporating weighted averages into the cycle-specific calculations. The DICE implementation used 3 conditions to represent the states and a single transition event to apply the probabilities; 3 additional events processed the special aspects, and profiles handled the 8 strata (0.12 MB file). One replication took 16 seconds. The original results were reproduced but extensive additional sensitivity analyses, including structural analyses, were enabled. CONCLUSION: Implementing a real Markov model using DICE simulation both preserves the advantages of the approach and expands the available tools, improving transparency and ease of use and review.

Does the use of health technology assessment have an impact on the utilisation of health care resources? Evidence from two European countries.

OBJECTIVES: A centralised approach to health technology assessment (HTA) may facilitate optimal use of HTA resources. A regional approach may increase the chances of local implementation of recommendations. This study aimed to compare assessment procedures in England (centralised HTA approach) with Spain (regional HTA approach) discussing key challenges and opportunities from both approaches. METHODS: We compared technology assessments of anticancer medicines in the two jurisdictions from 2008 to 2015. To assess the implementation of HTA recommendations, we assessed trends in medicine usage using regression methods. We used IQVIA data, from 2011 to 2016, for a sample of 11 medicines. We used CatSalut data from Catalonia to assess the implementation of local recommendations. RESULTS: In England, 66 assessments were undertaken by the National Institute for Health and Care Excellence (NICE), using a standardised methodology. In Spain, there were 79 reports undertaken by a range of bodies using a shared process and coordinated through the GENESIS collaboration; the assessment methods used varied substantially. Overall, the recommendations in the two jurisdictions were similar. Regression analyses indicate that where there is a positive recommendation by HTA bodies, the usage of the medicine responds most strongly (p < 0.001) in Catalonia (4.892), followed by England (3.120) and Spain (1.693). CONCLUSIONS: This study suggests that medicine utilisation does respond to the positive recommendations of HTA bodies. However, if HTA capacity is organised primarily regionally, considerable effort may be required in coordination, to ensure consistent and rigorous assessments and adequate implementation of HTA findings.

Supervisión de ensayos clínicos en hospitales del Seguro Social de Salud del Perú: enfoque administrativo y regulatorio / Supervision of clinical trials in Social Health Insurance at Peruvian Hospitals: administrative and regulatory approach

RESUMEN El objetivo del estudio fue describir las características de los ensayos clínicos (EC) supervisados por el Instituto de Evaluación de Tecnologías en Salud e Investigación en EsSalud entre el 2015 y 2018 y las principales observaciones de las supervisiones realizadas. Se realizó un estudio descriptivo de 82 ensayos clínicos supervisados entre 2015 y 2018. La mayoría de los ensayos clínicos fueron estudios de fase III (81,7%), la vía de administración más frecuente de los productos de estudio fue oral (47,6%) y la mayoría fueron patrocinados por la industria farmacéutica (96,3%). Las observaciones más frecuentes fueron las relacionadas al contrato de estudio (83,8%), al pago por concepto de overhead (57,3%) y a la falta de documentos regulatorios (47,6%). Estos hallazgos permiten la identificación de oportunidades de mejora en la regulación y gestión de la investigación.

ABSTRACT The objective of the study was to describe the characteristics of the Clinical Trials (CT) supervised by the Institute of Health Technology Assessment and Research carried out in EsSalud between 2015 and 2018 and the main observations of the supervisions completed. A descriptive study of 82 supervised clinical trials was conducted between 2015 and 2018. Most of the clinical trials were phase III studies (81.7%); the most frequent route of administration of the study products was oral (47.6%), and most were sponsored by the pharmaceutical industry (96.3%). The most frequent observations were those related to the study contract (83.8%), overhead payment (57.3%), and the lack of regulatory documents (47.6%). These findings allow the identification of opportunities for improvement in research regulation and management.

Stories of Patient Involvement Impact in Health Technology Assessments: A Discussion Paper.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

How Do Pharmaceutical Companies Model Survival of Cancer Patients? A Review of NICE Single Technology Appraisals in 2017.

OBJECTIVES: Before an intervention is publicly funded within the United Kingdom, the cost-effectiveness is assessed by the National Institute of Health and Care Excellence (NICE). The efficacy of an intervention across the patients' lifetime is often influential of the cost-effectiveness analyses, but is associated with large uncertainties. We reviewed committee documents containing company submissions and evidence review group (ERG) reports to establish the methods used when extrapolating survival data, whether these adhered to NICE Technical Support Document (TSD) 14, and how uncertainty was addressed. METHODS: A systematic search was completed on the NHS Evidence Search webpage limited to single technology appraisals of cancer interventions published in 2017, with information obtained from the NICE Web site. RESULTS: Twenty-eight appraisals were identified, covering twenty-two interventions across eighteen diseases. Every economic model used parametric curves to model survival. All submissions used goodness-of-fit statistics and plausibility of extrapolations when selecting a parametric curve. Twenty-five submissions considered alternate parametric curves in scenario analyses. Six submissions reported including the parameters of the survival curves in the probabilistic sensitivity analysis. ERGs agreed with the company's choice of parametric curve in nine appraisals, and agreed with all major survival-related assumptions in two appraisals. CONCLUSIONS: TSD 14 on survival extrapolation was followed in all appraisals. Despite this, the choice of parametric curve remains subjective. Recent developments in Bayesian approaches to extrapolation are not implemented. More precise guidance on the selection of curves and modelling of uncertainty may reduce subjectivity, accelerating the appraisal process.

Exploring the Application of Cost-Effectiveness Evaluation in the Japanese National Health Insurance System.

OBJECTIVES: Advances in health care due to the development and introduction of new drugs and medical devices have brought considerable benefits to people and patients in terms of upgraded quality of life and extended years of survival. However, some are concerned that the very advancement of health care would increase further the inflation of national healthcare costs. In response to these concerns, Japan's Central Social Insurance Medical Council ("Chuikyo") began in 2012 to examine how cost-effectiveness evaluation might be applied to the national health insurance system, and has been working toward establishing a system for its usage. METHODS: Cost-effectiveness evaluation was adopted on a trial basis in fiscal year (FY) 2016, targeting seven drugs and six medical devices. Analyses and re-analyses were performed by manufacturers and a public expert organization, respectively. Based on these analyses, a cost-effectiveness evaluation expert organization conducted an overall assessment ("appraisal"). Results of the evaluation were used to adjust the prices of the target items. RESULTS: Following the trial adoption of cost-effectiveness evaluation, price adjustments were performed for three items in April 2018. Meanwhile, a decision was also made to examine seven items for which technical requirements were identified due to differences in the understanding of analysis methods between involved parties. CONCLUSIONS: The Chuikyo will examine how to meet the newly identified technical requirements and discuss specific details with regard to establishing a system that incorporates cost-effectiveness evaluation. The Chuikyo plans to reach a conclusion by the end of FY 2018.

Outcomes and Impacts of 10-Year HTA Implementation in Taiwan.

OBJECTIVES: In 2007, Taiwan began conducting health technology assessments (HTA) to support the National Health Insurance Administration (NHIA) in its reimbursement decisions for drugs, medical devices, and medical services. METHODS: In this study, the development, missions, and procedures of the implementation of HTA in Taiwan are briefly introduced. Moreover, the value of HTA is examined by reviewing the outcomes and impacts of recent HTA-related research projects, which are classified into five categories: (i) pharmaceutical products, (ii) medical procedures, (iii) medical devices, (iv) health policy, and (v) social care. RESULTS: Overall, the 10-year implementation of HTA has not only supported the government's decision making but also enhanced patient care. Furthermore, patient evidence has been highlighted, and patient care pathways have been transformed through patient involvement in HTA. CONCLUSIONS: In conclusion, HTA's value has been determined by both government and social aspects in Taiwan.

What is driving HTA decision-making? Evidence from cancer drug reimbursement decisions from 6 European countries.

BACKGROUND: Decisions on the reimbursement of the same cancer drugs are different across European countries, but empirical work on the reasons behind these differences has been scarce. The main objective of this paper is to make a methodological contribution to existing research, specifically by outlining the systematic process of analysis to address such questions and determining the factors that might lead to different drug reimbursement decisions, and to explore its application in the field of oncology. METHODS: Reimbursement decisions on cancer drugs in six European countries (Belgium, England, Poland, Portugal, Scotland, and Sweden) between 2006 and 2014 were included in the study. A taxonomy was developed, comprising two groups of variables (system-level and product-specific) and an econometric model was specified (multilevel mixed-effects ordered probit). RESULTS: Only one in six evaluations in the sample reach the same reimbursement recommendation. Most health system variables were not determinants of a higher or lower probability of a positive reimbursement recommendation. However, the probability of reimbursement was higher when a drug was considered cost-effective by NICE/SMC and when there was a financial Managed Entry Agreement. This work also demonstrated a possible econometric approach for analysing differences in reimbursement decisions and contributes a structured approach for collecting and preparing data for such analyses. CONCLUSIONS: Drug reimbursement decisions can be analysed in detail along a set of factors that are related to each decision. This information is essential, not only for understanding why a particular drug is accepted in one country and not in another but also when trying to implement a new HTA system or reform an existing one. This analysis provides policy makers and stakeholders with a model that enables a better understanding of the factors that drive HTA decisions and is adaptable to answer similar questions. Moreover, the data collection limitations encountered and described in this work shed light on the need for greater accessibility and transparency in HTA systems and regarding HTA outcomes.

OVERCOMING THE BARRIERS TO ACHIEVING UNIVERSAL HEALTH CARE IN THE ASIAN REGION.

OBJECTIVES: The Health Technology Assessment International (HTAi) Asia Policy Forum (HAPF) met to discuss the challenges of achieving universal health care (UHC) in Asia. METHODS: Group discussions and presentations at the 2017 HAPF, informed by a background paper, including a literature review and the results of pre-meeting surveys of health technology assessment (HTA) agencies and industry, formed the basis of this article. RESULTS: Affordability was identified as the greatest barrier to establishing UHC; however, other impediments include the lack of political will to implement UHC, and the cultural issue of deference to expert opinion instead of evidence-based assessments. Although HTA was identified as an important prioritization tool when adding new technologies to benefit packages, it is used inconsistently in the region, resulting in a less transparent decision-making process for stakeholders. Although regional challenges exist around real-world data (RWD), including a lack of capacity to enable information and data sharing, most policy or funding decision makers in the region have access to data. However, there appears to be a disconnect with the experience of industry, whose representatives identify the lack of RWD as their primary issue. To overcome these issues, both HTA agencies and industry agree that collaboration and transparency should be fostered to support the development of robust evidence generation in the region. CONCLUSIONS: There is a willingness for HTA agencies and industry to collaborate to develop HTA methodology for the prioritization of technologies in the Asia region that support healthcare systems to achieve the ultimate outcome of UHC.

Health technology assessment: A primer for ophthalmology.

Rising healthcare costs and increasing demands for health care require techniques to choose between competing uses and even rationing of health care. Economic evaluations and health technology assessments are increasingly a means to assess the cost effectiveness of healthcare interventions so as to inform such resource allocation decisions. To date, the adoption of health technology assessments, as a way of assessing cost effectiveness, in ophthalmology has been slower, relative to their implementation in other specialities. Nevertheless, demands for eye services are increasing due to an ageing population. The prevalence of conditions such as glaucoma, cataract, diabetic eye disease and age-related macular degeneration increases with age, and it is predicted that global blindness will triple by 2050. So there is a challenge for ophthalmologists to ensure that they can contribute to, interpret, critically evaluate, and use findings from economic evaluations in their clinical practice. To aid this, this article serves as a primer on the use of health technology assessments to assess cost effectiveness using economic evaluation techniques for ophthalmologists. Healthcare systems face many challenges worldwide - changing demographics and evolution of new technologies are only going to intensify. With this in mind, ophthalmology needs to be ready and able to engage with health economists to prepare, interpret, critically evaluate and use findings of economic evaluations and health technology assessments.

ENVIRONMENTAL IMPACT ASSESSMENT OF A HEALTH TECHNOLOGY: A SCOPING REVIEW.

INTRODUCTION: The Health Technology Expert Review Panel is an advisory body to Canadian Agency for Drugs and Technologies in Health (CADTH) that develops recommendations on health technology assessments (HTAs) for nondrug health technologies using a deliberative framework. The framework spans several domains, including the environmental impact of the health technology(ies). Our research objective was to identify articles on frameworks, methods or case studies on the environmental impact assessment of health technologies. METHODS: A literature search in major databases and a focused gray literature search were conducted. The main search concepts were HTA and environmental impact/sustainability. Eligible articles were those that described a conceptual framework or methods used to conduct an environmental assessment of health technologies, and case studies on the application of an environmental assessment. RESULTS: From the 1,710 citations identified, thirteen publications were included. Two articles presented a framework to incorporate environmental assessment in HTAs. Other approaches described weight of evidence practices and comprehensive and integrated environmental impact assessments. Central themes derived include transparency and repeatability, integration of components in a framework or of evidence into a single outcome, data availability to ensure the accuracy of findings, and familiarity with the approach used. CONCLUSIONS: Each framework and methods presented have different foci related to the ecosystem, health economics, or engineering practices. Their descriptions suggested transparency, repeatability, and the integration of components or of evidence into a single outcome as their main strengths. Our review is an initial step of a larger initiative by CADTH to develop the methods and processes to address the environmental impact question in an HTA.

Health economic evaluation of a serum-based blood test for brain tumour diagnosis: exploration of two clinical scenarios.

OBJECTIVES: To determine the potential costs and health benefits of a serum-based spectroscopic triage tool for brain tumours, which could be developed to reduce diagnostic delays in the current clinical pathway. DESIGN: A model-based health pre-trial economic assessment. Decision tree models were constructed based on simplified diagnostic pathways. Models were populated with parameters identified from rapid reviews of the literature and clinical expert opinion. SETTING: Explored as a test in both primary and secondary care (neuroimaging) in the UK health service, as well as application to the USA. PARTICIPANTS: Calculations based on an initial cohort of 10 000 patients. In primary care, it is estimated that the volume of tests would approach 75 000 per annum. The volume of tests in secondary care is estimated at 53 000 per annum. MAIN OUTCOME MEASURES: The primary outcome measure was quality-adjusted life-years (QALY), which were employed to derive incremental cost-effectiveness ratios (ICER) in a cost-effectiveness analysis. RESULTS: Results indicate that using a blood-based spectroscopic test in both scenarios has the potential to be highly cost-effective in a health technology assessment agency decision-making process, as ICERs were well below standard threshold values of £20 000-£30 000 per QALY. This test may be cost-effective in both scenarios with test sensitivities and specificities as low as 80%; however, the price of the test would need to be lower (less than approximately £40). CONCLUSION: Use of this test as triage tool in primary care has the potential to be both more effective and cost saving for the health service. In secondary care, this test would also be deemed more effective than the current diagnostic pathway.

IMPORTANCE OF CONTEXTUAL DATA IN PRODUCING HEALTH TECHNOLOGY ASSESSMENT RECOMMENDATIONS: A CASE STUDY.

OBJECTIVES: Contextual data and local expertise are important sources of data that cannot be ignored in hospital-based health technology assessment (HTA) processes. Despite a lack of or unconvincing evidence in the scientific literature, technology can be recommended in a given context. We illustrate this using a case study regarding biplane angiography for vascular neurointervention. METHODS: A systematic literature review was conducted, along with an analysis of the context in our setting. The outcomes of interest were radiation doses, clinical complications, procedure times, purchase cost, impact on teaching program, the confidence of clinicians in the technology, quality of care, accessibility, and the volume of activity. A committee comprising managers, clinical experts, physicians, physicists and HTA experts was created to produce a recommendation regarding biplane technology acquisition to replace a monoplane device. RESULTS: The systematic literature review yielded nine eligible articles for analysis. Despite a very low level of evidence in the literature, the biplane system appears to reduce ionizing radiation and medical complications, as well as shorten procedure time. Contextual data indicated that the biplane system could improve operator confidence, which could translate into reduced risk, particularly for complex procedures. In addition, the biplane system can support our institution in its advanced procedures teaching program. CONCLUSIONS: Given the advantages provided by the biplane technology in our setting, the committee has recommended its acquisition. Contextual data were of utmost importance in this recommendation. Moreover, this technology should be implemented alongside a responsibility to collect outcome data to optimize clinical protocol in the doses of ionizing delivered.

Activities of the pan-Canadian Pharmaceutical Alliance: An Observational Analysis.

BACKGROUND: The pan-Canadian Pharmaceutical Alliance (pCPA) was established in 2010 to negotiate confidential prices for drugs coming forward from Canada's centralized health technology assessment (HTA) agency reviews, on behalf of the participating public drug plans. OBJECTIVE:  To analyze the activities of the pCPA, to determine: alignment of HTA agency recommendations and pCPA negotiation decisions; the role of health economics in pCPA activities; and patterns of implicit prioritization. METHODS: The analysis was based on the archive of drugs handled through the pCPA, as posted on its website. The period of observation was from inception to August 31, 2017. HTA recommendations were sourced from the websites of the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review. Descriptive and statistical analyses were conducted. RESULTS: The dataset contained 206 drug-indication pairings. There was close but imperfect alignment between HTA agency recommendations and the pCPA's decisions to negotiate; deviations occurred only with CDR-reviewed drugs. The median incremental cost-effectiveness ratio of negotiated drugs was $168K/QALY for oncology drugs, but $70K/QALY for non-oncology drugs. The time to initiate negotiations was dramatically shorter for oncology versus non-oncology drugs (mean 54 versus 263 days), and also differed between therapeutic areas at CDR. The time required for PCPA activity was surprisingly similar for drugs recommended without a price condition and for those conditional on a price reduction. CONCLUSION: These findings revealed a strong alignment between HTA recommendations and pCPA negotiations, an implicit prioritization favouring oncology drug negotiations, and an evolving role for health economics in Canada's reimbursement process.

An Evaluation of Clinical Economics and Cases of Cost-effectiveness.

In order to maintain and develop a universal health insurance system, it is crucial to utilize limited medical resources effectively. In this context, considerations are underway to introduce health technology assessments (HTAs), such as cost-effectiveness analyses (CEAs), into the medical treatment fee system. CEAs, which is the general term for these methods, are classified into four categories, such as cost-effectiveness analyses based on performance indicators, and in the comparison of health technologies, the incremental cost-effectiveness ratio (ICER) is also applied. When I comprehensively consider several Japanese studies based on these concepts, I find that, in the results of the analysis of the economic performance of healthcare systems, Japan shows the most promising trend in the world. In addition, there is research indicating the superior cost-effectiveness of Rituximab against refractory nephrotic syndrome, and it is expected that health economics will be actively applied to the valuation of technical innovations such as drug discovery.

Incorporação da Vacina contra o Papilomavírus Humano pelo Ministério da Saúde: uma análise do processo decisório / Incorporation of the Vaccine against the Human Papillomavirus by the Ministry of Health: an analysis of the decision-making process

A vacina contra o Papilomavírus Humano (HPV) protege contra quatro subtipos virais, sendo os subtipos 16 e 18 associados a cerca de 70% dos casos de câncer do colo de útero no mundo. A incorporação dessa vacina no Brasil ocorreu em um momento em que a avaliação de tecnologias em saúde se encontrava em institucionalização dentro do Ministério da Saúde. Esse estudo examinou o processo de incorporação da vacina Quadrivalente contra o HPV pelo Ministério da Saúde (MS), ocorrida no âmbito da Comissão Nacional de Incorporação de Tecnologias do SUS (CONITEC), a fim de (1) caracterizar o contexto político e institucional em que se deu esta decisão no país, identificando os principais atores envolvidos neste processo e suas posições e influências na tomada de decisão ocorrida; (2) mapear os critérios e fatores que foram considerados na decisão de introdução da vacina contra o HPV pelo governo brasileiro; (3) discutir os aspectos relacionados à implementação da vacina incorporada que foram considerados nos primeiros momentos de sua adoção no SUS. Foi conduzindo, assim, um estudo exploratório, com abordagem qualitativa, do tipo estudo de caso único. Os dados foram coletados através de análise de documentos governamentais, de projetos de lei legislativos e de oito entrevistas com atores-chave, identificados como participantes do processo através dos documentos ou referidos por outros entrevistados. A análise dos dados buscou identificar como ocorreu o processo; as arenas, governamentais ou não, onde foram travados os debates; as posições e os argumentos defendidos pelos atores e como foi realizada a análise pela CONITEC, procurando o entendimento do processo decisório como um todo. A vacina foi registrada pela Agência Nacional de Vigilância Sanitária em 2006 e, desde então, somaram-se as pressões para sua incorporação ao sistema público de saúde, levando à formação de diversos grupos de trabalho, ao longo dos anos. Os resultados iniciais das evidências disponíveis recomendavam a não incorporação da vacina, devido às lacunas do conhecimento acerca de sua eficácia e segurança e devido ao alto impacto orçamentário para o SUS decorrente de seus elevados preços, além de problemas de viabilidade técnica para sua oferta pelo Programa Nacional de Imunizações (PNI). Um estudo de custo-efetividade mostrou em 2012 que a vacina era custo-efetiva ao sistema, mas, antes disso, a Secretaria de Vigilância à Saúde e outras secretarias já avaliavam sua introdução no PNI. A transferência de tecnologia via estabelecimento de uma Parceria de Desenvolvimento Produtivo e a redução de preço foram elementos fundamentais para essa decisão. A incorporação da vacina foi um processo longo, que se estendeu por anos, tendo ocorrido mesmo quando ainda persistiam diversas incertezas sobre seu potencial impacto na incidência de câncer de colo de útero. Embora a decisão tenha ocorrido no âmbito da CONITEC, as discussões se estenderam a diversas arenas, incluindo o meio acadêmico e o legislativo. A incorporação foi aprovada por unanimidade pelo Plenário da CONITEC. A decisão publicada em DOU em novembro de 2013 e sua oferta no PNI fora iniciada em março de 2014, utilizando uma estratégia mista ao incluir escolas e serviços de saúde. Desde então, as coberturas vacinais alcançadas têm estado muito abaixo das metas recomendadas para a vacina alcançar seus objetivos propostos, o que ameaça colocar, em risco futuro, seus objetivos pretendidos de reduzir a incidência do câncer de colo de útero

The vaccine against the Human Papillomavirus (HPV) offers protection against four viral subtypes, and from these the subtypes 16 and 18 are associated with about 70% of cases of cervical cancer in the world. The incorporation of this vaccine in Brazil occurred at a time when the evaluation of health technologies was institutionalized within the Ministry of Health. This study examined the process of incorporation of the Quadrivalent vaccine against HPV by the Ministry of Health (MS), that occurred within the National Commission for the Incorporation of Technologies do SUS (CONITEC), in order to (1) characterize the political and institutional context in which this decision was made in the country, identifying the main actors involved in this process and their positions and influences in the decision-making; (2) map the criteria and factors that were considered in the decision to introduce the HPV vaccine by the Brazilian government; (3) discuss the aspects related to the implementation of the incorporated vaccine that were considered in the first moments of its adoption in the SUS. The exploratory study was conducted through a qualitative approach, of a single case study type. The data were collected through analysis of government documents, legislative bills and eight interviews with key actors, identified as process participants through the documents or referred by other interviewees. The analysis of the data sought to identify how the process occurred; the arenas, governmental or not, where the debates were held; the positions and arguments defended by the actors and how the analysis was carried out by CONITEC, seeking the understanding of the decision-making process as a whole. The vaccine was registered by the National Agency of Sanitary Surveillance in 2006 and, since then, added the pressures for its incorporation into the public health system, leading to the formation of several work groups over the years. The initial results of the available evidence do not recommend incorporation, due to the lack of knowledge about its efficacy and reliability and the high budgetary impact for the SUS due to its high prices and problems of technical feasibility for its offer by the National Program of Immunizations (PNI). A cost-effectiveness study showed in 2012 that the vaccine was cost-effective to the system, but before that the Department of Health Surveillance and other departments already evaluated its introduction in the PNI. The transfer of technology through the establishment of a Productive Development Partnership and the reduction of prices were fundamental elements for this decision. The incorporation of the vaccine was a long process, which lasted for years, occurring even when there were still uncertainties about its potential impact on the incidence of cervical cancer. Although the decision had occurred within CONITEC, the discussions have extended to several arenas, including the academia and legislative environment. The incorporation was unanimously approved by the CONITEC Plenary, the decision published in the DOU in November 2013, and its offer in the PNI was initiated in March 2014, which used a mixed strategy, including schools and health services. Since then, the vaccine coverage achieved has been far below the targets recommended for the vaccine to reach its proposed goals, risking its intended future goals of reducing the incidence of cervical cancer

HOW TO AVOID GIVING THE RIGHT ANSWERS TO THE WRONG QUESTIONS: THE NEED FOR INTEGRATED ASSESSMENTS OF COMPLEX HEALTH TECHNOLOGIES.

Health technologies are becoming increasingly complex and contemporary health technology assessment (HTA) is only partly equipped to address this complexity. The project "Integrated assessments of complex health technologies" (INTEGRATE-HTA), funded by the European Commission, was initiated with the overall objective to develop concepts and methods to enable patient-centered, integrated assessments of the effectiveness, and the economic, social, cultural, and ethical issues of complex technologies that take context and implementation issues into account. The project resulted in a series of guidances that should support the work of HTA scientists and decision makers alike.