PP41 Toward Rules For Stakeholders’ Involvement In Regional Health Technology Assessment Units

2018 ◽  
Vol 34 (S1) ◽  
pp. 81-82
Author(s):  
Mathieu Roy ◽  
Véronique Déry ◽  
Pierre Dagenais
Keyword(s):  
Health Technology Assessment ◽  
Social Services ◽  
Technology Assessment ◽  
User Involvement ◽  
Health Technology ◽  
Practical Experience ◽  
Steering Committee ◽  
Consensus Method ◽  
Delphi Consensus ◽  
Methodological Considerations

Introduction:Health services users must participate in health technology assessment (HTA) activities. Users, caregivers, and citizens have the practical experience of healthcare and social services. HTA outputs are more useful when values and preferences of patients, caregivers, and citizens are taken into account. Despite this, the best methods of stakeholders’ involvement, timing for doing so, selection of participants, and the type of users to recruit depending of methods and contexts remain unspecified. Herein, an involvement policy has been developed to formalize the participation of users, caregivers and citizens in the services offering of a regional HTA unit.Methods:A steering committee composed of stakeholders (i.e. user, caregiver, citizen, User Experience Service representative, manager, provincial HTA body representative, HTA unit members) was constituted to discuss user involvement in a regional HTA unit. A preliminary vision statement emerged from this committee, and included objectives and principles for users, caregivers, and citizens participation. This statement was deliberated using a Delphi consensus method. Three rounds of deliberations were needed to reach a strong consensus.Results:Four objectives and four principles that should underlie the development of an involvement policy reached consensus. Participants agreed that users, caregivers, and citizens should: i) propose principles of involvement for each HTA projects; ii) co-realize evaluations with HTA professionals; iii) contribute to evaluation processes; and, iv) be involved in some management decisions of regional HTA units. Four principles to formalize users, caregivers and citizens’ involvement in regional HTA units also emerged. These principles were about utility and feasibility of involvement as well as ethical and methodological considerations.Conclusions:Users, caregivers, and citizens must participate in the activities of regional HTA units. Each of them have different roles and can contribute to evaluation processes. Their involvement in HTA activities is warranted for co-producing better evaluation more adapted to users’ needs in healthcare and social services.

scholarly journals Real-world evidence: perspectives on challenges, value, and alignment of regulatory and national health technology assessment data collection requirements

2021 ◽  
Vol 37 ◽  
Author(s):  
Hannah Sievers ◽  
Angelika Joos ◽  
Mickaël Hiligsmann
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Practical Experience ◽  
Added Value ◽  
Real World Data ◽  
Conflicting Demands ◽  
Real World Evidence ◽  
Semistructured Interviews

Abstract Objective This study aims to assess stakeholder perceptions on the challenges and value of real-world evidence (RWE) post approval, the differences in regulatory and health technology assessment (HTA) real-world data (RWD) collection requirements under the German regulation for more safety in drug supply (GSAV), and future alignment opportunities to create a complementary framework for postapproval RWE requirements. Methods Eleven semistructured interviews were conducted purposively with pharmaceutical industry experts, regulatory authorities, health technology assessment bodies (HTAbs), and academia. The interview questions focused on the role of RWE post approval, the added value and challenges of RWE, the most important requirements for RWD collection, experience with registries as a source of RWD, perceptions on the GSAV law, RWE requirements in other countries, and the differences between regulatory and HTA requirements and alignment opportunities. The interviews were recorded, transcribed, and translated for coding in Nvivo to summarize the findings. Results All experts agree that RWE could close evidence gaps by showing the actual value of medicines in patients under real-world conditions. However, experts acknowledged certain challenges such as: (i) heterogeneous perspectives and differences in outcome measures for RWE generation and (ii) missing practical experience with RWD collected through mandatory registries within the German benefit assessment due to an unclear implementation of the GSAV. Conclusions This study revealed that all stakeholder groups recognize the added value of RWE but experience conflicting demands for RWD collection. Harmonizing requirements can be achieved through common postlicensing evidence generation (PLEG) plans and joint scientific advice to address uncertainties regarding evidence needs and to optimize drug development.

PP142 A Mental Health Hospital-based Health Technology Assessment In Quebec, Canada: Structure And Products

2017 ◽  
Vol 33 (S1) ◽  
pp. 137-138
Author(s):  
Ionela Gheorghiu ◽  
Alain Lesage ◽  
Adam Mongodin ◽  
Marlène Galdin
Keyword(s):  
Mental Health ◽  
Decision Making ◽  
Health Technology Assessment ◽  
Social Services ◽  
Technology Assessment ◽  
Literature Search ◽  
New Technologies ◽  
Psychiatric Patients ◽  
Health Technology ◽  
Decision Making Process

INTRODUCTION:Our Hospital-based Health Technology Assessment unit (HB-HTA) was founded in 2011 following the nomination of Louis-H. Lafontaine hospital as the Montreal University Mental Health Institute (IUSMM). From the beginning, the HB-HTA has been supporting and advising the Chief Executive Officer of IUSMM in the decision-making process concerning the implementation of new technologies and practices in mental health. Since 2015, the HB-HTA is part of the East of Montreal Regional Integrated Health and Social Services Centre (CIUSSS de l'Est-de-l’Île de Montréal), continuing to support decisions in mental health. Currently, the HB-HTA unit is nested in the Quality, Performance and Ethics department.METHODS:Formed by a coordinator, a scientific advisor and a manager, the HB-HTA team plans, organizes and sets up the evaluation activities. The unit benefits from the support of a Steering Committee which consists of representatives of clinical, administrative and research directions, as well as of health users and families. This committee determine the strategic orientation of the HB-HTA unit, prioritize the projects, approves the evaluation products and gives indications on the knowledge transfer process.RESULTS:To answer the decision questions, our HB-HTA unit employs two types of products: evaluation reports and informative notes. Based on an exhaustive literature search and consultations with stakeholders, the evaluation reports offer recommendations to support the decision-making process. The informative notes are rapid responses based on a partial literature search. The nature of this type of analysis does not allow the formulation of recommendations, however, a conclusion of the consulted literature is offered.CONCLUSIONS:Based on the work of our HB-HTA unit, some important decisions were made by the IUSMM. As an example, the systematic screening of psychiatric patients for drug and alcohol was not favored by our institution; rather than this, priority was given to staff training, in order to better identify and treat psychiatric patients with substance abuse comorbidity.

OP305 A Systematic Approach To Include Ethical Aspects In Health Technology Assessments – Experiences And Evaluation

2021 ◽  
Vol 37 (S1) ◽  
pp. 11-11
Author(s):  
Karin Willbe Ramsay
Keyword(s):  
Health Technology Assessment ◽  
Social Services ◽  
Technology Assessment ◽  
Systematic Approach ◽  
Health Technology ◽  
Time Frame ◽  
Ethical Framework ◽  
Systematic Evaluation ◽  
Ethical Aspects ◽  
Ethical Content

IntroductionThe Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) is commissioned to assess ethical aspects in their health technology assessment (HTA) reports, in addition to effects and health economic aspects of the examined interventions. For this purpose, a framework for systematic evaluation of ethical aspects of healthcare technologies has been developed and used at SBU since 2014. With seven years of practice, we decided it was time to evaluate experiences from using the ethical framework and consider possible adjustments to improve future use.MethodsSBU reports in the time period 2014–2020 were systematically screened for ethical content. Focus group meetings with users of the framework (mainly HTA project managers) were held where opinions regarding usability and possible obstacles were collected. A revised version of the document was sent for consultation to relevant stakeholders (possible users, reviewers and recipients) in order to collect additional views.ResultsOf fifty-eight HTA reports produced in the time frame, ethical aspects were evaluated in fifty-five reports (ninety-five percent), and in most cases, the framework had been used as support. In twenty-one cases (thirty-six percent), a professional ethicist had been engaged in the work. In twelve cases (twenty-one percent), ethical aspects were presented in the main conclusions of the report. Opinions from users and reviewers revealed that the framework was generally regarded as a helpful tool, but problems regarding interpretation of specific questions were highlighted and subjected to revision.ConclusionsThe ethical framework is a valuable tool for systematic and transparent identification and discussion of ethical aspects in the HTA context, and it has been well implemented at SBU. A systematic approach to assess ethical aspects can facilitate the communication and dissemination of ethical aspects as principal results from the HTA project.

scholarly journals Internal evaluation of the European network for Health Technology Assessment project

2009 ◽  
Vol 25 (S2) ◽  
pp. 99-106 ◽  
Author(s):  
Lise Lund Håheim ◽  
Iñaki Imaz ◽  
Marlène Läubli Loud ◽  
Teresa Gasparetto ◽  
Jesús González-Enriquez ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Steering Committee ◽  
Solid Base ◽  
European Network ◽  
Work Package ◽  
Cross Sectional ◽  
Internal Evaluation ◽  
Additional Information

Objectives: The internal evaluation studied the development of the European network for Health Technology Assessment (EUnetHTA) Project in achieving the general objective of establishing an effective and a sustainable network of health technology assessment (HTA) in Europe.Methods: The Work Package 3 group was dedicated to this task and performed the work. Information on activities during the project was collected from three sources. First, three yearly cross-sectional studies surveyed the participants’ opinions. Responses were by individuals or by institutions. The last round included surveys to the Steering Committee, the Stakeholder Forum, and the Secretariat. Second, the Work Package Lead Partners were interviewed bi-annually, five times in total, to update the information on the Project's progress. Third, additional information was sought in available documents.Results: The organizational structure remained stable. The Project succeeded in developing tools aimed at providing common methodology with intent to establish a standard of conducting and reporting HTA and to facilitate greater collaboration among agencies. The participants/agencies expressed their belief in a network and in maintaining local/national autonomy. The Work Package Leaders expressed a strong belief in the solid base of the Project for a future network on which to build, but were aware of the need for funding and governmental support.Conclusions: Participants and Work Package Leaders have expressed support for a future network that will improve national and international collaboration in HTA based on the experience from the EUnetHTA project.

HEALTH TECHNOLOGY ASSESSMENT IN AUSTRIA

2000 ◽  
Vol 16 (2) ◽  
pp. 303-324 ◽  
Author(s):  
Claudia Wild
Keyword(s):  
Health Technology Assessment ◽  
Social Services ◽  
Healthcare System ◽  
Technology Assessment ◽  
Social Health Insurance ◽  
Health Technology ◽  
Federal State ◽  
Structural Reforms ◽  
Financing System ◽  
Health Technologies

The Austrian healthcare system relies mainly on physicians in private practice and on various services provided by hospitals. The social health insurance scheme is compulsory, covering 99% of the population. The system is very decentralized. While the federal state provides the framework, the nine autonomous provinces are responsible for administering health and social services. There is ongoing public discussion about centralizing the healthcare system to make it more efficient and to enforce structural reforms. Because of concerns about healthcare expenditures, in 1997 the Performance-Related Hospital Financing System (LKF), a system similar to the diagnosis-related group system, was introduced for hospitals, including a plan for large medical devices. It is too early to evaluate the success of this new system, although some effects of the LKF system that could have been anticipated, such as shortened lengths of stay and more hospitalizations, have been seen. Previously, health technologies have been almost uncontrolled in Austria. The evaluation of health technologies as an instrument to support or to control their dissemination and use or to help define policies is not institutionalized or systematically used. It seems clear that structural reforms of the Austrian healthcare system are needed. Health technology assessment should be part of such reforms.

scholarly journals Information specialist collaboration in Europe: collaborative methods, processes, and infrastructure through EUnetHTA

2020 ◽  
pp. 1-6
Author(s):  
Siw Waffenscfhmidt ◽  
Marli van Amsterdam-Lunze ◽  
Rebeca Isabel Gomez ◽  
Maike Rehrmann ◽  
Ingrid Harboe ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Relative Effectiveness ◽  
Health Technology ◽  
Steering Committee ◽  
Daily Work ◽  
European Collaboration ◽  
Retrieval Processes ◽  
History Of ◽  
European Health

The history of European health technology assessment (HTA) goes back more than 30 years. Almost as old as HTA agencies themselves is the desire to achieve European collaboration. This gained further impetus with the establishment of the European Network of Health Technology Assessment (EUnetHTA) in 2006. In this context, the field of information management faced specific challenges. Although these services are an integral part of HTA and information specialists play a key role here, this field is often not adequately represented in the HTA agencies within EUnetHTA. Furthermore, the organization of HTA production, including the types of HTAs produced, as well as funding, varies considerably. In order to meet these different conditions, information specialists have created various products and defined processes. With the EUnetHTA guideline, a common methodological understanding for the production of rapid Relative Effectiveness Assessments now exists. Furthermore, the Standard Operating Procedures map the complex information retrieval processes within EUnetHTA in a hands-on manner. The newly established Information Specialist Network (ISN) will in future ensure that information specialists are involved in all EUnetHTA assessments and that the methods are applied consistently in all assessments. In addition, the steering committee of the ISN manages enquiries and can be contacted to discuss methodological issues. Major barriers such as heterogeneity in the daily work of the EUnetHTA members can only be overcome through more collaboration and training.

HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT (HB-HTA): A 10-YEAR SURVEY AT ONE UNIT

2016 ◽  
Vol 32 (3) ◽  
pp. 116-121 ◽  
Author(s):  
Xavier Grenon ◽  
Christophe Pinget ◽  
Jean-Blaise Wasserfallen
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Average Length ◽  
Scientific Evidence ◽  
Health Technology ◽  
Practical Experience ◽  
Structured Interview ◽  
Health Technologies ◽  
Average Length Of Stay

Introduction: Hospital-based health technology assessment (HB-HTA) has been introduced to help hospital management in decision making about the adoption of new health technologies (HTs). We reviewed the accuracy of the expected medical impact of HTs assessed at our hospital, as well as the acceptance of this process by clinicians.Methods: For each HT adopted between 2002 and 2011, a semi-structured interview with the involved clinician was conducted, assessing (i) the perceived utility of the HB-HTA process, (ii) the accuracy of the new HT's expected medical impact as compared with observed patient data from the year 2012, and (iii) the compliance with the indications of the HB-HTA report.Results: Over the 10-year period, forty HB-HTAs were carried out, of which thirty-four led to acceptance. Twenty-seven of the twenty-eight clinicians involved in these thirty-four HTs accepted the interview and 85 percent acknowledged the utility of the HB-HTA process. Five of the thirty-four HTs were no longer in use. For the twenty-nine remaining HTs, observed patients’ number was as expected in eight, higher in four, lower in fifteen, and not available in two cases. Available average length of stay was 61 percent longer than expected. Two HTs had a higher complication rate and three a lower success rate. Indications evolved in 55 percent of HTs after a few years (seven restrictions, six broadenings, and three other changes).Conclusions: A HB-HTA process is useful to improve quality in decision making. Follow-up analysis should routinely be performed to adapt HB-HTA reports’ conclusions to practical experience and new scientific evidence.

scholarly journals Health Technology Assessment System in Sweden

2019 ◽  
pp. 16-23
Author(s):  
Vitaly Vladimirovich Omelyanovskiy ◽  
Filipp Vasilievich Gorkavenko ◽  
Yegor Sergeevich Saybel ◽  
Georgii Rubenovich Khachatryan
Keyword(s):  
Health Technology Assessment ◽  
Social Services ◽  
Technology Assessment ◽  
Medical Technology ◽  
Health Technology ◽  
Assessment System ◽  
Reimbursement System ◽  
Medical Technologies ◽  
The World ◽  
Regulatory Functions

Sweden is one of the first countries who establish health technology assessment (HTA) agency. Nowadays, there are two HTA organizations in the country. The first is one of the oldest in the world – the Swedish agency for health technology assessment and assessment of social services (SBU), and the second is the Council The Dental and Pharmaceutical Benefits Agency (TLV). Having similar tasks, organizations are created for different purposes. TLV assesses medical technologies within state reimbursement system, its purpose is to ensure the efficient use of budget funds. The SBU does not participate in the reimbursement system and does not have any regulatory functions, its purpose is to respond to public inquiries regarding the use of any medical technology. Agencies differ in the number of annually published reports, their types and objects of evaluation. Wherein the work of both institutions is characterized by a wide involvement of independent experts, outside organizations and particular attention to the economic component of the assessment.

TOWARD INTERNATIONAL GOOD PRACTICES IN HEALTH TECHNOLOGY ASSESSMENT

2012 ◽  
Vol 28 (2) ◽  
pp. 169-170 ◽  
Author(s):  
Clifford Goodman
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Practical Experience ◽  
Public And Private ◽  
Good Practices ◽  
Medical Interventions ◽  
The Public ◽  
The 1960S ◽  
International Good

Since the origin of technology assessment (TA) in the 1960s, including TAs of certain medical interventions, and formal recognition and institutionalization of health technology assessment (HTA) in the 1970s, the field of HTA has evolved in programs large and small in the public and private sectors. It has diffused into an increasing number of nations in a range of policy-making and decision-support contexts. Since its inception, the development and diffusion of HTA have been strongly characterized by international collaboration involving sharing of expertise and practical experience, and joint efforts to advance the state of the art. Also during that time, there have been periodic collaborations to identify or develop standard frameworks, good practices, guiding principles, checklists, and other normative, “how-to” documentation for the field. Recognizing the diversity and ongoing evolution of HTA, these efforts have generally sought to balance the appeal of standardization with that of flexibility to accommodate the ranges of HTA program remits and contexts.

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