7 results
Scaling up health technology assessment capacities in selected African countries – A conceivable route ahead
- Debjani Mueller, Leila Alouane, Mouna Jameleddine, Irene Lenoir-Wijnkoop
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 39 / Issue 1 / 2023
- Published online by Cambridge University Press:
- 30 January 2023, e9
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Background
This study aimed to provide a structured description of the commonalities and differences in healthcare structures across Africa to establish a reliable basis for the health technology assessment (HTA) of nutrition and nutrition interventions. A ranking of current nutrition conditions in the general population of the participating countries was included to gain a better understanding of the factors influencing hospital malnutrition (HMN), which will inform future multi-country research.
MethodA questionnaire on the structure of the health systems was distributed among ten African countries. Subsections were included that inquired about the drivers or barriers to using principles of HTA to assess nutritional care. Analysis and ranking of malnutrition data were based on data from the Global Hunger Index report and two poverty indicators used by the World Bank.
ResultsThe health system structure of each country was identified and described, whereas questions about HTA could not always be analyzed due to a lack of adequate in-depth knowledge and skills in most countries. Early experience from some countries demonstrates a conceivable route ahead for African countries in strengthening the capacity for and implementing HTA in accordance with distinct national healthcare contexts and social determinants of health.
ConclusionProblems related to nutritional care represent one of the major priorities in the surveyed countries. A future HMN multi-country study will provide valuable insight into the potential of low-cost primary prevention orientations.
OP59 The Tunisian Guidelines For Pharmacoeconomic Analysis: What We Need To Know
- Nabil Harzallah, Jaafar Chemli, Hela Grati, Marie Jebali, Mouna Jameleddine, Chokri Hamouda
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, p. S23
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Introduction
As a new milestone in health technology assessment (HTA) implementation in Tunisia, L’Instance Nationale de l’Evaluation et de l’Accréditation en Santé (INEAS)—the Tunisian HTA body—published a set of methodological guidelines to support HTA dossier submission by the pharmaceutical industry. Including, ‘guide for submitting clinical data for an HTA at INEAS’, ‘methodological choices guide for pharmacoeconomic analysis at INEAS’, and ‘methodological choices guide for budget impact analysis at INEAS’. We aim to report the major methodological recommendations of the pharmacoeconomic analysis guideline.
MethodsThe ‘methodological choices for pharmacoeconomic analysis at INEAS’ guideline was reviewed and the major recommendations were retrieved and reported.
ResultsThe reference analysis required by INEAS is the cost-utility analysis systematically combined with a cost-effectiveness analysis (cost per life-year gained) from the public payers’ perspective. The choice of any other type of analysis must be duly justified. Comparators should include alternative treatments which are considered to be ‘the standard of care’ (i.e., interventions routinely used in Tunisia for the same indication) and in which public resources are invested. The time horizon should be sufficiently long to reflect all differences in costs and outcomes. Additionally, a discount rate of 5 percent per year is recommended. The best available evidence for efficacy, safety and quality of life is required. An indirect measure of patient preference, through a validated measurement instrument is preferred for utility calculation. Cost inputs should be identified from Tunisian sources. Health resource utilization should reflect the care pathway in Tunisia. INEAS favors the use of a recognized model. Uncertainty and impact of the input parameters on the results should be assessed and reported through probabilistic and deterministic sensitivity analyses. Model validation tests to assess face validity and internal validity should be performed, and a discussion of the methods used provided. Demonstration of external validity is required. Results should be presented in incremental cost-utility and cost-effectiveness ratios.
ConclusionsThe recommendations of ‘methodological choices for pharmacoeconomic evaluation at INEAS’ is an important step to facilitate and harmonize pharmaceutical companies’ submissions and to enhance the use of these analyses in decision-making.
PP46 INEAS Guidelines For Pharmacoeconomic Evaluation: Focus On Health-Related Quality of Life Recommendations
- Jaafar Chemli, Nabil Harzallah, Hela Grati, Marie Christine Jebali, Mouna Jameleddine, Chokri Hamouda
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- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, pp. S55-S56
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Introduction
In many low- and middle-income countries scarcity of local data on health outcomes and health-related quality of life (HRQoL) is a hindrance to conducting cost-effectiveness analyses. The Tunisian National Authority for Accreditation and Assessment in Healthcare (INEAS) developed a set of methodological guidelines to support pharmaceutical companies in the submission of health technology assessment (HTA) dossiers. The guidelines include INEAS’ methodological choices for pharmacoeconomic analysis, which take into consideration the specificities and constraints of the Tunisian context. We aimed to present the principal recommendations of the Tunisian guidelines for pharmacoeconomic studies, with a focus on patient-reported outcome and HRQoL measurement.
MethodsThe INEAS pharmacoeconomic analysis guidelines were reviewed and the recommendations regarding outcome measurement and HRQoL were retrieved and reported.
ResultsTo populate the economic model, INEAS recommends using the best available evidence. Health outcomes should be measured in terms of life-years gained and quality-adjusted life-years (QALYs); disability-adjusted life-years can be used but are not the preferred method. To estimate QALYs, INEAS favors the indirect measure of patient preferences with a validated measurement instrument. Alternatively, other measures of utility may be used, including those identified through a systematic review of the scientific literature and the publications of other HTA agencies. Justification and details of the source of the data must be provided. The utility values selected should be recent and representative of the Tunisian population, as far as possible. The guidelines refer to a set of generic preference-based HRQoL instruments, including the EuroQol five-dimensions (EQ5D), the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3), and the Short-Form Six-Dimension (SF-6D), but do not provide any explicit recommendations on their use.
ConclusionsThe INEAS pharmacoeconomic analysis guidelines adhere to international best practices but provide more flexibility for overcoming the lack of local data. The INEAS economic guidelines constitutes a further milestone in the process of implementing HTA in Tunisia and in the Middle Eastern and African regions.
PP101 Development Process Of The Economic Guidelines In Tunisia
- Mouna Jameleddine, Nabil Harzallah, Jaafar Chemli, Hela Grati, Marie Christine Jebali, Chokri Hamouda
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, pp. S73-S74
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Introduction
Health technology assessment (HTA) has become a critical support to health policy decision-making. The HTA evaluation process requires transparency, formalized processes, clear timelines, and standardization according to international best practice. Tunisia is establishing an HTA-based decision-making system through the National Authority for Accreditation and Assessment in Healthcare (INEAS) to ensure impartiality and fairness in decision-making, which is important for an emerging democracy. INEAS opted for a participatory approach in developing the national health economic guidelines to better engage healthcare sector stakeholders in the HTA process. We aimed to present the main phases of the process used to develop the Tunisian health economic guidelines, the methodological choices for pharmacoeconomic evaluations, and the methodological choices for budget impact analyses.
MethodsThe different phases of developing the guidelines were listed and reported.
ResultsThe guidelines were developed under a technical cooperation program of the World Health Organization and involved collaboration between the Institut national d’excellence en santé et en services sociaux (INESSS in Quebec, Canada) and INEAS. The first version of the guidelines was drafted following a review of international HTA guidelines and best practice reference books, taking into account the Tunisian healthcare system context. This first draft was discussed in a workshop with the main health system stakeholders and then peer reviewed by international experts. Based on the feedback from experts, a second version was prepared and published on the INEAS website for public consultation. The Union of Innovative Pharmaceutical Research Companies (SEPHIRE), the National Health Insurance Fund (CNAM), and healthcare professionals provided the majority of feedback. The comments provided by SEPHIRE were discussed during a second workshop. The guidelines were revised and updated based on the comments provided and the final version was published in November 2021.
ConclusionsINEAS adopted a participatory approach for developing its economic guidelines, which enhanced engagement of the major health system stakeholders in the HTA implementation process in Tunisia.
OP108 Health Intervention Assessment Report Adaptation: Tunisian Experience
- Wafa Allouche, Asma Ben Brahem, Hella Ouertatani, Mouna Jameleddine, Hela Grati, Khalil Jlassi, Mohamed Ben Hammouda, Randa Attieh, José Asua, Iñaki Gutiérrez-Ibarluzea, Khaled Zghal
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, pp. 50-51
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INTRODUCTION:
Health Technology Assessment (HTA) reports adaptation process is an important tool for emerging HTA agencies. INASanté (National Instance for Accreditation in Healthcare) has chosen to rely on this approach, to develop its first health intervention assessment report: comparative study of computed tomographic colonography versus standard colonoscopy for colorectal cancer screening.
METHODS:Following consultations with healthcare professionals, the PICO question related to the colorectal cancer screening issue in Tunisia was determined. A literature search strategy covering 10 years (2006-2016) was carried out. Several databases including HTA on the net were explored. Then two independent reviewers conducted literature screening and realized a PRISMA flow diagram. Full text selected reports were submitted to three critical appraisal tools: PRISMA checklist, INAHTA checklist and Critical Appraisal Tools (FLC 2.0). The EUnetHTA adaptation toolkit was used to determine reports adaptability by assessing relevance, reliability and transferability. A structured study of the Tunisian context based on a qualitative data analysis was elaborated. The data synthesis and reporting were finalized with the contribution of a working group. Then an external peer review was conducted before the report dissemination.
RESULTS:Eighty reports were screened to finally retain four eligible. After a critical appraisal performed by two independent reviewers, two reports from the Canadian Agency for Drug and Technolgies in Healthcare and AETSA were selected to be assessed using the EUnetHTA adaptation toolkit. Regarding transferability criteria, the second report was retained. The context study has consisted in a qualitative analysis of seventeen individual interviews with healthcare professionals involved in colorectal cancer screening issues and an up to date Tunisian literature review. The final adapted report was a combination between relevant extracted data from AETSA report and synthesis of the Tunisian context analysis.
CONCLUSIONS:This HTA report represents a tool for policy makers to establish the appropriate colorectal cancer screening program for the Tunisian context. HTA reports adaptation process is the best way to give evidence on emerging technologies without wasting time and resources.
PP168 Combination Therapy Versus Intensification Of Statin Monotherapy
- Mouna Jameleddine, Hela Grati, Asma Ben Brahem, Khalil Jlassi, Hella Ouertatani, Wafa Allouche, Khaled Zghal, Randa Attieh, José Asua, Iñaki Gutiérrez-Ibarluzea, Marie Christine Jebali
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, pp. 143-144
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INTRODUCTION:
Coronary heart disease (CHD) is the most common cause of mortality globally. The burden of CHD is a challenge for Tunisia causing 27.14 percent of total mortality (1).
Statins are the leading molecules used to prevent CHD in Tunisia. The amount paid by the national insurance fund for statins in 2015 represents 9 percent of total drug expenditures (2).
INASanté has launched a Health Technology Assessment (HTA) study to compare the intensification of statin monotherapy versus a combination therapy for the CHD prevention in patients with moderate to high cardiovascular risk. The aim of this contextualized HTA report is to diminish prescription variability and not justified therapies.
METHODS:Research was carried out in the following databases: CRD, NICE search evidence, Cochrane, Belgian Health Care Knowledge Centre (KCE), Canadian Agency for Drugs and Technologies in Health (CADTH), Adelaide Health Technology Assessment (AHTA), Institut National d'excellence En Santé et en Services Sociaux (INESS), Euroscan International Network, National Institute for Health Research (NIHR), Agency for Healthcare Research and Quality (AHRQ) and Haute Autorité de Santé (HAS) from 2006 to 2017. Title, abstract and full text screening were performed by two independent reviewers relying on prespecified eligibility criteria. Critical appraisal of literature was conducted using INAHTA and PRISMA checklists, FLC 2.0 and The European Network for HTA (EUnetHTA) adaptation toolkit. One review from AHRQ was retained.
An adaptation process has been launched. Data on lipid lowering agents intake from key institutions have been gathered and a qualitative study has been started through interviews with thirty-three cardiologists and general practitioners from public, private sector and scientifc societies. Interviews have been analysed using NVivo. After results discussion with the working group, the report will be synthesized and validated.
RESULTS:According to the AHRQ report, all evidence for clinical outcomes were graded insufficient when comparing the therapies. Results on lowering low density lipoprotein (LDL-C) depend on the combination agent Ezetimibe has shown remarkable results (3).
The Tunisian context shows that there is no standardized method to assess the cardiovascular risk according to the preliminary results. The only combination therapy reported is with fibrates, mainly in case of associated hypertriglyceridemia. Ezetimibe has not yet obtained the marketing authorization.
CONCLUSIONS:There are significant differences between contexts and among practitioners prescriptions. This can be related to the lack of common guidelines and inequitable access to drugs and healthcare resources in general.
VP70 Structuring The Process Of Innovation Uptake In Tunisia
- Mouna Jameleddine, Asma Ben Brahem, Hela Grati, Hella Ouertatani, Wafa Allouche, Khaled Zghal, José Asua, Iñaki Gutiérrez-Ibarluzea
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, pp. 181-182
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INTRODUCTION:
Tunisia recently implemented a Health Technology Assessment (HTA) agency (INASanté) to inform decisions around health technologies and to improve clinical practice by means of the elaboration of Clinical Practice Guidelines (CPG). However many decisions on new and emerging technologies, their implementation and coverage in the health care system are still taken at the hospital level without any structured process that informs the decisions. The aim of this project was to improve the methods and flow-chart of decision-making processes on innovation uptake in the Tunisia Healthcare System.
METHODS:By means of the toolkit of EuroScan for the implementation of an early awareness and alert system (EAAS), and its checklist, it was discussed specifically within INASanté the characteristics of the Tunisia Healthcare System and its specificities regarding decisions on drugs and medical devices. The analysis included the process of innovation uptake at the hospital level and its specific flow-chart. In depth interviews and a devoted workshop were performed with personal in INASanté: two physicians (one involved in CPG elaboration and the second in accreditation), three pharmacists (HTA), one nutritionist (HTA), two librarians and other stakeholders, including the Directorate of Hospitals.
RESULTS:The uptake of innovations in Tunisia does not follow a structured process. In fact, there is no central purchase of medical devices in Tunisia and most medical devices are purchased by hospitals within a tender process in accordance with the Tunisian public procurement law. The main pitfalls are: lack of awareness around innovations that could impact the system, non-structured process of information sharing among the different decision-makers that promotes inequity in access to technologies and services, and lack of explicit criteria that determine decisions around health technologies.
CONCLUSIONS:Tunisia requires a structured and informed process on decisions around innovation uptake in the healthcare system. The principles that should govern this system are: anticipation of the impact of new health technologies, establishing priorities and criteria for decision making in all places of decision. The decisions should be recorded and publicly shared to avoid inequities in the access to technologies.