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.

The ‘methodological choices for pharmacoeconomic analysis at INEAS’ guideline was reviewed and the major recommendations were retrieved and reported.

The 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.

The 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.

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.

The INEAS pharmacoeconomic analysis guidelines were reviewed and the recommendations regarding outcome measurement and HRQoL were retrieved and reported.

To 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.

The 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.

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.

The different phases of developing the guidelines were listed and reported.

The 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.

INEAS 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.

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.

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.

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.

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.