Non-adherence and non-persistence with antiretroviral treatment in Belgium: A real-world evaluation using a pharmacy database, 2018-2021.

Purpose: To evaluate the real-world rates of non-adherence and non-persistence to antiretroviral therapy (ART) among treatment-naïve adult patients with HIV after a 12-month follow-up period in Belgium.

Methods: A retrospective analysis of longitudinal pharmacy claims was conducted using the Pharmanet database from January 1, 2018, to December 31, 2021. Non-adherence was assessed over 12 months and reported as the proportion of days covered below the 80% threshold.

The impact of policy interventions to promote the uptake of biosimilar medicines in Belgium: a nationwide interrupted time series analysis.

Background: The Belgian government has taken several measures to increase the uptake of biosimilars in past years. However, no formal evaluation of the impact of these measures has been made yet. This study aimed to investigate the impact of the implemented measures on biosimilar uptake.

Trends and regional variations in prescriptions dispensed to stimulate uterine contractions at the end of pregnancy in Belgium: A community-based study from 2003 to 2018.

Purpose: To investigate trends and regional variations in uterotonics dispensed around birth between 2003 and 2018 in Belgium.

Methods: Data, including outpatient and inpatient prescriptions were extracted from a nationally representative prescription database. The prevalence of uterotonics dispensed during a period including the 7 days before birth, the delivery day and the 7 days after birth was computed over three 4-year-long study periods from 2003 to 2018.

Determinants of prescribing decisions for off-patent biological medicines in Belgium: a qualitative study.

Background: A competitive market for off-patent biologicals leads to more affordable and high-quality healthcare. In recent years, Belgium has been characterized by its low use of biosimilars and by its shifts from off-patent biologicals toward new alternative therapies. Yet, the prescribing decisions involved in these observations are poorly understood.

Perceptions About Biosimilar Medicines Among Belgian Patients in the Ambulatory Care.

Biosimilar medicines have been on the European market for 15 years. Despite the extensive and positive experience with biosimilars across Europe, their uptake remains limited in Belgium. One of the possible factors limiting uptake in clinical practice is the inadequate understanding and lack of trust in biosimilars among patients.

Cost-DALY comparison of hip replacement care in 12 Belgian hospitals.

Background: In view of the expected increase in expenditure on hip replacement treatment in Belgium, the complication rate and potential waste reduction, as estimated by the Organisation for Economic Cooperation and Development, we are not yet in a position to assess the efficiency of hip replacement treatment in Belgian hospitals. This objective study uses a cost-disability-adjusted life years (DALYs) ratio to propose a comparison of hip replacement surgery among 12 Belgian hospitals.

Methods: Our study seeks to innovate by proposing an interhospital comparison that simultaneously integrates the weighting of quality indicators and the costs of managing a patient.

Off-Patent Biological and Biosimilar Medicines in Belgium: A Market Landscape Analysis.

Best-value biological medicines may generate competition in the off-patent biologicals market, resulting in having more resources available to provide patients with access to necessary medicines while maintaining high-quality care. Belgium is a country known to have low biosimilar market shares, suggesting a malfunctioning market for off-patent biologicals. This study aims to gain an in-depth understanding of the Belgian off-patent biologicals market, by looking at the evolution in volumes and costs of the relevant products in the market.

The Off-Patent Biological Market in Belgium: Is the Health System Creating a Hurdle to Fair Market Competition?

We investigated the off-patent biological market in Belgium from a policy maker's perspective, in light of the Belgian pharmaceutical health system. The main barriers relate to a short-term budgetary focus, to the overwhelming innovator's reach and to a concertation model with assessment and appraisal being mixed which results in poorly effective policy measures.

The impact of early phase price agreements on prices of orphan drugs.

Background: Innovative orphan drugs often have an incremental cost-effectiveness ratio (ICER) which is higher than the maximum threshold for reimbursement. Payers have limited budgets and often cannot pay the full price of a new product, but pharmaceutical and biotechnology companies require a minimum price to satisfy their investors. The objective of this study was to present a possible solution to bridge this pricing gap by having early phase price agreements, which reduce the risk for investors.

Immunoglobulin Replacement Therapy is critical and cost-effective in increasing life expectancy and quality of life in patients suffering from Common Variable Immunodeficiency Disorders (CVID): A health-economic assessment.

Background: Common variable immunodeficiency disorders (CVID), the most common form of primary antibody deficiency, are rare conditions associated with considerable morbidity and mortality. The clinical benefit of immunoglobulin replacement therapy (IgGRT) is substantial: timely treatment with appropriate doses significantly reduces mortality and the incidence of CVID-complications such as major infections and bronchiectasis. Unfortunately, CVID-patients still face a median diagnostic delay of 4 years.

Informing Patients about Biosimilar Medicines: The Role of European Patient Associations.

Biosimilar medicines support the sustainability of national healthcare systems, by reducing costs of biological therapies through increased competition. However, their adoption into clinical practice largely depends on the acceptance of healthcare providers and patients. Patients are different from health care professionals (HCPs), who are informing themselves professionally.

Economic Evaluation of Vaccines: Belgian Reflections on the Need for a Broader Perspective.

Objectives: The standard framework of economic evaluation of health programs, which is increasingly used for policy funding decisions, is insufficiently equipped to reflect the full range of health and economic benefits conferred by vaccines and thus undervalues vaccination.

Methods: In 2019, a group of Belgian health economic and clinical experts, supported by 2 senior international vaccination experts (1 American, 1 Belgian), convened 4 roundtable meetings to highlight which particular value elements of vaccination remain neglected in economic evaluations.

Results: They concluded that the standard economic evaluation framework fails to reflect the full value of vaccination with respect to prevention of complications linked to some vaccine-preventable diseases, health gains for caregivers, herd effects, changes in exposure to and distribution of serotypes, the effect on antimicrobial resistance, productivity gains for caregivers and patients, and the distributive implications of vaccination programs.

Impact of health technology assessment and managed entry schemes on reimbursement decisions of centrally authorised medicinal products in Belgium.

Purpose: Centrally authorised medicinal products (CAMPs) in the European Union may offer added therapeutic value (ATV) but may be linked to high prices and limited efficiency. Health technology assessment (HTA) and managed entry schemes (MES) may facilitate the reimbursement decision by providing reliable estimates of the medicinal product's value and costs and by controlling the remaining uncertainty, respectively. We investigated the impact of HTA criteria and the initiation of a MES on the reimbursement decision of CAMPs in Belgium.

The hospital cost of hip replacement for old inpatients in Belgium.

Introduction: The objectives of this research are (i) to describe the medico-administrative characteristics of inpatients aged 65 and more who are hospitalized for hip joint replacement, (ii) to evaluate the complete hospital cost into costs of medical procedures, drugs costs, prostheses costs, and the administrative costs, and (iii) to identify and to evaluate from administrative database predictors influencing the complete hospital costs.

Methods: The study was based on 961 inpatient stays aged 65 and more, with the APR-DRG 301 "Hip joint replacement". The sample for this study was based on data collected in 2014 among nine Belgian general hospitals.

The burden of common variable immunodeficiency disorders: a retrospective analysis of the European Society for Immunodeficiency (ESID) registry data.

Background: Common variable immunodeficiency disorders (CVID) are a group of rare innate disorders characterized by specific antibody deficiency and increased rates of infections, comorbidities and mortality. The burden of CVID in Europe has not been previously estimated. We performed a retrospective analysis of the European Society for Immunodeficiencies (ESID) registry data on the subset of patients classified by their immunologist as CVID and treated between 2004 and 2014.

Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis.

The market authorization procedure for medicinal products for human use is relying on their demonstrated efficacy, safety, and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the first advanced therapy medicinal product (ATMP) has been authorized through the centralized procedure.

Access to orphan drugs despite poor quality of clinical evidence.

Aim: We analysed the Belgian reimbursement decisions of orphan drugs as compared with those of innovative drugs for more common but equally severe diseases, with special emphasis on the quality of clinical evidence.

Methods: Using the National Health Insurance Agency administrative database, we evaluated all submitted orphan drug files between 2002 and 2007. A quality analysis of the clinical evidence in the orphan reimbursement files was performed.

Belgian methodological guidelines for pharmacoeconomic evaluations: toward standardization of drug reimbursement requests.

Objective: To develop methodological guidelines for pharmacoeconomic evaluation (PE) submitted to the Belgian Drug Reimbursement Committee as part of a drug reimbursement request.

Methods: In 2006, preliminary pharmacoeconomic guidelines were developed by a multidisciplinary research team. Their feasibility was tested and discussed with all stakeholders.

History of health technology assessment in Belgium.

Objectives: This paper gives an overview of health technology assessment (HTA) in Belgium.

Methods: The information included in the overview is based on legal documents and publicly available year reports of the Belgian Health Care Knowledge Centre (KCE).

Results: Belgium has a relatively young history in HTA.

Introducing evidence-based medicine in reimbursement procedures: does it affect the outcome?

Objectives: The European Transparency Directive requires that reimbursement decisions of member states are taken in a transparent, objective, and verifiable way within strict timelines. We investigated whether evidence of therapeutic value was a factor affecting the Belgian pharmaceutical reimbursement decision without compromising the respect of strict timelines.

Methods: We analyzed 824 reimbursement submissions within the period 2002 to 2004.