Abstract
Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia, with substantial public health and economic impact on healthcare systems due to the prevention and management of thromboembolic and hemorrhagic complications. In Algeria, stroke is a leading cause of death, representing 15.6% of all deaths in 2012. Current data on the epidemiology and costs associated with non-valvular AF (NVAF) in Algeria are not available.
Methods: A three-step approach was undertaken to estimate the economic burden of NVAF in Algeria. First, a literature review identified the epidemiological burden of the disease. Second, expert clinicians practicing in Algerian hospitals were surveyed on consumed resources and unit costs of treatment and management of complications and prevention. Finally, these data were combined with event probabilities in an economic model to estimate the annual cost of NVAF prevention and complications for the Algerian healthcare system.
Results: Based on literature and demographics data, it was estimated that there are currently 187,686 subjects with NVAF in Algeria. Seventy per cent of this population was treated for prevention, half of which were controlled. Cost of prevention was estimated at 203 million DZD (€1.5 million) for drugs and 349 million DZD (€2.6 million) for examinations. Mean hospitalization costs for complications ranged between 123,500 and 435,500 DZD (€910–3,209), according to the type and severity of complications. Hospitalization costs for thromboembolic and hemorrhagic complications were estimated at 8,313 million DZD (€62 million), half of which was for untreated patients. Finally, the economic burden of NVAF was estimated at 8,865 million DZD (>€65 million) annually.
Conclusion: The economic burden of NVAF is important in Algeria, largely driven by untreated and INR-uncontrolled patients. There is a lack of information on the Algerian healthcare system that could increase uncertainty around this assessment, but it clearly establishes the importance of NVAF as a public health concern.
Introduction
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. It is characterized by a supravalvular arrhythmia with uncontrolled and chaotic atrial electrical activity, resulting in deterioration of atrial mechanical function. International studies show that AF affects 1–2% of the general population, with prevalence increasing with ageCitation1,Citation2. The severity and major public health impact of AF are mostly due to increased risk of thromboembolic and cerebral, in particular, complications, and to their hemodynamic consequences. Valvular and non-valvular etiologies are splitting the AF population in two very different sub-populations according to age in developing countriesCitation3. Presently, vitamin K antagonists (VKA) and aspirin are the most commonly used treatments to prevent thromboembolic risks in patients with AF. Clinical studies conducted up to date have proven the significant improvement of stroke risk control in patients treated with VKA vs aspirinCitation4. Nevertheless, because of their mechanism of action (anticoagulation), the use of VKA may be associated with an increased risk of hemorrhage if the dosage is not properly adjusted. Therefore, the use of VKA requires regular monitoring of the patient’s biological parameters, and more specifically of the INR (International Normalized Ratio).
Prophylactic treatment of AF and hospitalizations associated with its complications increase the consumption of healthcare resources and contribute to the substantial cost burden of AF on healthcare systems. In 2012, stroke was one of the leading causes of death in Algeria, representing 15.6% of all deaths. With an age-adjusted death rate of 139.3 per 100,000, Algeria ranked as the 31st country worldwide in terms of deaths due to stroke, figures were different in 2017, with the 108th rank and a rate of 74.7 per 100,000Citation5,Citation6. Epidemiology of AF in the Maghreb countries is divided into the two etiologies that do not present similar burdens. However, data on the prevalence of non-valvular AF (NVAF) in Algeria are very limited, and the current information systems do not allow for the estimation of costs of management and prevention of thromboembolic and hemorrhagic complications associated with it.
The present study aimed to estimate the economic burden of NVAF in Algeria. The exchange rate for the Algerian Dinar (DZD) was 135.7 DZD for 1€ and 115.57 DZD for 1 US$ as of December 11, 2017.
Algeria is the largest country in Africa, and has a population of more than 38 million inhabitants. The Algerian health system has both public and private health sectors. The public health sector is accessible and free-of-charge for all Algerian citizens; it is dually financed by government contributions and social insurance. The number of healthcare facilities varies from one area of the country to another, depending on the size of the local population.
There is a national medical insurance scheme run by the Caisse Nationale des Assurances Sociales des Travailleurs Salariés (CNAS) that covers 90% of the entire populationCitation7. Public health insurance is available for salaried employees and independent workers such as traders.
Medicines are reimbursed at 80% of the reference price; medical procedures (consultations, examinations, and tests) are also reimbursed at 80%. All patients who are employed in the formal sector and have chronic diseases (including diabetes) are reimbursed 100% of the costs of care and medicines: patients receive medicines free-of-charge as they are covered by health insurers who pay pharmacies a fixed price. Low-income formal sector workers (i.e. with health insurance) are identified by the Algerian Ministry of National Solidarity and Family and local authorities (districts and sub-districts). Individuals belonging to this patient group are provided a card which grants them access to free medication and care; the ministry and local authorities pay for their healthcare costs.
Methodology
A three-step approach was undertaken in order to address the objective of this study (Etude de l'épidémioLogie, des consommations de Ressources et des coûts en AlGérie associés à la Fibrillation Auriculaire (ELRAGFA): study for the epidemiology, resource use and costs in Algeria associated with atrial fibrillation) to estimate the economic burden of NVAF in Algeria. First, a literature review was conducted in order to assess the epidemiological and economic burden of the disease and to have an estimation of its prevalence in Algeria. Second, a sample of expert clinicians practicing in Algerian hospitals were surveyed on the prophylactic treatment and on the management of thromboembolic and hemorrhagic complications in atrial fibrillation and related costs. Finally, data collected in the two previous steps were combined with probabilities of events coming from the literature in an economic model to estimate the annual cost of NVAF from the perspective of the Algerian healthcare system.
Epidemiology of NVAF in Algeria
A literature review was performed on MEDLINE and Google in order to estimate the epidemiology of NVAF and its management in Algeria. Given the scarce available information, the review was extended to the other Maghreb countries, Morocco and Tunisia. Information on the management of AF available in the literature was also collected. Searches were performed in French and in English using the following keywords: atrial fibrillation, epidemiology, prevalence, and costs, in association with the name of the three countries.
A comparison with epidemiological data coming from literature reviewsCitation8,Citation9 was performed, allowing for a more precise estimation of NVAF prevalence in Algeria. These estimates were combined with local demographic dataCitation10 to provide an estimate of the Algerian NVAF population.
Prevention and management of complications: resources and costs
The estimated resources and costs included prophylactic treatments, monitoring of INR for patients treated with VKA, and hospitalizations associated with thromboembolic and hemorrhagic complications. Expert clinicians practicing in Algerian hospitals were surveyed based on a standardized questionnaire in order to estimate consumed resources and standard costs. Answers to the survey were collected from available information systems of the hospital or from the expert’s opinion. Either mode of origin was also recorded for quality assurance and sensitivity analysis purposes.
Selection of the sample of experts was performed on the basis of the largest regional medical centers from all the regions of Algeria (West, Centre, and East). Out of seven experts enrolled in the study, six were practicing in public hospitals and one was in the private sector.
Data provided by the experts were mostly obtained from the annual report of each hospital, which were collected for administrative purposes, and described resources used and related costs, aggregated by ward, type of disease, or examination.
Prophylactic treatments
Data collected from the expert clinicians were used to determine practices regarding the prevention of risks of thromboembolic and hemorrhagic events; these included types and doses of treatments used in practice. Data on costs of treatments were collected from the financial departments and patients’ registries of participating hospitals.
INR monitoring
The collected data were used to estimate the proportion of patients treated with VKA with controlled (≥2 and ≤3) or uncontrolled (<2 or >3) INR. The frequency of INR measurements over a year was also estimated based on the INR status (controlled or uncontrolled).
Hospitalization
Management costs of thromboembolic and hemorrhagic events were considered by taking into account hospitalization costs associated with them. These costs were estimated using data available from participating hospitals’ information systems or archives, in order to represent real clinical practice costs in Algeria. Hospitalization costs were estimated for the following events: ischemic stroke (independent, moderate disability, totally dependent or fatal, as measured on the modified Rankin Scale); intracranial hemorrhage (independent, moderate disability, totally dependent or fatal, as measured on the Glasgow Outcomes Scale); systemic embolism (non-fatal or fatal); transient ischemic attack (TIA); extracranial hemorrhage (non-fatal gastrointestinal (GI), non-fatal non-gastrointestinal, or fatal); and myocardial infarction (non-fatal or fatal). Hospitalization costs of the event were based on the frequency and the length of stay in the three following hospital departments: intensive care, neurology, and cardiology (frequency of stay × length of stay × daily management cost in the department). The total cost for the hospital stay was then calculated by summing up the management costs of the event in each department.
Cost-of-illness modeling
The RE-LY study, a phase-III international clinical trial of more than 18,000 patients, compared the use of dabigatran with warfarin. Results from this trial have since been shown to be robust and reliable, most notably thanks to its long-term multicenter extension RELY-ABLE which enrolled RE-LY patients for a median extension of 4.6 yearsCitation11, but also with a global prospective registry study, GLORIA-AF, which followed close to 3,000 new NVAF patients over 2 yearsCitation12, and also a MEDICARE-based real-world evidence study published by Graham et al.Citation13 in 2015, involving over 134,000 propensity score-matched patients for a total of over 37,500 patient-years’ follow-up. In 2011, Sorensen et al.Citation14 developed a medico-economic model based on the results of the RE-LY study. This model was adapted to different countries and described in international reviewsCitation15. In this article, we used the adaptation of the model to the French setting by Chevalier et al.Citation16 in order to obtain the frequency of occurrence of thromboembolic and hemorrhagic complications according to their outcomes in terms of dependence in patients treated with VKA. For uncontrolled and untreated patients, event rates were adjusted. First, we considered the average time with good control in the warfarin group from RE-LY that was representing 64.4% of the time under VKA treatment. Untreated patient complication rates were recalculated on the basis of a recent literature reviewCitation17 that compared VKA with no treatment and gave relative risk ratios. Patients treated with aspirin were included in the untreated group for the estimation of the stroke rates, adding their bleeding risk following European Society of Cardiology recommendationsCitation18. Then, a cost-of-illness model was constructed and adapted to the local context by integrating our estimations of prevention and management costs to identify the yearly cost of illness of NVAF in Algeria.
Sensitivity analyses
To explore the uncertainty of the assumptions and estimates that were incorporated in the model, we performed sensitivity analyses on the epidemiological and economic items with intervals of –10% and +10%.
Results
Epidemiology of NVAF in Algeria
Two relevant epidemiological studiesCitation19,Citation20 were identified through MEDLINE. A search directly performed in Google allowed us to retrieve a greater number of papers based on either epidemiological studiesCitation21–26 or observational studies of care practicesCitation27,Citation28. Finally, one epidemiological study was retrieved via Professor ZianeCitation29.
All the articles that were identified were analyzed. The initial analysis led to the conclusion that the epidemiology of AF in Algeria is different when it is compared with the results of the literature review on studies conducted in developed countries. This difference is obvious with regards to the mean age of patients, which is 7–12 years lower in the Maghreb countries. The distribution of AF etiologies can explain this difference; in Algeria and other Maghreb countries, atrial fibrillation is often associated with valvular diseases, affecting younger patients.
Four articlesCitation20,Citation24,Citation29,Citation30 were used to compare the patients’ characteristics and AF etiologies between France and the Maghreb countries. On the one hand, the comparison shows that patients treated in a Moroccan hospital are younger than French patients, and have mostly valvular AF. On the other hand, patients treated in private practices in Morocco are older, and the distributions of their etiologies are similar to what is observed in France. In the epidemiological study by Ouaha et al.Citation24 it can be noted that the age distribution of patients with AF hospitalized in Fes has two modes: one at 35–44 years and another at 65–74 years. This bimodal distribution could be explained by the existence of two populations: a young one with valvular diseases and an older one with other etiologies, as was described in the article of Temu et al.Citation3 in Kenya.
Two studiesCitation19,Citation20 were used to determine the NVAF population size in Algeria by using demographical data. Based on the results of a literature review, the authors were able to determine an AF prevalence curve according to the age of patients. The epidemiological studies used to do so were conducted in countries where valvular AF is negligible (i.e. the US, Australia, the Netherlands, and the UK). It can, therefore, be considered that these prevalence rates concern mostly non-valvular etiologies of AF. The prevalence of AF was significant only from the age of 50 and over. From then onwards, the prevalence rate nearly doubles every 10 years. After 80 years old, the prevalence rate reaches 10% (). By applying these prevalence figures to the Algerian populationCitation10, it was estimated that there are currently 187,686 subjects with NVAF in Algeria, and that 66.7% of them are likely to be over 65 years old.
Table 1. Non-valvular AF prevalence in Algeria.
Consumption of resources in the prevention and management of complications
Expert clinicians from seven Algerian hospitals were interviewed. The participating hospitals were selected in order to allow for extrapolation of the data. Data collected from the experts are summarized in .
Table 2. Expert clinicians’ answers to the survey.
Prophylactic treatment costs
Based on the collected data, it can be estimated that nearly 70% of patients with NVAF received treatment to prevent thromboembolic risks. The majority of these patients were treated with VKA and aspirin, respectively 82% and 13%. The use of treatments such as rivaroxaban (3%) or others (clopidogrel, persantine, …; 2%) remains very limited. These alternative treatments were not considered in the cost estimation, as rivaroxaban is not reimbursed by the Algerian health insurance system and other treatments account for a marginal part of total consumption.
Based on the experts’ responses, the mean daily dose used in practice was estimated at 170 mg per day for aspirin, and 0.63 tablet per day for VKA. Based on data obtained from the financial departments and patients’ registries, mean prices of VKA (SINTROM®, NOVAROL®) and aspirin (ASPEGIC®) were, respectively, estimated at 174 DZD for 30 tablets and 118 DZD for 2,000 mg. Finally, based on these figures, annual costs per patient were estimated at 3,651 DZD for aspirin and 1,323 DZD for VKA ().
Table 3. Treatment costs for VKA and aspirin.
Monitoring assessments of INR in patients treated with VKA
Based on the responses to the survey, the proportion of patients treated with VKA and with a controlled INR (between 2 and 3) was estimated at 52% (mean). The mean proportions for INRs lower than 2 and higher than 3 were, respectively, estimated at 31% and 17%. For patients with a controlled INR, the annual number of INR measurements was estimated between 8 and 18, with a mean of 13. This result is consistent with the international recommendations of 12 measurements per year. However, for patients with an uncontrolled INR, experts estimated the number of additional measurements as six. The mean cost of an INR measurement was estimated at 204 DZD.
Hospitalization costs for thromboembolic or hemorrhagic events
For each event of interest, the mean cost for one event was calculated based on the expert clinicians’ responses to the survey. The cost of an event per patient-year was then estimated based on the occurrence rate of each event, obtained from the model by Chevalier et al.Citation16. Complications for patients treated with VKA (warfarin) were estimated from the total population treated with warfarin in the RE-LY clinical trial, whether their INR was controlled or not. Therefore, these estimates can be used to measure the frequency of occurrence of events in the global population of Algerian patients treated with warfarin. In the end, mean hospitalization costs for thromboembolic and hemorrhagic events were comprised between 91,833 DZD (ischemic stroke; independent) and 435,500 DZD (systemic embolism; non-fatal) (). Costs of ischemic stroke and hemorrhagic stroke varied in function of the event’s level of disability outcomes.
Figure 1. Hospitalization costs of thromboembolic and hemorrhagic complications.
Economic burden of NVAF
Based on the previous cost estimates and on the prevalence estimate, the annual global costs of treatment, INR monitoring, and management of ischemic and hemorrhagic complications can be calculated. First, with 107,919 patients treated with VKA and 16,516 treated with aspirin, cumulated treatment costs amount to 203 million DZD a year for the treated NVAF Algerian population. Second, considering the proportions of controlled and uncontrolled patients treated with VKA, as well as their respective annual number of INR tests, the annual INR monitoring cost can be estimated at 3,236 DZD. Applied to the global non-valvular population treated with VKA, annual INR monitoring costs amount to 349 million DZD. Finally, based on hospitalization costs for thromboembolic and hemorrhagic complications and on their occurrence rates per 100 patient-years (), management costs are estimated to 33,221 DZD per year. This amounts to 4,238 million DZD for all patients with NVAF treated with VKA. INR-uncontrolled patients treated with VKA are representing 56% of the costs of complications, whereas they are only 43% of the patients. INR-controlled, VKA-treated patients are estimated to be 39% of the treated patients, but only account for 22% of the costs of complications. For the 30% of patients who are not treated, costs of thromboembolic events and hemorrhages were estimated at 4,075 million DZD, to be compared with the costs for treated patients (70%) which only add up to 4.238 million DZD.
Table 4. Occurrence rates of thromboembolic and hemorrhagic complications according to the treatment and level of control.
In the end, for the 187,686 patients with NVAF expected in Algeria, total prevention and management costs are estimated at 8,866 million DZD; 94% of these costs are attributable to hospital management of thromboembolic and hemorrhagic complications, while the remaining part is attributable to INR monitoring for patients treated with VKA (3.9%) and treatment costs (2.3%) ().
Figure 2. Total annual costs of prevention and management of thromboembolic and hemorrhagic complications.
Sensitivity analyses
Results of the sensitivity analyses are described in . The Tornado diagram shows that epidemiological estimates on the number of NVAF, rate of thromboembolic events, proportion of treated patients, and costs estimates for thromboembolic events are the main cost drivers of this economic assessment.
Figure 3. Tornado diagram of sensitivity analyses.
Discussion
To our knowledge, this is the first attempt to estimate the costs related to the thromboembolic and hemorrhagic complications of NVAF in Algeria.
Cost–of-illness estimates are rare in Algeria. Cost of diabetes was estimated by Lamri et al.Citation31 at 35,000 DZD per patient in 1998, and he recently updated this estimate to 60,000 DZD per patientCitation32.
The first point to consider is the epidemiology of the disease, and we were confronted by the lack of documentation in the country. To calculate the number of patients with NVAF, we first used information from Algeria when available, then regional information from the neighboring Maghreb countries, then finally information from the RealiseAF surveyCitation20. However, for some estimates such as rates by age, the only data available were from countries further afield. This is a clear limitation of our results, which hopefully future studies will address. Additionally, the RealiseAF surveyCitation20 did not distinguish in its findings between Middle East and Africa. However, the sample in this study was considered by the authors to be different (younger patients and more female patients) and homogeneous in terms of medication consumption, as compared to the other regions, and most of the patients in this sample (61%) were located in the Maghreb countries. Lastly, the main information coming from the RealiseAF survey in our modelling was the rate of treated patients (70%), which was similar to the rate provided by local experts.
Limitations of these economic studies in Algeria are also related to the lack of information on the healthcare system and costs, which requires performing dedicated surveys and making multiple hypotheses that could lead to extensive uncertainty. Consequently, part of the data was collected from information systems and archives, whereas in some cases due to the lack of actual data, expert opinion was used. Our sensitivity analyses showed that epidemiological parameters and some of the costs estimates (costs of stroke) are driving this burden-of-illness study.
The economic burden of NVAF is important in Algeria. The cost per patient with NVAF represents 113% of the average expense for healthcare in Algeria in 2014Citation33 (47,238 DZD/41,805 DZD).
We intentionally restricted our study to the thromboembolic and hemorrhagic hospital complications and prevention including medications and INR monitoring. Our findings are certainly under-estimated, because we did not include the costs of the medical management (visits to physicians) and some costs of complications like rehabilitation.
A large part of the costs is driven by the untreated and INR-uncontrolled patients. Costs of VKA-treated controlled patients appeared to be much lower.
Very limited information is available in the literature on this domain. A cost-effectiveness analysis was recently performedCitation34 for Algeria, and some of the costs estimates were very similar to ours, especially for the acute care of complications like stroke and intracranial hemorrhage.
Two studies were recently performed on the costs related with the use of warfarin in countries of similar standard of livingCitation35,Citation36, and distances were mainly related to the organizational differences of the healthcare systems and the fact that medical visits could not be included in our study.
Other studies were performed, like in DenmarkCitation37, that were based on claim databases and could be very precise and calculate the cost per patient and the cost of the different eventsCitation38. Other claim databases study the evolution of the AF costs over time in PortugalCitation39.
Training and motivation of physicians to treat more patients according to current standard of care and to increase control will improve patient care and will have a large impact on the costs.
Transparency
Declaration of financial/other interests
RS is an employee of Boehringer Ingelheim North West Africa. LY and JC are employees of Boehringer Ingelheim Middle East, Turkey & Africa. MT is an employee of CEMKA-EVAL, which received fees for the study. Peer reviewers on this manuscript have received an honorarium from JME for their review work, but have no other relevant financial relationships to disclose.
Acknowledgments
The authors acknowledge Rachel Pamart and Antoine Lafuma for the preparation of the manuscript.
Additional information
Funding
References
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