An Analysis of the Accounting Costs Associated with 20-Month DR TB Regimens in Maputo City, Mozambique ()
1. Introduction
Tuberculosis (TB) is one of deadliest infectious diseases in history. The World Health Organization reports that it not only devastates patients and their families but also negatively impacts a country’s economy and social life [1] [2] . In 2021, approximately 10.6 million new TB cases were diagnosed, and 1.6 million people died from the disease [3] .
TB mortality and incidence remain high due to increasing drug resistance. Antimicrobial resistance has made TB one of the leading causes of death [4] . Tuberculosis drug resistance includes resistance to effective first-line drugs (Rifampicin and Isoniazid), as well as fluoroquinolone resistance. Treating drug-resistant TB (DRTB) is more challenging because effective first-line drugs cannot be used [2] . Globally, DRTB has worsened treatment outcomes and accounted for 47% of national TB programs’ budgets, significantly straining national health systems [5] .
Mozambique is among the 30 high-burden countries that account for 90 percent of all tuberculosis (TB) cases worldwide. The World Health Organization (WHO) reports that Mozambique has a TB incidence rate of 361 per 100,000 people. In 2021, there were approximately 450,000 cases of drug-resistant TB (DRTB) globally, marking a 3.1% increase from the 437,000 cases reported in 2020. Mozambique’s TB, TB/HIV, and DRTB burdens are among the highest globally, with 98,000 TB cases reported in 2021, including 3.7% DRTB cases [3] . The treatment success rate improved from 40% in 2017 to 72% in 2021, yet it still falls short of the WHO’s 90% target [3] [6] [7] .
New diagnostic platforms and treatment regimens have significantly advanced the detection and treatment of drug-resistant tuberculosis (DRTB) worldwide. Since 2013, Mozambique has employed molecular tests (Xpert® MTB/RIF) as the initial tests in its tuberculosis program. By 2018, there were 109 machines across the country. This expansion increased announcements of drug-resistant cases [8] . As of 2019, Mozambique implemented oral regimens for DRTB treatment to reduce adverse effects on patients and improve adherence to treatment [9] .
Based on current guidelines, Mozambique recommends a 20-month oral regimen for drug-resistant tuberculosis (DR TB), consisting of a 6-month intensive phase and a 14-month maintenance phase. Patients are primarily treated in outpatient clinics. During the intensive phase, the regimen includes five oral medications: Linezolid (Lzd) for one month, and Bedaquiline (Bdq), Levofloxacin (Lfx), Clofazimine (Cfz), and Cicloserine (Cs) for six months. For the maintenance phase, patients continue with Levofloxacin (Lfx), Clofazimine (Cfz), and Cicloserine (Cs). Delamanid (DLM) may be added for patients meeting specific criteria, such as resistance to fluoroquinolones. To prevent neuropathy side effects from DR TB treatment, vitamin B6 (pyridoxine) is administered concurrently. Primary health care centers in Mozambique manage and report TB cases [10] .
The WHO notes that these new TB treatment regimens are more expensive than previous injectable ones [1] . To combat TB globally, an annual $13 billion is needed, yet only $5.4 billion was secured in 2021, a decrease from $6.0 billion in 2019 [3] . In 2020, Mozambique’s national TB program received $26,225,047 in funding, with 12% from domestic sources and 88% from external sources such as the Global Fund and USAID. Over half of these funds were allocated to treatment [1] [9] .
An analysis of the direct costs associated with drug-resistant tuberculosis (DRTB) treatment in low and middle-income countries (LMICs) for regimens lasting 18 - 24 months was conducted. Direct costs included drugs, hospital stays, outpatient clinic visits, laboratory tests, program supervision, and side effect management. The study found that DRTB treatment costs ranged from $2423 to $14,657 per patient, with an average cost of $13,259 per patient under the outpatient model [11] . A randomized controlled trial in Ethiopia and South Africa compared the costs of long-term (20 to 22 months) and short-term (9 to 11 months) DRTB treatment regimens. Using both bottom-up and top-down approaches to calculate health system costs, it was determined that the long regimen was significantly more expensive than the short regimen: $6096.6 versus $4552.3 in Ethiopia and $8340.7 versus $6618.0 in South Africa [12] .
Low-resource countries like Mozambique struggle to access drug-resistant TB (DRTB) treatments due to high costs. Treatment for DRTB patients is significantly more expensive than for those with drug-sensitive TB [13] [14] . Mozambique’s national TB program, Programa Nacional de Controlo da Tuberculose (PNCT), provides free screening, diagnosis, and treatment for TB. However, a resource-constrained health system such as Mozambique’s could be further burdened by DRTB. To our knowledge, Mozambique does not collect data on the direct medical costs of DRTB treatment.
The Ministry of Health in Mozambique covers all direct costs (health staff salaries, medications, etc.) [15] [16] related to the treatment of DRTB (with the support of cooperation partners). The public health sector offers these services free of charge [10] . Activities related to the tuberculosis program are integrated with those of the national health system, and the direct costs for all programs are combined. Estimating non-medical costs of TB services, such as administrative expenses, physical facilities, and utilities, is often challenging. However, direct medical costs, including drugs, consultations, laboratory tests, and diagnostic devices, are easier to calculate. Thus, this study aims to estimate the average direct medical cost of TB treatment in 19 health centers in Maputo, Mozambique.
This study, focusing on an accounting cost analysis of drug-resistant tuberculosis (DRTB) treatment per patient, will help Mozambique’s national TB program optimize the use of limited resources. Establishing the essential financial requirements for DRTB treatment, including medication, consultations, and diagnostics costs, is crucial for adequate funding. Understanding these accounting costs can lead to more efficient financial planning and optimization, ensuring consistent and reliable funding for drug-resistant TB programs. Additionally, knowledge of the accounting costs of DRTB treatment enables beneficiaries and the public to understand how public funds are allocated in national TB programs.
2. Materials and Methods
2.1. Study Design
A retrospective cost analysis was conducted, including revision of records, which were collected from patients who completed the standard 20-month DRTB treatment regimen in 2019. Data collection took place between December 2022 and April 2023.
2.2. Study Site and Population
We conducted a study in all primary health centers in Maputo City, Mozambique, that had diagnosed and notified at least one DRTB case. We included records of adults who completed the standard 20-month DRTB treatment regimen between January 1, 2019, and December 31, 2019, in all 19 health centers.
We selected Maputo city’s health centers because a) they reported the highest number of DRTB notifications in 2019, accounting for 20% of the country’s total (see Supplementary material 1), b) Maputo has a superior record management system compared to other regions, and c) the health facilities in Maputo are closely located and easily accessible, which reduces the study’s logistics costs. The study aimed to evaluate the direct medical costs associated with complete DRTB treatment, hence a representative sample for the entire country was not necessary.
Maputo, the capital and largest city of Mozambique, is situated in the southern part of the country. It is bordered by Maputo Bay to the east and Maputo Province to the south, comprising seven districts: Kampfumo, Nlhamankulu, KaMaxaquene, KaMavota, KaMubukwana, KaTembe, and KaNyaka. The city has a population density of 3245 inhabitants per square kilometer, with an estimated population of 1,112,607 [17] .
The city hosts four general hospitals, one mental health hospital, 36 public health units, and 30 health clinics. In 2019, 19 clinics reported patients with DRTB (Table 1). Maputo employs 3210 medical professionals, including 720 doctors and 9 pulmonologists [9] .
2.3. Participant Selection
The study did not aim to calculate the Ministry of Health’s expenditure on DRTB treatment throughout the study period. Instead, it estimated the average direct medical costs of DRTB treatment per patient, following the standard recommended 20-month regimen. The analysis focused solely on patient records that adhered to the guidelines and completed both intensive and maintenance phases.
2.3.1. Inclusion Criteria
A study team reviewed the clinical records of patients aged 18 and older who
![]()
Table 1. Health clinics that notified and registered DRTB cases in 2019.
completed DRTB treatment in 2019 and had a treatment outcome at the time of review.
2.3.2. Exclusion Criteria
We excluded patients who were still on treatment, died, or were lost to follow-up, received treatment in the private sector, were inpatients, lacked outcome evaluations, or had incomplete clinical records during the study period. This exclusion was due to the difficulties in quantifying costs. Additionally, the pediatric drug-resistant tuberculosis (DRTB) group was excluded because their treatment regimens involve different formulations and dosages, and the sample size at the selected sites was very small.
2.4. Sample Size
A total of 274 patients from 19 health facilities, registered in the Mozambique health information system (SIS-MA 2021), were included in the study. Given the relatively small population of DRTB patients, all participants meeting the inclusion criteria were incorporated into the study. However, out of the 274 DRTB patients registered, 134 did not meet the inclusion criteria and were deemed ineligible. Consequently, only 140 patients were included and considered in the study sample (Table 1).
2.5. Operational Definitions
Direct medicalcosts include expenses for patient consultations, laboratory tests, medications, and X-ray services.
Direct nonmedicalcosts cover transportation, family care, and other expenses unrelated to medical care.
Direct costs cover both direct medical and non-medical expenses related to patient care.
Indirect costs include the patient’s loss of productivity due to illness.
Total costs combine direct and indirect expenses involved in managing TB, including screening, diagnosis, treatment, and follow-up.
DRTB treatment is defined as a full 20-month treatment, which includes a six-month intensive phase and a fourteen-month maintenance phase.
The intensive phase of treatment, which is the initial six months aimed at reducing transmissibility, includes five oral medications, monthly sputum smears, full blood counts, and biochemistry tests. X-rays are performed as deemed necessary by the treating clinician.
A maintenance phase of treatment lasts 14 months, aiming for sterilization. This phase involves three oral medications, monthly clinic visits, monthly sputum smears for the first 12 months, and then every two months until treatment concludes. A complete blood count and biochemistry are conducted every two months. X-rays are performed as needed, at the treating clinician’s discretion.
Cured: a complete treatment cycle, as recommended by program standards, with no evidence of failure and three or more consecutive negative cultures collected 30 days apart after the intensive phase.
Treatment completion: A complete treatment cycle, as per program standards, without evidence of failure but fewer than three consecutive negative cultures collected 30 days after intensive treatment.
2.6. Cost Ascertainment
The cost data were collected from the health system perspective, excluding direct non-medical and indirect costs. Direct medical costs included laboratory diagnostic tests for TB (GeneXpert, LPA), HIV tests, X-ray examinations, laboratory tests during diagnosis and treatment, clinic visits, and medication during intensive and maintenance phases.
Since there is no combined fixed-dose regimen for treating DRTB, the unit cost of each drug was calculated using the Global Fund price list. The cost of each medication (Table 2) was determined by multiplying the average number of pills for each medication by the price per pill, based on the average patient
![]()
Table 2. Cost of medicines in united states dollars ($).
Source: Global fund catalogue (2023).
weight outlined by the National TB Control Programme [10] . The conversion rate to US dollars was set at 1$ = 65 Meticais, according to the Bank of Mozambique’s rate at the time of the study. (source: Bank of Mozambique).
A pattern emerged in the clinical diary’s record of medical interventions during the review of clinical records. The diary indicated that medical consultations, sputum smears, blood counts, biochemistry, radiography, GeneXpert tests, and HIV serology were the most frequent interventions.
Table 3 illustrates the frequency of medical interventions performed and medications prescribed during the two phases of DRTB treatment.
The costs of the interventions mentioned above are presented in Table 4.
Unit costs were derived by visiting three private health units in Maputo and obtaining the costs for each intervention, followed by calculating the average cost. Unlike the public sector, which aggregates costs for all diseases, private health units provide clearly defined costs for each intervention. This approach enabled the estimation of the cost of similar interventions in the public sector.
2.7. Data Management and Analysis
The collection of data was done using a dedicated check-list for the clinical record revision (Supplementary Material 2).
Data from clinical records were entered into an Excel spreadsheet using a checklist and analyzed with IBM® SPSS Statistics 20.0. Descriptive statistics (frequencies) were generated for the sociodemographic and clinical variables of
![]()
Table 3. Frequency of medical interventions and medical prescriptions per treatment phase.
*refers to the average number of months of treatment estimated in the study sample. The mode refers to the most prevalent trend (which is most repeated) of months of treatment (it is the most common to be observed at an individual level in the sample).
![]()
Table 4. Costs of medical interventions/patient in United States Dollars ($).
the study participants. Measures of central tendency (means) were calculated for medical consultations, clinical analyses, diagnostic tests, and treatment costs. Additionally, the most frequently performed laboratory tests (mode) and treatment lines were analyzed. Using the standard deviation, we estimated the dispersion trend of treatment costs, indicating the degree of variation from the mean, along with the minimum and maximum estimates, to better understand the dispersion trend of treatment costs.
2.8. Ethics Statement
The principles of the Declaration of Helsinki, along with Good Clinical Practice (GCP) guidelines and national regulations, were adhered to during this study. The Institutional Ethics Committee (CIBS) in Beira approved the protocol and informed consent documents on 8 December 2022 (Reference number 069/CIBS-Sofala/2022). Additionally, approval was secured from the Ministry of Health and the Maputo Municipality’s Department of Health and Social Action. Data was pseudonymized, and no patient identifiers were included in the analysis to ensure confidentiality. For this retrospective review of patient records, a waiver for informed consent was granted. However, for the broader project analyzing the cost of DRTB treatment on patients, informed consent was obtained from all adult patients, as approved by Beira’s Institutional Ethics Committee (CIBS) on 8 December 2022 (Reference number 069/CIBS-Sofala/2022).
3. Results
3.1. Sociodemographic and Clinical Profile of Patients Undergoing DRTB Treatment in Health Units in the City of Maputo
Approximately 64.3% of the 140 cases that completed treatment were male, and 35.7% were female. The majority of cases (n = 112) were cured, while the remainder completed treatment. KaMavota district had the highest number of patients (25.7%), followed by Kampfumo district (23.6%), and KaTembe had the fewest (2.1%). Among the revised records, 27.1% did not have an identified profession, followed by domestic workers at 21.4% and traders at 12.1% (See Table 5).
3.2. Treatment Regimens and Associated Costs
During the review of clinical records, it was noted that while a standard treatment regimen is recommended for each phase, variations may occur in practice based on the patient’s clinical and laboratory characteristics. Table 6 below displays the different treatment variations encountered, the number of patients on each treatment, and the cost of the medications for one month, calculated using the National TB Control Programme’s unit cost of acquiring medicines.
During the intensive phase of DRTB treatment, health professionals opt first for the CS-LFX-LZD-BDQ-CFZ regimen (51 patients) valued at $159.05. This is followed by the BDQ-DLM-LZD-CFZ-CS-B6 regimen (48 patients) estimated at $269.85, and the BDQ-LZD-LFX-CS CFZ-B6 regimen (41 patients) valued at $186.50.
During the maintenance phase, the most used regimens are LFX-CFZ-CS (51 patients) valued at $56.36, LZD-CFZ-CS (48 patients) valued at $60.60, LFX-CS-CFZ-B6 (41 patients) valued at $56.81.
3.3. Medical Interventions and Associated Costs
GeneXpert has the highest cost per patient among medical interventions, with a unit cost of $193.68. Following this are biochemistry exams, a combination of several tests, with a unit cost of $46.57. Among the interventions, Line Probe Assays (LPAs) have the lowest unit cost at $3.23 per patient.
![]()
Table 5. Sociodemographic profile of patients treated for DR-TB in 2019.
![]()
![]()
Table 6. Cost of the most used treatment lines in United States Dollars ($).
*Bedaquiline (BDQ), Linezolid (LZD), Levofloxacin (LFX), Cycloserine (Cs), Clofazimine (CFZ), Vitamin B6/pyridoxine (B6), Delamanid (DLM).
Every drug prescribed during the intensive and maintenance phases of treatment was calculated based on its unit cost per pill. In the intensive phase, the average unit cost was $2276.74 per patient for medications, with a maximum of $4047.76 per patient. In the maintenance phase, the average unit cost was approximately $475.61 per patient for medications, with a maximum of $732.66 per patient.
When considering the sum of clinical interventions and treatment, the average direct medical cost for a complete DRTB treatment per patient is $4789.43, with a maximum value of $6568.00 per patient and a standard deviation of $753.26.
The total costs incurred by the national health system for the 140 patients included in the study are presented in Table 8, which sums up the costs of all 140 patients for each intervention.
The Mozambique national health system spent $670778.45 on direct medical costs for 140 patients, as defined in this study. Over the 20-month treatment period, HIV serology tests were the least expensive, while biochemistry tests were the most costly and performed more frequently.
4. Discussion
Based on an analysis of 140 records, the intensive phase treatment cost per patient was estimated at $2276.74, totaling $318743.60 for all 140 patients undergoing DRTB treatment. This cost represents 50% of all direct medical costs associated with DRTB treatment in the study.
In the study, the total cost of medical interventions and medications for DRTB treatment was approximately $4789.43 per patient. This amount equates to 35.55 months of minimum wages, given that Mozambique’s minimum wage for public servants is $134.74 per month [18] . Approximately $670778.45 was covered by state funds, equivalent to 4978.32 months of minimum wages in Mozambique.
In Mozambique, the Global Fund is the primary financier of tuberculosis (TB) programs, disbursing $167,437,586 in 2019 to fight HIV/AIDS, TB/HIV co-infection, TB, and malaria. Of this, only 5.4% ($9,092,885) was allocated to TB, Table 7. Total direct medical costs incurred in diagnosing and treating DRTB per patient.
![]()
Table 8. Summary of the cumulative direct costs of the interventions and treatment for the 140 patients.
while 57.8% ($96,786,444) and 35.8% ($50,895,945) were dedicated to HIV and malaria, respectively [19] . In the same year, Mozambique reported 1398 cases of DRTB [9] . Considering the direct medical costs per patient, a significant portion of the TB budget, over 50%, would be required to cover basic treatment costs for DRTB, leaving minimal funds for other critical activities such as patient support, prevention, and community engagement, essential for TB control.
These findings align with Lange et al. (2014), who argue that the high cost of DRTB treatment can be prohibitive for some national TB programs. They suggest that, in theory, the costs of treating DRTB cases could surpass the total healthcare budgets of developing countries [20] . It is crucial to explore innovative financing methods for DRTB treatment, including alternative funding sources and increasing access to generic medicines. Cost reduction could be achieved through strategies such as early detection and diagnosis in the community, ensuring patient and healthcare provider adherence to treatment protocols, and advocating for lower prices for DRTB medications in resource-limited settings.
In resource-limited settings, challenges such as limited access to affordable diagnostics and drugs, insufficient healthcare infrastructure and expertise, and restricted resources for patient monitoring and support exacerbate the costs of treating drug-resistant tuberculosis (DRTB). These challenges hinder effective treatment and prevention, leading to increased transmission and poorer health outcomes for affected individuals and communities [21] [22] . Therefore, it is crucial to emphasize the importance of strengthening health systems and building capacity in these settings to effectively address DRTB treatment costs. Investing in training healthcare workers, improving laboratory infrastructure, and implementing robust surveillance systems can enhance the ability to diagnose, treat, and prevent DRTB more efficiently and sustainably. Applying such holistic approaches is essential to improving health outcomes for individuals and communities affected by DRTB. Future research could explore the cost-effectiveness of various financing strategies for DRTB treatment, such as social health insurance schemes or public-private partnerships.
5. Limitations
While this study represents an important initial step in generating cost evidence for DRTB treatment in Mozambique, it has limitations. The study is constrained by the absence of comprehensive cost data for all components of DR-TB treatment, leading to potential underestimation or overestimation of direct medical costs. Moreover, it only accounts for direct healthcare expenditures, omitting indirect costs such as productivity losses and patient transportation expenses, thus rendering the economic burden assessment of DR-TB incomplete.
The severity of illness, presence of comorbidities, and response to treatment vary among patient populations. Our study did not account for this heterogeneity, limiting our understanding of cost variation. We only captured direct medical costs during a specific period, without considering long-term costs associated with relapses, treatment failures, or post-treatment monitoring. Since healthcare infrastructure, drug pricing, and patient demographics vary by region, our results cannot be generalized to other countries or regions. Additionally, our cost estimations may be affected by inflation over the year 2019, which was not considered in our analysis.
6. Conclusion
In Mozambique, the direct medical cost of a basic drug-resistant tuberculosis (DRTB) treatment package per patient is equivalent to about 36 months of minimum wages, significantly burdening the limited available tuberculosis resources. It is crucial to identify alternative and innovative funding sources for DRTB treatment and reduce costs by increasing access to generic medicines.
Acknowledgements
The authors would like to thank all staff and patients of the health facilities that participated in the study. The authors would like to thank all staff of the National TB Control Programme of Mozambique.
Availability of Data and Materials
All datasets and materials of the study are available from corresponding author upon reasonable request.
Authors Contribution
• Conceptualization: Júlia Malache António, Pereira Zindoga, Simeão Nhabinde.
• Methodology: Júlia Malache António, Pereira Zindoga, Simeão Nhabinde.
• Investigation: Júlia Malache António, Pereira Zindoga, Isaías Benzana.
• Project administration, resources, supervision: Benedita José.
• Data curation: Júlia Malache António, Isaías Benzana.
• Formal analysis: Júlia Malache António, Pereira Zindoga, Simeão Nhabinde, Isaías Benzana.
• Validation and visualization: Júlia Malache António, Isaías Benzana.
• Writing original draft: Júlia Malache António, Isaías Benzana, Isabelle Munyangaju.
• Writing review & editing: Júlia Malache António, Isabelle Munyangaju, Dulce Osório, Edy Nacarapa, Benedita José, Simeão Nhabinde, Pereira Zindoga.
All authors read and approved the final version of the manuscript.
Supplementary Material 1
![]()
Table S1. DRTB cases notified per province in Mozambique (2019).
Supplementary Material 2
Patient Clinical Record Data Collection Instrument
I) Identification
Health Facility: ___________________________________________________
Sex F ( ) M ( ) Age:_____ (in years)
Occupation: _____________________________________________________
Residential address: _______________________________________________
II) Follow-up at the Health Unit
III) Case Closure
( ) Cure ( ) Treatment completion ( ) Date: _____________________________
Researcher: ________________________
NOTES
*These authors are contributed equally to the work.
#Corresponding author.