Browsing by Author "Cleary, Susan"

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    A cost-utility and budget impact analysis of long-acting insulin analogues, (determir, glargine and degludec) for the treatment of adults with T1DM in South Africa
    (2023) Verryn, Mark; Cleary, Susan
    Background: Type 1 Diabetes Mellitus (T1DM) is a life-threatening condition that is managed with administered insulin. Intermediate- to long-acting insulin represents the basal insulin constituent of the total insulin used in treating T1DM and has received much research and development over the years. In South Africa, intermediate-acting Neutral Protamine Hagedorn (NPH) insulin has been the mainstay basal insulin recommended in the public sector. Newer (ultra) long-acting insulin analogues, however, have subsequently been approved for use. Costutility and budget impact analyses of the newer long-acting insulin analogues detemir, glargine and degludec have yet to be performed in the South African public health sector context. Methods: A systematic search for clinical evidence was performed to inform the economic evaluation. A cost-utility analysis was carried out utilising Markov modelling. Seven comparators were modelled representing the various insulin types and treatment regimens. For each comparator, three Markov states were created, one in which no complications occurred and another two states representing nocturnal and daytime hypoglycaemic events respectively. Three scenarios were modelled in order to capture the variable rates of complications reported in the clinical evidence. Quality-Adjusted Life Years per patient year was the health outcome utilised. Costs were included as South African Rands and then converted to United States dollars. A cost-effectiveness threshold range appropriate for the South African context was used to assess value for money. Thereafter, a budget impact analysis was conducted. Results: Three systematic reviews were identified in the systematic search for inclusion in this study. Subsequently, three scenarios were modelled in order to capture the clinical significance identified in the three systematic reviews. All three models favoured NPH insulin over the alternatives, as NPH insulin dominated most other insulins, barring insulin detemir, insulin glargine-U300 and insulin degludec. Insulin detemir was the most cost-effective option of the alternatives to NPH insulin (ICER of 10,783.75 USD/QALY). However, insulin detemir was still not cost-effective in relation to South Africa's cost-effectiveness threshold (CET 1,175 - 8,909 USD/QALY). The NPH insulin twice daily regimen was also found to dominate the NPH once daily regimen. Conclusions: The status quo of NPH insulin in the management of T1DM in adults remains the most cost-effective option for the South African public health sector. Further research and consideration could be made for the use of NPH insulin twice daily, as opposed to once daily.
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    A Retrospective, Observational Study of Medico-legal Cases against Obstetricians and Gynaecologists in South Africa's Private Sector
    (2020) Taylor, Bettina; Cleary, Susan
    South Africa is experiencing a medico-legal crisis that is threatening the delivery of essential health care services, especially relating to maternal and fetal health. In the private sector, professional indemnity premiums for obstetricians to provide insurance cover in the event of medico-legal challenges have increased more than 10-fold in a 10-year period. In the State, exponential increases in contingent liabilities for claims due to alleged negligence are usurping health care budgets allocated towards the delivery of health care, with about half of these claims relating to obstetrics and gynaecology and three quarter of latter to cerebral palsy for reasons of alleged hypoxic brain injury of the newborn. Despite the ominous implications of these developments for the supply side of health care, there is a scarcity of information in terms of contributing factors. Whilst many assume that the main driving force of burgeoning professional indemnity premiums for obstetricians and gynaecologists in the private sector have also been as a result of claims for cerebral palsy, there are no empirical data to explain developments over recent years and guide risk management interventions in this regard. To understand claim trends and identify potential predictors of patient dissatisfaction that result in engagement of the regulatory and legal system in the private sector, obstetric and gynaecological medico-legal data recorded by Constantia Insurance Limited, a local professional indemnity provider, were analysed. Other than confirming a steep increase in medico-legal notifications for obstetric- and gynaecology-related complaints from about 2003 to 2012, a high proportion of number of claims and paid settlements for gynaecology relative to obstetric-related cases was noted. This is contrary to international and public sector experiences, where number of demands relating to obstetrics consistently exceed those associated with gynaecological care. This finding, together with the fact that the majority of pay-outs on behalf of doctors related to surgical complications, especially unintended intraoperative injuries to internal organs and vessels, calls for further research into the clinical outcomes of private gynaecological practice, as well as potential review of aspects of surgical training standards and accreditation in gynaecology and consideration of surgical mentorship programmes. The latter is particularly relevant in the context of surgical registrars having expressed concerns about their readiness to practice independently following specialist graduation. Whereas claims for severe neurological injury of the newborn constituted less than 15% of all claims settled on behalf of obstetricians and gynaecologists entered into the study, they accounted for about half of all known paid settlements relating to pregnancy-related care. Whilst not dominating in terms of claim frequency overall, they nevertheless are an important focus area for risk management interventions, given the high quantum of demand typically associated with these cases. In this regard, more research into the etiology of errors is required, including the contribution of nursing and other system failures that could not be quantified adequately as part of this research project. Another important finding was the disproportionate contribution of medico-legal risk by a small cohort of practitioners, which suggests a need for doctor-focused support and interventions, including effective peer review and regulatory oversight by the Health Professions Council. To reverse the high financial burden of professional indemnity fees and fear of litigation amongst private sector obstetricians and gynaecologists, multidimensional risk management interventions, which include enhancements at the point of care, are required. If medicolegal trends and their negative consequences are to be reversed, medico-legal hotspots should become an important source of information and consideration in the development of solutions aimed at preventing human error and strengthening the healthcare system in terms of improved patient safety and satisfaction.
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    Access barriers to antiretroviral therapy (ART) in Zimbabwe: a case study of Chivhu Hospital
    (2012) Siduna, Willie; Cleary, Susan
    Access to healthcare is one of the basic social goods which ensures that individuals lead healthy and long lives. There is an increased need towards ensuring access to health care for all, which has led to the question of how access is defined. Access in this study is defined as the degree of fit between the health care system and patients. It involves an interaction between the system and patients in a way which removes access barriers to care. A comprehensive framework was used to measure access in this study. The framework allows for a systematic approach to the concept of access and measures access in three dimensions namely affordability, availability and acceptability. Using this framework, the study looked into the factors affecting access to antiretroviral therapy (ART) by patients at Chivhu Hospital in Zimbabwe. Chivhu was chosen because it has a mixed population of urban and rural patients which represents the typical Zimbabwean population. A cross sectional study design was adopted for this study.
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    An analysis of adherence & equity in access to TB services in Mitchell's Plain, South Africa
    (2012) Docrat, Sumaiyah; Cleary, Susan
    The control of tuberculosis (TB) in South Africa has fallen short of the targets outlined by the World Health Organization and without improvement; TB is expected to have grave consequences for both the mortality and morbidity of South Africans as well as crippling financial consequences for the public health system. While services in the public sector are free at the point of use, little is known about overall access barriers and their implications for treatment adherence. This paper explores these barriers from the perspective of TB patients enrolled in Directly Observed Treatment, Short-Course (DOTS) in Mitchell's Plain, South Africa. Using a comprehensive framework of access, in-depth interviews were conducted with 334 TB patients across five facilities in Mitchell's Plain, to assess barriers across the dimensions of availability, affordability and acceptability. Summary statistics were computed and comparisons of access barriers between adherent and non-adherent groups, and between socioeconomic groups were explored using bivariate, multivariate linear and logistic regressions. Among the respondents, 244 (73.05%) met the criteria for adherence (i.e. reported that they had never missed a dose of TB medication) while 90 (26.95%) met the criteria for non-adherence. Marital status, age, birth province, costs of self-care and costs of other providers were found to be significantly associated with adherence (P-values <0.05). There was no significant evidence of inequalities in access by socioeconomic status (all P-values > 0.05). Nonetheless, the results revealed that the poor face increased costs of accessing TB-services, compared to the rich, though this association was not deemed to be significant.
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    An analysis of expenditure on HIV/AIDS patients in Zambia
    (2006) Kaliki, Chipalo; Cleary, Susan
    According to the 2000/2001 Zambia Demographic and Health Survey (ZDHS), HIV/AIDS prevalence is 16% and is expected to be higher in the next five years. The disease is quite pervasive across all sectors of economic activity, but the impact is especially acute on the Zambian health sector, which is faced with increasing demands on healthcare for not only HIV/AIDS but other diseases such as malaria, tuberculosis, cholera, diarrhoea, to mention but a few. It is therefore essential that expenditure on HIV-related care among different health care systems be analysed so as to determine areas of relatively greater need. It is against this background that this study entitled, "An analysis of expenditure on HIVIAIDS patients in Zambia", was conducted. The main objective of the study is to analyse expenditure on HIV-related care and treatment among the different health care systems and geographical localities in Zambia. The study used utilisation data on total and HIV-related outpatient visits and inpatient days collected from the country's facility based database called the Health Management Information System (HMIS); and HIV-prevalence data compiled from the Central Statistics Office's report on Epidemiological Projections. Expenditure data on the other hand was compiled from the National Health Accounts (NHA) report for 1999-2002 and separate data on HIV/AIDS expenditure was collected from the District Health Boards reports for 2003. Utilisation and HIV-prevalence data were then combined with expenditure data to estimate the overall utilisation of services by HIV-positive patients and the annual expenditure required to meet the burden of HIV/AIDS. Both utilisation and expenditure statistics were analysed and compared according to different levels of healthcare and geographical localities. Data analysis was exploratory and descriptive.
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    Assessing access barriers to Tuberculosis (TB) and Antiretroviral (ARV) treatment in Mitchell's Plain, Cape Town South Africa
    (2011) Mweemba, Chrispin; Cleary, Susan
    Access to health care is a very important concept which has equally important implications to the health status of individuals. However, there have been a lot of debates among researchers and policy makers on what constitutes access, and how it can be made less conceptual and more operational. The concept of access has continued to receive increased attention because of a growing realisation of its importance in health policy. Furthermore, provision of services alone without understanding barriers individuals face in accessing services could result in less optimal outcomes. It is therefore necessary to have an understanding of what "access" entails and factors that influence it if we are to have a real chance of improving access to health services and therefore enhance health. In this thesis access is viewed as consisting of three (3) interrelated and measurable dimensions (availability, affordability and acceptability). These access dimensions are related to both the system and user characteristics. Access is therefore said to have been achieved when all the three dimensions have been satisfied. Using the above definition of access, the main focus of this thesis is on access barriers (in relation to the three access dimensions) to both Tuberculosis (TB) and Antiretroviral Treatment (ART) services in Mitchell's Plain, Cape Town South Africa. Secondary cross-sectional data was used for this purpose. Access to TB and HIV treatment has been given priority because the two diseases have had a massive and negative impact on public health in the country. In addition, patients using these services may face similar barriers to care. Findings of this thesis are expected to provide insights into the barriers TB and HIV patients face in seeking care vis-a-vis availability, affordability and acceptability of services. Findings will therefore prove valuable in as far as improving access is concerned.
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    Assessing the barriers to accessing prevention of mother-to-child transmission (PMTCT) services in Marondera Zimbabwe
    (2011) Magaso, Farai Beverley; Cleary, Susan
    Although Zimbabwe has invested in nationwide scale-up of prevention of mother to child transmission (PMTCT) services, high HIV-specific under-five mortality rates continue to be observed. This study aimed to document the potential reasons for low PMTCT uptake by examining factors constraining access to PMTCT services.
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    Brief interventions to address substance use in emergency departments in the Western Cape: a cost-effectiveness analysis
    (2014) Dwommoh, Rebecca Akua Kyerewaa; Cleary, Susan
    Includes abstract. Includes bibliographical references.
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    Clinical and financial burdens of secondary level care in a public sector antiretroviral roll-out setting (G F Jooste Hospital)
    (Academy of Science of South Africa, 2009) Kevany, Sebastian; Meintjes, Graeme; Rebe, Kevin; Maartens, Gary; Cleary, Susan
    Background: Antiretroviral therapy (ART) is being extended across South Africa. While efforts have been made to assess the costs of providing ART via accredited service points, little information is available on its downstream costs, particularly in public secondary level hospitals. Objectives: To determine the cost of care for inpatients and outpatients at a dedicated antiretroviral referral unit treating and caring for antiretroviral-related conditions in a South African peri-urban setting; to identify key epidemiological cost drivers; and to examine the associated clinical and outcome data. Methods: A prospective costing study on 48 outpatients and 25 inpatients was conducted from a health system perspective. Incremental economic costs and clinical data were collected from primary sources at G F Jooste Hospital, Cape Town, over a 1-month period (March 2005). Results: Incremental cost per outpatient was R1 280, and per inpatient R5 802. Costs were dominated by medical staff costs (62% inpatient and 58% outpatient, respectively). Infections predominated among diagnoses and costs – 55% and 67% respectively for inpatients, and 49% and 54% respectively for outpatients. Most inpatients and outpatients were judged by attending physicians to have improved or stabilised as a result of treatment (52% and 59% respectively). Conclusions. The costs of providing secondary level care for patients on or immediately preceding ART initiation can be significant and should be included in the government’s strategic planning: (i) so that the service can be expanded to meet current and future needs; and (ii) to avoid crowding out other secondary level health services.
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    Comparing dedicated and designated models of integrating mental health into chronic disease care: study protocol for a cluster randomized controlled trial
    (BioMed Central, 2018-03-16) Myers, Bronwyn; Lund, Crick; Lombard, Carl; Joska, John; Levitt, Naomi; Butler, Christopher; Cleary, Susan; Naledi, Tracey; Milligan, Peter; Stein, Dan J; Sorsdahl, Katherine
    Background In low- and middle-income countries (LMIC), it is uncertain whether a “dedicated” approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a “designated” approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes. Methods/Design This is a cluster randomised trial. We will randomise 24 primary health care facilities in the Western Cape Province of South Africa to one of three study arms. Within each cluster, we will recruit 25 patients from HIV and 25 from diabetes services for a total sample of 1200 participants. Eligible patients will be aged 18 years or older, take medication for HIV or diabetes, and screen positive on the Alcohol Use Disorder Identification Test for hazardous/harmful alcohol use or depression on the Centre for Epidemiology Scale on Depression. Participants recruited in clinics assigned to the designated or dedicated approach will receive three sessions of motivational interviewing and problem-solving therapy, while those recruited at TAU-assigned clinics will be referred for further assessment. Participants will complete an interviewer-administered questionnaire at baseline, and at 6 and 12 months post-enrolment to assess change in self-reported outcomes. At these end points, we will test HIV RNA viral load for participants with HIV and HbA1c levels for participants with diabetes. Primary outcomes are reductions in self-reported hazardous/harmful alcohol use and risk of depression. Secondary outcomes are improvements in adherence to chronic disease treatment, biomarkers of chronic disease outcomes, and health-related quality of life. Mixed-effect linear regression models will model the effect of the interventions on primary and secondary outcomes. The cost-effectiveness of each approach will be assessed using incremental cost-effectiveness ratios. Discussion Study findings will guide decision-making around how best to integrate mental health counselling into chronic disease care in a LMIC setting. Trial registration Pan African Clinical Trials Registry, Trial registration number: ACTR201610001825403 . Registered 17 October 2016.
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    Conducting a cost analysis to address issues of budget constraints on the implementation of the indoor residual spray program. an intervention to control and eliminate Malaria in two districts of Maputo Province, Mozambique
    (2019) Canana, Neide Mércia de Orlando Hussene; Cleary, Susan
    Introduction: Over the past few years, the capacity of the government of Mozambique to sustain the cost of payment of salaries to operationalize the Indoor Residual Spray (IRS), a widely recommended tool to control and prevent malaria, is facing numerous challenges. This is due to recent restrictions of the Official Development Assistance (ODA), an external aid scheme and the main source of financing of the Mozambican government budget. Objective: The objective of this study was to estimate the cost of IRS operationalization activities in Matutuine and Namaacha districts health directorates, in Maputo Province, Mozambique. Methods: A cost analysis using an approach from the provider’s perspective was conducted in two district health directorates in the Maputo province, Matutuine and Namaacha. The institutions were purposely selected since in 2014 in both districts the expenditure on salaries to operationalize IRS was funded by the government budget. Cost information was collected retrospectively and both economic and financial costs were calculated. Uncertainty of results was tested using “one-way” deterministic sensitivity analysis. Results: The average total annual economic cost was 117,351.34 US$. The average economic cost per households sprayed totalled 16.35 US$. On average the economic costs per person protected is 4.09 US$ in total. In the financial analysis, the average total annual financial costs totalled 69,174.83 US$. The average financial cost per household sprayed and per person protected were 9.84 US$ and 2.46 US$ respectively. Vehicles, personnel salaries and consumables were the major substantial cost components. Conclusion: Setting aside the ODA restriction and focusing on the aim of implementing IRS within the existing resources, the study makessuggestions for improving efficiency by focusing on areas with a higher need and pays attention to cost drivers in order to reduce the costs.
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    Cost effectiveness analysis of two alternative interventions for the integration of Tenofovir into South Africa's public sector First Line Antiretroviral treatment regimen
    (2009) Lin, Iming; Cleary, Susan; Meintjies, Graeme; Rebe, Kevin
    In 2003, South Africa's National Department of Health (DoH) initiated the roll out of antiretroviral therapy (ART) for HIV positive individuals in the public health sector. Based on World Health Organization (WHO) guidelines, South Africa's ART programme provides a first line regimen based on a backbone of two nucleoside reverse transcriptase enzyme inhibitors (NRTI) with one non-nucleoside reverse transcriptase inhibitor (NNRTI) while the second line regimen is based on a protease inhibitor (PI) with two NRTIs. Similar to many developing countries, South Africa's NRTI backbone in the first line treatment regimen is stavudine (d4T) combined with lamivudine (3TC), and the NNRTI which is either efavirenz (EFV) or nevirapine (NVP). In some cases, stavudine is replaced with the NRTI zidovudine (AZT) in the first line regimen. Both d4T and AZT have been recognized to contribute to drug related toxicities or side effects, particularly lactic acidosis, lypodystrophy, peripheral neuropathy, and anaemia. However, developing country governments have been limited to these NRTI choices due to the higher cost of alternative treatment options. There is compelling logic that the life long commitment of ART can be made more tolerable, and that adherence among patients and the success of a public sector ART programme can be increased through the provision of ART regimens with the fewest side effects. In addition, the costs and complications associated with treating and managing adverse events associated with d4T and AZT create further burden on the public health sector. By providing tenofovir as an alternative to d4T and AZT in first line ART therapy, the South African government would increase the chance of successful ART therapy for patients and the long-term success of the national ART programme. This cost effectiveness analysis will compare the currently available first line ART options (the status quo) to two alternative options in order to assess the costeffectiveness of the provision of tenofovir in place of d4T/AZT.
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    Cost effectiveness of cryptococcal antigen screening as a strategy to prevent HIV-associated cryptococcal meningitis in South Africa
    (Public Library of Science, 2013) Jarvis, Joseph N; Harrison, Thomas S; Lawn, Stephen D; Meintjes, Graeme; Wood, Robin; Cleary, Susan
    Objectives Cryptococcal meningitis (CM)-related mortality may be prevented by screening patients for sub-clinical cryptococcal antigenaemia (CRAG) at antiretroviral-therapy (ART) initiation and pre-emptively treating those testing positive. Prior to programmatic implementation in South Africa we performed a cost-effectiveness analysis of alternative preventive strategies for CM. Design Cost-effectiveness analysis. METHODS: Using South African data we modelled the cost-effectiveness of four strategies for patients with CD4 cell-counts <100 cells/µl starting ART 1) no screening or prophylaxis (standard of care), 2) universal primary fluconazole prophylaxis, 3) CRAG screening with fluconazole treatment if antigen-positive, 4) CRAG screening with lumbar puncture if antigen-positive and either amphotericin-B for those with CNS disease or fluconazole for those without. Analysis was limited to the first year of ART. RESULTS: The least costly strategy was CRAG screening followed by high-dose fluconazole treatment of all CRAG-positive individuals. This strategy dominated the standard of care at CRAG prevalence ≥0.6%. Although CRAG screening followed by lumbar puncture in all antigen-positive individuals was the most effective strategy clinically, the incremental benefit of LPs and amphotericin therapy for those with CNS disease was small and additional costs were large (US$158 versus US$51per person year; incremental cost effectiveness ratio(ICER) US$889,267 per life year gained). Both CRAG screening strategies are less costly and more clinically effective than current practice. Primary prophylaxis is more effective than current practice, but relatively cost-ineffective (ICER US$20,495). CONCLUSIONS: CRAG screening would be a cost-effective strategy to prevent CM-related mortality among patients initiating ART in South Africa. These findings provide further justification for programmatic implementation of CRAG screening.
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    Cost utility and budget impact analysis of bortezomib and lenalidomide for the treatment of relapsed/refractory multiple myeloma in the South African public health sector
    (2021) Matsela, Lineo Marie; Cleary, Susan; Wilkinson, Thomas
    Multiple myeloma (MM) is the second most common haematologic cancer, accounting for approximately 13% of all blood cancer cases worldwide. The global incidence rate increased by 126% from 1990 to 2016. In South Africa, multiple myeloma accounts for approximately 9% of haematological cancers and less than 1% of all cancers. Nevertheless, some studies have reported that the incidence is likely underestimated due to an underdiagnosis of the cancer. Thus, the disease could possibly be an issue of greater concern in South Africa than current statistics indicate. The nature of the MM tumour makes patients prone to resistance of chemotherapy and multiple relapses leading to the development of relapse/refractory multiple myeloma (RRMM). During the relapse/refractory period, the patient is nonresponsive to treatment and/or experiences progressive disease When a patient experiences relapse/refractory MM, their prior, (first line) treatment is readministered if it was clinically efficacious and well-tolerated. Contrarily, a change in regimen is recommended if “an insufficient response, a rapid relapse and poor tolerance” to the first-line treatment is experienced by a patient. Second-line regimens that are recommended due to their proven high clinical efficacy are lenalidomide plus low-dose dexamethasone (LEN/DEX) and bortezomib monotherapy (BORT). The clinical effectiveness of both regimens for second-line treatment of RRMM was reported in the MM009/010 and the APEX studies, respectively, where each regimen was compared against dexamethasone monotherapy. Given this proven clinical effectiveness for RRMM, lenalidomide is under consideration for inclusion in the South African Essential Medicines list. Three treatment strategies for second line RRMM treatment were modelled from a provider's perspective. These strategies were dexamethasone (standard of care), BORT and LEN/DEX. For each strategy we modelled a hypothetical cohort of relapsed/refractory multiple myeloma patients using a three-state Markov model (pre-progression, progression and dead) over a 15-year time horizon. Efficacy data was obtained from the MM009/010 and APEX trials, while utilisation rates were obtained from a European study. Other input data was sourced from local literature. Outcomes were reported in quality adjusted life years (QALYs). Incremental cost effectiveness ratios (ICERs) were calculated for BORT and LEN/DEX and compared to the local cost-effectiveness threshold to determine if the drugs are good value for money for the South African government. The total costs per patient using DEX, BORT and LEN/DEX over 15 years differed significantly resulting in estimates of R8 312.32, R234 995.50 and R1 135 323.37, respectively. The associated health benefits in terms of quality-adjusted life years gained from the treatments were 1.14, 1.49 and 2.29. Hence, for every quality adjusted life year gained from BORT relative to DEX, an additional R654 648.52 would need to be spent. In contrast, when BORT is compared to LEN/DEX, an additional R1 225 542.23 would need to be spent for an additional quality adjusted life year gained from LEN/DEX. Both the BORT and LEN/DEX treatments were not cost-effective relative to the costeffectiveness threshold of R38 500 per DALY gained. Due to the high costs, both BORT and LEN/DEX could potentially have significant economic impacts on the South African public health sector budget. The study suggests that one year of treatment for 337 RRMM patients in South Africa using the BORT and LEN/DEX would increase the budget budget-cost of RRMM treatment by 3136% and 8684%, respectively. Both BORT and LEN/DEX treatments would not be cost-effective strategies for second-line treatment of RRMM in South Africa. The results indicate that the drug prices of lenalidomide and bortezomib hinder the cost-effectiveness of BORT and LEN/DEX. Price reductions could potentially make BORT more cost-effective and allow it to be considered as an option for second-line treatment for RRMM patients.
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    Cost-effectiveness analysis of alternative statin prescribing strategies for the secondary prevention of cardiovascular disease at a South African public sector tertiary hospital
    (2016) De Waal, Reneé; Cleary, Susan; Steyn, Krisela; Levitt, Naomi S
    Strokes and ischaemic heart disease are among the top ten causes of death in South Africa. Given that burden of disease, it is important to establish whether interventions aimed at preventing cardiovascular disease are not only effective, but cost effective too. Cost-effectiveness analyses compare interventions in terms of both their costs and consequences and are a useful tool for policymakers. Statins reduce the risk of cardiovascular events such as myocardial infarctions and strokes, by lowering low density lipoprotein cholesterol (LDL-C) concentrations. Several studies, mostly conducted in Europe or North America, have demonstrated that statins are cost effective, particularly when used to reduce the risk of further cardiovascular events in patients who already have cardiovascular disease (secondary prevention). Despite their widespread use, there are no published cost-effectiveness analyses of statins for the secondary prevention of cardiovascular disease in South Africa. There are also only limited local efficacy data from clinical trials and no costing data of cardiovascular events from a public healthcare sector perspective. There is some debate regarding the optimal statin dose. Some guidelines recommend increasing statin doses until target LDL-C concentrations are achieved, while others recommend prescribing statins at a fixed high dose without monitoring LDL-C. Monitoring LDL-C is relatively expensive compared to the cost of statins, but there is limited evidence that it might improve adherence. I compared the costs (from a provider perspective) and outcomes (life years), of increasing statin doses based on regular measurement of LDL-C concentrations, to achieve a target LDL-C concentration of <1.8 mmol/L; prescribing atorvastatin 80 mg without LDL-C monitoring; and the status quo, simvastatin 20 mg without LDL-C monitoring. I constructed a Markov model with annual cycles; a five-year timeline; starting age of 60 years; and the following health states: ≤1 year after first cardiovascular event, ≤1 year after subsequent cardiovascular event, >1 year after any cardiovascular event, and dead. I estimated transition probabilities using published literature. I estimated the costs of hospitalisation for myocardial infarctions, strokes, unstable angina pectoris and coronary revascularisation procedures using health services utilisation and expenditure data from a sample of patients at a public sector hospital. I discounted costs and outcomes at 3% per year; and explored alternative scenarios and timelines in sensitivity analyses. Atorvastatin 80 mg without LDL-C monitoring, was both the cheapest and most effective option over a five-year period. It remained the most effective option over a lifetime period, but with an incremental cost-effectiveness ratio (ICER) of $146.94 per life year gained relative to the status quo. Treat to target was as effective as atorvastatin 80 mg if I assumed adherence rates of 80% and 60% respectively, but with an ICER of $54 930.96. Treat to target would dominate atorvastin 80 mg only if the frequency of LDL-C monitoring was reduced from 3-monthly to 6-monthly until targets were reached, and the cost of LDL-C monitoring decreased by $9.25 (84%). Fixed-dose statin treatment without cholesterol monitoring is the most cost-effective option for providing statins for the secondary prevention of cardiovascular disease. The costs of regular LDL-C monitoring currently make a treat to target strategy unaffordable in our setting. These results might be used to help guide policy regarding secondary prevention of cardiovascular disease in South Africa.
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    The cost-effectiveness of Antiretroviral Treatment in Khayelitsha, South Africa - a primary data analysis
    (BioMed Central Ltd, 2006) Cleary, Susan; McIntyre, Di; Boulle, Andrew
    BACKGROUND:Given the size of the HIV epidemic in South Africa and other developing countries, scaling up antiretroviral treatment (ART) represents one of the key public health challenges of the next decade. Appropriate priority setting and budgeting can be assisted by economic data on the costs and cost-effectiveness of ART. The objectives of this research were therefore to estimate HIV healthcare utilisation, the unit costs of HIV services and the cost per life year (LY) and quality adjusted life year (QALY) gained of HIV treatment interventions from a provider's perspective. METHODS: Data on service utilisation, outcomes and costs were collected in the Western Cape Province of South Africa. Utilisation of a full range of HIV healthcare services was estimated from 1,729 patients in the Khayelitsha cohort (1,146 No-ART patient-years, 2,229 ART patient-years) using a before and after study design. Full economic costs of HIV-related services were calculated and were complemented by appropriate secondary data. ART effects (deaths, therapy discontinuation and switching to second-line) were from the same 1,729 patients followed for a maximum of 4 years on ART. No-ART outcomes were estimated from a local natural history cohort. Health-related quality of life was assessed on a sub-sample of 95 patients. Markov modelling was used to calculate lifetime costs, LYs and QALYs and uncertainty was assessed through probabilistic sensitivity analysis on all utilisation and outcome variables. An alternative scenario was constructed to enhance generalizability. RESULTS: Discounted lifetime costs for No-ART and ART were US$2,743 and US$9,435 over 2 and 8 QALYs respectively. The incremental cost-effectiveness ratio through the use of ART versus No-ART was US$1,102 (95% CI 1,043-1,210) per QALY and US$984 (95% CI 913-1,078) per life year gained. In an alternative scenario where adjustments were made across cost, outcome and utilisation parameters, costs and outcomes were lower, but the ICER was similar. CONCLUSION: Decisions to scale-up ART across sub-Saharan Africa have been made in the absence of incremental lifetime cost and cost-effectiveness data which seriously limits attempts to secure funds at the global level for HIV treatment or to set priorities at the country level. This article presents baseline cost-effectiveness data from one of the longest running public healthcare antiretroviral treatment programmes in Africa that could assist in enhancing efficient resource allocation and equitable access to HIV treatment.
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    Costs and effects of a multifaceted intervention to improve the quality of care of children in district hospitals in Kenya
    (2011) Barasa, Edwine W; Cleary, Susan; English, Mike
    In Kenya, an intervention to improve the quality of care of children was developed and tested in district hospitals. This was a multifaceted intervention employing clinical practice guidelines, training, supervision, feedback and facilitation, for brevity called the Emergency Triage and Treatment Plus (ETAT+) strategy. This thesis presents an economic evaluation of this complex intervention.
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    Disability Grant: a precarious lifeline for HIV/AIDS patients in South Africa
    (Biomed Central Ltd, 2015) Govender, Veloshnee; Fried, Jana; Birch, Stephen; Chimbindi, Natsayi; Cleary, Susan
    BACKGROUND:In South Africa, HIV/AIDS remains a major public health problem. In a context of chronic unemployment and deepening poverty, social assistance through a Disability Grant (DG) is extended to adults with HIV/AIDS who are unable to work because of a mental or physical disability. Using a mixed methods approach, we consider 1) inequalities in access to the DG for patients on ART and 2) implications of DG access for on-going access to healthcare. METHODS: Data were collected in exit interviews with 1200 ART patients in two rural and two urban health sub-districts in four different South African provinces. Additionally, 17 and 18 in-depth interviews were completed with patients on ART treatment and ART providers, respectively, in three of the four sites included in the quantitative phase. RESULTS: Grant recipients were comparatively worse off than non-recipients in terms of employment (9.1% vs. 29.9%) and wealth (58.3% in the poorest half vs. 45.8%). After controlling for socioeconomic and demographic factors, site, treatment duration, adherence and concomitant TB treatment, the regression analyses showed that the employed were significantly less likely to receive the DG than the unemployed (p<0.001). Also, patients who were longer on treatment and receiving concomitant treatment (i.e., ART and tuberculosis care) were more likely to receive the DG (significant at the 5% level). The qualitative analyses indicated that the DG alleviated the burden of healthcare related costs for ART patients. Both patients and healthcare providers spoke of the complexity of the grants process and eligibility criteria as a barrier to accessing the grant. This impacted adversely on patient-provider relationships. CONCLUSIONS: These findings highlight the appropriateness of the DG for people living with HIV/AIDS. However, improved collaboration between the Departments of Social Development and Health is essential for preparing healthcare providers who are at the interface between social security and potential recipients.
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    Early and late direct costs in a Southern African antiretroviral treatment programme: a retrospective cohort analysis
    (Public Library of Science, 2009) Leisegang, Rory; Cleary, Susan; Hislop, Michael; Davidse, Alistair; Regensberg, Leon; Little, Francesca; Maartens, Gary
    Gary Maartens and colleagues describe the direct heath care costs and identify the drivers of cost over time in an HIV managed care program in Southern Africa.
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    Early severe morbidity and resource utilization in South African adults on antiretroviral therapy
    (BioMed Central Ltd, 2009) de Cherif, Teresa; Schoeman, Jan; Cleary, Susan; Meintjes, Graeme; Rebe, Kevin; Maartens, Gary
    BACKGROUND:High rates of mortality and morbidity have been described in sub-Saharan African patients within the first few months of starting highly active antiretroviral therapy (HAART). There is limited data on the causes of early morbidity on HAART and the associated resource utilization. METHODS: A cross-sectional study was conducted of medical admissions at a secondary-level hospital in Cape Town, South Africa. Patients on HAART were identified from a register and HIV-infected patients not on HAART were matched by gender, month of admission, and age group to correspond with the first admission of each case. Primary reasons for admission were determined by chart review. Direct health care costs were determined from the provider's perspective. RESULTS: There were 53 in the HAART group with 70 admissions and 53 in the no-HAART group with 60 admissions. The median duration of HAART was 1 month (interquartile range 1-3 months). Median baseline CD4 count in the HAART group was 57 x 106 cells/L (IQR 15-115). The primary reasons for admission in the HAART group were more likely to be due to adverse drug reactions and less likely to be due to AIDS events than the no-HAART group (34% versus 7%; p < 0.001 and 39% versus 63%; p = 0.005 respectively). Immune reconstitution inflammatory syndrome was the primary reason for admission in 10% of the HAART group. Lengths of hospital stay per admission and inpatient survival were not significantly different between the two groups. Five of the 15 deaths in the HAART group were due to IRIS or adverse drug reactions. Median costs per admission of diagnostic and therapeutic services (laboratory investigations, radiology, intravenous fluids and blood, and non-ART medications) were higher in the HAART group compared with the no-HAART group (US$190 versus US$111; p = 0.001), but the more expensive non-curative costs (overhead, capital, and clinical staff) were not significantly different (US$1199 versus US$1128; p = 0.525). CONCLUSIONS: Causes of early morbidity are different and more complex in HIV-infected patients on HAART. This results in greater resource utilization of diagnostic and therapeutic services.