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OBJECTIVES Private managed healthcare organizations in South Africa (SA) use a capitation model of care for patients within their healthcare delivery systems for the optimal management of type 2 diabetes mellitus (T2DM) to reduce healthcare costs. Few studies have categorized healthcare costs at a patient level to determine the actual healthcare costs incurred by private insurers for T2DM in SA. This study estimated the direct medical costs of patients with T2DM registered with a private health insurer over a 5-year period between 2 funding models: a capitated risk-sharing model (CM) versus a traditional fee-for-service (FFS) model. METHODS This population-based cohort study used retrospective claims data of patients with T2DM from 2012 to 2016 of a private medical scheme in SA. Annual healthcare costs of T2DM were assessed. RESULTS During the 5-year period, most of the identified patients with T2DM were enrolled in CM-534 (64%) of 828 in 2012, which rose to 789 (81%) of 971 in 2016. The median annual healthcare costs of the treatment and management of the patients with T2DM was significantly higher in CM ($2002 [interquartile range (IQR) 2106] in 2012 to $1095 [IQR 1042] in 2016) than FFS ($582 [IQR 772] to $296 [IQR 507]) (P

This cost-outcome study estimated, from the perspective of the service provider, the total annual cost per client on antiretroviral therapy (ART) and total annual cost per client virally suppressed (defined as Using retrospective client record review of a cohort of clients over a two-year period, with bottom-up collection of clients’ resource utilization data, top-down collection of above-delivery level and delivery-level providers’ fixed operational costs, and local unit costs. Forty-seven DSDMs located at facilities or community-based points in the four regions of Uganda were included in the study, with 653 adults on ART (> 18 years old) enrolled in a DSDM. The study found that retention in care was 98% for the sample as a whole [96–100%], and viral suppression, 91% [86-93%]. The mean cost to the provider (MOH or NGO implementers) was $152 per annum per client treated, ranging from $141 to $166. Differences among the models’ costs were largely due to clients’ ARV regimens and the proportions of clients on second line regimens. Service delivery costs, excluding ARVs, other medicines and laboratory tests, were modest, ranging from $9.66–16.43 per client per year. We conclude that differentiated ART service delivery in Uganda achieved excellent treatment outcomes at a cost similar to the standard of care. While large budgetary savings might not be immediately realized, the reallocation of “saved” staff time could improve health system efficiency and with their equivalent or better outcomes and large benefits to clients, client-centred differentiated models would nevertheless add great societal value.

Background The proposed National Health Insurance (NHI) system aims to re-engineer primary healthcare (PHC) in South Africa, envisioning both private sector providers and public sector clinics as independent contracting units to the NHI Fund. In 2017, 16% of the South African population had private medical insurance and predominately utilised private providers. However, it is estimated that up to 28% of the population access private PHC services, with a meaningful segment of the low-income, uninsured population paying for these services out-of-pocket. The study objective was to characterise the health seeking behaviour of low-income, patients accessing PHC services in both the public and private sectors, patient movement between sectors, and factors influencing their facility choice. Methods We conducted once-off patient interviews on a random sample of 153 patients at 7 private PHC providers (primarily providing services to the low-income mostly uninsured patient population) and their matched public PHC clinic (7 facilities). Results The majority of participants were economically active (96/153, 63%), 139/153 (91%) did not have health insurance, and 104/153 (68%) earned up to $621/month. A multiple response question found affordability (67%) and convenience (60%) were ranked as the most important reasons for choosing to usually access care at public clinics (48%); whilst convenience (71%) and quality of care (59%) were key reasons for choosing the private sector (32%). There is movement between sectors: 23/76 (30%) of those interviewed at a private facility and 8/77 (10%) of those interviewed at a public facility indicated usually accessing PHC services at a mix of private and public facilities. Results indicate cycling between the private and public sectors with different factors influencing facility choice. Conclusions It is imperative to understand the potential impact on where PHC services are accessed once affordability is mitigated through the NHI as this has implications on planning and contracting of services under the NHI.

Background Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11–2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance. Results Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification. Conclusions The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

IntroductionAdequate and sustainable funding of national medicine regulatory agencies (NMRAs) is key for assurance of quality, safety and efficacy of medical products circulating in a market. The study aimed to determine factors affecting NMRAs funding in five East African Community (EAC) countries namely: Burundi, Kenya, Rwanda, Tanzania (Mainland and Zanzibar) and Uganda.MethodologyAn exploratory, mixed method design using both qualitative and quantitative data, was employed. Data from six NMRAs was collected through a combination of semi-structured interviews, questionnaires, and checklists for the period 2011/12-2014/15 while 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs and monitoring and evaluation experts of the respective agencies. NMRA's financing was assessed using six indicators namely, funding policy, financial autonomy, the total annual budget, actual funding per annum, funds received from various sources, and the NMRA expenditure.ResultsThe average total annual budget for all the EAC countries during the study period 2011-2015 ranged from USD 824,328.67 to USD 10,724,536.50. The low budget in Zanzibar may be attributed to population and pharmaceutical market size. Uganda's attainment of 98.75% (USD 10,656,704) revenue from industry fees is a result of deliberate government policy change from 100% reliance on donor funding over a period of 10 years (1995-2015). On average, the proportion of revenue against budget per annum is 54.8% (USD 458,970.11), 98.7% (USD 10,302,295.25) and 100% (USD 7,375,802.08) for Zanzibar Food & Drugs Agency (ZFDA), Uganda National Drug Authority (NDA) and Tanzania Medicines and Medical Devices Authority (TMDA) respectively. Governments, industry fees and donors are the major sources of funding across all NMRAs in the EAC region, with TMDA and Uganda NDA relying more on industry fees by 73.20% (USD 4,664,777.59) and 98.25% (USD 8,077,238.20) respectively. While Burundi relies solely on government funding, ZFDA, on the other hand, received on average 50.40% (USD 252,557.22) from government and 40.60% (USD 165,303.34) from industry fees and the remaining 9% from donors and other sources. An overall contribution of funds received from donors by each NMRA was the least among other sources of financing. Observation of expenditure patterns indicated operational costs to be the major expense in the majority of the NMRAs, followed by salaries and infrastructure development. The Kenya NMRA has the highest degree of average expenditure across all three categories, with the least average expenditures being marked by Burundi NMRA. The operational costs on average increased considerably in all the NMRAs during the study period.ConclusionEvidence from the EAC suggests that government and industry fees are the main sources of funding while donor contributions vary from country to country. Government policy, legal framework, and fees structure are the key enablers of NMRAs funding sustainability.

Background South Africa’s divided healthcare system is believed to be inequitable as the population serviced by each sector and the treatment received differs while annual healthcare expenditure is similar. The appropriateness of treatment received and in particular the cost of the same treatment between the sectors remains debatable and raises concerns around equitable healthcare. Colorectal cancer places considerable pressure on the funders, yet treatment utilization data and the associated costs of non-communicable diseases, in particular colorectal cancer, are limited for South Africa. Resources need to be appropriately managed while ensuring equitable healthcare is provided regardless of where the patient is able to receive their treatment. Therefore the aim of this study was to determine the cost of colorectal cancer treatment in a privately insured patient population in order to compare the costs and utilization to a previously published public sector patient cohort. Methods Private sector costs were determined using de-identified claim-based data for all newly diagnosed CRC patients between 2012 and 2014. The costs obtained from this patient cohort were compared to previously published public sector data for the same period. The costs compared were costs incurred by the relevant sector funder and didn’t include out-of-pocket costs. Results The comparison shows private sector patients gain access to more of the approved regimens (12 vs. 4) but the same regimens are more costly, for example CAPOX costs approximately €150 more per cycle. The cost difference between 5FU and capecitabine monotherapy is less than €30 per cycle however, irinotecan is cheaper in comparison to oxaliplatin in the private sector (FOLFOX approx. €500 vs. FOLFIRI aprox. €460). Administrative costs account for up to 45% of total costs compared to the previously published data of these costs totaling Conclusion This comparison highlights the disparities between sectors while illustrating the need for further research to improve resource management to attain equitable healthcare.

Reported colorectal cancer incidence is increasing in South Africa and places strain on the public healthcare system especially as costs associated with chemotherapy globally are rising. The exact costs associated with colorectal cancer chemotherapy in South Africa however have not been previously determined. This study aimed to determine the costs of early and advanced colorectal cancer chemotherapy based on the clinical pathways used in the public healthcare sector. A retrospective chemotherapy medicine utilisation review (2012–2014) was conducted at a public healthcare Medical Oncology Clinic and the costs of chemotherapy, administration and concomitant/supportive therapies calculated based on the patient cohort (n=162). These costs were compared to theoretical costs, based on the developed clinical pathways, standard dosages and treatment cycles. First line treatments for early and advanced colorectal cancer comprised mainly of oral capecitabine, either alone or in combination. The medicine utilisation shows the use of capecitabine to be favoured over infusional 5-FU/LV for convenience reasons. Oxaliplatin was usually combined with either fluoropyrimidine (early and advanced disease) however some patients received second line irinotecan albeit was not on the Essential Medicine List at the time. Our findings reflect the complexity of CRC chemotherapy treatment with more pharmacoeconomic and outcomes research required in order to refine the clinical pathways as well as improve access to care in resource constrained settings.

The African Medicines Regulatory Harmonization Initiative (AMRH) has contributed to reduce marketing authorization timelines in East African Community and the Southern African Development Community member states. Challenges still exist in using the outcome of the regional joint dossier review processes for national decision making processes by the national medicines regulatory agencies. Progress in domestication of the African Union Model Law on Medical Products Regulation by twelve countries provides basis for improving regulatory systems. This is coupled by the designation of eleven regional centers of regulatory excellence which will ensure sustainable training programmes and subsequent increase in Africa’s regulatory workforce. The Biennial Scientific Conferences on Medical Products Regulation in Africa is a strategic platform for knowledge and ideas exchange among key stakeholders in the pharmaceutical sector. The ongoing alignment of the African Vaccines Regulators Forum, the Network of Medicines Control Laboratories in Sub-Saharan Africa, Pan African Harmonization Working Party on the regulation of medical devices and diagnostics, the planned establishment of a forum for blood and blood with AMRH serves as a solid foundation for establishment of the African Medicines Agency (AMA). AMA will be a key driver to remove technical barriers for trading among the region countries by contributing to the continental socio-economic development agenda.

Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy. This review provides a summary of the current status of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to improve their performance. All countries in Africa (except Sahrawi Republic), have NMRAs but their organizational set-up and functionality is variable. Some are located within Ministries of Health and others are semi-autonomous. There is progressive improvement in regulatory capacity, particularly in quality control and post-marketing surveillance, pharmacovigilance and clinical trials oversight. The African Vaccines Regulatory Forum, African Medicines Regulatory Harmonization Initiative, Network of Official Medicines Control Laboratories and WHO Prequalification Scheme have helped countries strengthen their regulatory capacities. The potential establishment of the African Medicines Agency (AMA) in 2018 is an opportunity to improve NMRAs’ capacity in Africa.