Budget Impact Analysis of Empagliflozin in the Treatment of Patients With Type 2 Diabetes With Established Cardiovascular Disease in South Africa.

OBJECTIVES: This study aimed to estimate the budget impact and affordability of empagliflozin added to usual care compared with usual care alone, in a diabetic population with established cardiovascular disease, from a private healthcare payer perspective in South Africa. METHODS: A budget impact model was adapted and localized. Epidemiological data were obtained from the South African Council for Medical Schemes. Clinical event rates were sourced from the EMPA-REG OUTCOME trial and drug costs from list prices. Clinical event costs were derived from a claims data analysis of the South African private healthcare sector and microcosting. Scenario analyses were performed on select inputs. The modeled outcomes included annual budget impact of empagliflozin, the incremental cost per life per month, cardiovascular deaths averted, and incremental cost per life saved, over 3 years. RESULTS: A total of 9 503 patients were eligible for empagliflozin (year 1), 12 670 (year 2), and 16 947 (year 3). The incremental cost was $1 272 297, $1 764 705, and $2 455 235, for years 1 to 3, respectively. The incremental cost per beneficiary per month was calculated as $0.012 (year 1), $0.016 (year 2), and $0.023 (year 3). The model estimated a 38.6% reduction in cardiovascular deaths, 305 lives saved, and an incremental cost per life saved of $17 999. CONCLUSIONS: Adding empagliflozin to usual care has a marginal budget implication and is highly affordable for private healthcare payers, with an acceptable incremental cost based on clinical outcomes.

Vaccine financing in the Middle East and Africa: An overview from 2010 to 2019.

BACKGROUND: Vaccination is a cost-effective disease prevention measure. Sustainable financing is critical to successful implementation of vaccination programs. Countries in the Middle East and Africa (MEA) have vaccination programs that remain highly vulnerable to budget limitations. OBJECTIVES: The objectives of this study were to understand the current vaccine financing landscape in MEA; to assess the availability and variability of data on vaccination budgets, expenditure and schedules including introductions of new vaccines; and to identify and describe key trends. METHOD: A targeted literature review was conducted for 69 MEA countries for data between 2010 and 2019. Descriptive analysis of the collected data was conducted. RESULTS: Data on vaccination expenditure were available for 96% of the countries. However, data on vaccination budget were limited, and the variability was high. The median vaccination expenditure per capita was between US$0.57 and US$1.02. High-income countries spent the most on vaccination per capita (median US$3.41) compared to low-income countries (median US$0.69). The highest vaccination expenditure per capita was in countries that receive 100% government funding of vaccination programs (US$0.87) compared to those where government pays for > 0% to < 50% of vaccination expenditure (US$0.74). Vaccination expenditure as a proportion of gross domestic product was the highest (0.10%) in low-income countries and the lowest in high-income countries (0.01%). Vaccination expenditure as proportion of healthcare expenditure was the highest (1.76%) in low-income countries and the lowest in high-income countries (0.33%). Statistically significant trends in median expenditure per capita were identified for 27% of the countries. During this period, an average of 4.4 vaccines were introduced. CONCLUSION: Data on vaccination expenditure in MEA was available for detailed analysis, and it was useful to understand the characteristics of vaccination funding in the region. It is important to secure adequate financing to sustain current vaccination programs and to introduce new vaccines.

Ipilimumab in Pretreated Patients With Advanced Malignant Melanoma: Results of the South African Expanded-Access Program.

PURPOSE: The primary objective of this study was to evaluate 1- and 2-year survival rates and durable remissions in pretreated patients with advanced (unresectable or metastatic) malignant melanoma treated with ipilimumab in a South African expanded-access program (SA-EAP). PATIENTS AND METHODS: This multicenter, retrospective study obtained data from pretreated patients with advanced malignant melanoma who were eligible for the ipilimumab SA-EAP. Ipilimumab was administered at a dose of 3 mg/kg intravenously every 3 weeks for four cycles to adults with advanced melanoma for whom at least one line of treatment for metastatic disease had failed. Data from the medical records of 108 patients treated within the SA-EAP were collected and statistically analyzed to determine overall (OS) and progression-free survival (PFS) at 1 and 2 years. RESULTS: In the population of 108 patients, a median OS of 8.98 months (95% CI, 7.47 to 10.79 months) was observed. One-year OS was 36% (95% CI, 26% to 45%), and 2-year survival was observed as 20% (95% CI, 12% to 27%). The median survival without progression (ie, PFS) was 3.44 months (95% CI, 2.98 to 4.16 months), and 1- and 2-year PFS were 22% (95% CI, 14% to 29%) and 14% (95% CI, 8% to 21%), respectively. The longest recorded survival was 3.4 years. No independent prognostic variables were identified to predict for OS by multivariate Cox proportional hazards model. CONCLUSION: In this multicenter South African setting, ipilimumab at a dose of 3 mg/kg was an effective treatment with long-term OS in a subset of patients with pretreated advanced malignant melanoma.

Depression in the South African workplace.

Depression is a common psychiatric disorder and can be costly, having a significant impact on the individual and employers. The South African Depression and Anxiety Group (SADAG) in partnership with HEXOR, with the support of Lundbeck, undertook research into depression in the workplace, because South African information is not available on this topic. It provides insight into the prevalence of depression within the workplace in South Africa, as well as the impact of depression on the employees and employers in terms of sick leave and levels of productivity, especially when the symptoms include cognitive impairment. It is apparent that stigma plays a pivotal role in the reasons for non-disclosure to employers. It further highlights the magnitude of awareness, early detection and the provision of a holistic support system within the work environment, free from bias, to ensure that optimum benefit can be achieved for both employer and employee.

A first step towards transparency in pricing of medicines and scheduled substances - publication of guidelines for pharmaco-economic submissions.

The National Department of Health of South Africa recently published guidelines for pharmaco-economic (PE) submissions in accordance with the Medicines and Related Substances Act (Act 101 of 1965), which came into effect on 1 April 2013. These guidelines relate to the compilation of PE submissions for evidence of cost-effectiveness of medicine or scheduled substances. The PE guidelines are a first step towards the creation of a mechanism whereby the value of medicine can be quantified in a transparent manner. The 'voluntary' nature of PE submissions speaks to the current lack of knowledge, understanding and capacity related to pharmaco-economics that exists in the private healthcare market. The current disconnect between the PE guidelines and the Medical Schemes Act should be addressed as a matter of urgency to provide a mechanism whereby guidance in terms of cost-effectiveness from a PE evaluation will be supported by guaranteed reimbursement by medical schemes.