Availability and use of long-acting insulin analogues across Africa including biosimilars; current situation and implications

Background: Prevalence rates of diabetes mellitus are growing, and likely reach 34.2 million people in sub-Saharan Africa by 2040. This has significant implications on morbidity, mortality, and costs exacerbated by complications. Complications in patients requiring insulins enhanced by hypoglycaemia. Long-acting insulin analogues can reduce hypoglycaemia and improve patient compliance. However, typically appreciably more expensive than other insulins, limiting their listing on national essential medicine lists (EMLs). Biosimilars may help reduce prices and enhance listing. Objectives: Assess current listing and funding for insulins including long-acting insulin analogues across Africa. Methods: Mixed methods approach including documentation of utilisation patterns and prices nationally as well as from hospitals, ambulatory care, wholesalers and pharmacies among a range of African countries. Input from senior level government, academic, and healthcare professionals on the current situation with long-acting insulin analogues and potential changes needed to enhance future funding of biosimilar long-acting insulins. Results: Variable listing of long-acting insulin analogues on national EMLs across Africa due to high prices and issues of affordability. Even when listed in EMLs, utilisation in public healthcare systems is limited due to similar issues including affordability. Appreciably lowering the prices of long-acting insulin analogues via biosimilars should enhance future listing on EMLs and use accompanied by educational and other initiatives. However to date, limited price reductions for biosimilars versus originators across Europe and Asia. Conclusion: There are concerns with funding long-acting insulin analogues across Africa including biosimilars. A number of activities have been identified to improve future listing on EMLs and subsequent us

Availability and use of long-acting insulin analogues including their biosimilars across Africa; findings and implications

Background: Prevalence rates of diabetes mellitus are growing across Africa with an appreciable number likely to be on insulin to manage their condition. This has significant implications on future morbidity and mortality exacerbated by high complication rates. Complication rates in patients requiring insulins are enhanced by hypoglycaemia. Long-acting insulin analogues were developed to reduce hypoglycaemia and improve patient compliance. However, they are typically appreciably more expensive than human and other insulins in Africa, and continuing controversies surrounding their benefits limits their listing on national essential medicine lists (EMLs). Biosimilars can reduce the prices long-acting insulin analogues. This needs assessing. Methods: Mixed methods approach including documentation of insulin utilisation patterns and prices among a range of African countries. In addition, input from senior level government, academic, and healthcare professionals from across Africa on the current situation with long-acting insulin analogues as well as potential changes needed to enhance future funding of long-acting analogue biosimilars. Results: There is variable listing of long-acting insulin analogues on national EMLs across Africa due to their high prices and issues of affordability. Even when listed, utilisation of long-acting insulin analogues is limited by similar issues including affordability. Appreciably lowering the prices of long-acting insulin analogues via biosimilars should enhance future listing on EMLs and use accompanied by educational and other initiatives. However, this will require increased competition to lower prices. Conclusion: There are concerns with value and funding of long-acting insulin analogues across Africa including biosimilars. A number of activities have been identified to improve future funding and listing on EMLs

Nutritional rickets among children admitted with severe pneumonia at Mulago hospital, Uganda: a cross-sectional study

Abstract Background There’s abundant sunshine in the tropics but severe rickets is still observed. Nutritional rickets is associated with an increased risk of acute lower respiratory infections. Pneumonia is the leading cause of death in the under 5 -year old children with the highest burden in developing countries. Both Pneumonia and rickets are common in the developing countries and may affect clinical presentation and outcome. This study aimed to determine the prevalence and associated factors of nutritional rickets in children admitted with severe pneumonia. Methods This was a cross-sectional study of children aged 2–59 months presenting with severe pneumonia at an emergency unit. We enrolled 221 children between February and June 2012 after consent. A pre-coded questionnaire was used to collect data on socio-demographic, nutritional and past medical history. Physical exam was done for signs of rickets and anthropometric measurements. Serum calcium, phosphorus, and alkaline phosphatase (ALP) were assessed. Children with any physical signs of rickets or biochemical rickets (ALP > 400 IU); had a wrist x-ray done. Nutritional rickets was defined as the presence of radiological changes of cupping or fraying and/ or metaphyseal thickening. Severe pneumonia was defined using the WHO criteria. Statistical analysis was performed using the Stata 10 statistical package. P- value < 0.05 was significant. Results The prevalence of nutritional rickets among children with severe pneumonia is 9.5%. However, 14.5% had raised ALP (biochemical rickets). The factors independently associated with rickets was an elevated alkaline phosphatase; p-value < 0.001, or 32.95 95% CI (10.54–102.93). Other factors like breastfeeding, big family size, birth order were not significantly associated with rickets. Low serum calcium was detected in 22 (9.9%) of the 221 participants. Overall few children with rickets had typical clinical features of rickets on physical examination. Conclusion Rickets is a common problem in our setting despite ample sunshine. Clinicians should actively assess children for rickets in this setting and screen for rickets in those children at high risk even without clinical features

Healthcare delivery for paediatric and adolescent diabetes in low resource settings: Type 1 diabetes clinics in Uganda

The management of type 1 diabetes (T1DM) includes setting up organised follow-up clinics. A programme for establishing such clinics in Uganda commenced in 2009. The clinics were established along the chronic care model and were integrated into the health structure of other chronic diseases. Web-based electronic medical records were utilised to establish a centralised registry. All children with diabetes below 18 years of age were encouraged to enrol into the programme by attending the nearest established T1DM clinic. At the commencement of the programme, there were 178 patients with T1DM receiving care in various health facilities but without organised follow-up T1DM clinics. These patients were subsequently enrolled into the programme and as of June 30, 2018, the programme had a total of 32 clinics with 1187 children; 3 with neonatal diabetes. Challenges encountered included difficulties in timely diagnosis, failure to provide adequate care in the remote rural areas and failure to achieve pre-defined glycated haemoglobin (HbA1c) goals. Despite these challenges, this observational study demonstrates that healthcare delivery for T1DM organised along the chronic care model and supported by web-based electronic medical records is achievable and provides care that is sustainable. Addressing the encountered challenges should result in improved outcomes for T1DM

The current situation regarding long-acting insulin analogues including biosimilars among african, Asian, European, and South American countries : findings and implications for the future

Background: Diabetes mellitus rates continue to rise, which coupled with increasing costs of associated complications has appreciably increased global expenditure in recent years. The risk of complications are enhanced by poor glycaemic control including hypoglycaemia. Long-acting insulin analogues were developed to reduce hypoglycaemia and improve adherence. Their considerably higher costs though have impacted their funding and use. Biosimilars can help reduce medicine costs. However, their introduction has been affected by a number of factors. These include the originator company dropping its price as well as promoting patented higher strength 300 IU/ml insulin glargine. There can also be concerns with different devices between the manufacturers. Objective: To assess current utilisation rates for insulins, especially long-acting insulin analogues, and the rationale for patterns seen, across multiple countries to inform strategies to enhance future utilisation of long-acting insulin analogue biosimilars to benefit all key stakeholders. Our approach: Multiple approaches including assessing the utilisation, expenditure and prices of insulins, including biosimilar insulin glargine, across multiple continents and countries. Results: There was considerable variation in the use of long-acting insulin analogues as a percentage of all insulins prescribed and dispensed across countries and continents. This ranged from limited use of long-acting insulin analogues among African countries compared to routine funding and use across Europe in view of their perceived benefits. Increasing use was also seen among Asian countries including Bangladesh and India for similar reasons. However, concerns with costs and value limited their use across Africa, Brazil and Pakistan. There was though limited use of biosimilar insulin glargine 100 IU/ml compared with other recent biosimilars especially among European countries and Korea. This was principally driven by small price differences in reality between the originator and biosimilars coupled with increasing use of the patented 300 IU/ml formulation. A number of activities were identified to enhance future biosimilar use. These included only reimbursing biosimilar long-acting insulin analogues, introducing prescribing targets and increasing competition among manufacturers including stimulating local production. Conclusions: There are concerns with the availability and use of insulin glargine biosimilars despite lower costs. This can be addressed by multiple activities