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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.

Prevalence rates for patients with diabetes mellitus are rising across countries including sub-Saharan African countries, which will continue. As a result, there are an increasing number of patients with insulin-dependent diabetes across sub-Saharan Africa including Kenya. Growing prevalence rates are increasing the costs of treating patients with diabetes enhanced by associated complications. These include both microvascular and macrovascular complications, with hypoglycaemia and generally poor control of diabetes contributing to the burden. Long-acting insulin analogues were developed to reduce rates of hypoglycaemia associated with insulin usage, including nocturnal hypoglycaemia, and improve adherence through improving patient convenience. As a result, they are now included in the Kenyan Essential Medicines List. However, long-acting insulin analogues are typically considerably more expensive than standard insulins limiting their use in practice, especially in countries such as Kenya with concerns with affordability even for standard insulins such as Mixtard®. Consequently, a need to ascertain current utilisation and expenditure patterns for the different insulins including long-acting insulin analogues across Kenya starting with leading referral hospitals. Research in Kenyatta National Hospital (KNH) showed growing use of insulin glargine reaching up to 3.4 to 3.6% of total insulin utilisation in 2019 and 2020. However, prescribing was limited by considerably higher prices (3.4 fold higher) than standard insulins on a defined daily dose basis. Considerably higher prices resulted in no utilisation of long-acting insulin analogues in another leading referral hospital in Kenya. Overall, appreciably lowering the prices of long-acting insulin analogues through instigating local production and other activities should increase their use benefiting patients and the healthcare system in Kenya and wider. These are considerations for the future.

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.