The availability of insulin for the treatment of diabetes mellitus, a chronic disease that increases with age, and its financial sustainability are of general concerns, especially for universal healthcare systems, such as the Brazilian Unified Health System (Sistema Único de Saúde, SUS) [1]. This is why similar biotherapeutic products (produtos bioterapêuticos similares, SBP) can be a cost reduction strategy in improving access to essential supplies for the population. These drugs demand less investment and acquisition cost [2].
In a 2022 study, Thais Catão and colleagues evaluated the purchases of insulins and insulin analogues existing in the clinical protocols and therapeutic guidelines (protocolos clínicos e diretrizes terapêuticas, PCDTs) carried out by the Brazilian federal government between 2015 and 2020. The databases of the integrated system for the administration of general services (Sistema Integrado De Administração De Serviços Gerais, SIASG) were consulted for analysing unit prices, volume purchased, total expenses, purchasing agencies, suppliers, purchase modality and the brand. The defined daily doses (DDDs) acquire, average expenditures per DDD, weighted average unit prices (preços unitários médios ponderados, PMPs) and total expenditures with these drugs were estimated. The values were adjusted by the Broad Consumer Price Index (Índice de Preços ao Consumidor Amplo, IPCA) [3].
Between 2015 and 2020, purchases of 17 types of insulin and/or analogues were identified in 45 different pharmaceutical presentations. About 121 million units were purchased, totalling approximately US$269.5 million. Comparing 2020 with the base year 2015, the expenses and the acquired DDDs exceeded +1,000% variation. There was a trend towards a reduction in average expenditure per DDD of 63% for NPH insulins and 14% for regular insulins. Most DDDs purchased (69%) were reference insulins and 31% of DDDs were biosimilars [3].
SBPs of three types of insulin were purchased: NPH, regular and glargine. Basaglar branded glargine insulins (SBPs) cost an average of US$10.91, less than the US$20.22 of original Lantus® insulins. In 2019 alone, Basaglar® brand insulin glargine (SBP) cost US$20.82, more than the US$16.53 paid for Lantus®. The NPH and regular biosimilar insulins purchased were Wosulin®, Insunorm® and Bahiafarma®. The average expenditure per DDD for reference insulins was approximately US$1.50 and for biosimilars, US$0.20. Only those of the Bahiafarma® brand, produced from productive development for partnerships (parcerias para o desenvolvimento produtivo, PDPs) between private and public laboratories, had a lower PMP in all the years they were purchased by the government [3].
The authors of the study concluded that the reduction in average expenditures by DDD and the growth of public purchases of biosimilars contribute to the expansion of access to insulin, either through competition or through the lower PMPs of biosimilars. Policies to encourage the production of SBPs, such as PDPs, make the strategy of producing cheaper medicines viable. These results, in turn, deserve a careful analysis, as the savings in resources with the purchase of SBPs are not necessarily real for all drug classes in Brazil. It is still essential to expand the stimulus to competition and transparency in Brazilian bidding processes.
Biosimilar insulins can offer a lower-cost alternative to originator insulins and substantial savings for all healthcare systems [4], and in this case in particular for the Brazilian healthcare system.
Conflict of interest
The authors of the research paper [3] declared that there was no conflict of interest.
Abstracted by Thais Pereira Catão, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.
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References
1. Ministério da Saúde. Protocolo clínico e diretrizes terapêuticas do diabete melito tipo 2. Secretaria de ciência, tecnologia, inovação e insumos estratégicos em Saúde. 2020 [homepage on the Internet]. [cited 2022 Jun 17]. Available from: http://conitec.gov.br/images/Consultas/Relatorios/2020/20201113_Relatorio_PCDT_565_Diabete_Melito_Tipo_2.pdf
2. Van de Wiele VL, Beall RF, Kesselheim AS, et al. The characteristics of patents impacting availability of biosimilars. Nat Biotechnol. 2022;40(1):22-5.
3. Catão TP, Mosegui GBG, Vianna CM de M, et al. Perfil de compras federais de insulinas no Brasil: o impacto da entrada de biossimilares. Res Soc Dev. 2022;11(4):e1511427073.
4. GaBI Online - Generics and Biosimilars Initiative. Key considerations when switching to biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 17]. Available from: www.gabionline.net/biosimilars/general/key-considerations-when-switching-to-biosimilar-insulin
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