Budget Impact of Long-Acting Insulin Analogues: The Case in Brazil

Abstract

BackgroundLong-acting insulin analogues for type 1 diabetes (T1D) treatment have been available on the Brazilian market since 2002. However, the population cannot access the analogues through the public health system.ObjectiveTo estimate the incremental budget impact of long-acting insulin analogues coverage for T1D patients in the Brazilian public health system compared to NPH insulin.MethodsWe performed a budget impact analysis of a five-year period. The eligible population was projected using epidemiological data from the International Diabetes Federation estimates for patients between 0–14 and 20–79 years old. The prevalence of T1D was estimated in children, and the same proportion was applied to the 15-19-year-old group due to a gap in epidemiological information. We considered 4,944 new cases per year and a 34.61/100,000 inhabitants mortality rate. Market share for long-acting insulin analogues was assumed as 20% in the first year, reaching 40% in the fifth year. The mean daily dose was taken from clinical trials. We calculated the bargaining power of the Ministry of Health by dividing the price paid for human insulin in the last purchase by the average regulated price. We performed univariate and multivariate sensitivity analyses.ResultsThe incremental budget impact of long-acting insulin analogues was US$ 28.6 million in the first year, and reached US$ 58.7 million in the fifth year. The total incremental budget impact was US$ 217.9 million over the five-year period. The sensitivity analysis showed that the percentage of T1D among diabetic adults and the insulin analogue price were the main factors that affected the budget impact.ConclusionsThe cost of the first year of long-acting insulin analogue coverage would correspond to 0.03% of total public health expenditure. The main advantage of this study is that it identifies potential bargaining power because it features more realistic profiles of resource usage, once centralized purchasing is established as an economically sustainable strategy. Clinical guidelines restricting the use of insulin analogues would make the decision towards insulin analogue coverage more affordable.

The High “Cost” of Experimental Drugs Obtained Through Health Litigation in Brazil

“…The speed with which evidence is produced and the pressure for incorporation discourage a conservative approach to the use of technologies. Rapid-and slow-acting insulins, for example, which are leading objects of lawsuits against SUS, were incorporated, even after several studies that showed the lack of gains in effectiveness from the system's perspective (De Souza et al, 2014;Laranjeira et al, 2016;Chieffi et al, 2017;CONITEC, 2019a;CONITEC, 2019b).…”

Budget Impact Analysis of Diabetes Drugs: A Systematic Literature Review

“…More than half of the studies (n = 11) were from Europe and the U.S., of which five studies were conducted in US (20,(24)(25)(26)(27), two in Italy (14,22), one in Netherlands (19), one in Spain (18), one in England (13)and one in Bosnia and Herzegovina (15). Apart from these, three studies were conducted in China (10)(11)(12), two in Brazil (21,23), one in Egypt (17) and one in Thailand (16). Among the 18 studies, most of them (n = 11) were conducted from a payer's perspective and a few studies (n = 5) from the perspective of health care system, while one study (17) was conducted from both of the payer and social perspectives.…”

“…The majority of studies (n = 15) focused on BIA only, while the other studies (n = 3) combined the BIA with cost-effectiveness analysis. About half of the BIA studies (n = 8) evaluated the budget impact of insulin, including basal insulin (n = 5) (13,(20)(21)(22)26), pre-mix insulin (n = 1) ( 16), bolus insulin (n = 1) (24). One study focused on the administration route of insulin (continuous subcutaneous insulin infusion vs. multiple daily insulin injections) instead of the specific type of insulin (18).…”

“…The eligible population were mainly chosen according to the indication of intervention and the coverage of the payer's plan. The majority of studies (n = 13) (10-12, 14-17, 19, 22-25, 27) restricted the target population on type 2 diabetes patients while some targeted type 1 diabetes patients (n = 2) (18,21), or type 1 and type 2 diabetes patients (n = 2) (20,26), and one study did not specify the target population (13). Six studies estimated the eligible population size based on a hypothetical health plan (20,(23)(24)(25)(26)(27), of which the assumed size varied widely ranging from 1 million to 35 million.…”

Assistência farmacêutica aos portadores de diabetes mellitus: impacto do farmácia popular e do acesso via judicalização da saúde

“…De maneira exemplificativa, apresentamos na Tabela 45 as marcas requisitadas para itens disponibilizados nas três listas do SUS.Tabela 45 -Requisição Marca Específica -Lista de Componentes SUS 2019) 7 . De todo modo, a comparação é relevante e os resultados encontrados estão, ainda, em linha com conclusões de estudos que avaliaram o custo de incorporação da insulina análoga no mundo (LARANJEIRA; SILVA;PEREIRA, 2016;SOPPI et al, 2018). o intuito de apresentar a participação de médicos e advogados, segregados por agentes privados versus públicos nessa judicialização, por portadores de DM, contra o Estado.…”