Availability, treatment costs and affordability of SGLT-2 inhibitors and GLP-1 RAs for diabetes in 10 countries: a cross-sectional study.

backgroundDiabetes complicated by cardiovascular diseases and chronic kidney diseases poses a growing global burden. Sodium-glucose co-transporter-2 (SGLT-2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly recommended, yet their availability, treatment costs and affordability across countries of different income levels remain poorly understood.

objectivesTo evaluate the regulatory availability, treatment costs and affordability of all marketed SGLT-2 inhibitors and GLP-1 RAs across 10 countries, including Nepal, Pakistan, Bangladesh, Sri Lanka, South Africa, Brazil, China, Türkiye, Italy and France. RESEARCH DESIGN AND

methodsWe examined 22 SGLT-2 inhibitors and GLP-1 RAs across 10 countries using publicly available sources. Regulatory availability was defined as marketing authorisation in a given country. Monthly treatment costs were estimated using minimum 28-day retail medicine prices based on recommended dosing regimens. Affordability was assessed as the proportion of the national minimum monthly wage required to purchase 1 month of treatment. Differences in regulatory availability across income groups were assessed using the Kruskal-Wallis test, with subgroup analyses by regulatory capacity. Associations between treatment costs and gross domestic product (GDP) per capita were examined using Spearman correlation. Given the small sample size, analyses were exploratory and hypothesis-generating.

resultsRegulatory availability ranged from 2 medicines in Nepal to 15 in China (9.1%-68.2%). No statistically significant differences in regulatory availability were observed across or within income groups. Regulatory availability of SGLT-2 inhibitors did not vary by regulatory capacity, whereas countries with higher regulatory capacity had greater regulatory approval coverage for GLP-1 RAs (p=0.045). Minimum monthly treatment costs ranged from US$3.68-50.30 for SGLT-2 inhibitors and US$22.95-220.80 for GLP-1 RAs. SGLT-2 inhibitor treatment costs increased with GDP per capita (ρ=0.939; p<0.001), while no statistically significant association was observed for GLP-1 RAs. SGLT-2 inhibitors were more affordable than GLP-1 RAs, requiring 0.7%-5.1% versus 1.6%-110.4% of monthly minimum wages.

conclusionSubstantial cross-country variation exists in the regulatory availability, treatment costs and affordability of SGLT-2 inhibitors and GLP-1 RAs. Higher regulatory capacity was associated with greater regulatory availability for GLP-1 RAs. Coordinated efforts to strengthen regulatory capacity and improve affordability may help improve the regulatory availability and affordability of these therapies across countries.