Pills or Pins? Financial Burdens of Combined Insulin Therapy Versus Oral Hypoglycemic Therapy Among Type 2 Diabetes Mellitus Patients During COVID-19 Pandemic

INTRODUCTION

Type 2 Diabetes Mellitus (T2DM) affected 529 million globally in 2021.^[1] T2DM is a significant public health concern, accounting for 6% of the total age-standardised Diabetes prevalence.^[1,2] India, known as the “Diabetes Capital of the World,” has an estimated 262·9% increase in DALY count from 1990-2021, impacting individual patients and the healthcare system.^[1,3] Diabetes patients require medication to manage and prevent complications, along with additional medical care like foot care, kidney disease screening, and eye examination at regular intervals.^[4]

Managing T2DM in rural areas can be challenging due to scarce healthcare resources and difficult economic circumstances.^[5] Insulin prices have doubled in a decade in the United States of America(USA), leading to catastrophic spending for 14.1% of users.^[6] However, the Inflation Reduction Act caps in the USA cost $35 per month, potentially saving only 20% on these medicines, with a higher correlation of out-of-pocket expenses (OOPE) among those with poor adherence to higher insulin requirements.^[6,7]

Studies in India have shown that insulin therapy among T2DM patients attending healthcare facilities has higher OOPE, with a median annual cost of $39, influenced by travel and medication costs, and it is increased by up to 2.3 times for patients with multiple comorbidities.^[8,9]

T2DM patients in rural communities incur significant financial impacts, including direct medical costs like hospital visits, medications, and diagnostic tests, as well as indirect costs like lost productivity and transportation expenses.^[10] For many families in lower socio-economic strata, the burden of managing T2DM can often lead to catastrophic health expenditures (CHEs).^[11] A study highlighted that the cost of managing diabetes in rural areas can consume a significant portion of household income, pushing many families into poverty.^[12] The lack of accessible and affordable healthcare in rural areas contributes to delayed diagnosis and poor management of T2DM, further increasing the financial burden on patients and their families.^[13] A study conducted in Tanzania had shown a relative increase in travel costs, leading to an overall increase in the costs related to treatment among patients with diabetes.^[14] While several Indian studies have examined OOPE in diabetic populations, few have compared catastrophic costs between insulin and OHA users in rural settings during the COVID-19 pandemic. This study examines the financial burdens associated with costs, out-of-pocket expenditures, and catastrophic health spending, stratified by treatment modality, in a rural community in Karnataka.

The current study examines the economic challenges of managing T2DM in rural communities in Karnataka, India, and estimates the direct and indirect costs, including OOPE and catastrophic spending among Insulin vs. Oral hypoglycaemic therapy in patients with T2DM. The findings of this study provide a comparative cost analysis of the burden of treatment with a focus on OOPE and CHE among patients with T2DM, which can help in decision-making of healthcare policies for non-communicable diseases like T2DM in the context of the COVID-19 pandemic.

MATERIAL AND METHODS

The present study findings are a part of a larger study conducted as part of a partial economic evaluation on non-communicable diseases, namely T2DM, Hypertension (HTN), and dual burden of T2DM and HTN, focusing on the experiences and costs of illness among those only with T2DM. The study was to assess the socio-economic impact and financial burden among patients with only T2DM in a rural community in Karnataka. The results of the study related to HTN have already been published.^[15]

In six villages under a rural Primary Health Centre (PHC) that serves around 28,000 people in three sub-centres, quantitative data were gathered between 2019 and 2022. Approximately 883 people with T2DM were reported in the NCD registration in the PHC’s catchment region, of whom approximately had DM alone and no other co-morbidities. Purposive sampling was employed to recruit 66 participants aged ≤18 years, diagnosed with both T2DM for at least one year, and residing in the selected villages for a minimum of six months. Based on a study conducted in an urban underprivileged area of Mumbai in 2014, it was found that 72.5% of the costs incurred by the T2DM patients were attributed to direct costs incurred by the patients. Assuming similar results in direct costs related to T2DM in this population, and in a population size of 883 patients with T2DM, the study required a minimum sample size of 62 patients to 15% precision relative to the expected proportion (i.e., 0.15 × 0.72 = 10.8% absolute precision) and 95% confidence level.^[16]

RESULTS

DISCUSSION

This study illustrates that individuals with T2DM undergoing combination insulin therapy experience a much greater financial burden than those utilising OHA, mostly attributable to increased direct medical expenses, including drugs, consultations, and diagnostic services. This discrepancy is probably caused by a higher incidence of complications among insulin users, longer time from diagnosis, and more severe disease, rather than socioeconomic differences.^[8,9,24]

The percentage of CHE was much greater among insulin users, which is in line with regional and international results that insulin therapy is more expensive, especially in rural areas with low resources.^[6,14,22] The CHE proportion in this study was 9.1%, which was less than the national average of 38%.^[27] This pattern is consistent with data from both high- and low-income nations, where the high cost of insulin has been demonstrated to significantly strain household finances.^[6,14,22] Indirect and non-medical costs did not significantly change between treatment groups, although insulin users’ transportation costs were greater, confirming earlier research showing that service availability and location might have a major impact on diabetes-related expenditures.^[14] The low contribution of socioeconomic status to the explanation of expenditure disparities implies that clinical profile and treatment mode are more important factors in determining the cost burden in this population.^[8,9] These results have significant policy ramifications. Through actions like adding insulin to the PHC level’s National List of Essential Medicines (NLEM), increasing Jan Aushadi coverage for diabetes medications, and incorporating T2DM management under Ayushman Bharat (PM-JAY), it may be possible to lower OOPE and shield households from unaffordable expenses.^[5,6,28]

Prior studies by Brixner et al. have found that insulin-based regimens are linked to significantly higher direct medical expenses than oral medication, which supports our conclusion that T2DM patients are more financially burdened by combination insulin therapy than by OHA alone.^[29] While direct medical expenses were the main contributor in our context, especially for patients receiving combined insulin and OHA therapy, a study conducted in Yogyakarta, Indonesia, found that indirect expenditures accounted for the biggest portion of the overall cost of illness. These discrepancies might be a reflection of how healthcare is financed, how services are provided, and how patients seek care in various contexts.^[30]

CONCLUSION

The comparative financial burden of median direct medical costs (INR), catastrophic expenditure, and OOPE for individuals on combined insulin therapy was significantly higher than those on only OHA. Median non-medical and indirect expenditures did not significantly differ between individuals on combined insulin therapy and those on OHA.