Pharmacoeconomic Evaluation of Antidiabetic Therapy and Economic Burden of Diabetes Management in a Tertiary Care Hospital

INTRODUCTION

Type 2 Diabetes Mellitus (T2DM) represents a heterogeneous and progressively debilitating metabolic disorder characterized by chronic hyperglycaemia arising from complex interactions between insulin resistance, β-cell dysfunction, impaired incretin activity, and dysregulated glucose homeostasis (American Diabetes Association Professional Practice Committee, 2025). Over recent decades, T2DM has evolved into a major global health crisis, imposing substantial clinical, epidemiological, and socioeconomic consequences on healthcare systems worldwide (Anjana et al., 2017). The escalating prevalence of diabetes has been attributed to rapid urbanization, demographic transitions, sedentary lifestyles, nutritional excesses, obesity, and population aging, thereby contributing significantly to the global burden of non-communicable diseases (Bahia et al., 2011).

The pathophysiological complexity of T2DM extends beyond glycaemic dysregulation and encompasses a wide spectrum of microvascular and macrovascular complications, including diabetic nephropathy, retinopathy, neuropathy, coronary artery disease, cerebrovascular disease, and peripheral vascular disorders (Beran and Yudkin, 2006). These complications are associated with increased morbidity, premature mortality, diminished quality of life, and substantial healthcare resource utilization (Bommer et al., 2017). Consequently, diabetes management necessitates lifelong pharmacological intervention, continuous metabolic monitoring, and multidisciplinary therapeutic approaches aimed at preventing disease progression and associated complications (Bommer et al., 2018).

The contemporary therapeutic armamentarium for T2DM has expanded considerably with the introduction of novel pharmacological classes such as DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, and advanced insulin analogues (Buse et al., 2020). Although these therapeutic innovations have demonstrated superior glycaemic efficacy and favourable cardiovascular and renal outcomes, their widespread utilization has simultaneously amplified treatment-related expenditures (Cameron et al., 2009). The increasing dependence on multidrug regimens, fixed-dose combinations, and insulin-based therapies has further intensified the economic burden associated with long-term diabetes management (Davies et al., 2022).

In developing economies such as India, where a substantial proportion of healthcare expenditure is financed through out-ofpocket payments, the financial implications of diabetes represent a critical public health concern (DeFronzo et al., 2017). Direct medical costs associated with pharmacotherapy, laboratory investigations, physician consultations, hospitalization, and management of chronic complications constitute major contributors to treatment expenditure (Dunne et al., 2014). Furthermore, indirect costs arising from productivity losses, disability, and premature mortality substantially magnify the overall societal burden of the disease (Forbes and Cooper, 2013).

Pharmacoeconomics has emerged as a pivotal discipline for evaluating the economic consequences of therapeutic interventions and optimizing healthcare resource allocation (Freund and Dittus, 1992). Comprehensive pharmacoeconomic assessments facilitate identification of cost-driving factors, evaluation of prescribing patterns, and determination of economically sustainable treatment strategies (GBD, 2021 Diabetes Collaborators, 2023). Therefore, the present study was undertaken to evaluate the pharmacoeconomic profile of antidiabetic therapy, analyse medication-related expenditures, assess prescribing practices, and quantify the economic burden of diabetes management in a tertiary care teaching hospital. The findings are expected to provide evidence supporting rational pharmacotherapy and cost-effective diabetes care (Genitsaridi et al., 2026).

MATERIALS AND METHODS

Study Design and Setting

A Prospective, Observational, Pharmacoeconomic study was conducted to evaluate the economic implications of antidiabetic pharmacotherapy and to quantify the financial burden associated with diabetes management among patients receiving treatment in a tertiary care teaching hospital. The study was designed to systematically assess prescribing patterns, medication utilization trends, treatment-related expenditures, and pharmacoeconomic determinants influencing the overall cost of diabetes care. The investigation was carried out in the Department of General Medicine and affiliated diabetic clinics of a tertiary care teaching hospital catering to a large and diverse patient population.

Study Duration

The study was conducted over a period of twelve months. During the study period, eligible patients attending both outpatient and inpatient departments were screened and enrolled consecutively following fulfilment of the predefined inclusion criteria.

Study Population and Sample Size

The study population comprised adult patients diagnosed with Type 2 Diabetes Mellitus receiving pharmacological treatment for glycaemic control. A total of 400 patients were included in the study and subjected to pharmacoeconomic evaluation. The sample was considered adequate to provide a comprehensive assessment of treatment expenditure, prescribing practices, and economic burden associated with diabetes management.

Inclusion Criteria

Patients were considered eligible for inclusion if they fulfilled the following criteria:

• Age ≥18 years.
• Confirmed diagnosis of Type 2 Diabetes Mellitus. • Receiving one or more antidiabetic medications.
• Availability of complete prescription and treatment records.
• Willingness to provide informed consent for participation.

Exclusion Criteria

Patients meeting any of the following criteria were excluded:

• Type 1 Diabetes Mellitus.
• Gestational Diabetes Mellitus.
• Critically ill patients requiring intensive care management.
• Patients with incomplete medical records.
• Patients unwilling to participate in the study.

Data Collection

Data were collected prospectively using a structured and pre-validated data collection form. Relevant information was obtained through review of patient case records, prescription charts, laboratory reports, and direct patient interviews. The following variables were documented:

The following variables were documented:

• Demographic characteristics (age and gender).
• Duration of diabetes mellitus.
• Associated comorbid conditions.
• Antidiabetic medications prescribed.
• Drug class, dosage, frequency, and route of administration.
• Therapeutic regimen pattern (monotherapy, dual therapy, triple therapy, quadruple therapy).
• Insulin utilization pattern.
• Fixed-Dose Combination (FDC) utilization.
• Generic and branded prescribing practices.
• Concomitant medications prescribed for comorbidities.
• Direct medication-related expenditures.

Pharmacoeconomic Assessment

The pharmacoeconomic evaluation primarily focused on direct medical costs associated with antidiabetic pharmacotherapy. Cost analysis was performed from the patient perspective to estimate the financial burden imposed by diabetes treatment.

Cost Identification

The following direct cost components were included:

• Cost of oral antidiabetic medications.
• Cost of insulin preparations and insulin analogues.
• Cost of fixed-dose combination products.
• Cost of concomitant medications prescribed for diabetes-associated comorbidities.

Cost Measurement

Medication costs were estimated using prevailing market prices available during the study period. Drug prices were obtained from hospital pharmacy records, Current Index of Medical Specialities (CIMS), Indian Drug Review (IDR), and standard pharmaceutical pricing databases.

Monthly treatment expenditure was calculated using the prescribed daily dose and corresponding unit price of each medication.

Annual treatment expenditure was estimated using:

Cost Categorization

Based on monthly expenditure, treatment costs were categorized as follows:

• Low Cost: < ₹500/month.
• Moderate Cost: ₹500-1500/month.
• High Cost: ₹1500-3000/month.
• Very High Cost: > ₹3000/month.

Assessment of Economic Burden

The economic burden of diabetes management was evaluated by comparing treatment-related expenditures across different therapeutic categories. Cost burden assessment was performed according to:

• Type of antidiabetic therapy.
• Complexity of therapeutic regimen.
• Utilization of insulin and insulin analogues.
• Fixed-dose combination therapy.
• Presence of associated comorbidities.
• Generic versus branded prescribing patterns.

The pharmacoeconomic impact of treatment was further assessed by identifying the most economical therapy, highest-cost therapy, major cost-driving medications, and treatment strategies associated with the greatest financial burden.

Outcome Measures

Primary Outcome

To evaluate the pharmacoeconomic profile and direct treatment costs associated with antidiabetic therapy among patients with Type 2 Diabetes Mellitus.

Secondary Outcomes

To estimate monthly and annual treatment expenditure.

• To compare costs associated with different therapeutic regimens.
• To assess the economic implications of insulin and insulin analogue utilization.
• To evaluate the influence of prescribing patterns on treatment costs.
• To determine the impact of diabetes-related comorbidities on overall expenditure.
• To identify major cost-driving factors contributing to the economic burden of diabetes management.

Ethical Considerations

The study protocol was reviewed and approved by the Institutional Ethics KIMS/IEC/A146/P/2023 Committee prior to commencement of the study. Written informed consent was obtained from all participants before enrolment. The study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and Good Clinical Practice guidelines. Confidentiality and anonymity of patient information were maintained throughout the study.

Statistical Analysis

Data were entered into Microsoft Excel and analysed using Statistical Package for Social Sciences (SPSS) software version 32.0. Descriptive statistical methods were employed for data analysis. Categorical variables were expressed as frequencies and percentages, whereas continuous variables were presented as mean, standard deviation, median, and range where appropriate. Cost data were summarized as monthly and annual treatment expenditures. Results were presented using tables and graphical representations to facilitate interpretation of pharmacoeconomic outcomes.

RESULTS

A total of 400 study participants were included in the study. The pharmacoeconomic evaluation assessed the cost of commonly prescribed antidiabetic medications, different treatment patterns, generic and brand prescribing, fixed-dose combinations, annual treatment expenditure, and the effect of comorbidities on treatment costs.

The estimated average monthly cost of commonly prescribed antidiabetic medications varied considerably. Metformin-based therapy showed comparatively lower treatment costs, whereas newer agents such as SGLT2 and DPP-4 inhibitors were associated with higher monthly expenditure. Insulin analogues, particularly insulin glargine, demonstrated the highest estimated monthly treatment cost (Table 1).

The estimated average monthly expenditure increased with increasing complexity of antidiabetic therapy. Monotherapy represented the lower-cost treatment pattern, whereas triple therapy, quadruple therapy, and insulin-based treatment were associated with higher monthly expenditure (Table 2).

Generic prescribing was associated with comparatively lower estimated monthly treatment expenditure than brand prescribing. Among the study participants, generic prescribing accounted for 38.5% of prescriptions, while brand prescribing accounted for 61.5%, with brand prescribing showing a higher estimated monthly cost range (Table 3).

The economic burden of antidiabetic treatment varied according to the type and complexity of therapy. Oral monotherapy was categorized as a low-cost treatment option, whereas triple oral therapy and insulin-containing therapy were associated with moderate-to-high and high economic burden, respectively. Insulin analogue therapy represented the very-high-cost treatment category (Table 4).

The estimated monthly cost of fixed-dose combinations varied according to the drugs included in the combination. Metformin-glimepiride was associated with comparatively lower expenditure, whereas combinations containing newer agents such as sitagliptin, dapagliflozin, and vildagliptin demonstrated higher monthly treatment costs (Table 5).

The estimated annual treatment expenditure increased substantially according to the treatment pattern. Metformin monotherapy represented the lowest annual expenditure range, whereas insulin analogue therapy demonstrated the highest estimated annual treatment cost, ranging from ₹54,000 to ₹1,08,000 (Table 6).

The presence of comorbidities was associated with higher estimated treatment-cost ranges. Participants with chronic kidney disease and coronary artery disease demonstrated higher monthly treatment-cost ranges compared with those without major comorbidities (Table 7).

Overall, the pharmacoeconomic evaluation demonstrated substantial variation in treatment expenditure according to the choice and complexity of antidiabetic therapy. Metformin monotherapy represented the most economical therapy, whereas insulin analogue-based multidrug therapy represented the most expensive treatment strategy. Generic prescribing was identified as a cost-saving prescribing practice, while newer antidiabetic agents contributed substantially to treatment expenditure (Table 8).

DISCUSSION

The present pharmacoeconomic investigation provides a comprehensive assessment of treatment-related expenditures associated with Type 2 Diabetes Mellitus (T2DM) and highlights the substantial economic burden imposed by contemporary diabetes management strategies. The findings demonstrate considerable variability in treatment costs across different antidiabetic therapeutic classes, prescribing patterns, and treatment intensification levels. These observations reinforce the growing body of evidence indicating that diabetes is not only a major clinical challenge but also a significant economic concern for patients, healthcare providers, and healthcare systems globally (Harding et al., 2019).

One of the most notable findings of the present study was the identification of metformin as the most economical antidiabetic agent, with an estimated monthly expenditure ranging from ₹80-250. This observation is consistent with previous pharmacoeconomic investigations conducted by Wang et al., who reported that metformin remains the most cost-effective first-line pharmacological intervention because of its proven efficacy, favourable safety profile, and low acquisition cost (Hex et al., 2012). Similarly, the recommendations of international diabetes treatment guidelines continue to advocate metformin as the preferred initial therapy for most patients with T2DM owing to its superior cost-effectiveness ratio (Inzucchi et al., 2015).

Conversely, insulin glargine was identified as the highest-cost individual medication in the present study, generating monthly expenditures of ₹2200-4500. Similar findings were reported by Palmer et al., who demonstrated that long-acting insulin analogues substantially increase treatment costs despite providing improved glycaemic stability and reduced risk of hypoglycaemia (Kalyani et al., 2023). Although insulin analogues offer significant therapeutic benefits, their widespread utilization may present affordability challenges in low-and middle-income countries where healthcare financing is predominantly dependent upon out-of-pocket expenditure (Li et al., 2023).

The present study further demonstrated a progressive increase in treatment expenditure with increasing therapeutic complexity. Patients receiving monotherapy incurred comparatively lower costs, whereas those receiving dual, triple, quadruple, and insulin-containing regimens experienced substantially higher expenditures. These findings are in agreement with those reported by Nichols et al., who observed a direct relationship between therapeutic intensification and healthcare spending among patients with T2DM (Liu, 2009). Disease progression often necessitates multiple pharmacological agents to achieve adequate glycaemic control, inevitably increasing direct treatment costs and healthcare resource utilization (Marso et al., 2016).

New-generation antidiabetic agents, particularly DPP-4 inhibitors and SGLT2 inhibitors, emerged as major contributors to overall medication expenditure in the present study. Comparable findings have been reported in several international cost analyses, where SGLT2 inhibitors and incretin-based therapies were associated with significantly greater acquisition costs compared with traditional oral antidiabetic agents (Perkovic et al., 2019). However, emerging evidence suggests that these agents may provide long-term economic benefits through reduction of cardiovascular events, hospitalization rates, and progression of diabetic kidney disease (Piragine et al., 2023). Consequently, future pharmacoeconomic evaluations incorporating long-term outcome measures may be necessary to fully determine their cost-effectiveness within Indian healthcare settings.

The analysis of prescribing patterns revealed that generic prescribing was associated with substantially lower treatment costs than branded prescribing. This finding corroborates previous investigations demonstrating that generic substitution significantly

No major comorbidity ₹800-2200 reduces healthcare expenditure without compromising therapeutic efficacy or patient safety (Seuring et al., 2015). In countries with high out-of-pocket healthcare expenditure, increased utilization of generic medicines has been recognized as an effective strategy for improving treatment accessibility and adherence among economically disadvantaged populations (Woehl et al., 2008).

Another important observation of the present study was the marked increase in treatment costs among patients with diabetes-associated comorbidities, particularly chronic kidney disease and coronary artery disease. Similar observations were documented by Hex et al., who reported that diabetes-related complications represent the principal drivers of long-term healthcare expenditure (Yesudian et al., 2014). The coexistence of cardiovascular and renal complications frequently necessitates polypharmacy, specialist consultations, laboratory monitoring, and repeated hospital admissions, thereby substantially increasing direct medical costs (Zhang et al., 2010). These findings underscore the importance of early diagnosis, aggressive risk-factor modification, and prevention of complications as essential strategies for reducing long-term economic burden.

The annual treatment expenditure observed in the present study ranged from ₹2400-7200 for metformin monotherapy to ₹54,000-1,08,000 for insulin analogue-based therapy. Comparable cost ranges have been reported in pharmacoeconomic studies conducted across Asia and other developing regions, emphasizing the profound financial impact of advanced diabetes therapy on household healthcare expenditure. The increasing prevalence of diabetes, coupled with expanding utilization of newer therapeutic agents, is expected to further escalate healthcare costs in the coming decades, thereby necessitating implementation of cost-containment strategies and rational prescribing practices.

Overall, the findings of the present investigation highlight the substantial pharmacoeconomic burden associated with diabetes management and emphasize the importance of balancing clinical effectiveness with economic sustainability. Rational drug selection, evidence-based therapeutic intensification, promotion of generic prescribing, and prevention of diabetes-related complications remain critical components for optimizing both clinical and economic outcomes in patients with Type 2 Diabetes Mellitus.

apy to ₹54,000-1,08,000 for insulin analogue-based therapy.

CONCLUSION

The present pharmacoeconomic evaluation demonstrated that Type 2 Diabetes Mellitus imposes a substantial and progressively increasing economic burden on patients receiving treatment in a tertiary care healthcare setting. Treatment-related expenditure was strongly influenced by therapeutic complexity, utilization of insulin analogues, incorporation of newer antidiabetic agents, and the presence of diabetes-associated comorbidities. Metformin remained the most economically favourable therapeutic option, whereas insulin analogue-based regimens generated the highest treatment costs. Generic prescribing practices were associated with considerable cost savings when compared with branded formulations. Furthermore, patients with chronic kidney disease and coronary artery disease experienced significantly greater healthcare expenditures, highlighting the economic consequences of diabetes-related complications. The findings underscore the importance of rational prescribing, early glycaemic control, prevention of complications, and promotion of cost-effective therapeutic strategies to optimize both clinical outcomes and healthcare resource utilization. Integration of pharmacoeconomic principles into routine diabetes management may contribute substantially to improving treatment affordability and long-term healthcare sustainability.

SUMMARY

The present prospective observational pharmacoeconomic study evaluated the treatment-related economic burden of Type 2 Diabetes Mellitus among 400 patients receiving antidiabetic therapy in a tertiary care teaching hospital. The study assessed antidiabetic prescribing patterns, therapeutic complexity, insulin and fixed-dose combination utilization, generic versus branded prescribing, direct medication-related costs, and the influence of diabetes-associated comorbidities on treatment expenditure.

Substantial variation in treatment costs was observed across therapeutic classes and treatment regimens. Metformin was identified as the most economical commonly used antidiabetic medication, with an estimated monthly cost of ₹80-250. In contrast, insulin glargine represented the highest-cost individual medication, with an estimated monthly expenditure of ₹2,200-4,500. Treatment expenditure increased progressively with therapeutic intensification, ranging from ₹180-600 per month for monotherapy to ₹2,500-7,000 for insulin-based therapy. Annual treatment expenditure ranged from ₹2,400-7,200 for metformin monotherapy to ₹54,000-1,08,000 for insulin analogue-based therapy.

Generic prescribing was associated with lower treatment expenditure than branded prescribing. Patients with comorbid chronic kidney disease and coronary artery disease demonstrated the highest treatment-related costs. Newer antidiabetic agents, particularly DPP-4 and SGLT2 inhibitors, also contributed substantially to medication expenditure.

lin analogue utilization, newer antidiabetic medications, and diabetes-associated comorbidities. Promotion of generic pre- Overall, the findings demonstrate that diabetes management imposes a considerable and progressively increasing economic burden, largely influenced by therapeutic complexity, insu newer antidiabetic medications, and Promotion of generic prescribing, rational therapeutic selection, prevention of complications, and integration of pharmacoeconomic principles into routine diabetes care may improve treatment affordability and healthcare resource utilization.

ACKNOWLEDGEMENT

The authors express their sincere gratitude to the physicians, healthcare professionals, hospital administration, and study participants whose cooperation and support made this investigation possible.

ABBREVIATIONS

ADA

American Diabetes Association

CA

Coronary Artery Disease

CIMS

Current Index of Medical Specialities

GLP-1

Glucagon-Like Peptide-1

IDR

Indian Drug Review

INR

Indian Rupee

SPSS

Statistical Package for the Social Sciences

SGLT2

Sodium-Glucose Cotransporter-2

T2DM

Type 2 Diabetes Mellitus

WHO

World Health Organization.

CONFLICT OF INTEREST

The authors declare that there is no conflict of interest.

AUTHORS CONTRIBUTIONS

Dr. Syed Raziuddin Faisal: Contributed to the conception and design of the study, development of the study methodology, data collection, pharmacoeconomic assessment, data analysis and interpretation, and preparation of the manuscript. Dr. Shekar H. S.: Contributed to study supervision, methodological guidance, interpretation of findings, critical revision of the manuscript, and overall scientific oversight. Dr. B. Nagaraju: Contributed to study conceptualization, methodological review, interpretation of pharmacoeconomic findings, critical evaluation of the manuscript, and scientific guidance. All authors contributed to the preparation and critical revision of the manuscript, approved the final version, and agreed to be accountable for all aspects of the work.