Hypertension is a significant public health issue in India, with over 200 million adults affected and less than 10% achieving controlled blood pressure (BP). This lack of control contributes to a substantial burden of cardiovascular disease (CVD), resulting in approximately 1.6 million deaths annually and significant economic losses. To address this, large-scale hypertension control programs are crucial, and the adoption of drug and dose-specific treatment protocols, as recommended by the World Health Organization (WHO)-HEARTS Initiative, is considered key. These protocols provide standardized treatment pathways, facilitating simpler, scalable, and faster program implementation, improving treatment coverage and BP control by reducing clinical variability and therapeutic inertia. The India Hypertension Control Initiative (IHCI) has adopted such protocols. However, a financial assessment is necessary to guide public funding and policy decisions for sustainable implementation. This study aims to estimate the annual medication cost per patient for protocol-based hypertension treatment, comparing costs across different protocols and sectors in India.

Existing literature highlights the substantial global burden of hypertension and its associated CVD complications, especially in low- and middle-income countries (LMICs) like India. Studies show that a significant proportion of the hypertensive population remains undiagnosed, untreated, or uncontrolled, leading to premature mortality and substantial economic strain. The cost-effectiveness of implementing hypertension control strategies in LMICs has been a subject of various economic modeling studies, demonstrating the potential for significant returns on investment, especially through public sector interventions. However, evidence on cost-effectiveness specifically concerning standardized treatment protocols in LMICs, like those recommended by WHO-HEARTS, has been limited, leading to the need for this study.

This study estimated the annual medication cost of hypertension treatment using three WHO-HEARTS aligned protocols. Protocols 1 and 2 involved a five-step escalation using Amlodipine (CCB), Telmisartan (ARB), and Chlorthalidone (diuretic), differing in drug order. Protocol 3 utilized a four-step approach with an SPC of Amlodipine/Telmisartan, with Chlorthalidone added if necessary. Four scenarios of BP control assumptions, ranging from conservative to optimistic, were applied to each protocol. Drug costs were sourced from the private sector (including brand-name and generic drugs from Jan Aushadhi stores), and the public sector using data from the Ministry of Health and Family Welfare. An MS-Excel-based tool calculated the annual drug requirement per patient for each scenario and protocol. The annual medication cost was then calculated by multiplying the annual drug requirement by the respective cost per pill. This process determined the cost in the private sector (brand-name and generic drugs), and the public sector. The public sector cost represents the cost to the government, as patients receive medications for free.

The study found substantial variation in medication costs across sectors and protocols. In the private sector, the annual cost per patient ranged from $33.88 to $58.44 for protocols 1 and 2 and $51.57 to $68.83 for protocol 3. Using generic drugs from Jan Aushadhi stores significantly reduced the cost, to $5.78–$9.57 and $7.35–$9.89 respectively. The public sector demonstrated the lowest cost, ranging from $2.05 to $3.89 for protocols 1 and 2, and $2.94 to $3.98 for protocol 3. The total number of pills required per patient per year varied between 664-877 pills for protocols 1 and 2, and 365-493 pills for protocol 3. Using higher-dose tablets (Amlodipine 10 mg, Telmisartan 80 mg) could reduce the pill count but might complicate supply chains. Protocol 3's significantly lower pill requirement suggests that most patients may achieve BP control with a single daily tablet. These findings are detailed in Table 5 of the original paper.

The study's findings highlight the potential for cost-effective hypertension control in India using protocol-based approaches. The low medication costs in the public sector, less than $4 per patient annually, demonstrate its feasibility as a large-scale public health intervention. The considerable cost difference between private and public sectors emphasizes the need to increase public sector coverage and to improve affordability in the private sector. The comparable costs of SPC and non-SPC protocols in the public sector, coupled with the advantages of SPCs (simplified logistics, reduced pill burden, enhanced adherence), suggest that SPCs should be prioritized for public health programs. The study also underscores the potential of expanding access to low-cost generic drugs through networks like Jan Aushadhi to reduce out-of-pocket expenses for patients in the private sector.

This study provides a practical method for estimating medication costs for protocol-based hypertension management, highlighting the significant cost-effectiveness of public sector interventions. Expanding access to affordable generic medications and integrating SPCs into national essential medicines lists are crucial steps to enhance hypertension control efforts. Further research could explore the long-term cost-effectiveness of different protocols, including factors beyond medication costs (e.g., healthcare utilization, lost productivity) and evaluating the impact of various strategies to improve adherence.

The study's limitations include focusing on only three specific treatment protocols, although they align with WHO-HEARTS recommendations. The cost estimates are based on a specific time period and location, and costs may vary. The analysis only considers medication costs and does not incorporate other costs (e.g., diagnostic tests). Additionally, the study does not account for patients requiring treatment beyond the scope of the selected protocols. Protocol 1 and 2, using single-molecule drugs, might affect medication adherence compared to SPCs. Finally, the study relied on simulated BP control scenarios; real-world implementation may lead to different costs.