Financial implications of protocol-based hypertension treatment: an insight into medication costs in public and private health sectors in India

In India, over 200 million adults have hypertension, yet fewer than 10% have controlled blood pressure. Uncontrolled blood pressure is a major cardiovascular disease (CVD) risk factor, contributing to approximately 1.6 million deaths annually, primarily from ischemic heart disease and stroke. The World Economic Forum estimated over $2 trillion in CVD-related economic losses in India between 2012 and 2030. Scaling up public health programs with standardized, drug- and dose-specific hypertension treatment protocols (as recommended in WHO-HEARTS) is critical for simplifying care pathways, decentralizing hypertension management to primary care, reducing clinical variability and therapeutic inertia, and improving coverage and control. The India Hypertension Control Initiative (IHCI) has adopted such protocols. This study aims to estimate the annual medication cost per patient of protocol-based hypertension treatment, and to compare alternative protocols across public and private sectors in India to inform funding and policy decisions for improving access to affordable antihypertensive medicines.

The paper references prior evidence that hypertension control strategies in LMICs are cost-effective, largely due to low medication costs in public sectors. WHO estimated per capita costs for population-based NCD interventions under $1–1.5 in low- and middle-income settings and annual multidrug hypertension regimen costs of roughly $70–84 per treated high-risk patient, though estimates vary by data source and context. Evidence gaps remain on program elements affecting cost-effectiveness, including standardized treatment protocols. Studies advocate for improving access to affordable cardiovascular medicines via generics, reliable sourcing, and minimizing supply chain margins. Fixed-dose combinations (single-pill combinations, SPCs) are recommended to improve adherence and BP control and are listed on WHO’s Essential Medicines List, but antihypertensive SPCs are not yet on India’s National EML, limiting public sector availability. Price control policies can affect affordability and market participation, requiring balanced implementation.

Design: Cost simulation of annual antihypertensive medication per patient under three WHO-HEARTS-aligned treatment protocols using multiple control-rate scenarios, priced across public procurement, private branded, and private generic (Jan Aushadhi) sources in India. Protocols: All include a calcium channel blocker (CCB), an angiotensin receptor blocker (ARB), and a diuretic. - Protocol 1 (AATTC, five steps): Step 1 Amlodipine 5 mg; Step 2 Amlodipine 10 mg; Step 3 add Telmisartan 40 mg; Step 4 Telmisartan 80 mg; Step 5 add Chlorthalidone 12.5 mg. - Protocol 2 (ATTAC, five steps): Step 1 Amlodipine 5 mg; Step 2 add Telmisartan 40 mg; Step 3 Telmisartan 80 mg; Step 4 Amlodipine 10 mg; Step 5 add Chlorthalidone 12.5 mg. - Protocol 3 (SPC, four steps): Single-pill combination Amlodipine 5 mg + Telmisartan 40 mg: Step 1 half tablet; Step 2 one tablet; Step 3 two tablets; Step 4 add Chlorthalidone 12.5 mg. Control-rate scenarios: For each protocol, four step-wise distributions of patients across steps reflecting BP control probabilities (summing to 100%). For Protocols 1 and 2: Scenario 1: 30:30:20:10:10; Scenario 2: 40:25:15:10:10; Scenario 3: 50:20:15:10:5; Scenario 4: 60:15:13:7:5. For Protocol 3 (four steps): Scenario 1: 30:30:30:10; Scenario 2: 40:25:25:10; Scenario 3: 50:20:25:5; Scenario 4: 60:15:20:5. Computation of drug requirements: Monthly (30-day) pill requirements per 100 patients calculated via a matrix applying the step-wise distributions to the medication regimen at each step. Example provided for Protocol 1, Scenario 1: aggregate monthly pills of Amlodipine 5 mg, Telmisartan 40 mg, and Chlorthalidone 12.5 mg across steps; then converted to average monthly per patient and annualized. Pricing data sources: Private sector median prices for most-prescribed brands (2019–2020 INR) from prior study; Jan Aushadhi generic retail prices (accessed July 2021); public procurement prices from the Ministry of Health and Family Welfare Drug and Vaccine Delivery Management System central dashboard. Price per pill (INR): Amlodipine 5 mg: private 2.8, Jan Aushadhi 0.5, public 0.14; Telmisartan 40 mg: private 7.19, Jan Aushadhi 1.1, public 0.5; Chlorthalidone 12.5 mg: private 5.79, Jan Aushadhi 1.3, public 0.7; SPC Amlodipine 5 mg + Telmisartan 40 mg: private 10.7, Jan Aushadhi 1.5, public 0.59. Costing approach: Annual cost per patient = (annual pills of Amlodipine × price per pill) + (annual pills of Telmisartan × price per pill) + (annual pills of Chlorthalidone × price per pill). For SPC protocol, SPC pill counts priced accordingly plus Chlorthalidone where indicated. Exchange rate: 1 USD = 74 INR. Outputs produced for private branded, private low-cost generic (Jan Aushadhi), and public sector procurement (cost to government; patients receive free in public sector).

- Price per pill (INR): Amlodipine 5 mg: private 2.8; Jan Aushadhi 0.5; public 0.14. Telmisartan 40 mg: private 7.19; Jan Aushadhi 1.1; public 0.5. Chlorthalidone 12.5 mg: private 5.79; Jan Aushadhi 1.3; public 0.7. SPC Amlodipine 5 mg + Telmisartan 40 mg: private 10.7; Jan Aushadhi 1.5; public 0.59. - Annual pill requirements per patient: • Protocols 1 and 2 (single-molecule): total 664–877 pills/year across scenarios; could be reduced to 530–657 pills if higher-strength single tablets (Amlodipine 10 mg, Telmisartan 80 mg) are used at maximum doses. • Protocol 3 (SPC): total 365–493 pills/year across scenarios, indicating many patients may achieve control with one tablet/day. - Annual medication cost per patient (USD; 1 USD = 74 INR): • Private sector: Protocols 1 and 2: $33.88–58.44; Protocol 3 (SPC): $51.57–68.83. • Private low-cost generic (Jan Aushadhi): Protocols 1 and 2: $5.78–9.57; Protocol 3: $7.35–9.89. • Public sector procurement (cost to government; patients free): Protocols 1 and 2: $2.05–3.89; Protocol 3: $2.94–3.98. - Programmatic implication: Protocol-based treatment in the public sector can cost under $4 per patient per year; expanding generic retail networks substantially lowers private sector costs. SPC costs are comparable to non-SPC protocols in the public sector while simplifying logistics and potentially improving adherence and BP control.

The study addresses the central question of the cost of protocol-based hypertension treatment in India by demonstrating that standardized WHO-HEARTS-aligned protocols can be delivered at very low medication cost when procured publicly, supporting large-scale program expansion. Public procurement achieves per-patient annual costs that are less than one-fifteenth of private branded costs, reinforcing the value of centralized tendering and generic sourcing. Compared with previous global estimates, these costs are notably lower, highlighting contextual advantages in India’s public sector procurement and generics markets. Adoption of SPC-based protocols in public programs can yield comparable costs to single-molecule pathways, while offering operational benefits—reduced pill burden, simplified supply chains, improved adherence, and faster BP control. Inclusion of antihypertensive SPCs in the National Essential Medicines List would facilitate broader public sector availability. In the private sector, SPCs are approximately 25% costlier than single-molecule regimens; judicious price control, especially for SPCs whose components are already price-controlled, may enhance affordability without discouraging market participation. Expanding generic retail options (e.g., Jan Aushadhi) can reduce out-of-pocket expenditures by up to 80%, offering an immediate pathway to improve affordability outside the public sector.

Standardized drug–dose-specific treatment protocols enable cost-effective hypertension control at scale in India. With public sector procurement, annual medication costs can be under $4 per patient, supporting decentralization to primary care and averting CVD complications. The approach provides a practical framework for estimating medication budgets to inform protocol selection and resource allocation for national hypertension programs. Policymakers should expand public sector coverage, strengthen generic procurement and distribution, consider inclusion of antihypertensive SPCs in the National EML, and enhance access to low-cost generics in private markets to improve affordability and outcomes.

- Only three WHO-HEARTS-aligned protocols were evaluated; other protocols may have different costs. - Cost structures and prices may vary across settings; however, the methodology is generalizable to other LMICs. - Some patients may require treatment beyond the selected protocols; costs of advanced regimens were not included. - Analysis is limited to medication costs and excludes costs of investigations and other services. - Protocols 1 and 2 use single-molecule drugs, which may affect adherence; SPCs (Protocol 3) may improve adherence and mitigate clinical inertia. Wide-ranging control scenarios were simulated to bound cost estimates.