Nationwide Insights on Immunotherapy in a Low- and Middle-Income Country: Armenia's Struggle for Equitable Cancer Care in an Out-of-Pocket System.

Abstract

Purpose: In Armenia, a lower-middle-income country, cancer causes 21% of all deaths, with over half of cases diagnosed at advanced stages. Without universal health insurance, patients rely on out-of-pocket payments or black-market channels for costly immunotherapies, underscoring the need for real-world data to inform equitable policy reforms.

Methods: We conducted a multicenter, retrospective cohort study of patients who received at least one dose of an immune checkpoint inhibitor (ICI) between January 2017 and December 2023 across six Armenian oncology centers. Eligible patients had histologically confirmed malignancy and ≥6 months of follow-up. Demographic, clinical, biomarker, and treatment data were extracted from records. Overall survival (OS) was estimated by the Kaplan-Meier method; log-rank tests and Cox models evaluated associations. A 6-month landmark analysis adjusted for immortal time bias.

Results: Of the 585 patients screened, 373 met inclusion criteria (67% male; median age, 61 years); 68% had stage IV disease. The median OS was 31 months. Liver metastases predicted poorer survival (19 v 26 months, P = .027). Nonsmokers had better OS than smokers (31 v 24 months, P = .019). High PD-L1 expression (≥50%) was associated with improved OS (40 v 16 months, P = .025). Receiving >6 ICI cycles conferred longer OS (45 v 23 months, P < .001), although not significant in landmark analysis (P = .64). Financial hardship and disease progression were key reasons for early discontinuation.

Conclusion: Immunotherapy shows promise in Armenia despite financial barriers. Drawing on models from India and China, pooled procurement, negotiated pricing, and partial reimbursement, Armenia could expand biomarker testing, reduce drug costs, and implement tiered insurance. These steps are vital to optimize access and outcomes in this resource-limited setting.