Economic modelling to inform pricing for LMICs of immune checkpoint inhibitors in advanced PD-L1-high non-small cell lung cancer.

1518 Background: Lung cancer is the most common cancer and cause of cancer death, encompassing for 16.8% of all cancer-related deaths worldwide. Anti-PD(L)1 Immune Checkpoint Inhibitors (ICIs) as monotherapy currently represent the standard of care (SoC) for advanced Non-Small Cell Lung Cancer with high (≥50%) PD-L1 expression in high-income countries. Despite their efficacy, ICIs remain largely inaccessible in low- and middle-income countries (LMICs), with affordability being a significant barrier. Providing evidence on cost-effective (CE) price ranges for ICIs in LMICs is critical for global health policymakers to devise strategies to enhance access. Methods: A partitioned-survival model was used to estimate CE price targets for three ICIs (atezolizumab, cemiplimab, and pembrolizumab) as single agents compared to platinum-based combination chemotherapy (current SoC in several LMICs). Treatment duration was assumed of up to 35 cycles or until disease progression. Cost-effectiveness thresholds were set at 1, 2, and 3 times the gross domestic product (GDP) per capita per quality-adjusted life year (QALY) gained. Case studies were modelled in two LMICs (India and South Africa – not all ICIs were registered in both countries) to determine the maximum price at which ICIs would be CE from the perspective of publicly-funded health systems. Primary efficacy data were sourced from phase III clinical trials (KEYNOTE-024, IMpower110, and EMPOWER-Lung 1), and country-specific data were collected through interviews with key technical stakeholders. Values were reported in USD for 2023. Results: The analysis determined that the maximum acquisition costs for ICIs to be cost-effective at 1-, 2-, and 3-times GDP per capita in India and South Africa, range from $14.20 to $648.00 per cycle per patient. Current reference prices would require discounts of up to 93.3% to meet the 3 GDP threshold. Dose-optimization strategies such as low-dose and vial sharing were identified as feasible and evidence-based approaches to achieve partial price reduction (sensitivity analysis will be provided). Conclusions: To make ICIs cost-effective in LMICs, significant discounts from current reference prices are needed. Similar price reductions (up 93%) have been achieved for other monoclonal antibodies, such as trastuzumab, in India and South Africa, also driven by the availability and uptake of quality-assured biosimilars. A comprehensive approach, combining accelerated biosimilar availability, also leveraging voluntary licensing and technology transfer, with dose and treatment-duration optimization strategies could help achieve target price levels and improve accessibility. Country WTP threshold (xGDP) Pembrolizumab Atezolizumab Cemiplimab India 1 $72.6 $74.2 $66.5 2 $199.7 $166.9 $181.5 3 $308.6 $259.6 $300.0 South Africa 1 $51.5 $53.1 $14.2 2 $349.9 $289.0 $314.7 3 $648.2 $525.0 $615.2