OBJECTIVES:

This study investigated the impact of time to reimbursement of drug treatments for non-small cell lung cancer (NSCLC) on life-years (LYs) and quality-adjusted life-years (QALYs) in patients in Europe and Latin America (LatAm).

METHODS:

The time delay for marketing authorization and reimbursement was estimated by comparing the time between US FDA approval for a market basket of NSCLC products (nivolumab, pembrolizumab, critozinib, ceritinib, gefitinib, erlotinib, and afatinib) and the dates of marketing authorization and reimbursement by public payers in five European (EU5: United Kingdom, France, Germany, Spain, Italy) and four LatAm (Mexico, Colombia, Argentina, Brazil) countries. A cost-utility model consisting of three health states (progression-free survival (PFS), progressive disease, death) was used to estimate LYs and QALYs for each product and existing standard of care (SoC). Transition probabilities were estimated from median PFS and overall survival (OS) data from products’ respective FDA labels. NSCLC incidence rates and health state utilities were sourced from health technology assessment reports. Population-level LYs and QALYs were calculated by multiplying country-level NSCLC incidence by the estimated per-patient LYs and QALYs lost due to lack of reimbursement of each product in each geography.

RESULTS:

The median time to access in the EU5 for the NSCLC market basket was 278 days; no product was reimbursed in LatAm according to publicly available sources. The product associated with the largest amount of LYs and QALYs lost was nivolumab (1,806 and 901, respectively), due to lack of reimbursement in the UK and LatAM. Despite LatAm having fewer total NSCLC patients than the EU5 (~25k vs. ~40k), population-level LYs and QALYs lost were greater (LYs: 2,425 vs. 985; QALYs: 1,719 vs. 813).

CONCLUSIONS:

Slower access to innovative medicines has a significant impact on population-level patient outcomes across the EU and LatAm, highlighting the need to accelerate access to novel therapies in NSCLC.