Can you explain the global disparities in access to new therapies for advanced Non-Small Cell Lung Cancer?

Access to new therapies for advanced non-small cell lung cancer (NSCLC) varies widely around the world. While countries like the U.S. have approved many targeted drugs and immunotherapies, patients in low- and middle-income countries often face delays or lack access entirely. The main drivers of these disparities include regulatory approval timelines, high drug costs, limited genetic testing, and weak healthcare infrastructure.

What the research says

New therapies for advanced NSCLC include immune checkpoint inhibitors (ICIs) like nivolumab and pembrolizumab, as well as targeted drugs for specific mutations. For example, the FDA has approved nivolumab (OPDIVO QVANTIG) for several advanced cancers, including NSCLC, and lazertinib with amivantamab for EGFR-mutant NSCLC ²⁵. Pembrolizumab is a standard first-line treatment for advanced NSCLC with high PD-L1 expression ⁸. However, these approvals are primarily in the U.S. and other high-income countries. In many regions, these drugs may not be approved or may take years to become available.

Even when drugs are approved, cost is a major barrier. ICIs and targeted therapies are expensive, and not all healthcare systems cover them. A 2024 meta-analysis found that pembrolizumab monotherapy for advanced NSCLC with PD-L1 ≥50% had a pooled mean overall survival of 21.0 months, but real-world access depends on insurance and national health policies ⁸. Similarly, the combination of lazertinib and amivantamab for EGFR-mutant NSCLC is a significant advance, but its high price limits use in lower-resource settings ⁵.

Another key disparity is in genetic testing. Targeted therapies require identifying specific mutations, such as EGFR exon 19 deletions or MET exon 14 skipping mutations ³⁵. In many countries, access to next-generation sequencing or even basic PCR testing is limited, meaning patients may never know if they are eligible for these drugs. Without testing, effective treatments are missed.

Healthcare infrastructure also matters. Administering ICIs requires trained staff and monitoring for side effects. A meta-analysis of real-world pembrolizumab use found that 52% of patients experienced any-grade adverse events, and 12% had grade ≥3 events ⁸. Managing these complications is challenging in settings with limited hospital resources. Additionally, timing of ICI administration may affect outcomes; a meta-analysis suggested that early time-of-day administration improves survival, but this requires consistent scheduling that may not be feasible everywhere ⁶.

What to ask your doctor

• What new therapies for advanced NSCLC are approved in my country, and are they covered by my insurance or national health system?
• Is genetic testing (for EGFR, MET, PD-L1, and other markers) available and affordable for me?
• Are there patient assistance programs or clinical trials that could help me access newer treatments?
• How do the costs and benefits of immunotherapy versus targeted therapy compare for my specific cancer type?
• What is the expected wait time for approval or reimbursement of new drugs in my region?