New analysis weighs survival benefits and costs of Imfinzi in small cell lung cancer

For patients with limited-stage small cell lung cancer (LS-SCLC), a disease long marked by poor outcomes and few treatment advances, immunotherapy has offered renewed hope. But a new analysis suggests that progress may come at a steep cost.

In a study published in December 2025 in JCO Global Oncology, researchers from Sylvester Comprehensive Cancer Center at the University of Miami report that Imfinzi (durvalumab), used as consolidation therapy after chemoradiation, significantly improves survival but is not cost-effective for most patients with LS-SCLC at current U.S. list prices. The incremental cost-effectiveness ratio (ICER) far exceeded commonly used willingness-to-pay thresholds, raising concerns about affordability and access.

“While durvalumab delivers meaningful survival benefits in limited-stage small cell lung cancer, our analysis highlights the need to align clinical innovation with cost-effectiveness to ensure sustainable adoption in the U.S. healthcare system,” said Chinmay Jani, M.D., the study’s lead author and Chief Fellow of Hematology and Oncology at Sylvester Comprehensive Cancer Center.

Small cell lung cancer accounts for roughly 15% of lung cancer cases and is linked to heavy smoking. For decades, limited-stage SCLC has been treated with chemotherapy and radiation, with only about 25% to 30% of patients surviving five years. In the ADRIATIC trial, the PD-L1 inhibitor Imfinzi improved (OS) and progression-free survival (PFS), leading to the FDA’s December 2024 decision to expand its indications to include limited-stage SCLC after chemoradiation.

Against that backdrop, the researchers set out to evaluate whether the survival gains seen in ADRIATIC justify the added costs. Using a partitioned survival model, they compared Imfinzi consolidation therapy with the standard of care across three health states (progression-free survival, disease progression and death) and calculated costs per quality-adjusted life year (QALY) gained.

The model showed that adding Imfinzi extended median OS to 66.1 months and PFS to 40.2 months, compared with 57.8 months and 31.8 months, respectively, for standard therapy. Total treatment costs were estimated at $163,722 for Imfinzi versus $25,816, resulting in an incremental cost of nearly $138,000. The resulting ICER was $383,069 per QALY, which is well above the $150,000 threshold commonly used in the United States.

One exception emerged. In patients whose disease progressed outside the chest, Imfinzi’s ICER fell to $151,137 per QALY, narrowly exceeding the threshold and suggesting potential value in a subset of patients.

In their paper, the authors note a persistent tension in oncology between therapies that improve survival and their growing economic burden. They found that, under current U.S. pricing, broad use of Imfinzi in LS-SCLC would likely worsen financial toxicity and could further limit access. At the same time, evolving federal drug price negotiation policies may eventually alter the equation. For now, the study suggests that while Imfinzi represents a clinical step forward, its cost may limit how far that progress can go.

“As immunotherapy reshapes the standard of care in limited-stage SCLC, integrating cost-effectiveness with clinical benefit will be critical to achieving both improved outcomes and affordability,” Jani stated.

In an accompanying editorial, Yuchen Li, M.D., M.P.H., and Fabio Ynoe de Moraes, M.D., Ph.D., MBA, of Queen’s University in Kingston, Ontario, note the difference between the ICER of $383,000 per QALY and the common willingness to pay threshold of $150,000. But they note that the analysis used U.S. list prices that are often much higher than the net prices paid by public and other payers after various discounting. Similarly, they note that the U.S. list prices are higher than the publicly posted prices in the United Kingdom and Canada.

Beyond the particulars of prices, Li and de Moraes comment that upfront expenditures on durvalumab — they used the generic, not the brand name — need to be seen in the context of averted cost for recurrent or metastatic SCLC, which they described as “resource-intensive, often involving hospitalizations, complex supportive care, and later-line therapies.” They added that “as the treatment landscape evolves, future evaluations should incorporate these downstream costs to provide a more complete estimate of long-term value.”

Li and de Moraes also mention steps that might be taken to make Imfinzi more affordable, especially in low- and middle-income countries where, they said, the annual cost of durvalumab may exceed a patient's lifetime earnings or an institution's entire oncology budget. For example, they note that some preliminary data support the use of lower doses and longer intervals between doses. Costs might also be lowered by regional pooled procurement, tiered pricing, outcomes-based contracts and nonprofit distribution models, they said. Such approaches have broadened access to vaccines and antiretroviral therapies and might be applicable to cancer immunotherapy.