OBJECTIVES: To assess the cost-effectiveness of nivolumab + PDC as treatment for resectable non-metastatic NSCLC (nmNSCLC) among patients who meet the criteria of the approved indication (PD-L1 expression ≥ 1% and Stage II-IIIA resectable nmNSCLC based on 7th TNM AJCC edition) relative to other options for managing this disease in Slovenia. To meet this objective, a global health economic model was adapted to Slovenian settings.

METHODS: A three-state Markov model was used with following modelled health states: event free, progressive disease, and death. The modelled population and key clinical inputs were based on the second interim analysis of the CheckMate-816 trial PD-L1 expression ≥ 1% subgroup. Comparators considered were neoadjuvant PDC, neoadjuvant chemoradiation, surgery alone, and adjuvant PDC. The model considered costs of treatment acquisition and administration, surgery, treatment adverse events, medical resource use and terminal care. The analysis was performed from the perspective of the payer The Health Insurance Institute of Slovenia, the analysis period is lifetime, the discount rate for costs and benefits is 3.5%.

RESULTS: The results of the analysis are presented as the ratio between incremental costs and outcomes of treatment, which is calculated in terms of quality-adjusted-life-years gained. The neoadjuvant treatment with nivolumab in combination with PDC is more effective, but also more expensive than neoadjuvant PDC, surgery alone or adjuvant PDC, with incremental cost effectiveness ratios (ICERs) of 5.568 EUR/QALY, 8.067 EUR/QALY and 7.534 EUR/QALY, respectively.

CONCLUSIONS: The new neoadjuvant therapy with nivolumab for the treatment of patients with nmNSCLC is cost effective according to the Slovenian cost-effectiveness threshold set at 25.000 EUR/QALYG and represents a new standard of care for patients with resectable nmNSCLC.