Valutazione economica in base allo studio NAVoTRIAL01 con riferimento al contesto sanitario italiano: Vinorelbine orale e Cisplatino o Pemetrexed e Cisplatino seguiti da mantenimento rispettivamente con Vinorelbine orale e Pemetrexed nel trattamento del Carcinoma Polmonare Non a Piccole Cellule Non Squamoso (NS-NSCLC) in stadio avanzato

Background: Vinorelbine and Cisplatin is a standard treatment in non small cell lung cancer; oral Vinorelbine is registered in 45 countries. Pemetrexed and Cisplatin are recommended in front-line chemotherapy of non-squamous non small cell lung cancer (NS-NSCLC). An economic evaluation of oral Vinorelbine plus Cisplatin and Pemetrexed plus Cisplatin was implemented in NS-NSCLC patients, adopting specific costs and clinical settings reflecting the Italian practice. Materials and methods: A cost evaluation was conducted from the perspective of the Italian National Health Service, based on a randomized phase II study in NS-NSCLC (NAVoTRIAL01), with 100 oral Vinorelbine + Cisplatin patients (arm A) and 51 Pemetrexed + Cisplatin patients (arm B). Overall, Arm A/Arm B reported respectively: Disease Control Rate, including combination (4 cycles) and maintenance periods, of 75%/76.5%; median Progression Free and Overall Survival of 4.2/4.3 and 10.2/10.8 months. Costs considered in the analysis were for anti-cancer drugs, administration settings (i.e. out-patient/in-patient/at home), serious adverse events (defined as involving hospitalization and suspected to be due to anti-cancer drugs), concomitant medications, blood transfusions. Unit costs used for anti-cancer drugs were official ex-factory prices, with further percent deductions enforced by law. The distribution of administration settings was re-modelled according to the respective frequencies found for the subset of Italian patients participating in NAVoTRIAL01; for out/in-patient settings, DRG (Diagnosis-Related Group) and other tariffs (day-hospital or one day admission) were used (no cost was charged when administration was at home). Hospitalization costs were assessed for serious adverse events on the basis of appropriate DRG tariffs. For concomitant medications, prices were ex-factory or 50% of retail price. Blood transfusions were evaluated using public tariffs. Results: The average cost per patient for the overall treatment was €4,511 (of which: €1,763 for anti-cancer drugs, €1,801 for administration settings, and €611 for serious adverse events) in arm A; the respective costs were €14,793 (€13,615, €344, €567) in arm B. Conclusions: Given the reported efficacy outcomes with both regimens, oral Vinorelbine + Cisplatin followed by maintenance with oral Vinorelbine provides substantial savings (€10,282 per patient on average), appearing a cost-effective treatment option in advanced non-squamous non small cell lung cancer. Sensitivity analysis shows the robustness of the results, which should be confirmed by a phase III trial