OBJECTIVES: In a challenging scenario in terms of evidence requirements for HTA assessments, an integrated approach on Real Word Evidence (RWE) generation allows value and data-driven discussions that results in products value recognition. In 2017, following Italian Medicine Agency (AIFA) request to renegotiate Erlotinib, we started the analysis on the AIFA National Registries to support the product’s value through RWE.

METHODS: The analysis is based on aggregated data of patients from the registry related to patients treated with Erlotinib respectively for first line NSCLC EGFR mutated (6.695) and second line wild-type (378), indications reimbursed by the NHS. The period examined is from January 2013 to June 2015, since after June 2015 the registries of first and second lines were unified no longer allowing an analysis by line of treatment. For the evaluation of the efficacy of Erlotinib in terms of average treatment duration, the average number of dispensations given for each patient treated with Erlotinib was used as a proxy, normalizing it for the duration of the single cycle (30 days) and assuming a 100% compliance.

RESULTS: The real life population treated with Erlotinib respectively for the 1L and 2L is elderly than the population enrolled in the pivotal trials (68 vs 58; 67 vs 62). Despite this, the duration of treatment shown in real life is higher for 1L (11.4 vs 8.2 months) and aligned for 2L compared to the pivotal trial

CONCLUSIONS: This is an approach of RWE generation that can be successfully implemented with payers in the context of an HTA process and we hope that a greater access to Real Word Data will be granted.