L’oncologia mutazionale del carcinoma polmonare: marcatori molecolari, farmaci, condizioni negoziali ed esperienze in centri di riferimento nazionale

The gradual availability of genomic profiling tests and the "agnostic approvals" from FDA and EMA have opened the oncology mutational model phase, which complements and integrates the traditional hystological approach. The non-small-cell lung cancer (NSCLC) is characterized by many molecular alterations and represents the need of a change from the traditional diagnostic, therapeutic and organisational paradigms to the "mutational" ones. From the Italian National Healthcare System point of view, access and reimbursement of drugs based on the hystological model were managed thorugh the Italian Medicines Agency's (AIFA) monitoring registries and the managed entry agreements: risk-sharing, cost-sharing and payment by results. The Italian reference oncological centres, which contributed to this report with their experiences, have shown the heterogenous approach to the molecular diagnostics (included next generation system tests). Facing the high complexity of the mutational model, outcomes handling and genomic profiling tests access inevitably result different among centres. The activation of multidisciplinary groups for the government of clinical processes, appropriateness and economic sustainability are essential. The Molecular Tumor Board (MTB) allows the management of such complexity, the interpretation of genomic profiling outcomes and the choice of drugs that are alrealdy authorized by AIFA, off-label or still under investigation. Moreover, in order to guarantee the uniformity, the data traceability and the transparency of assessment reports, a network of MTB must be validated by AIFA through specific criteria. To date, the oncological centres presented by this report are undergoing the experimental phase of the national genomic operating system implementation and represent the starting point of the deep organisational changement to the mutational approach and of its real and appropriate integration into the daily clinical practice.