Novartis - Taf + Mek external control analysis (BRAF V600E NSCLC), from Flatiron Health's RWE case studies (ResearchX Episode 5)

Novartis received a negative HTA reimbursement decision in Canada in 2017 for Taf + Mek despite FDA approval, for a rare BRAF V600E-mutated NSCLC population (about 160 patients/year in Canada). Using Flatiron's Enhanced Data Mart, Novartis first ran an external control analysis comparing trial patients to real-world standard-of-care patients, then a real-world-vs-real-world comparison with propensity score weighting. This produced comparative-effectiveness evidence showing superiority over platinum-based chemotherapy and immunotherapy, and Canada issued a positive HTA recommendation in 2021.

Flatiron Health is a Roche-owned company supplying EHR-derived oncology real-world data, captured at the source through its own OncoEMR software.

This sits in the Data Providers stage of the AI use-case lifecycle: Named examples from the real-world-data, claims and competitive-intelligence providers pharma AI systems are trained on, benchmarked against, or run inside of.