Garcia de Albeniz X, Riera Guardia N, Gutierrez L, Bahmanyar S, Blin P, Droz C, Heinig M, Linder M, Moore N, Schulze-Rath R, Sultana J, Trifiro G, Zhang WW, Zong J. Feasibility of studying the use of tissue-agnostic cancer drugs in population-based European health databases. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.

BACKGROUND: Tissue-agnostic cancer drugs, indicated based on tumour biology rather than its anatomic origin, represent a state of the art in cancer therapeutics. Larotrectinib is an oral inhibitor of three kinases (TRKA, TRKB, TRKC) active in several tumours. Larotrectinib is approved by the US FDA and by the EMA as monotherapy in patients with solid tumours that have an NTRK gene fusion without an acquired resistant mutation, that are metastatic, or where surgical resection is likely to result in severe morbidity, or that have no satisfactory alternative treatment options or that have progressed following treatment.

OBJECTIVES: To assess the feasibility of conducting a drug utilisation study of larotrectinib using various European data sources.

METHODS: We developed a feasibility assessment form with questions targeted to assess the data availability on expected use of larotrectinib and other cancer drugs, tumour diagnosis and its status when a drug is started, and biomarker testing, specifically NTRK fusion and tests results. Researchers from seven European databases contributed; we present the results from six: German Pharmacoepidemiological Research Database (GePaRD), Swedish National Health Registers (SNHR), Norwegian Health Databases and Registers (NHDR), System National de Données de Santé (SNDS), Italian Health Databases of Caserta/Palermo (IHD), and Public Health England (PHE).

All databases allow a characterization of demographics, comorbidities, and health care utilization, as well as oral cancer drugs dispensed by ambulatory pharmacies. Full information on oral cancer drugs dispensed by a hospital pharmacy (likely for larotrectinib) is available in all except SNDS and GePaRD. For SNDS only, data of new expensive cancer drugs are available, while in GePaRD, the information available is the administration of a drug in a hospital. No database contains information on specific genetic tests or their results, except for PHE. PHE has information on the most common tests run for somatic genetic alterations, as well as a field (“other”) for less common tests. Except for IHD, all databases are linkable to cancer registries, although due to data protection laws involving a burdensome effort, linkage in GePaRD may not be feasible.

CONCLUSIONS: Only PHE contains all elements to evaluate the use of larotrectinib in routine practice. Nevertheless, PHE recency, a lag time up to 5 years for 100% completeness, and the lack of published research on cancer with genetic alterations should be considered. The custodians of the rest of the databases are not aware of plans to add tumour genetic information.

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