HEADS UP

Rationale: Pembrolizumab has two HNSCC indication approved by EMA (KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic and/or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumors express PD-L1 with a CPS ≥ 1; KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic HNSCC in adults whose tumors express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy). Czech reimbursement submission for Keytruda 1L HNSCC is currently under preparation and planned to be submitted Q4 2020 (awaiting NICE recommendation – Q3 2020). In the Czech Republic the HTA process takes approximately 15 to 20 months in total, so as soon as data from LDG is available it will serve as supporting RWE data to Sick Funds/HTA agency. At the time of the LDG results availability the reimbursement submission will be still running, and new evidence could be submitted and accepted into submission.
Primary Objectives: To explore treatment patterns by line of therapy, including type of treatment and treatment duration in R/M head and neck cancer patients (distant metastatic stage IVc and/or unresectable recurrent) with treatment initiation between January 2016 and October 2018 in high volume centers in the Czech Republic.
Study Design: Retrospective, observational data collection