OBJECTIVES: Chimeric antigen receptor T-cell therapy (CAR T-cell therapy) has been approved in Europe since August 2018, for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and B-cell acute lymphoblastic leukaemia (B-ALL). We aimed to understand whether CAR T-cell therapy was considered a priority from a reimbursement perspective across Europe.

METHODS: We reviewed the reimbursement status of tisagenlecleucel and axicabtagene ciloleucel across the 30 EEA countries and Switzerland as of June 2020, and analysed the reimbursement lag for these therapies versus the “time to availability” range for oncology and orphan drugs per country, as reported in the EFPIA Patient WAIT Indicator 2019 Survey. We also analysed the list price and GDP per capita in each country, to identify potential impact on reimbursement.

RESULTS: Reimbursement status was available for 20 countries, of which pricing information was available for 17. The median time from regulatory approval to reimbursement of CAR T-cell therapy (in B-ALL or DLBCL, whichever was earliest) was 7.5 months (range 1-22 months). When analysed versus the time to availability for oncology and orphan drugs, access was granted earlier than expected for B-ALL in 60% of countries (median 8 vs 12 months) and for DLBCL in 40% of countries (median 10 vs 15 months). While list price was aligned across Europe, four countries granted reimbursement earlier than expected in both B-ALL and DLBCL despite lower than average GDP per capita (Spain, Greece, Czechia, Croatia). In opposite, three countries took longer than expected or still have not reimbursed CAR T-cell therapy despite a higher than average GDP per capita (Denmark, Ireland, Switzerland).

CONCLUSIONS: Despite wide variability across European countries, overall CAR T-cell therapy reimbursement was granted earlier or in line with expected timelines, suggesting a consensus on the perceived added value brought by CAR T-cell therapy in addressing treatment unmet needs.