OBJECTIVES: The promising CAR-T therapies are gaining reimbursement in most EU countries. The objective of this study is to identify the framework under which big five EU countries (Germany, France, UK, Spain and Italy) reimbursed those therapies, compare it with the current Greek system, and propose an appropriate reimbursement scheme for those therapies that are still under Health Technology Assessment process in Greece.

METHODS: A systematic search of the literature was performed based on published literature from 2018 to June 2020, using multiple databases (Cochrane, MEDLINE, Google Scholar). Researchers used a combination of terms like tisangeleucel, Kymriah, axicabtagene ciloleucel, Yescarta, CAR-T, gene, cell, reimbursement, managed entry agreements, Germany, France, UK, Spain, Italy and others.

RESULTS: The literature screening identified 19 articles, of these, 14 were excluded as non relevant thus concluding with a review of 5 articles. The available studies revealed that in the respective 5 countries both CAR-T treatments have granted reimbursement under specific outcome-based schemes. In France and UK, re-assessment was based on longer term follow up data from pivotal trials and real world evidence data from French and UK patients respectively. In Germany, Italy and Spain, outcome based agreement was associated with survival as the outcome of scope and payment based on specific installments, two for Spain and three for Italy. In Greece outcome based agreements have not yet been implemented by the Greek Negotiation Committee but based on the example of the big 5 European countries, outcomes based agreement seems to be the most appropriate reimbursement scheme.

CONCLUSIONS: Greece needs to follow the example of big EU5 countries and update its current reimbursement system, by allowing more sophisticated price-volume and outcome-based agreements by the use of registries and real world evidence especially in the case of high cost and high value CAR-T therapies.