RESUMEN
Chimeric antigen receptor T-cell therapies (CAR-T therapies) are a type of advanced therapy medicinal product (ATMP) that belong to a new generation of personalised cancer immunotherapies. This paper compares the approval, availability and financing of CAR-T cell therapies in ten countries. It also examines the implementation of this type of ATMP within the health care system, describing the organizational elements of CAR-T therapy delivery and the challenges of ensuring equitable access to all those in need, taking a more systems-oriented view. It finds that the availability of CAR-T therapies varies across countries, reflecting the heterogeneity in the organization and financing of specialised care, particularly oncology care. Countries have been cautious in designing reimbursement models for CAR-T cell therapies, establishing limited managed entry arrangements under public payers, either based on outcomes or as an evidence development scheme to allow for the study of real-world therapeutic efficacy. The delivery model of CAR-T therapies is concentrated around existing experienced cancer centres and highlights the need for high networking and referral capacity. Some countries have transparent and systematic eligibility criteria to help ensure more equitable access to therapies. Overall, as with other pharmaceuticals, there is limited transparency in pricing, eligibility criteria and budgeting decisions in this therapeutic area.
RESUMEN
Growing evidences are showing the potential indirect effects of COVID-19 on the health systems of low-resource settings, where diseases such as Tuberculosis, HIV and Malaria represent major killers. Therefore, we performed a retrospective study aimed to evaluate the impact of COVID-19 on Malaria programs in a peripheral region of Sierra Leone, previously involved by the Ebola outbreak in 2015, when malaria care have been impaired since local health systems were overwhelmed by Ebola cases. During COVID-19 in Sierra Leone, we did not notice a drop in malaria diagnosis in children, suggesting that a proactive approach in the management of malaria in endemic countries during COVID-19 may have had a positive impact. A comprehensive approach that include also educational activities to sensitize the local population, was useful to guarantee successful malaria diagnosis and treatment, and prevents excess of malaria deaths due to potential disruption of the local health systems related to the SARS-CoV-2 pandemic. Contribution to the fieldwe performed a retrospective study aimed to evaluate the impact of COVID-19 on Malaria programs in a peripheral region of Sierra Leone, previously involved by the Ebola outbreak in 2015, when malaria care have been impaired since local health systems were overwhelmed by Ebola cases. During COVID-19 in Sierra Leone, we did not notice a significant change in the middle term period in malaria diagnosis in children, suggesting that a proactive approach in the management of malaria in endemic countries during COVID-19 may have had a positive impact. A comprehensive approach that include also educational activities to sensitize the local population, was useful to guarantee successful malaria diagnosis and treatment, and prevents excess of malaria deaths due to potential disruption of the local health systems related to the SARS-CoV-2 pandemic. Funding statementnothing to declare Ethics statementsO_ST_ABSStudies involving animal subjectsC_ST_ABSGenerated Statement: No animal studies are presented in this manuscript. Studies involving human subjectsGenerated Statement: The studies involving human participants were reviewed and approved by Bureh Town Community Hospital. Written informed consent to participate in this study was provided by the participants legal guardian/next of kin. Inclusion of identifiable human dataGenerated Statement: No potentially identifiable human images or data is presented in this study. Data availability statementGenerated Statement: The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.