Health Policy

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JCR分区 ▼
Yulia Litvinova ; Yulia Litvinova ; Sherry Merkur ; Sara Allin ; Ester Angulo-Pueyo ; Daiga Behmane ; Enrique Bernal-Delgado ; Miriam Dalmas ; Antonio De Belvis ; Nigel Edwards ; Francisco Estupiñán-Romero ; Peter Gaal ; Sophie Gerkens ; Margaret Jamieson ; Alisha Morsella ; Dario Picecchi ; Hilde Røshol ; Ingrid Sperre Saunes ; Terry Sullivan ; Balázs Szécsényi-Nagy ; Inneke Van De Vijver ; Dimitra Panteli

亮点

  • Availability of CAR-T cell therapies varies across countries, reflecting heterogeneity in organization and financing of oncology care.
  • Financing relies on management entry agreements through public reimbursement and special funds.
  • Eligibility criteria, affordability, and the availability and location of treatment centres are linked to equity concerns.
  • The concentrated provision of treatment requires improved referral and networking capacities.
  • Development of CAR-T therapies via hospital exemption can enhance accessibility, but authorisation limitations exist.

摘要

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.

Chimeric antigen receptor (CAR) T-cell therapies; Advanced Therapy Medicinal Products (ATMPs); Cancer, Pharmaceutical policy; Oncology care

10.5

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