CREATIC ATMP newsletter

Challenges and Opportunities in Expanding CAR T-Cell Therapy Access in Czechia

PharmDr. Zora Čechová, Ph.D. Regulatory Specialist, MUNI | CREATIC

CAR T-cell therapies have revolutionised the treatment of haematological malignancies since their introduction to the market in 2018. Czechia is at the forefront of adopting these innovative treatments in Central and Eastern Europe, with three out of six authorised CAR T-cell therapies already available to patients. The other two therapies, Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel) have had their maximum prices determined and are nearing rollout. However, this progress also introduces significant challenges, especially with regard to multiple myeloma treatment with Abecma.

Despite substantial advancements, multiple myeloma remains an incurable disease with increasing incidence and prevalence. Approximately 550 new cases are diagnosed annually in Czechia. While advances in therapy have extended survival, most patients relapse and require subsequent treatment lines, driving demand for Abecma as a third-line treatment. The estimates approach one hundred patients per year.

Several bottlenecks remain in delivering this highly personalised treatment to patients who need it, starting with the complex, patient-specific manufacturing process, which requires careful coordination to ensure the timely availability of manufacturing slots. Additionally, although there are nine specialized centres certified to administer CAR T-cell products in Czechia, these facilities may still face personnel and capacity constraints as the number of eligible patients continues to grow.

Pricing and reimbursement procedures present another significant challenge. Although the State Institute of Drug Control has determined the maximum price for Abecma, a formal reimbursement procedure, including health technology assessment, is not required for medicinal products administered solely in inpatient settings. These products, including CAR T-cell, are available to Czech patients within all EMA-approved indications, they are fully covered by public health insurance, and patients do not contribute to their financing. However, this might not be sufficient to cover the full financing from payers to healthcare providers, as it is secured only up to the limit calculated based on the year before last. Therefore, budget planning does not account for unexpected increases in demand for new treatment options, such as Abecma for treating multiple myeloma patients. Further, as the high cost of CAR T-cell treatments adds pressure to the healthcare budget, to mitigate the financial burden, arrangements between manufacturers and payers are essential. So far, the only type of agreement used to limit the budget impact of ATMPs is price reduction agreements. Value-based pricing models, where financing aligns with clinical outcomes, offer a potential solution but require complex negotiations. However, the lack of healthcare digitalisation remains a key barrier in Czechia to implementing such agreements effectively.

A cohesive strategy involving all stakeholders – clinicians, healthcare providers, regulators, payers, and manufacturers – is essential to address these challenges. Collaboration will be critical to ensuring broader patient access without compromising the quality of care.